Page last updated: 2024-10-16

carbamates and Co-infection

carbamates has been researched along with Co-infection in 67 studies

Research Excerpts

ExcerptRelevanceReference
"Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients."9.24TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir. ( Adeyemi, O; Bhatti, L; Hu, YB; Khatri, A; King, JR; Lalezari, J; Ruane, P; Saag, M; Shulman, NS; Trinh, R; Viani, RM; Wyles, D, 2017)
" In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection."9.20Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015)
" The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection."9.20Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015)
"A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) and PHOTON-2 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C [Genotype 1, 2, 3, 4, 5, or 6] Subjects Coinfected With Human Immunodeficiency Virus [HIV])."8.93Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016)
"We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir."7.91Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019)
"Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation."7.85Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017)
"Safety and tolerability evaluation of adapted dose regimens containing fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis co-infection."7.83Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study. ( Cerini, C; Cozzi-Lepri, A; d'Arminio Monforte, A; Giralda, M; Nasta, P; Pimenta, JM; Salmon, D; Winnock, M, 2016)
" However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen."6.82Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 2016)
"The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting."5.62Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021)
"DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8."5.43Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016)
" No discontinuations were attributed to treatment-related adverse events."5.4312 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. ( Ackerman, P; Bhore, R; Luetkemeyer, AF; McDonald, C; Noviello, S; Ramgopal, M, 2016)
"We conducted a nonrandomized clinical trial of 12 or 24 weeks of paritaprevir-ritonavir-ombitasvir plus dasabuvir (PrOD) with or without ribavirin in persons with HCV-1/HIV coinfection suppressed with antiretroviral therapy."5.34Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation. ( Alston-Smith, BL; Anthony, DD; Balagopal, A; Bhattacharya, D; Cohen, DE; Damjanovska, S; Kowal, CM; Shive, CL; Smeaton, LM; Sulkowski, MS; Wyles, DL, 2020)
"Elbasvir/grazoprevir is a once-daily fixed-dose combination therapy for the treatment of chronic HCV infection, including HCV/HIV coinfection."5.30Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir. ( Butterton, JR; Caro, L; Fandozzi, C; Feng, HP; Fraser, I; Guo, Z; Huang, X; Iwamoto, M; Jumes, P; Ma, J; Mangin, E; Marshall, WL; Panebianco, D; Ross, LL; Talaty, J; Yeh, WW, 2019)
"To evaluate the efficacy and safety of pegylated interferon-lambda-1a (Lambda)/ribavirin (RBV)/daclatasvir (DCV) for treatment of patients coinfected with chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV)."5.24Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. ( Conway, B; Lazzarin, A; Luetkemeyer, A; Molina, JM; Nelson, M; Portsmouth, S; Romanova, S; Rubio, R; Srinivasan, S; Xu, D, 2017)
"Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients."5.24TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir. ( Adeyemi, O; Bhatti, L; Hu, YB; Khatri, A; King, JR; Lalezari, J; Ruane, P; Saag, M; Shulman, NS; Trinh, R; Viani, RM; Wyles, D, 2017)
" In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection."5.20Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015)
" The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection."5.20Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015)
"AbbVie's 3 direct-acting antiviral (3D) regimen containing ombitasvir, paritaprevir, ritonavir, and dasabuvir with and without ribavirin is approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection."4.95Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir: Drug Interactions With Antiretroviral Agents and Drugs forSubstance Abuse. ( King, JR; Menon, RM, 2017)
"A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) and PHOTON-2 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C [Genotype 1, 2, 3, 4, 5, or 6] Subjects Coinfected With Human Immunodeficiency Virus [HIV])."4.93Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016)
"The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV)."4.02Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. ( Dehghan Manshadi, SA; Kalantari, S; Karimi, J; Malekzadeh, R; Malekzadeh, Z; Mardani, M; Merat, D; Merat, S; Mirminachi, B; Mohraz, M; Nikbin, M; Norouzi, A; Poustchi, H; Rasoolinejad, M; Sali, S; Sedghi, R; Sharifi, AH; Somi, MH; Tabarsi, P; Tayeri, K, 2021)
" Twelve weeks long treatment with sofsobuvir, daclatasvir, ribavirin, and tenofovir resulted in sustained virological response (SVR) and cleared HBV, HCV, and HEV in diabetic and asthmatic patient."3.96Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report. ( Wahid, B, 2020)
"We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir."3.91Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019)
"Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation."3.85Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017)
"The combination of ombitasvir, dasabuvir, and paritaprevir/ritonavir (considered as the 3D regimen) has proven to be associated with high sustained virologic response and optimal tolerability in hepatitis C virus-infected patients."3.83Severe Hyperbilirubinemia in an HIV-HCV-Coinfected Patient Starting the 3D Regimen That Resolved After TDM-Guided Atazanavir Dose Reduction. ( Cattaneo, D; Clementi, E; Gervasoni, C; Milazzo, L; Riva, A, 2016)
"Safety and tolerability evaluation of adapted dose regimens containing fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis co-infection."3.83Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study. ( Cerini, C; Cozzi-Lepri, A; d'Arminio Monforte, A; Giralda, M; Nasta, P; Pimenta, JM; Salmon, D; Winnock, M, 2016)
" Most common adverse events (AEs) were fatigue, neutropenia, anemia, asthenia and headache."2.84Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. ( Ackerman, P; Berenguer, J; Cheinquer, H; Côté, P; Dieterich, D; Eley, T; Fessel, WJ; Gadano, A; Hernandez, D; Hughes, E; Lazzarin, A; Liu, Z; Matthews, G; McPhee, F; Mendez, P; Molina, JM; Moreno, C; Noviello, S; Pineda, JA; Pulido, F; Rivero, A; Rockstroh, J; Sulkowski, MS; Zakharova, N, 2017)
" However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen."2.82Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 2016)
"The pharmacokinetic data support coadministration of daclatasvir with atazanavir/ritonavir, efavirenz and/or tenofovir."2.78Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir. ( Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013)
"6%) were the most effective combinations for HIV/HCV co-infected patients, with SVR rates of approximately 94% and above while severe adverse events were rare."2.66Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis. ( Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020)
" The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies."2.55Hepatitis C: efficacy and safety in real life. ( Flisiak, R; Flisiak-Jackiewicz, M; Pogorzelska, J, 2017)
"The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting."1.62Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021)
" Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to identify factors associated with LAE."1.56Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts. ( Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020)
"7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision."1.51Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study. ( Ahumada, A; Aldamiz-Echevarría, T; Baliellas, C; Barril, G; Benlloch, S; Bonet, L; Carmona, I; Castaño, MA; Castro, Á; de Álvaro, C; de Los Santos, I; Delgado, M; Devesa-Medina, MJ; García-Buey, L; García-Samaniego, J; Gea-Rodríguez, F; González-Parra, E; Gutiérrez, ML; Jiménez-Pérez, M; Laguno, M; Londoño, MC; Losa, JE; Mallolas, J; Manzanares, A; Martín-Granizo, I; Montero-Alonso, M; Montes, ML; Morán-Sánchez, S; Morano, L; Muñoz-Gómez, R; Navascués, CA; Polo-Lorduy, B; Riveiro-Barciela, M; Rivero, A; Roget, M; Serra, MÁ, 2019)
" Serious adverse events occurred in 3."1.48The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection. ( Barr, E; Cheng, W; George, J; Hwang, P; Kumada, H; Platt, H; Robertson, M; Serfaty, L; Sperl, J; Strasser, S; Talwani, R; Vierling, J; Wahl, J; Zeuzem, S, 2018)
" No discontinuations were attributed to treatment-related adverse events."1.4312 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. ( Ackerman, P; Bhore, R; Luetkemeyer, AF; McDonald, C; Noviello, S; Ramgopal, M, 2016)
"DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8."1.43Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016)
"HRQoL/fatigue was evaluated at baseline (BL), midway, and 12 weeks after the end of treatment (FU)."1.43Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. ( Aichelburg, MC; Bucsics, T; Chromy, D; Grabmeier-Pfistershammer, K; Mandorfer, M; Peck-Radosavljevic, M; Reiberger, T; Scheiner, B; Schwabl, P; Steiner, S; Trauner, M, 2016)
" Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy."1.42Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir. ( Barrail-Tran, A; Cheret, A; Furlan, V; Molina, JM; Piroth, L; Rosa, I; Rosenthal, E; Taburet, AM; Vincent, C, 2015)

Research

Studies (67)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's56 (83.58)24.3611
2020's11 (16.42)2.80

Authors

AuthorsStudies
Foroghi Biland, L1
Ferrari, L1
Malagnino, V1
Teti, E1
Cerva, C1
Gentile, A1
Aragri, M1
Salpini, R1
Svicher, V1
Andreoni, M1
Sarmati, L1
Londoño, MC1
Riveiro-Barciela, M1
Ahumada, A1
Muñoz-Gómez, R1
Roget, M1
Devesa-Medina, MJ1
Serra, MÁ1
Navascués, CA1
Baliellas, C1
Aldamiz-Echevarría, T1
Gutiérrez, ML1
Polo-Lorduy, B1
Carmona, I1
Benlloch, S1
Bonet, L1
García-Samaniego, J1
Jiménez-Pérez, M1
Morán-Sánchez, S1
Castro, Á1
Delgado, M1
Gea-Rodríguez, F1
Martín-Granizo, I1
Montes, ML1
Morano, L1
Castaño, MA1
de Los Santos, I1
Laguno, M1
Losa, JE1
Montero-Alonso, M1
Rivero, A2
de Álvaro, C1
Manzanares, A1
Mallolas, J3
Barril, G1
González-Parra, E1
García-Buey, L1
Cordie, A1
Elsharkawy, A1
Abdel Alem, S1
Meshaal, S1
El Akel, W1
Abdellatif, Z1
Kamal, W1
Al Askalany, M1
Kamel, S1
Abdel Aziz, H1
Kandeel, A1
Esmat, G1
Rossotti, R1
Tavelli, A1
Bonora, S1
Cingolani, A1
Lo Caputo, S1
Saracino, A1
Soria, A1
Marinaro, L1
Uberti-Foppa, C1
Mussini, C1
Puoti, M1
d'Arminio Monforte, A2
Patel, SV1
Jayaweera, DT1
Althoff, KN1
Eron, JJ1
Radtchenko, J1
Mills, A1
Moyle, G1
Santiago, S1
Sax, PE1
Gillman, J1
Mounzer, K1
Elion, RA1
Huhn, GD1
Balagopal, A2
Smeaton, LM2
Quinn, J1
Venuto, CS1
Morse, GD1
Vu, V1
Alston-Smith, B1
Cohen, DE2
Santana-Bagur, JL1
Anthony, DD2
Sulkowski, MS4
Wyles, DL2
Talal, AH1
Zheng, YX1
Ma, SJ1
Xiong, YH1
Fan, XG1
Damjanovska, S1
Shive, CL1
Kowal, CM1
Bhattacharya, D2
Alston-Smith, BL1
Wong, YJ1
Thurairajah, PH1
Kumar, R1
Tan, J1
Fock, KM1
Law, NM1
Li, W1
Kwek, A1
Tan, YB1
Koh, J1
Lee, ZC1
Kumar, LS1
Teo, EK1
Ang, TL1
Dehghan Manshadi, SA1
Merat, S1
Mohraz, M1
Rasoolinejad, M1
Sali, S1
Mardani, M1
Tabarsi, P1
Somi, MH1
Sedghi, R1
Tayeri, K1
Nikbin, M1
Karimi, J1
Sharifi, AH1
Kalantari, S1
Norouzi, A1
Merat, D1
Malekzadeh, Z1
Mirminachi, B1
Poustchi, H1
Malekzadeh, R1
Yunihastuti, E1
Amelia, F1
Hapsari, AI1
Wicaksana, B1
Natali, V1
Widhani, A1
Sulaiman, AS1
Karjadi, TH1
Wyles, D3
Saag, M1
Viani, RM1
Lalezari, J2
Adeyemi, O2
Bhatti, L1
Khatri, A2
King, JR2
Hu, YB1
Trinh, R2
Shulman, NS1
Ruane, P2
Taton, A1
Colson, P1
Dhiver, C2
Ruiz, JM1
Bregigeon, S1
Tomei, C1
Ressiot, E1
Menard, A1
Poizot-Martin, I1
Ravaux, I1
Lacarelle, B1
Solas, C1
Bräu, N1
Kottilil, S2
Daar, ES1
Workowski, K1
Luetkemeyer, A2
Kim, AY1
Doehle, B1
Huang, KC1
Mogalian, E1
Osinusi, A1
McNally, J1
Brainard, DM2
McHutchison, JG2
Naggie, S1
Sulkowski, M4
Younossi, ZM1
Stepanova, M1
Hunt, S1
Antón, MD1
Polanco, A1
Ferrando, I1
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Clinical Trials (15)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)[NCT02194998]Phase 246 participants (Actual)Interventional2015-09-16Terminated (stopped due to The study closed to accrual before the planned accrual goal was attained due to the availability of newer directly-acting antiviral (DAA) treatments for HCV.)
Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus[NCT03369327]Phase 3232 participants (Actual)Interventional2017-01-01Completed
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection[NCT02480712]Phase 3107 participants (Actual)Interventional2015-07-01Completed
A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1, 4 [NCT02358044]Phase 3257 participants (Actual)Interventional2015-02-27Completed
Open-Labeled Trial Of Direct-Acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors[NCT02743897]Phase 1/Phase 262 participants (Actual)Interventional2016-05-01Completed
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection[NCT01717326]Phase 2573 participants (Actual)Interventional2013-02-07Completed
Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors[NCT03146741]Phase 1/Phase 220 participants (Actual)Interventional2017-05-16Completed
Pilot Study to Assess the Efficacy and Tolerance to a QUadruple Therapy With Asunaprevir , Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a, in HIV-HCV Genotype 1 or 4 Coinfected Patients Previously Null Responders to a Standard Pegylated Interfer[NCT01725542]Phase 275 participants (Actual)Interventional2012-12-31Completed
Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks[NCT02886624]Phase 230 participants (Actual)Interventional2017-05-31Completed
Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial[NCT03098121]Phase 440 participants (Actual)Interventional2017-10-20Completed
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV[NCT02105662]Phase 3218 participants (Actual)Interventional2014-06-03Completed
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)[NCT02032888]Phase 3238 participants (Actual)Interventional2014-02-28Completed
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C[NCT02097966]0 participants Expanded AccessNo longer available
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)[NCT01471574]Phase 3549 participants (Actual)Interventional2011-12-31Completed
Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With H[NCT01866930]Phase 3453 participants (Actual)Interventional2013-07-11Terminated (stopped due to Sponsor decision not based on any new unexpected safety findings or efficacy observations.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants Who Experienced HIV-1 Virologic Failure (VF)

HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL. (NCT02194998)
Timeframe: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1

Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)

HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA NCT02194998)
Timeframe: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.

Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation. (NCT02194998)
Timeframe: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.

"Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.~If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]5
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]3
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria

Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment. (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]2
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher

"Participants with signs/symptoms of grade 3 or higher post treatment initiation.~Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]2
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)

Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome. (NCT02194998)
Timeframe: At confirmation of HIV-1 virologic failure.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)

"SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.~For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Interventionpercentage of participants (Number)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]95.2
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]60
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]100
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]100

Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)

"SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.~For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Interventionpercentage of participants (Number)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]90.5
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]60
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]93.3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]100

Change in IP-10 Concentration.

Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionpg/mL (Median)
Change from baseline to EOTChange from baseline to 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-244.4-127
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-22.2-29.1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-116-83.1
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-61.1-114.9

Change in Soluble CD14 (sCD14)

Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionng/mL (Median)
Change from baseline to EOTChange from baseline to 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]307.6145.2
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-1,063.2-894.2
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-380.3-22.6
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]318.2-987.0

Levels of IP-10 Concentration.

Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionpg/mL (Median)
IP-10 at baselineIP-10 at EOTIP-10 at 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]379100.994.6
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]120.260.485.5
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]225.576.682.5
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]196.4182.6159.5

Levels of Soluble CD14 (sCD14)

Levels of sCD14. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionng/mL (Median)
sCD14 at BaselinesCD14 at EOTsCD14 at 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1,832.02,126.51,977.3
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]2,226.81,132.81,367.4
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3,157.02,421.13,424.5
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]3,092.02,801.32,608.3

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02480712)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks1.9

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02480712)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks95.3

Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02480712)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks1.9

HCV RNA Change From Baseline/Day 1

(NCT02480712)
Timeframe: Baseline to Week 12

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12
SOF/VEL 12 Weeks-4.47-4.97-5.15-5.18-5.17-5.17-5.17

Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

(NCT02480712)
Timeframe: Up to 12 Weeks

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)94.496.396.2
SOF/VEL 12 Weeks (Non TDF Containing Regimens)10010092.9
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)97.197.1100

Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02480712)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
SOF/VEL 12 Weeks25.768.092.299.0100.0100.0100.0

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02480712)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks95.395.3

Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12

(NCT02480712)
Timeframe: Week 12; Posttreatment Week 12

,,
Interventionmg/dL (Mean)
Change at Week 12Change at Posttreatment Week 12
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)0.090.04
SOF/VEL 12 Weeks (Non TDF Containing Regimens)0.00-0.06
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)0.040.02

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)

HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA NCT02358044)
Timeframe: 24 weeks after end of all therapy (Study Week 36)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir98.4
SOF + PR89.7

Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)

HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA NCT02358044)
Timeframe: 4 weeks after end of all therapy (Study Week 16)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir99.2
SOF + PR92.1

Percentage of Participants Discontinuing Study Treatment Due to an AE

"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial." (NCT02358044)
Timeframe: Up to Week 12

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir0.8
SOF + PR0.8

Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir51.9
SOF + PR93.7

Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)

Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (NCT02358044)
Timeframe: 12 weeks after end of all therapy (Study Week 24)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir99.2
SOF + PR90.5

Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days

Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)

,
Interventionpercentage of participants (Number)
Total Tier 1 AEsTier 1 AE: Serious drug-related AETier 1 AE: DC due to drug-related AETier 1 AE: Neutrophil count <0.75 x 10^9/LTier 1 AE: Hemoglobin <10 g/dLTier 1 AE: Severe depressionTier 1 AE: Hepatic event of clinical interestTier 1 AE: Trial DC due to stopping rule
Grazoprevir + Elbasvir0.80.00.00.00.80.00.00.0
SOF + PR27.82.40.812.714.30.00.00.0

Number of Subjects Cured

Subjects with post-treatment sustained virologic response (SVR) = Number of subjects with negative HCV RNA 12 weeks after completing therapy / number of subjects treated post-kidney transplantation (NCT02743897)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Direct-acting Antiviral Treatment for HCV62

Number of Subjects With SAE Attributable to HCV Therapy

Number of subjects with major adverse events attributable to HCV therapy in post-kidney transplant (NCT02743897)
Timeframe: Baseline to 52 weeks

InterventionParticipants (Count of Participants)
Direct-acting Antiviral Treatment for HCV1

Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA. (NCT01717326)
Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)

Interventiondays (Mean)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk21.7
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk19.2
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk23.4
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk27.9
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk30.7
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk32.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk37.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk33.2
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk33.1
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk33.7
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk31.9
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk37.4
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk37.4
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk42.7
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk27.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk29.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk23.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk34.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk30.1
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk19.8

Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.3
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk100.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk100.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk75.0

Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk91.3
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk92.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk91.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk86.2
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk73.3
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk77.4
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk60.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk79.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk78.1
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk67.7
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk77.4
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk66.7
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk57.6
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk62.5
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk89.7
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk76.7
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk76.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk61.3
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk70.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk85.0

Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk100.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk90.3
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk97.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.8
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk96.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk65.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk83.3

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 12 weeks after end of therapy (up to 30 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk82.8
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.5
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk90.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk93.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk61.1

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 24 weeks after end of therapy (up to 42 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk78.6
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.1
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk90.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk88.9
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk93.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk58.8

Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 4 weeks after end of therapy (up to 22 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.3
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.7
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.8
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.1
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk96.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk50.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk61.1

Percentage of Participants Achieving Undetectable HCV RNA at Week 12

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.3
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk100.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.1
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.7
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk65.0

Percentage of Participants Achieving Undetectable HCV RNA at Week 2

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk52.2
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk44.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk41.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk44.8
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk20.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk16.1
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk6.7
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk10.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk25.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk16.1
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk12.9
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk6.1
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk6.1
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk6.3
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk37.9
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk40.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk46.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk12.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk40.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk70.0

Percentage of Participants Achieving Undetectable HCV RNA at Week 4

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk73.9
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk91.7
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk75.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk73.3
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk83.3
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk77.4
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk60.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk79.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk71.9
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk71.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk83.3
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk68.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk69.7
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk53.1
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk75.9
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk78.6
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk86.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk74.2
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk50.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk77.8

Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk0.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk0.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk6.3
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk0.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk3.1
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk0.0
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk0.0
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk4.8

Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk88.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk85.7
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk91.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk90.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk72.7
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk87.1
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk77.4
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk65.5
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk87.5
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk83.9
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk81.3
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk78.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk97.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk81.3
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk65.5
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk53.3
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk73.3
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk54.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk85.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk90.5

Number of Participants With Post-treatment Sustained Virologic Response (SVR)

The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation) (NCT03146741)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)9

Number of Severe Adverse Events (SAE) Attributable to HCV Therapy Post-heart Transplant

(NCT03146741)
Timeframe: Baseline to 52 weeks

InterventionSevere adverse event (Number)
Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)0

CD4 Cell Count

CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks

Interventioncells/mm^3 (Median)
Grazoprevir/Elbasvir655

Number of Participants With Undetectable HIV RNA

Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Grazoprevir/Elbasvir27

Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment. (NCT02886624)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Grazoprevir/Elbasvir28

Treatment Adherence

Number of patients missing study drug within the last four days during treatment (NCT02886624)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Grazoprevir/Elbasvir2

Virological Failure

Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment (NCT02886624)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Grazoprevir/Elbasvir1

Incidence of HCV Re-infection

Number of patients with positive HCV RNA 48-weeks post treatment. (NCT02886624)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
With phylogentically different strainWith phylogentically similar strain
Grazoprevir/Elbasvir21

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 12 weeks after end of all therapy (Study Week 24)

Interventionpercentage of participants (Number)
Grazoprevir+Elbasvir96.3

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 24 weeks after end of all therapy (Study Week 36)

Interventionpercentage of participants (Number)
Grazoprevir+Elbasvir93.1

Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period (up to 12 weeks)

Interventionpercentage of participants (Number)
Grazoprevir+Elbasvir0.0

Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period plus first 14 follow-up days (up to 14 weeks)

Interventionpercentage of participants (Number)
Grazoprevir+Elbasvir73.9

Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks96.4

Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks97.7

Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNANCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks75.6

Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA levels NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks97.0
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks76.0
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks98.1

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)

,,
InterventionParticipants (Number)
AEsSAEsAEs requiring dose interruption or discontinuationTreatment-related AEsTreatment-related Grade 3 to 4 AEsGrade 3 to 4 AEsDeath
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks373017040
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks751039030
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks290013120

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.

,,
InterventionParticipants (Number)
AEsSAEsAEs Grade 3 to 4SAEs Grade 3 to 4Death
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks50000
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks113321
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks51111

Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results

Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. (NCT02032888)
Timeframe: From screening up to week 24 of post treatment follow--up

,,
InterventionParticipants (Number)
International normalized ratioLeukocytesAspartate aminotransferaseBilirubin (total)Lipase (total)Alanine aminotransferase
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks111211
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks100550
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks001111

Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels

Participants with HCV RNA levels NCT02032888)
Timeframe: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment

,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatment
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks5.823.163.594.2100.098.1100.0
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks9.933.770.389.198.096.099.0
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks6.034.078.090.096.0NA100.0

Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be

Participants with hepatitis C virus CV) levels to be NCT02032888)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24

,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatmentFollow-up Week 4Follow-up Week 24
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks34.671.292.398.1100.098.1100.096.292.3
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks34.777.293.199.098.096.099.098.092.1
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks44.078.098.098.096.0NA100.082.072.0

Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR is defined as hepatitis C virus RNA NCT02032888)
Timeframe: At Follow-up Week 12

,,
InterventionPercentage of participants (Number)
CC Genotype (n=28,13,13)Non-CC Genotype (n=73,37, 39)
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks100.097.4
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks100.095.9
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks69.278.4

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg75
HAART Therapy: Daclatasvir, 60 mg71.8
HAART: Daclatasvir, 30 mg + 60 mg71.7
HAART Therapy: Daclatasvir 30 or 60 or 90 mg73.3
Non-HAART Therapy: Daclatasvir, 60 mg87.5

Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation

Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: From Day 1 to 7 days post last dose of study treatment (up to Week 48)

,,,,
InterventionParticipants (Number)
DeathsSAEsGrade 3 to 4 AEsAEs leading to discontinuation
HAART Therapy: Daclatasvir 30 or 60 or 90 mg2249317
HAART Therapy: Daclatasvir, 30 mg + 60 mg06356
HAART Therapy: Daclatasvir, 60 mg16124
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg012467
Non-HAART Therapy: Daclatasvir, 60 mg0041

Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)

Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12End of treatmentFollow-up Week 12Follow-up Week 24
HAART Therapy: Daclatasvir 30 or 60 or 90 mg39.771.582.784.184.185.278.784.873.370.4
Non-HAART Therapy: Daclatasvir, 60 mg41.791.795.887.595.891.791.795.887.583.3

Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)

Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12End of treatmentFollow-up Week 12Follow-up Week 24
HAART Therapy: Daclatasvir 30 or 60 or 90 mg933.964.374.47881.261.484.873.370.4
Non-HAART Therapy: Daclatasvir, 60 mg16.75091.787.595.891.787.595.887.583.3

Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL

Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. (NCT01471574)
Timeframe: End of treatment (up to Week 48)

,,,
InterventionPercentage of participants (Number)
HIV RNA <40 copies/mLHIV RNA ≥400 copies/mL
HAART Therapy: Daclatasvir 30 or 60 or 90 mg90.60.4
HAART Therapy: Daclatasvir, 30mg + 60 mg93.40.0
HAART Therapy: Daclatasvir, 60 mg89.72.6
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg88.60.0

Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

Percentages calculated as number of responders/number who received treatment. (NCT01471574)
Timeframe: Follow-up Week 12

,,,,
InterventionPercentage of participants (Number)
CC Genotype (n=36, 14, 39, 89, 6)CT Genotype (n=72, 22, 50,144, 15)TT Genotype (n=22, 3, 12, 37, 2)Not reported (n=2, 0, 5, 7, 1)
HAART Therapy: Daclatasvir 30, 60 or 90 mg87.667.462.271.4
HAART Therapy: Daclatasvir, 30 mg + 60 mg79.570.058.360.0
HAART Therapy: Daclatasvir, 60 mg92.963.633.30.0
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg94.466.768.2100.0
Non-HAART Therapy: Daclatasvir, 60 mg100.093.350.00.0

Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionCells/uL (Mean)
Cohort A: HCV GT-2 or GT-3-42.4
Cohort B: HCV GT-1 or GT-4-104.9

Mean Change in Platelet Count From Baseline to End of Treatment

All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10^9 cells/L). (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

Intervention10^9 cells/L (Mean)
Cohort A: HCV GT-2 or GT-332.7
Cohort B: HCV GT-1 or GT-433.3

Mean Change in Total Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionCells/µL (Mean)
Cohort A: HCV GT-2 or GT-3-0.38
Cohort B: HCV GT-1 or GT-4-0.50

Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-3-4.0
Cohort B: HCV GT-1 or GT-4-13.4

Mean Percent Change in Platelet Count From Baseline to End of Treatment

All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-316.9
Cohort B: HCV GT-1 or GT-420.1

Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-3-15.33
Cohort B: HCV GT-1 or GT-4-22.95

Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)

SVR12 was defined as HCV RNA less than lower limit of quantification (< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12. (NCT01866930)
Timeframe: Follow-up week 12

InterventionParticipants (Count of Participants)
Cohort A: HCV GT-2 or GT-388
Cohort B: HCV GT-1 or GT-4149

Number of Participants With Treatment Emergent Cytopenic Abnormalities

All treated participants were monitored for treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000/mm3) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

InterventionParticipants (Count of Participants)
Cohort A: HCV GT-2 or GT-34
Cohort B: HCV GT-1 or GT-415

Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
DeathsSAEsLambda Dose ReductionDiscontinuation due to AEs
Cohort A: HCV GT-2 or GT-30644
Cohort B: HCV GT-1 or GT-43121913

Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms

All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
Musculoskeletal symptomsFlu-like symptoms
Cohort A: HCV GT-2 or GT-366
Cohort B: HCV GT-1 or GT-42119

Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR)

RVR is defined as HCV RNA < LLOQ target not detected at Week 4 and eRVR defined as HCV RNA < LLOQ target not detected at Weeks 4 and 12 (NCT01866930)
Timeframe: Treatment weeks 4 and 12

,
InterventionParticipants (Count of Participants)
RVReRVR
Cohort A: HCV GT-2 or GT-38280
Cohort B: HCV GT-1 or GT-4149138

Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities

Grade 3/4 treatment-emergent lab abnormalities that occurred in >=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
Total BilirubinASTALT
Cohort A: HCV GT-2 or GT-326102
Cohort B: HCV GT-1 or GT-4631310

Reviews

8 reviews available for carbamates and Co-infection

ArticleYear
Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
    Journal of gastroenterology and hepatology, 2020, Volume: 35, Issue:9

    Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; C

2020
Are there any challenges left in hepatitis C virus therapy of HIV-infected patients?
    International journal of antimicrobial agents, 2020, Volume: 56, Issue:1

    Topics: Antiretroviral Therapy, Highly Active; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Dr

2020
Treating HCV in HIV 2013: on the cusp of change.
    Liver international : official journal of the International Association for the Study of the Liver, 2014, Volume: 34 Suppl 1

    Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Coinfection; Drug Interactions; Drug Therapy, C

2014
Advances in hepatitis C therapies.
    Expert opinion on pharmacotherapy, 2015, Volume: 16, Issue:13

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit

2015
Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.
    Clinical therapeutics, 2016, Volume: 38, Issue:2

    Topics: Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Coinfection; Drug Therapy, Combin

2016
Grazoprevir + elbasvir for the treatment of hepatitis C virus infection.
    Expert opinion on pharmacotherapy, 2016, Volume: 17, Issue:5

    Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug Combinations; Dr

2016
Hepatitis C: efficacy and safety in real life.
    Liver international : official journal of the International Association for the Study of the Liver, 2017, Volume: 37 Suppl 1

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit

2017
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir: Drug Interactions With Antiretroviral Agents and Drugs forSubstance Abuse.
    Clinical pharmacology in drug development, 2017, Volume: 6, Issue:2

    Topics: 2-Naphthylamine; Anilides; Anti-Retroviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Inte

2017

Trials

14 trials available for carbamates and Co-infection

ArticleYear
Intrahepatic Viral Kinetics During Direct-Acting Antivirals for Hepatitis C in Human Immunodeficiency Virus Coinfection: The AIDS Clinical Trials Group A5335S Substudy.
    The Journal of infectious diseases, 2020, 07-23, Volume: 222, Issue:4

    Topics: 2-Naphthylamine; Acquired Immunodeficiency Syndrome; Adult; Anilides; Antiviral Agents; Carbamates;

2020
Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation.
    The Journal of infectious diseases, 2020, 09-14, Volume: 222, Issue:8

    Topics: 2-Naphthylamine; Adult; Anilides; Anti-HIV Agents; Antiviral Agents; Biomarkers; Carbamates; Coinfec

2020
TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir.
    The Journal of infectious diseases, 2017, 02-15, Volume: 215, Issue:4

    Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Anti-Retroviral Agents; Body Mass Index; Carbama

2017
Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017, Jul-01, Volume: 65, Issue:1

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Female; Hepatitis C; Heterocyclic Compounds,

2017
Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL-5 study.
    Liver international : official journal of the International Association for the Study of the Liver, 2017, Volume: 37, Issue:12

    Topics: Antiviral Agents; Carbamates; Case-Control Studies; Cohort Studies; Coinfection; Drug Combinations;

2017
Interferon-free therapy with direct acting antivirals for HCV/HIV-1 co-infected Japanese patients with inherited bleeding disorders.
    PloS one, 2017, Volume: 12, Issue:10

    Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Drug Therapy, Combination; Female;

2017
Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir.
    The Journal of antimicrobial chemotherapy, 2019, 03-01, Volume: 74, Issue:3

    Topics: Adult; Amides; Antiretroviral Therapy, Highly Active; Antiviral Agents; Benzofurans; Carbamates; Chr

2019
Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir.
    Antiviral therapy, 2013, Volume: 18, Issue:7

    Topics: Adenine; Adolescent; Adult; Alkynes; Anti-HIV Agents; Atazanavir Sulfate; Benzoxazines; Carbamates;

2013
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
    Lancet (London, England), 2015, Mar-21, Volume: 385, Issue:9973

    Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The

2015
High Cure Rate With 24 Weeks of Daclatasvir-Based Quadruple Therapy in Treatment-Experienced, Null-Responder Patients With HIV/Hepatitis C Virus Genotype 1/4 Coinfection: The ANRS HC30 QUADRIH Study.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015, Sep-01, Volume: 61, Issue:5

    Topics: Antiviral Agents; Carbamates; Coinfection; Female; Hepacivirus; Hepatitis C, Chronic; HIV Infections

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
    The lancet. HIV, 2015, Volume: 2, Issue:8

    Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru

2015
Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016, Apr-15, Volume: 62, Issue:8

    Topics: 2-Naphthylamine; Adolescent; Adult; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropan

2016
Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.
    Hepatology international, 2017, Volume: 11, Issue:2

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivir

2017
Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients.
    Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research, 2017, Volume: 37, Issue:3

    Topics: Adult; Aged; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Therapy, Combination; Female; Genot

2017

Other Studies

45 other studies available for carbamates and Co-infection

ArticleYear
Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r
    Journal of medical case reports, 2019, Sep-22, Volume: 13, Issue:1

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis B; Hepatit

2019
Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study.
    PloS one, 2019, Volume: 14, Issue:9

    Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Ther

2019
Sustained virologic response and changes in liver fibrosis parameters following 12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected patients with HCV genotype 4 infection.
    Transactions of the Royal Society of Tropical Medicine and Hygiene, 2020, 04-08, Volume: 114, Issue:4

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit

2020
Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
    Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2020, Volume: 52, Issue:4

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic;

2020
Real-world efficacy of direct acting antiviral therapies in patients with HIV/HCV.
    PloS one, 2020, Volume: 15, Issue:2

    Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Drug Therapy, Combination; F

2020
Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
    Journal of gastroenterology and hepatology, 2021, Volume: 36, Issue:5

    Topics: Adult; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis

2021
Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus.
    International journal of clinical practice, 2021, Volume: 75, Issue:8

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis C, Chronic

2021
Impact of sofosbuvir and daclastavir on health-related quality of life in patients co-infected with hepatitis C and human immunodeficiency virus.
    Health and quality of life outcomes, 2021, May-26, Volume: 19, Issue:1

    Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Ch

2021
Daclatasvir plasma concentration assessment in HIV-HCV-coinfected real-life patients.
    Antiviral therapy, 2017, Volume: 22, Issue:8

    Topics: Antiviral Agents; Carbamates; Coinfection; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chronic;

2017
Hepatitis B reactivation in a patient with chronic hepatitis C treated with direct-acting antivirals.
    Gastroenterologia y hepatologia, 2018, Volume: 41, Issue:5

    Topics: Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Therapy, Combination; Guani

2018
Brief Report: High Need to Switch cART or Comedication With the Initiation of DAAs in Elderly HIV/HCV-Coinfected Patients.
    Journal of acquired immune deficiency syndromes (1999), 2017, 10-01, Volume: 76, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Amides; Anti-Retroviral Agents; Antiviral Agents; Benzofurans; Carba

2017
Plasma trough concentrations of antiretrovirals in HIV-infected persons treated with direct-acting antiviral agents for hepatitis C in the real world.
    The Journal of antimicrobial chemotherapy, 2018, Jan-01, Volume: 73, Issue:1

    Topics: 2-Naphthylamine; Anilides; Anti-Retroviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Inte

2018
Remarkable plasma HIV RNA decrease by ombitasvir/paritaprevir/ritonavir in an HIV-HCV coinfection case.
    AIDS (London, England), 2018, 01-02, Volume: 32, Issue:1

    Topics: Adult; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Hepacivirus; Hepatitis C,

2018
UPLC-MS/MS method for the simultaneous quantification of sofosbuvir, sofosbuvir metabolite (GS-331007) and daclatasvir in plasma of HIV/HCV co-infected patients.
    Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2018, Jan-15, Volume: 1073

    Topics: Antiviral Agents; Carbamates; Chromatography, High Pressure Liquid; Coinfection; Hepatitis C; HIV In

2018
The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection.
    Journal of gastroenterology, 2018, Volume: 53, Issue:5

    Topics: Adolescent; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, Phase I

2018
The Proof Is in the Patient: Hepatitis C Virus Microelimination in the Swiss Human Immunodeficiency Virus Cohort Study.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019, 02-01, Volume: 68, Issue:4

    Topics: Amides; Benzofurans; Carbamates; Cohort Studies; Coinfection; Cyclopropanes; Hepacivirus; HIV; HIV I

2019
Successful treatment of genotype 3 hepatitis C infection in a noncirrhotic HIV infected patient on chronic dialysis with the combination of sofosbuvir and velpatasvir: A case report.
    Medicine, 2018, Volume: 97, Issue:51

    Topics: Antiviral Agents; Carbamates; Coinfection; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More R

2018
Effectiveness of ombitasvir/paritaprevir/ritonavir, dasabuvir for HCV in HIV/HCV coinfected subjects: a comprehensive analysis.
    Virology journal, 2019, 01-17, Volume: 16, Issue:1

    Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Clinical Trials as Topic; Coinfectio

2019
Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients.
    BMC infectious diseases, 2019, May-03, Volume: 19, Issue:1

    Topics: Adult; Aged; Aminoisobutyric Acids; Anti-Retroviral Agents; Antiviral Agents; Benzimidazoles; Carbam

2019
Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report.
    Journal of infection and public health, 2020, Volume: 13, Issue:1

    Topics: Aged; Antiviral Agents; Asthma; Carbamates; Coinfection; Diabetes Complications; Drug Administration

2020
Hepatotoxicity and virological breakthrough of HCV following treatment with sofosbuvir, daclatasvir, and ribavirin in patients previously treated for tuberculosis.
    Journal of medical virology, 2019, Volume: 91, Issue:12

    Topics: Aged; Antitubercular Agents; Antiviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; C

2019
Antiviral therapy for HCV in hemophilia A patients with HIV-1 co-infection.
    Medicine, 2019, Volume: 98, Issue:30

    Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Therapy, Combination; H

2019
HIV-hepatitis C co-infection.
    The Lancet. Infectious diseases, 2015, Volume: 15, Issue:4

    Topics: Antiviral Agents; Carbamates; Coinfection; Hepatitis C; HIV Infections; Humans; Imidazoles; Pyrrolid

2015
Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
    Antimicrobial agents and chemotherapy, 2015, Volume: 59, Issue:12

    Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivirus; He

2015
Paritaprevir/ritonavir, ombitasvir, and dasabuvir for treatment of recurrent hepatitis C virus infection in the human immunodeficiency virus coinfected liver transplant recipient.
    Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, 2016, Volume: 22, Issue:2

    Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Therapy, C

2016
Paritaprevir/ritonavir/ombitasvir and dasabuvir for the treatment of chronic hepatitis C virus infection.
    Expert opinion on pharmacotherapy, 2015, Volume: 16, Issue:18

    Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase II as Topic; Clinica

2015
Interferon-free treatment with sofosbuvir/daclatasvir achieves sustained virologic response in 100% of HIV/hepatitis C virus-coinfected patients with advanced liver disease.
    AIDS (London, England), 2016, Apr-24, Volume: 30, Issue:7

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic;

2016
Severe Hyperbilirubinemia in an HIV-HCV-Coinfected Patient Starting the 3D Regimen That Resolved After TDM-Guided Atazanavir Dose Reduction.
    Therapeutic drug monitoring, 2016, Volume: 38, Issue:3

    Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Atazanavir Sulfate; Carbamates; Coinfection; Cyclopropa

2016
Treatment of chronic hepatitis C with direct acting antiviral agents in patients with haemophilia, end-stage liver disease and coinfected with HIV.
    Haemophilia : the official journal of the World Federation of Hemophilia, 2016, Volume: 22, Issue:3

    Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Interactions; Hemophili

2016
12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016, 06-15, Volume: 62, Issue:12

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivir

2016
Treatment of severe recurrent hepatitis C after liver transplantation in HIV infected patients using sofosbuvir-based therapy.
    Alimentary pharmacology & therapeutics, 2016, Volume: 43, Issue:12

    Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; End Stage Liver Disease

2016
Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an observational multicohort study.
    HIV clinical trials, 2016, Volume: 17, Issue:3

    Topics: Adult; Antiretroviral Therapy, Highly Active; Carbamates; Cause of Death; CD4 Lymphocyte Count; Coin

2016
Darunavir-based Antiretroviral Therapy may Affect the Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in HCV/HIV-1 Coinfected Patients.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016, 07-15, Volume: 63, Issue:2

    Topics: 2-Naphthylamine; Anilides; Carbamates; Coinfection; Cyclopropanes; Darunavir; Hepatitis C; HIV Infec

2016
Sixty milligram daclatasvir is the right dose for hepatitis C virus treatment in combination with etravirine and darunavir/ritonavir.
    AIDS (London, England), 2016, 06-01, Volume: 30, Issue:9

    Topics: Anti-HIV Agents; Antiviral Agents; Area Under Curve; Carbamates; Coinfection; Darunavir; Diuretics;

2016
Direct Observed Therapy of Chronic Hepatitis C With Interferon-Free All-Oral Regimens at a Low-Threshold Drug Treatment Facility-a New Concept for Treatment of Patients With Borderline Compliance Receiving Opioid Substitution Therapy.
    The American journal of gastroenterology, 2016, Volume: 111, Issue:6

    Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Directly Observed Therapy; Drug Th

2016
A case of acute hepatitis B in a chronic hepatitis C patient after daclatasvir and asunaprevir combination therapy: hepatitis B virus reactivation or acute self-limited hepatitis?
    Clinical journal of gastroenterology, 2016, Volume: 9, Issue:4

    Topics: Acute Disease; Aged, 80 and over; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combinati

2016
Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2016, Volume: 49

    Topics: Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Drug Therapy, Combination; Female

2016
Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study.
    Medicine, 2016, Volume: 95, Issue:27

    Topics: Antiviral Agents; Austria; Benzimidazoles; Carbamates; Coinfection; Fatigue; Female; Fluorenes; Hepa

2016
Successful treatment of three patients with human immunodeficiency virus and hepatitis C virus genotype 1b co-infection by daclatasvir plus asunaprevir.
    Clinical journal of gastroenterology, 2017, Volume: 10, Issue:1

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepaciv

2017
Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.
    Antiviral therapy, 2017, Volume: 22, Issue:3

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype;

2017
Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong.
    Journal of gastroenterology and hepatology, 2017, Volume: 32, Issue:6

    Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Administra

2017
Effectiveness of All-Oral Antiviral Regimens in 996 Human Immunodeficiency Virus/Hepatitis C Virus Genotype 1-Coinfected Patients Treated in Routine Practice.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017, Jun-15, Volume: 64, Issue:12

    Topics: Administration, Oral; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies;

2017
Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort.
    Journal of acquired immune deficiency syndromes (1999), 2017, 05-01, Volume: 75, Issue:1

    Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug-Related Side Effects and Adverse Reacti

2017
[Biliary and kidney lithiasis during treatment with daclatasvir/sofosbuvir/ribavirin and atazanavir/ritonavir + abacavir/lamivudine in an HIV/HCV genotype 4-infected patient: a case report.]
    Recenti progressi in medicina, 2017, Volume: 108, Issue:2

    Topics: Adult; Anti-HIV Agents; Antiviral Agents; Atazanavir Sulfate; Biliary Tract Diseases; Carbamates; Co

2017
Prevalence of natural polymorphisms at the HCV NS5A gene associated with resistance to daclatasvir, an NS5A inhibitor.
    Antiviral therapy, 2012, Volume: 17, Issue:5

    Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Female; Genotype; Hepacivi

2012