Page last updated: 2024-10-27

foscarnet and Viremia

foscarnet has been researched along with Viremia in 31 studies

Foscarnet: An antiviral agent used in the treatment of cytomegalovirus retinitis. Foscarnet also shows activity against human herpesviruses and HIV.
phosphonoformic acid : Phosphoric acid in which one of the hydroxy groups is replaced by a carboxylic acid group. It is used as the trisodium salt as an antiviral agent in the treatment of cytomegalovirus retinitis (CMV retinitis, an inflamation of the retina that can lead to blindness) and as an alternative to ganciclovir for AIDS patients who require concurrent antiretroviral therapy but are unable to tolerate ganciclovir due to haematological toxicity.

Viremia: The presence of viruses in the blood.

Research Excerpts

ExcerptRelevanceReference
"A randomized open-label phase 2 trial compared the virological and clinical effects on cytomegalovirus (CMV) infection of a 14-day course of intravenous foscarnet (100 mg/[kg x 12 h]) or no treatment in 42 HIV-infected patients with < 100 CD4 cells/mm3 and persistent asymptomatic CMV viremia."9.09Effect of a 14-day course of foscarnet on cytomegalovirus (CMV) blood markers in a randomized study of human immunodeficiency virus-infected patients with persistent CMV viremia. Agence National de Recherche du SIDA 023 Study Group. ( Aboulker, JP; Brun-Vézinet, F; Carrière, I; Fillet, AM; Gérard, L; Houhou, N; Leport, C; Ostinelli, J; Salmon-Céron, D; Vildé, JL, 1999)
"Ganciclovir (GCV) and foscarnet (FOS) are the most commonly used antivirals for preemptive treatment of cytomegalovirus (CMV) viremia in recipients of allogeneic hematopoietic cell transplantation (alloHCT)."7.96Cost analysis of ganciclovir and foscarnet in recipients of allogeneic hematopoietic cell transplant with cytomegalovirus viremia. ( Abella Ross, J; Al Malki, MM; Chen, J; Dadwal, SS; Dickter, JK; Ito, JI; Kriengkauykiat, J; Mokhtari, S; Nakamura, R; Tegtmeier, B; Yang, D; Zaia, JA, 2020)
"This single-center, retrospective study included immunosuppressed adults with CMV viremia who received foscarnet between January 2012-July 2017."7.91Recommended foscarnet dose is not associated with improved outcomes in cytomegalovirus salvage therapy. ( Athans, V; Koval, CE; Lam, SW; Spinner, ML, 2019)
" Immunosuppressive therapy was reduced, and the patient was treated with foscarnet for 2 weeks, leading to a dramatic normalization of blood cell counts, concomitantly with the disappearance of HHV-8 viremia."7.71Severe pancytopenia and hemophagocytosis after HHV-8 primary infection in a renal transplant patient successfully treated with foscarnet. ( Barozzi, P; Facchetti, F; Luppi, M; Rasini, V; Re, A; Riva, G; Rossi, G; Sandrini, S; Setti, G; Torelli, G, 2002)
" In this report we describe the effects of foscarnet on HHV-8 viremia in an HIV-infected patient with disseminated Kaposi s sarcoma and a presumably HHV-8 associated hemophagocytic syndrome."7.70Suppression of HHV-8 viremia by foscarnet in an HIV-infected patient with Kaposi's sarcoma and HHV-8 associated hemophagocytic syndrome. ( Fleckenstein, B; Harrer, T; Kalden, JR; Löw, P; Manger, B; Neipel, F; Rascu, A; Steininger, H, 1998)
"Foscarnet-resistant cytomegalovirus (ID50 > 300 microM) was isolated from two patients, one of whom was being treated with foscarnet."7.69Viral sensitivity testing in patients with cytomegalovirus retinitis clinically resistant to foscarnet or ganciclovir. ( Apuzzo, L; Charache, P; Dunn, JP; Forman, MS; Jabs, DA; MacCumber, MW, 1995)
"Cytomegalovirus (CMV) infection is still a problem for organ transplant recipients despite studies that long-term prophylaxis with high dose of acyclovir or ganciclovir given to all organ recipients may limit the consequences of infection and disease."7.69Early ganciclovir therapy effectively controls viremia and avoids the need for cytomegalovirus (CMV) prophylaxis in renal transplant patients with cytomegalovirus antigenemia. ( Baruzzo, S; Gotti, E; Moioli, F; Perani, V; Remuzzi, G; Suter, F, 1996)
"In this phase 3, open-label study, hematopoietic-cell and solid-organ transplant recipients with R/R cytomegalovirus were randomized 2:1 to maribavir 400 mg twice daily or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for 8 weeks, with 12 weeks of follow-up."5.51Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial. ( Alain, S; Alexander, BD; Avery, RK; Blumberg, EA; Chemaly, RF; Cordonnier, C; Duarte, RF; Florescu, DF; Fournier, M; Kamar, N; Kumar, D; Maertens, J; Marty, FM; Papanicolaou, GA; Silveira, FP; Sundberg, AK; Witzke, O; Wu, J, 2022)
"A randomized open-label phase 2 trial compared the virological and clinical effects on cytomegalovirus (CMV) infection of a 14-day course of intravenous foscarnet (100 mg/[kg x 12 h]) or no treatment in 42 HIV-infected patients with < 100 CD4 cells/mm3 and persistent asymptomatic CMV viremia."5.09Effect of a 14-day course of foscarnet on cytomegalovirus (CMV) blood markers in a randomized study of human immunodeficiency virus-infected patients with persistent CMV viremia. Agence National de Recherche du SIDA 023 Study Group. ( Aboulker, JP; Brun-Vézinet, F; Carrière, I; Fillet, AM; Gérard, L; Houhou, N; Leport, C; Ostinelli, J; Salmon-Céron, D; Vildé, JL, 1999)
"Ganciclovir (GCV) and foscarnet (FOS) are the most commonly used antivirals for preemptive treatment of cytomegalovirus (CMV) viremia in recipients of allogeneic hematopoietic cell transplantation (alloHCT)."3.96Cost analysis of ganciclovir and foscarnet in recipients of allogeneic hematopoietic cell transplant with cytomegalovirus viremia. ( Abella Ross, J; Al Malki, MM; Chen, J; Dadwal, SS; Dickter, JK; Ito, JI; Kriengkauykiat, J; Mokhtari, S; Nakamura, R; Tegtmeier, B; Yang, D; Zaia, JA, 2020)
"This single-center, retrospective study included immunosuppressed adults with CMV viremia who received foscarnet between January 2012-July 2017."3.91Recommended foscarnet dose is not associated with improved outcomes in cytomegalovirus salvage therapy. ( Athans, V; Koval, CE; Lam, SW; Spinner, ML, 2019)
" Immunosuppressive therapy was reduced, and the patient was treated with foscarnet for 2 weeks, leading to a dramatic normalization of blood cell counts, concomitantly with the disappearance of HHV-8 viremia."3.71Severe pancytopenia and hemophagocytosis after HHV-8 primary infection in a renal transplant patient successfully treated with foscarnet. ( Barozzi, P; Facchetti, F; Luppi, M; Rasini, V; Re, A; Riva, G; Rossi, G; Sandrini, S; Setti, G; Torelli, G, 2002)
"Seventeen AIDS patients with cytomegalovirus (CMV), herpes simplex virus (HSV), varicella-zoster virus (VZV) infection, Kaposi's sarcoma (KS), or a combination of these were treated with foscarnet."3.70Foscarnet decreases HIV-1 plasma load. ( Barbeau, P; Breilh, D; Denisi, R; Devianne-Garrigue, I; Dupon, M; Fleury, HJ; Leng, B; Pellegrin, I; Pellegrin, JL; Ragnaud, JM, 1998)
" In this report we describe the effects of foscarnet on HHV-8 viremia in an HIV-infected patient with disseminated Kaposi s sarcoma and a presumably HHV-8 associated hemophagocytic syndrome."3.70Suppression of HHV-8 viremia by foscarnet in an HIV-infected patient with Kaposi's sarcoma and HHV-8 associated hemophagocytic syndrome. ( Fleckenstein, B; Harrer, T; Kalden, JR; Löw, P; Manger, B; Neipel, F; Rascu, A; Steininger, H, 1998)
"Foscarnet-resistant cytomegalovirus (ID50 > 300 microM) was isolated from two patients, one of whom was being treated with foscarnet."3.69Viral sensitivity testing in patients with cytomegalovirus retinitis clinically resistant to foscarnet or ganciclovir. ( Apuzzo, L; Charache, P; Dunn, JP; Forman, MS; Jabs, DA; MacCumber, MW, 1995)
" The first developed three episodes of cytomegaloviremia requiring anti-viral therapy; the third episode accompanied by cytomegalovirus hepatitis which required prolonged therapy with foscarnet."3.69Unusual infections following allogeneic bone marrow transplantation for chronic lymphocytic leukemia. ( Brincat, S; Catovsky, D; Iveson, T; Jameson, B; Mehta, J; Paul, B; Powles, R; Singhal, S; Treleaven, J; Zomas, A, 1994)
"To determine the prevalence of cytomegalovirus (CMV) isolates resistant to ganciclovir sodium or foscarnet sodium at the time of diagnosis of CMV retinitis, prior to the initiation of therapy."3.69Cytomegalovirus retinitis and viral resistance. Prevalence of resistance at diagnosis, 1994. Cytomegalovirus Retinitis and Viral Resistance Study Group. ( Bressler, N; Charache, P; Dunn, JP; Enger, C; Forman, M; Jabs, DA, 1996)
"Cytomegalovirus (CMV) infection is still a problem for organ transplant recipients despite studies that long-term prophylaxis with high dose of acyclovir or ganciclovir given to all organ recipients may limit the consequences of infection and disease."3.69Early ganciclovir therapy effectively controls viremia and avoids the need for cytomegalovirus (CMV) prophylaxis in renal transplant patients with cytomegalovirus antigenemia. ( Baruzzo, S; Gotti, E; Moioli, F; Perani, V; Remuzzi, G; Suter, F, 1996)
" Cytomegalovirus prophylaxis consisted of acyclovir for SIBs and foscarnet for MUDs."3.69Bone marrow transplantation for chronic myeloid leukemia (CML) from unrelated and sibling donors: single center experience. ( Bacigalupo, A; Barbanti, M; Corvo, R; Delfino, L; Ferrara, GB; Ficai, G; Frassoni, F; Ghinatti, C; Gualandi, F; Lamparelli, T; Morabito, A; Occhini, D; Pozzi, S; Sacchi, N; Van Lint, MT; Vitale, V; Zikos, P, 1997)
" Grade 3 or greater adverse events occurred in 9 of the 10 prophylactic PFA patients and in 7 of the 10 control patients who had clinical backgrounds similar to the study subjects and underwent SCT during the same period."2.77Safety of pre-engraftment prophylactic foscarnet administration after allogeneic stem cell transplantation. ( Hosokawa, K; Ishiyama, K; Katagiri, T; Kondo, Y; Nakao, S; Ohata, K; Takami, A; Yamazaki, H, 2012)
"However, it may develop in patients with acute lymphoblastic leukemia (ALL) who have not undergone hematopoietic cell transplantation."2.53Cytomegalovirus Retinitis in Three Pediatric Cases with Acute Lymphoblastic Leukemia: Case Series and Review of the Literature. ( Akkoç, G; Atıcı, S; Bakır, M; Çeliker, H; Demir, SÖ; Kadayifci, EK; Karaaslan, A; Kazokoğlu, H; Koç, A; Şenay, E; Soysal, A; Yakut, N, 2016)
"Foscarnet was restarted and continued until day +269 UCBT due to multiple HHV-6 recurrences with persistent hyponatremia."1.91Human herpesvirus 6 (HHV-6) associated permanent hyponatremia in umbilical cord blood transplant recipient. ( Gannamani, V; Nathan, S; Ustun, C; Varma, A, 2023)
" Continued induction dosing or re-induction may protect against early breakthrough CMV disease and CMV-related death among patients with rising antigenemia on preemptive therapy."1.31Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes. ( Boeckh, M; Corey, L; Davis, C; Drew, WL; Gooley, T; Huang, M; Miner, R; Nichols, WG, 2001)
"CMV viremia was present in 4 patients."1.29Cytomegalovirus ventriculoencephalitis in AIDS patients. ( Fernandez-Viladrich, P; Ferrer, I; Gudiol, F; Perez, JL; Podzamczer, D; Reñe, R; Salazar, A; Santin, M, 1995)

Research

Studies (31)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's15 (48.39)18.2507
2000's6 (19.35)29.6817
2010's7 (22.58)24.3611
2020's3 (9.68)2.80

Authors

AuthorsStudies
Avery, RK1
Alain, S1
Alexander, BD1
Blumberg, EA1
Chemaly, RF1
Cordonnier, C1
Duarte, RF1
Florescu, DF1
Kamar, N1
Kumar, D1
Maertens, J1
Marty, FM1
Papanicolaou, GA1
Silveira, FP2
Witzke, O1
Wu, J1
Sundberg, AK1
Fournier, M1
Gannamani, V1
Varma, A1
Nathan, S1
Ustun, C1
Spinner, ML1
Lam, SW1
Koval, CE1
Athans, V1
Chen, J1
Abella Ross, J1
Tegtmeier, B1
Yang, D1
Ito, JI1
Zaia, JA1
Dickter, JK1
Nakamura, R1
Mokhtari, S1
Kriengkauykiat, J1
Al Malki, MM1
Dadwal, SS1
Wieruszewski, PM1
Vijayvargiya, P1
Wilhelm, MP1
Razonable, RR1
Vora, SB1
Brothers, AW1
Waghmare, A1
Englund, JA1
Minces, LR1
Nguyen, MH1
Mitsani, D1
Shields, RK1
Kwak, EJ1
Abdel-Massih, R1
Pilewski, JM1
Crespo, MM1
Bermudez, C1
Bhama, JK1
Toyoda, Y1
Clancy, CJ1
Demir, SÖ1
Çeliker, H1
Karaaslan, A1
Kadayifci, EK1
Akkoç, G1
Atıcı, S1
Yakut, N1
Şenay, E1
Kazokoğlu, H1
Koç, A1
Bakır, M1
Soysal, A1
Ambrose, T1
Sharkey, LM1
Louis-Auguste, J1
Rutter, CS1
Duncan, S1
English, S1
Gkrania-Klotsas, E1
Carmichael, A1
Woodward, JM1
Russell, N1
Massey, D1
Butler, A1
Middleton, S1
Wang, H1
Zhu, L1
Xue, M1
Liu, J1
Guo, Z1
Ishiyama, K1
Katagiri, T1
Ohata, K1
Hosokawa, K1
Kondo, Y1
Yamazaki, H1
Takami, A1
Nakao, S1
Luppi, M1
Barozzi, P1
Rasini, V1
Riva, G1
Re, A1
Rossi, G1
Setti, G1
Sandrini, S1
Facchetti, F1
Torelli, G1
Salazar, A1
Podzamczer, D1
Reñe, R1
Santin, M1
Perez, JL1
Ferrer, I1
Fernandez-Viladrich, P1
Gudiol, F1
Dunn, JP3
MacCumber, MW1
Forman, MS1
Charache, P2
Apuzzo, L1
Jabs, DA3
Zomas, A1
Mehta, J1
Powles, R1
Treleaven, J1
Iveson, T1
Singhal, S1
Jameson, B1
Paul, B1
Brincat, S1
Catovsky, D1
Drobyski, WR1
Dunne, WM1
Burd, EM1
Knox, KK1
Ash, RC1
Horowitz, MM1
Flomenberg, N1
Carrigan, DR1
Enger, C2
Forman, M2
Bressler, N1
Ljungman, P1
Loré, K1
Aschan, J1
Klaesson, S1
Lewensohn-Fuchs, I1
Lönnqvist, B1
Ringdén, O1
Winiarski, J1
Ehrnst, A1
Gotti, E1
Suter, F1
Baruzzo, S1
Perani, V1
Moioli, F1
Remuzzi, G1
Lamparelli, T1
Van Lint, MT1
Gualandi, F1
Occhini, D1
Barbanti, M1
Sacchi, N1
Ficai, G1
Ghinatti, C1
Ferrara, GB1
Delfino, L1
Pozzi, S1
Morabito, A1
Zikos, P1
Vitale, V1
Corvo, R1
Frassoni, F1
Bacigalupo, A1
Devianne-Garrigue, I1
Pellegrin, I1
Denisi, R1
Dupon, M1
Ragnaud, JM1
Barbeau, P1
Breilh, D1
Leng, B1
Fleury, HJ1
Pellegrin, JL1
Löw, P1
Neipel, F1
Rascu, A1
Steininger, H1
Manger, B1
Fleckenstein, B1
Kalden, JR1
Harrer, T1
Hubbard, L1
Baldanti, F1
Revello, MG1
Percivalle, E1
Gerna, G1
Stocchi, R1
Ward, KN1
Fanin, R1
Baccarani, M1
Apperley, JF1
Boivin, G1
Handfield, J1
Toma, E1
Lalonde, R1
Bergeron, MG1
Salmon-Céron, D1
Fillet, AM1
Aboulker, JP1
Gérard, L1
Houhou, N1
Carrière, I1
Ostinelli, J1
Vildé, JL1
Brun-Vézinet, F1
Leport, C1
Nichols, WG1
Corey, L1
Gooley, T1
Drew, WL1
Miner, R1
Huang, M1
Davis, C1
Boeckh, M1
Kiehl, MG1
Basara, N1
Castagnola, E1
Miano, M1
Morreale, G1
Cristina, E1
Chierici, M1
Lanino, E1
Chakrabarti, S1
Collingham, KE1
Osman, H1
Fegan, CD1
Milligan, DW1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory[NCT02931539]Phase 3352 participants (Actual)Interventional2016-12-22Completed
Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant[NCT00386412]Phase 2132 participants (Anticipated)Interventional2005-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With All-cause Mortality by the End of the Study

All-cause mortality was analyzed by the end of study regardless of the use of rescue treatment or alternative anti-CMV treatment. Number of participants who died during the entire study period were reported. (NCT02931539)
Timeframe: From enrollment up to end of study (approximately 44 months)

InterventionParticipants (Count of Participants)
Investigator-assigned Anti-CMV Treatment (IAT)13
Maribavir 400 mg27

Percentage of Participants Receiving Maribavir Rescue Treatment Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: Up to Week 16

Interventionpercentage of participants (Number)
Maribavir Rescue Arm27.3

Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: From start of maribavir rescue treatment through 8 weeks

Interventionpercentage of participants (Number)
Maribavir Rescue Arm50.0

Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is, <137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported. (NCT02931539)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)23.9
Maribavir 400 mg55.7

Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: Up to Week 16

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)10.3
Maribavir 400 mg18.7

Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported. (NCT02931539)
Timeframe: End of Week 8 up to Week 20 (12 weeks follow-up period)

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)35.5
Maribavir 400 mg40.9

Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 20 weeks of study were reported. (NCT02931539)
Timeframe: Baseline up to Week 20

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)45.2
Maribavir 400 mg56.1

Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported. (NCT02931539)
Timeframe: Baseline up to Week 8

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)9.7
Maribavir 400 mg15.2

Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. (NCT02931539)
Timeframe: Baseline up to Week 20

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)33.8
Maribavir 400 mg56.5

Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. (NCT02931539)
Timeframe: End of Week 8 up to Week 20 (12 weeks follow-up period)

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)21.5
Maribavir 400 mg38.6

Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

Recurrence of CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. (NCT02931539)
Timeframe: At Week 8

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)12.3
Maribavir 400 mg17.9

Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while off study-assigned treatment during follow-up period were reported. (NCT02931539)
Timeframe: Termination of study treatment (Week 8) up to the End of the Study (Week 20)

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)29.2
Maribavir 400 mg40.8

Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while on study-assigned treatment period were reported. (NCT02931539)
Timeframe: Baseline up to termination of study treatment (up to Week 8)

Interventionpercentage of participants (Number)
Investigator-assigned Anti-CMV Treatment (IAT)4.6
Maribavir 400 mg15.8

Time to All Cause Mortality

The time to all-cause mortality by the end of the study participation in days was calculated. Participants who were alive at the last study follow-up (regardless of use of rescue or alternative anti-CMV treatment), withdrew from study or were lost to follow-up were censored at the date of last contact. (NCT02931539)
Timeframe: From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)

Interventiondays (Median)
Investigator-assigned Anti-CMV Treatment (IAT)73.0
Maribavir 400 mg55.0

Number of Participants Who Had Maribavir CMV Resistance at Baseline

Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had maribavir CMV resistance at baseline were reported. (NCT02931539)
Timeframe: At Baseline

,,
InterventionParticipants (Count of Participants)
RASs associated with pUL97 onlyRASs associated with pUL27 onlyRASs associated with pUL97 and pUL27
Investigator-assigned Anti-CMV Treatment (IAT)300
Maribavir 400 mg010
Maribavir Rescue Arm100

Number of Participants Who Had Post-baseline Resistance to Maribavir

Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had post-baseline resistance to maribavir were reported. (NCT02931539)
Timeframe: After first dose of study drug up to Week 20

,,
InterventionParticipants (Count of Participants)
RASs associated with pUL97 onlyRASs associated with pUL27 onlyRASs associated with pUL97 and pUL27
Investigator-assigned Anti-CMV Treatment (IAT)000
Maribavir 400 mg4500
Maribavir Rescue Arm400

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study-assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment. (NCT02931539)
Timeframe: Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)

,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEs
Investigator-assigned Anti-CMV Treatment (IAT)10643
Maribavir 400 mg22890
Maribavir Rescue Arm2211

Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: At Week 8 through Weeks 12, 16 and 20

,
Interventionpercentage of participants (Number)
At Week 8At Week 12At Week 16At Week 20
Investigator-assigned Anti-CMV Treatment (IAT)18.85.15.14.3
Maribavir 400 mg54.922.618.718.3

Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: At Week 8 through Weeks 12, 16 and 20

,
Interventionpercentage of participants (Number)
At Week 8At Week 12At Week 16At Week 20
Investigator-assigned Anti-CMV Treatment (IAT)18.85.15.14.3
Maribavir 400 mg54.922.618.718.3

Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration NCT02931539)
Timeframe: At Week 8 through Weeks 12 and 20

,
Interventionpercentage of participants (Number)
At Week 8At Week 12At Week 20
Investigator-assigned Anti-CMV Treatment (IAT)23.910.39.4
Maribavir 400 mg55.722.618.3

Predose Concentration (Cmin) of Maribavir

Cmin of maribavir was reported. (NCT02931539)
Timeframe: Predose at Week 1, 4 and 8

,
Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cmin at Week 1Cmin at Week 4Cmin at Week 8
Maribavir 400 mg8.777.597.19
Maribavir Rescue Arm8.575.755.65

Reviews

3 reviews available for foscarnet and Viremia

ArticleYear
Cytomegalovirus Retinitis in Three Pediatric Cases with Acute Lymphoblastic Leukemia: Case Series and Review of the Literature.
    Japanese journal of infectious diseases, 2016, Nov-22, Volume: 69, Issue:6

    Topics: Administration, Intravenous; Administration, Oral; Adolescent; Antiviral Agents; Child; Child, Presc

2016
Use of the human cytomegalovirus (HCMV) antigenemia assay for diagnosis and monitoring of HCMV infections and detection of antiviral drug resistance in the immunocompromised.
    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 1998, Jul-24, Volume: 11, Issue:1

    Topics: Antigens, Viral; Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections; DNA, Viral; Drug Res

1998
Management of human cytomegalovirus infection and disease after allogeneic bone marrow transplantation.
    Haematologica, 1999, Volume: 84, Issue:1

    Topics: Acyclovir; Adolescent; Adult; Antigens, Viral; Antiviral Agents; Bone Marrow Transplantation; Child;

1999

Trials

5 trials available for foscarnet and Viremia

ArticleYear
Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022, 09-10, Volume: 75, Issue:4

    Topics: Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections; Dichlororibofuranosylbenzimidazole; D

2022
Safety of pre-engraftment prophylactic foscarnet administration after allogeneic stem cell transplantation.
    Transplant infectious disease : an official journal of the Transplantation Society, 2012, Volume: 14, Issue:1

    Topics: Adolescent; Adult; Antiviral Agents; DNA, Viral; Encephalitis, Viral; Female; Foscarnet; Hematopoiet

2012
Use of a semi-quantitative PCR for cytomegalovirus DNA as a basis for pre-emptive antiviral therapy in allogeneic bone marrow transplant patients.
    Bone marrow transplantation, 1996, Volume: 17, Issue:4

    Topics: Antiviral Agents; Bone Marrow Transplantation; Cytomegalovirus; Cytomegalovirus Infections; DNA, Vir

1996
Effect of a 14-day course of foscarnet on cytomegalovirus (CMV) blood markers in a randomized study of human immunodeficiency virus-infected patients with persistent CMV viremia. Agence National de Recherche du SIDA 023 Study Group.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 1999, Volume: 28, Issue:4

    Topics: AIDS-Related Opportunistic Infections; Antigens, Viral; Antiviral Agents; Biomarkers; Cytomegaloviru

1999
Cidofovir for cytomegalovirus-preemptive therapy in stem cell transplant recipients.
    Blood, 2001, Sep-01, Volume: 98, Issue:5

    Topics: Antiviral Agents; Cidofovir; Cytomegalovirus; Cytomegalovirus Infections; Cytosine; Drug Resistance,

2001

Other Studies

23 other studies available for foscarnet and Viremia

ArticleYear
Human herpesvirus 6 (HHV-6) associated permanent hyponatremia in umbilical cord blood transplant recipient.
    Transplant immunology, 2023, Volume: 76

    Topics: Cord Blood Stem Cell Transplantation; Female; Foscarnet; Herpesvirus 6, Human; Humans; Hyponatremia;

2023
Recommended foscarnet dose is not associated with improved outcomes in cytomegalovirus salvage therapy.
    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2019, Volume: 120

    Topics: Adult; Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections; Drug Dosage Calculations; Fema

2019
Cost analysis of ganciclovir and foscarnet in recipients of allogeneic hematopoietic cell transplant with cytomegalovirus viremia.
    Transplant infectious disease : an official journal of the Transplantation Society, 2020, Volume: 22, Issue:2

    Topics: Adolescent; Adult; Aged; Antiviral Agents; Chemoprevention; Child; Costs and Cost Analysis; Cytomega

2020
Cytomegaloviraemia clearance with foscarnet during renal replacement therapy.
    The Journal of antimicrobial chemotherapy, 2018, 02-01, Volume: 73, Issue:2

    Topics: Aged; Antiviral Agents; Cytomegalovirus Infections; Foscarnet; Hemofiltration; Humans; Male; Renal D

2018
Antiviral combination therapy for cytomegalovirus infection in high-risk infants.
    Antiviral therapy, 2018, Volume: 23, Issue:6

    Topics: Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections; Drug Therapy, Combination; Female; Fo

2018
Ganciclovir-resistant cytomegalovirus infections among lung transplant recipients are associated with poor outcomes despite treatment with foscarnet-containing regimens.
    Antimicrobial agents and chemotherapy, 2014, Volume: 58, Issue:1

    Topics: Adult; Aged; Antiviral Agents; Cytomegalovirus Infections; Drug Resistance, Viral; Female; Foscarnet

2014
Cytomegalovirus Infection and Rates of Antiviral Resistance Following Intestinal and Multivisceral Transplantation.
    Transplantation proceedings, 2016, Volume: 48, Issue:2

    Topics: Adult; Aged; Antiviral Agents; Cytomegalovirus Infections; Drug Resistance, Viral; Female; Foscarnet

2016
Low-dose foscarnet preemptive therapy for cytomegalovirus viremia after haploidentical bone marrow transplantation.
    Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2009, Volume: 15, Issue:4

    Topics: Antiviral Agents; Bone Marrow Transplantation; Cytomegalovirus; Cytomegalovirus Infections; Female;

2009
Severe pancytopenia and hemophagocytosis after HHV-8 primary infection in a renal transplant patient successfully treated with foscarnet.
    Transplantation, 2002, Jul-15, Volume: 74, Issue:1

    Topics: Antiviral Agents; DNA, Viral; Foscarnet; Herpesvirus 8, Human; Humans; Kidney Transplantation; Male;

2002
Cytomegalovirus ventriculoencephalitis in AIDS patients.
    Scandinavian journal of infectious diseases, 1995, Volume: 27, Issue:2

    Topics: Adult; AIDS-Related Opportunistic Infections; Autopsy; Brain; Cerebral Ventricles; Cerebrospinal Flu

1995
Viral sensitivity testing in patients with cytomegalovirus retinitis clinically resistant to foscarnet or ganciclovir.
    American journal of ophthalmology, 1995, Volume: 119, Issue:5

    Topics: Adult; AIDS-Related Opportunistic Infections; Cytomegalovirus; Cytomegalovirus Retinitis; Disease Pr

1995
Unusual infections following allogeneic bone marrow transplantation for chronic lymphocytic leukemia.
    Bone marrow transplantation, 1994, Volume: 14, Issue:5

    Topics: Adult; Anti-Bacterial Agents; Bone Marrow Transplantation; Cytomegalovirus Infections; Drug Therapy,

1994
Human herpesvirus-6 (HHV-6) infection in allogeneic bone marrow transplant recipients: evidence of a marrow-suppressive role for HHV-6 in vivo.
    The Journal of infectious diseases, 1993, Volume: 167, Issue:3

    Topics: Adult; Base Sequence; Bone Marrow; Bone Marrow Transplantation; Cohort Studies; Colony-Forming Units

1993
Cytomegalovirus retinitis and viral resistance. Prevalence of resistance at diagnosis, 1994. Cytomegalovirus Retinitis and Viral Resistance Study Group.
    Archives of ophthalmology (Chicago, Ill. : 1960), 1996, Volume: 114, Issue:7

    Topics: Adult; AIDS-Related Opportunistic Infections; Antiviral Agents; Baltimore; Cytomegalovirus; Cytomega

1996
Early ganciclovir therapy effectively controls viremia and avoids the need for cytomegalovirus (CMV) prophylaxis in renal transplant patients with cytomegalovirus antigenemia.
    Clinical transplantation, 1996, Volume: 10, Issue:6 Pt 1

    Topics: Adolescent; Adult; Antigens, Viral; Antiviral Agents; Chemoprevention; Child; Cytomegalovirus; Cytom

1996
Bone marrow transplantation for chronic myeloid leukemia (CML) from unrelated and sibling donors: single center experience.
    Bone marrow transplantation, 1997, Volume: 20, Issue:12

    Topics: Acyclovir; Adolescent; Adult; Antigens, Viral; Antiviral Agents; Bone Marrow Transplantation; Cause

1997
Foscarnet decreases HIV-1 plasma load.
    Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association, 1998, May-01, Volume: 18, Issue:1

    Topics: Acquired Immunodeficiency Syndrome; Adult; Aged; Antiviral Agents; Cytomegalovirus Infections; Femal

1998
Suppression of HHV-8 viremia by foscarnet in an HIV-infected patient with Kaposi's sarcoma and HHV-8 associated hemophagocytic syndrome.
    European journal of medical research, 1998, Oct-14, Volume: 3, Issue:10

    Topics: Adult; AIDS-Related Opportunistic Infections; Antiviral Agents; DNA, Viral; Foscarnet; Herpesvirus 8

1998
Cytomegalovirus retinitis and viral resistance: 3. Culture results. CMV Retinitis and Viral Resistance Study Group.
    American journal of ophthalmology, 1998, Volume: 126, Issue:4

    Topics: Adult; AIDS-Related Opportunistic Infections; Antiviral Agents; Baltimore; Blood; Cidofovir; Cytomeg

1998
Expression of the late cytomegalovirus (CMV) pp150 transcript in leukocytes of AIDS patients is associated with a high viral DNA load in leukocytes and presence of CMV DNA in plasma.
    The Journal of infectious diseases, 1999, Volume: 179, Issue:5

    Topics: AIDS-Related Opportunistic Infections; Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections

1999
Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes.
    Blood, 2001, Feb-15, Volume: 97, Issue:4

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Antigens, Viral; Antiviral Agents; Cause of Death;

2001
Strategies for management of cytomegalovirus (CMV) infection after allogeneic bone marrow transplantation: the "doubling of baseline CMV pp65 antigenemia" and the "cidofovir as rescue treatment approaches.
    Blood, 2001, Sep-01, Volume: 98, Issue:5

    Topics: Antigens, Viral; Antiviral Agents; Bone Marrow Transplantation; Child; Cidofovir; Cytomegalovirus; C

2001
Cidofovir as primary pre-emptive therapy for post-transplant cytomegalovirus infections.
    Bone marrow transplantation, 2001, Volume: 28, Issue:9

    Topics: Adult; Antiviral Agents; Cidofovir; Cyclosporine; Cytomegalovirus; Cytomegalovirus Infections; Cytos

2001