nevirapine and Acute Liver Injury, Drug-Induced studies

Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.
nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.

Research Excerpts

Excerpt	Relevance	Reference
"The aims of the study were to document the frequency of cutaneous and hepatic toxicity secondary to nevirapine use during pregnancy and to compare rates in women starting nevirapine during the current pregnancy with those in women who had commenced nevirapine prior to the current pregnancy."	9.12	Safety of nevirapine in pregnancy. ( Anderson, J; de Ruiter, A; Edwards, SG; Hay, P; McDonald, C; Natarajan, U; Pym, A; Taylor, GP; Velisetty, P; Welch, J, 2007)
" Patients were allocated to 2groups according to exposure to nevirapine during pregnancy."	7.83	[Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy]. ( Figueras-Nadal, C; Fortuny-Guasch, C; Iveli, P; Martín-Nalda, A; Noguera-Julian, A; Rovira-Girabal, N; Soler-Palacín, P, 2016)
"Coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) in HIV-infected patients receiving a commonly used nevirapine-based antiretroviral therapy is a major concern for African clinicians owing to its high prevalence, the infrequent testing and treatment of viral hepatitis, and the impact of liver disease on the tolerability and effectiveness of anti-HIV treatment."	7.76	Hepatotoxicity and effectiveness of a Nevirapine-based antiretroviral therapy in HIV-infected patients with or without viral hepatitis B or C infection in Cameroon. ( Bourgeois, A; Calmy, A; Ciaffi, L; Delaporte, E; Ducos, J; Gwet, H; Kouanfack, C; Koulla-Shiro, S; Laurent, C; Mbougua, JB; Molinari, N; Mpoudi-Ngolé, E, 2010)
"A retrospective study was carried out of all women prescribed nevirapine as part of combination antiretroviral therapy in pregnancy at three HIV centres in Dublin, Ireland (October 2000 to February 2003)."	7.73	Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy. ( Bergin, C; Geoghegan, J; Hopkins, S; Kelleher, B; Lyons, F; McCormick, PA; McGeary, A; Mulcahy, FM; Sheehan, G, 2006)
"Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated."	7.73	Nelfinavir and nevirapine side effects during pregnancy. ( Boer, K; de Wolf, F; Dieleman, J; Godfried, MH; Nellen, J; Schneider, ME; Sprenger, H; Tempelman, C; Timmermans, S; van der Ende, ME, 2005)
" We report the case of a pregnant human immunodeficiency virus type 1-infected woman who developed drug rash with eosinophilia and systemic symptoms syndrome and renal failure shortly after initiation of a nevirapine-containing antiretroviral regimen at 27 weeks' gestation."	7.72	Drug rash with eosinophilia and systemic symptoms syndrome and renal toxicity with a nevirapine-containing regimen in a pregnant patient with human immunodeficiency virus. ( Boswell, H; Fan-Havard, P; Knudtson, E; Para, M, 2003)
"Both chronic hepatitis C and nevirapine (NVP) use are risk factors for transaminase elevation under highly active antiretroviral therapy."	7.72	Short communication: interactions between nevirapine plasma levels, chronic hepatitis C, and the development of liver toxicity in HIV-infected patients. ( González-Lahoz, J; González-Requena, D; Núñez, M; Soriano, V, 2003)
"Nevirapine has been used as antiretroviral agent since early '90."	5.48	Clinical and genetic factors associated with increased risk of severe liver toxicity in a monocentric cohort of HIV positive patients receiving nevirapine-based antiretroviral therapy. ( Cattaneo, D; Cheli, S; Clementi, E; Di Cristo, V; Falvella, FS; Galli, M; Giacomelli, A; Lupo, A; Oreni, ML; Renisi, G; Ridolfo, AL; Riva, A; Rusconi, S, 2018)
"Nevirapine is a non-nucleoside reverse transcriptase inhibitor used in the treatment of human immunodeficiency virus (HIV)-infected patients and in post-exposure prophylaxis."	5.32	Severe leukopenia associated with mild hepatotoxicity in an HIV carrier treated with nevirapine. ( Krivoy, N; Pollack, S; Shahar, E; Weltfriend, S, 2004)
"Nevirapine has been associated with a skin rash in 32 to 48% of patients."	5.31	Jaundice and hepatocellular damage associated with nevirapine therapy. ( Bonacini, M; Poreddy, V; Prakash, M; Tiyyagura, L, 2001)
"The aims of the study were to document the frequency of cutaneous and hepatic toxicity secondary to nevirapine use during pregnancy and to compare rates in women starting nevirapine during the current pregnancy with those in women who had commenced nevirapine prior to the current pregnancy."	5.12	Safety of nevirapine in pregnancy. ( Anderson, J; de Ruiter, A; Edwards, SG; Hay, P; McDonald, C; Natarajan, U; Pym, A; Taylor, GP; Velisetty, P; Welch, J, 2007)
" Patients were allocated to 2groups according to exposure to nevirapine during pregnancy."	3.83	[Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy]. ( Figueras-Nadal, C; Fortuny-Guasch, C; Iveli, P; Martín-Nalda, A; Noguera-Julian, A; Rovira-Girabal, N; Soler-Palacín, P, 2016)
" Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART."	3.77	HAART induced adverse drug reactions: a retrospective analysis at a tertiary referral health care center in India. ( Anwikar, SR; Bandekar, MS; Kshirsagar, NA; Pazare, AP; Smrati, B; Tatke, PA, 2011)
"Coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) in HIV-infected patients receiving a commonly used nevirapine-based antiretroviral therapy is a major concern for African clinicians owing to its high prevalence, the infrequent testing and treatment of viral hepatitis, and the impact of liver disease on the tolerability and effectiveness of anti-HIV treatment."	3.76	Hepatotoxicity and effectiveness of a Nevirapine-based antiretroviral therapy in HIV-infected patients with or without viral hepatitis B or C infection in Cameroon. ( Bourgeois, A; Calmy, A; Ciaffi, L; Delaporte, E; Ducos, J; Gwet, H; Kouanfack, C; Koulla-Shiro, S; Laurent, C; Mbougua, JB; Molinari, N; Mpoudi-Ngolé, E, 2010)
"To report on 1) clinical, immunological and virological outcomes and 2) safety among human immunodeficiency virus (HIV) infected patients with tuberculosis (TB) who received concurrent nevirapine (NVP) and rifampicin (RMP) based treatment."	3.76	Outcomes and safety of concomitant nevirapine and rifampicin treatment under programme conditions in Malawi. ( Bauerfeind, A; Foncha, C; Harries, AD; Kwanjana, J; Manzi, M; Misinde, D; Moses, M; Mwagomba, B; Tayler-Smith, K; Zachariah, R, 2010)
"To investigate the incidence of hepatotoxicity in acquired immunodeficiency syndrome (AIDS) patients on combined anti-retroviral therapy (cART) containing nevirapine (NVP) and to assess the risk factors and its impact on cART."	3.76	[Nevirapine related hepatotoxicity: the prevalence and risk factors in a cohort of ART naive Han Chinese with AIDS]. ( Deng, LP; Gao, SC; Gui, XE; Liang, K; Rong, YP; Yan, YJ; Yang, RR; Zhang, YX, 2010)
"To estimate whether the association between nevirapine (NVP) and hepatotoxicity differs according to pregnancy status in HIV-infected women."	3.75	Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure. ( Brogly, SB; French, AL; Hershow, RC; Leighty, RM; Lu, M; Ouyang, DW; Shapiro, DE; Thompson, B; Tuomala, RE, 2009)
"A retrospective study was carried out of all women prescribed nevirapine as part of combination antiretroviral therapy in pregnancy at three HIV centres in Dublin, Ireland (October 2000 to February 2003)."	3.73	Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy. ( Bergin, C; Geoghegan, J; Hopkins, S; Kelleher, B; Lyons, F; McCormick, PA; McGeary, A; Mulcahy, FM; Sheehan, G, 2006)
"Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated."	3.73	Nelfinavir and nevirapine side effects during pregnancy. ( Boer, K; de Wolf, F; Dieleman, J; Godfried, MH; Nellen, J; Schneider, ME; Sprenger, H; Tempelman, C; Timmermans, S; van der Ende, ME, 2005)
" We report the case of a pregnant human immunodeficiency virus type 1-infected woman who developed drug rash with eosinophilia and systemic symptoms syndrome and renal failure shortly after initiation of a nevirapine-containing antiretroviral regimen at 27 weeks' gestation."	3.72	Drug rash with eosinophilia and systemic symptoms syndrome and renal toxicity with a nevirapine-containing regimen in a pregnant patient with human immunodeficiency virus. ( Boswell, H; Fan-Havard, P; Knudtson, E; Para, M, 2003)
"Both chronic hepatitis C and nevirapine (NVP) use are risk factors for transaminase elevation under highly active antiretroviral therapy."	3.72	Short communication: interactions between nevirapine plasma levels, chronic hepatitis C, and the development of liver toxicity in HIV-infected patients. ( González-Lahoz, J; González-Requena, D; Núñez, M; Soriano, V, 2003)
" In one case, a 43-year-old female health-care worker required liver transplantation after developing fulminant hepatitis and end-stage hepatic failure while taking NVP, zidovudine, and lamivudine as PEP following a needlestick injury (1)."	3.71	Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000. ( , 2001)
" Risk factors were higher baseline alanine aminotransferase levels, chronic hepatitis B or C virus infection, antiretroviral therapy-naive patients undergoing their first HAART regimen, recent start of a regimen of nevirapine or high-dose ritonavir, and female sex."	3.71	Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. ( Jurriaans, S; Lange, JM; Weel, J; Weverling, GJ; Wit, FW, 2002)
"Hepatotoxicity was a common adverse effect of NVP among men and women with CD4 >250 cells per microliter."	2.78	The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China: a change in national treatment guidelines may be warranted. ( Ghanem, KG; Guo, F; Han, Y; Li, T; Li, Y; Qiu, Z; Wang, H; Wang, W; Xie, J; Zhang, C; Zhou, M, 2013)
"NVP pharmacokinetics were modeled by population pharmacokinetic analysis."	2.77	Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women. ( Aweeka, FT; Currier, JS; Dong, BJ; Frymoyer, A; Hughes, MD; Lizak, P; Lockman, S; Sawe, F; Verotta, D; Zheng, Y, 2012)
"Severe hyperbilirubinemia (grade 3 or 4) occurred in 7 patients (5."	2.76	Hepatotoxicity in patients co-infected with tuberculosis and HIV-1 while receiving non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy and rifampicin-containing anti-tuberculosis regimen. ( Lueangniyomkul, A; Mankhatitham, W; Manosuthi, W, 2011)
"Children were randomized to initiate antiretroviral therapy with full-dose (FD) nevirapine (Triomune Baby or Junior in the morning and evening) versus DE (half-dose nevirapine for 14 days [Triomune in the morning and stavudine-lamivudine {Lamivir-S} in the evening], then FD), in accordance with World Health Organization weight-band dosing tables."	2.75	Strategies for nevirapine initiation in HIV-infected children taking pediatric fixed-dose combination "baby pills" in Zambia: a randomized controlled trial. ( Burger, D; Chijoka, C; Chintu, C; Cook, A; Ferrier, A; Gibb, DM; Kabamba, D; Kalengo, C; Kankasa, C; Kityo, C; Mulenga, V; Thomason, M; Walker, AS, 2010)
" Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%)."	2.71	Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. ( Burger, D; Clotet, B; Galindos, MJ; Gel, S; Miralles, C; Moltó, J; Muñoz-Moreno, JA; Negredo, E; Pedrol, E; Puig, J; Ribera, E; Rodriguez Fumaz, C; Rodríguez, E; Ruiz, L; Viciana, P; Videla, S, 2004)
" The OR (95% CI) for HLA-B*35 and cutaneous adverse drug reactions (cADRs) was 2."	2.52	HLA-allelotype associations with nevirapine-induced hypersensitivity reactions and hepatotoxicity: a systematic review of the literature and meta-analysis. ( Alfirevic, A; Carr, DF; Cornejo Castro, EM; Jorgensen, AL; Pirmohamed, M, 2015)
" Sources included adverse event reports from pharmaceutical manufacturers and the US FDA, reports from peer-reviewed journals/scientific meetings and the Research on Adverse Drug events And Reports (RADAR) project."	2.45	Hepatotoxicity associated with long- versus short-course HIV-prophylactic nevirapine use: a systematic review and meta-analysis from the Research on Adverse Drug events And Reports (RADAR) project. ( Bennett, CL; Chandler, KL; Differding, V; Johnson, S; McKoy, JM; Obadina, E; Palella, F; Parada, JP; Raisch, DW; Scarsi, KK; Scheetz, MH; Sutton, S; Yarnold, PR, 2009)
" Both drugs have demonstrated interindividual pharmacokinetic variability."	2.44	Efavirenz and nevirapine in HIV-1 infection : is there a role for clinical pharmacokinetic monitoring? ( Dahri, K; Ensom, MH, 2007)
"Liver toxicity is one of the most relevant adverse effects of antiretroviral therapy."	2.44	Liver toxicity induced by non-nucleoside reverse transcriptase inhibitors. ( Mira, JA; Pineda, JA; Rivero, A, 2007)
" All papers, abstracts, or presentations, regardless of study design, that made reference to the response of patients who were switched from one NNRTI to another as a result of an adverse drug reaction were included."	2.44	Is it safe to switch between efavirenz and nevirapine in the event of toxicity? ( Maartens, G; Mehta, U, 2007)
"In the context of attempts to simplify treatment regimens and enhance adherence, there is great interest in once-daily dosing regimens for the treatment of HIV-1 infection."	2.44	Once-daily nevirapine dosing: a pharmacokinetics, efficacy and safety review. ( Cooper, CL; van Heeswijk, RP, 2007)
" Based on current knowledge, the immense benefits of antiretroviral prophylaxis in reducing the risk of MTCT, far outweigh the potential for adverse effects."	2.43	The safety of antiretroviral drugs in pregnancy. ( Newell, ML; Thorne, C, 2005)
"Nevirapine has been used as antiretroviral agent since early '90."	1.48	Clinical and genetic factors associated with increased risk of severe liver toxicity in a monocentric cohort of HIV positive patients receiving nevirapine-based antiretroviral therapy. ( Cattaneo, D; Cheli, S; Clementi, E; Di Cristo, V; Falvella, FS; Galli, M; Giacomelli, A; Lupo, A; Oreni, ML; Renisi, G; Ridolfo, AL; Riva, A; Rusconi, S, 2018)
"Nevirapine (NVP) is an effective nonnucleoside reverse transcriptase inhibitor (NNRTI) of particular interest as it is often used in resource limited countries."	1.40	Proteomic analysis of serum and urine of HIV-monoinfected and HIV/HCV-coinfected patients undergoing long term treatment with nevirapine. ( Janphen, K; Kumrapich, B; Praparattanapan, J; Roytrakul, S; Smith, DR; Supparatpinyo, K; Thongtan, T; Wongtrakul, J, 2014)
"We compared adverse events among breast-feeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy, including either nevirapine or nelfinavir."	1.38	Rash, hepatotoxicity and hyperbilirubinemia among Kenyan infants born to HIV-infected women receiving triple-antiretroviral drugs for the prevention of mother-to-child HIV transmission. ( Akoth, B; Angira, F; Masaba, R; Mills, LA; Minniear, TD; Ndivo, R; Oyaro, B; Peters, PJ; Polle, N; Thomas, TK; Zeh, C, 2012)
"Demographic, treatment and pregnancy related data were collected."	1.38	Hcv coinfection, an important risk factor for hepatotoxicity in pregnant women starting antiretroviral therapy. ( Boer, K; de Wolf, F; Godfried, MH; Nellen, JF; Smit, C; Snijdewind, IJ; van der Ende, ME, 2012)
" Male Cbl-b(-/-) mice dosed with NVP had an increase in ALT of >200 U/L, which also resolved despite continued treatment."	1.38	Bioactivation of nevirapine to a reactive quinone methide: implications for liver injury. ( Hayes, MA; Li, Y; Novalen, M; Sharma, AM; Uetrecht, J, 2012)
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."	1.37	FDA-approved drug labeling for the study of drug-induced liver injury. ( Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011)
"Nevirapine-based ART was initiated in 820 women and baseline ALT or AST results were abnormal (≥ grade 1) in 113 (14%) women."	1.36	Nevirapine-associated hepatotoxicity was not predicted by CD4 count ≥250 cells/μL among women in Zambia, Thailand and Kenya. ( Bolu, O; Borkowf, CB; Brooks, JT; Intalapaporn, P; Kiarie, J; McConnell, MS; Mutsotso, W; Peters, PJ; Potter, D; Ratanasuwan, W; Stringer, J; Weidle, PJ; Zulu, I, 2010)
"In resource-limited settings where nevirapine-containing regimen is the preferred regimen in women, data on severe adverse events (SAEs) according to CD4 cell count are limited."	1.36	Incidence and risk factors of severe adverse events with nevirapine-based antiretroviral therapy in HIV-infected women. MTCT-Plus program, Abidjan, Côte d'Ivoire. ( Abrams, EJ; Amani-Bosse, C; Bédikou, G; Coffie, PA; Dabis, F; Ekouevi, DK; Tanon, AK; Tonwe-Gold, B, 2010)
"Nevirapine is widely used to treat HIV-1 infection to prevent mother-to-child transmission; unfortunately adverse drug reactions have been reported."	1.36	Nevirapine-induced hepatotoxicity and pharmacogenetics: a retrospective study in a population from Mozambique. ( Altan, AM; Borgiani, P; Bramanti, P; Ceffa, S; Ciccacci, C; Marazzi, MC; Novelli, G; Palombi, L; Paturzo, G; Sirianni, E, 2010)
"Liver diseases are common in patients with HIV due to viral hepatitis B and C co-infections, opportunistic infections or malignancies, antiretroviral drugs and drugs for opportunistic infections."	1.35	The spectrum of liver diseases in HIV infected individuals at an HIV treatment clinic in Kampala, Uganda. ( Colebunders, R; Feld, J; Kambugu, A; Katabira, E; Katwere, M; Ocama, P; Opio, KC; Piloya, T; Ronald, A; Thomas, D, 2008)
"Non-nevirapine regimens were initiated following biochemical and symptomatic improvement; symptoms did not recur."	1.35	Incidence of nevirapine-associated hepatitis in an antenatal clinic. ( Black, V; Rees, H, 2008)
"To determine the incidence of clinically significant adverse events after long-term, fixed-dose, generic highly active antiretroviral therapy (HAART) use among HIV-infected individuals in South India, we examined the experiences of 3154 HIV-infected individuals who received a minimum of 3 months of generic HAART between February 1996 and December 2006 at a tertiary HIV care referral center in South India."	1.35	Spectrum of adverse events after generic HAART in southern Indian HIV-infected patients. ( Balakrishnan, P; Cecelia, AJ; Devaleenal, B; Flanigan, TP; Kumarasamy, N; Lai, AR; Mayer, KH; Poongulali, S; Saghayam, S; Solomon, S; Venkatesh, KK; Yepthomi, T, 2008)
"All nevirapine side effects were developed in less than seven weeks."	1.34	Nevirapine-induced side effects in pregnant women: experience of a Brazilian university hospital. ( Carraro, EA; Cornelsen, TC; Dias, JM; Kondo, W; Macedo, RL; Perini, J; Prandel, E; Sasaki, Md; Sbalquiero, R, 2007)
"The relationships between adverse events (AEs) and plasma concentrations of nevirapine (NVP) and efavirenz (EFV) were investigated as part of the large, international, randomized 2NN study."	1.33	Are adverse events of nevirapine and efavirenz related to plasma concentrations? ( Baraldi, E; Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Montella, F; Robinson, PA; Russell, DB; Thompson, MA; Uip, DE; van Leth, F, 2005)
"Nevirapine is an antiretroviral drug that is used for treatment as well as for the prevention of mother-to-child transmission of the human immunodeficiency virus (HIV)."	1.33	RAT CYP3A and CYP2B1/2 were not associated with nevirapine-induced hepatotoxicity. ( Abraham, AM; Barr, S; Walubo, A, 2006)
"The prolonged elimination half-life of NVP compared with NRTIs, which persists even after 20 weeks of therapy, raises concern over the development of NNRTI resistance if all three drugs are stopped together."	1.32	Clinical implications of stopping nevirapine-based antiretroviral therapy: relative pharmacokinetics and avoidance of drug resistance. ( Back, D; Clarke, JR; Fidler, S; Mackie, NE; Tamm, N; Taylor, GP; Weber, JN, 2004)
"Nevirapine is a non-nucleoside reverse transcriptase inhibitor used in the treatment of human immunodeficiency virus (HIV)-infected patients and in post-exposure prophylaxis."	1.32	Severe leukopenia associated with mild hepatotoxicity in an HIV carrier treated with nevirapine. ( Krivoy, N; Pollack, S; Shahar, E; Weltfriend, S, 2004)
"Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor used as part of combination antiretroviral therapy for the treatment of HIV infection."	1.31	Late onset hepatitis and prolonged deterioration in hepatic function associated with nevirapine therapy. ( Clarke, S; Condon, C; Harrington, P; Kelleher, D; Mulcahy, F; Smith, OP, 2000)
"(1) Introduce nevirapine at half the target dose, and monitor the skin, mucous membranes and liver to avoid fatal adverse effects."	1.31	Severe hepatic and cutaneous adverse effects with nevirapine. ( , 2000)
"Nevirapine has been associated with a skin rash in 32 to 48% of patients."	1.31	Jaundice and hepatocellular damage associated with nevirapine therapy. ( Bonacini, M; Poreddy, V; Prakash, M; Tiyyagura, L, 2001)

Research

Studies (114)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Number of Participants Who Experienced HIV-related Disease Progression or Death

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (0.88)	18.2507
2000's	70 (61.40)	29.6817
2010's	42 (36.84)	24.3611
2020's	1 (0.88)	2.80

Authors	Studies
Fourches, D	1
Barnes, JC	1
Day, NC	1
Bradley, P	1
Reed, JZ	1
Tropsha, A	1
Morgan, RE	2
Trauner, M	1
van Staden, CJ	2
Lee, PH	1
Ramachandran, B	1
Eschenberg, M	1
Afshari, CA	2
Qualls, CW	2
Lightfoot-Dunn, R	1
Hamadeh, HK	2
Chen, M	2
Vijay, V	1
Shi, Q	2
Liu, Z	2
Fang, H	2
Tong, W	3
Ding, D	1
Kelly, R	1
Sakatis, MZ	1
Reese, MJ	1
Harrell, AW	1
Taylor, MA	1
Baines, IA	1
Chen, L	1
Bloomer, JC	1
Yang, EY	1
Ellens, HM	1
Ambroso, JL	1
Lovatt, CA	1
Ayrton, AD	1
Clarke, SE	1
Warner, DJ	1
Chen, H	1
Cantin, LD	1
Kenna, JG	1
Stahl, S	1
Walker, CL	1
Noeske, T	1
Chen, Y	1
Kalyanaraman, N	1
Kalanzi, J	1
Dunn, RT	1
Suzuki, A	1
Thakkar, S	1
Yu, K	1
Hu, C	1
Singh, H	2
Lata, S	2
Choudhari, R	1
Dhole, TN	2
Su, S	1
Fairley, CK	1
Sasadeusz, J	1
He, J	1
Wei, X	1
Zeng, H	1
Jing, J	1
Mao, L	1
Chen, X	1
Zhang, L	1
Bokore, A	1
Korme, B	1
Bayisa, G	1
Giacomelli, A	1
Riva, A	1
Falvella, FS	1
Oreni, ML	1
Cattaneo, D	1
Cheli, S	1
Renisi, G	1
Di Cristo, V	1
Lupo, A	1
Clementi, E	1
Rusconi, S	1
Galli, M	1
Ridolfo, AL	1
Gangakhedkar, RR	1
Otegbayo, JA	1
Kuti, MA	1
Ogunbode, O	1
Irabor, AE	1
Adewoles, IF	1
Vispo, E	1
Fernández-Montero, JV	1
Labarga, P	1
Barreiro, P	1
Soriano, V	3
Andreotti, M	1
Pirillo, MF	1
Liotta, G	1
Jere, H	1
Maulidi, M	1
Sagno, JB	1
Luhanga, R	1
Amici, R	1
Mancini, MG	1
Gennaro, E	1
Marazzi, MC	2
Vella, S	1
Giuliano, M	1
Palombi, L	2
Mancinelli, S	1
Iveli, P	1
Noguera-Julian, A	1
Soler-Palacín, P	1
Martín-Nalda, A	1
Rovira-Girabal, N	1
Fortuny-Guasch, C	1
Figueras-Nadal, C	1
Wongtrakul, J	1
Thongtan, T	1
Roytrakul, S	1
Kumrapich, B	1
Janphen, K	1
Praparattanapan, J	1
Supparatpinyo, K	1
Smith, DR	1
Cornejo Castro, EM	1
Carr, DF	1
Jorgensen, AL	1
Alfirevic, A	1
Pirmohamed, M	2
Mak, A	1
Uetrecht, J	2
Terelius, Y	1
Figler, RA	1
Marukian, S	1
Collado, MS	1
Lawson, MJ	1
Mackey, AJ	1
Manka, D	1
Blackman, BR	1
Wamhoff, BR	1
Dash, A	1
Sathia, L	1
Obiorah, I	1
Taylor, G	1
Kon, O	1
O'Donoghue, M	1
Gibbins, S	1
Walsh, J	1
Winston, A	1
Brück, S	1
Witte, S	1
Brust, J	1
Schuster, D	1
Mosthaf, F	1
Procaccianti, M	1
Rump, JA	1
Klinker, H	1
Petzold, D	1
Hartmann, M	1
McKoy, JM	1
Bennett, CL	2
Scheetz, MH	1
Differding, V	1
Chandler, KL	1
Scarsi, KK	1
Yarnold, PR	1
Sutton, S	1
Palella, F	1
Johnson, S	2
Obadina, E	1
Raisch, DW	1
Parada, JP	1
Ocama, P	1
Katwere, M	1
Piloya, T	1
Feld, J	1
Opio, KC	1
Kambugu, A	1
Katabira, E	1
Thomas, D	1
Colebunders, R	1
Ronald, A	1
Colafigli, M	1
Di Giambenedetto, S	1
Bracciale, L	1
Fanti, I	1
Prosperi, M	1
Cauda, R	1
De Luca, A	1
Ouyang, DW	2
Shapiro, DE	2
Lu, M	2
Brogly, SB	2
French, AL	2
Leighty, RM	2
Thompson, B	2
Tuomala, RE	2
Hershow, RC	2
Ciccacci, C	1
Borgiani, P	1
Ceffa, S	1
Sirianni, E	1
Altan, AM	1
Paturzo, G	1
Bramanti, P	1
Novelli, G	1
Moses, M	1
Zachariah, R	2
Tayler-Smith, K	1
Misinde, D	1
Foncha, C	1
Manzi, M	2
Bauerfeind, A	1
Mwagomba, B	1
Kwanjana, J	1
Harries, AD	1
Chu, KM	2
Boulle, AM	1
Ford, N	1
Goemaere, E	1
Asselman, V	1
Van Cutsem, G	1
Mbougua, JB	1
Laurent, C	1
Kouanfack, C	1
Bourgeois, A	1
Ciaffi, L	1
Calmy, A	1
Gwet, H	1
Koulla-Shiro, S	1
Ducos, J	1
Mpoudi-Ngolé, E	1
Molinari, N	1
Delaporte, E	1
Coffie, PA	1
Tonwe-Gold, B	1
Tanon, AK	1
Amani-Bosse, C	1
Bédikou, G	1
Abrams, EJ	1
Dabis, F	1
Ekouevi, DK	1
Peters, PJ	2
Stringer, J	1
McConnell, MS	1
Kiarie, J	1
Ratanasuwan, W	1
Intalapaporn, P	1
Potter, D	1
Mutsotso, W	1
Zulu, I	1
Borkowf, CB	1
Bolu, O	1
Brooks, JT	2
Weidle, PJ	2
Mulenga, V	1
Cook, A	1
Walker, AS	1
Kabamba, D	1
Chijoka, C	1
Ferrier, A	1
Kalengo, C	1
Kityo, C	1
Kankasa, C	1
Burger, D	2
Thomason, M	1
Chintu, C	1
Gibb, DM	1
Gao, SC	1
Gui, XE	1
Deng, LP	1
Zhang, YX	1
Yan, YJ	1
Rong, YP	1
Liang, K	1
Yang, RR	1
Górgolas, M	1
Hidalgo, C	1
Williams, F	1
Guerrero, MF	1
Mankhatitham, W	1
Lueangniyomkul, A	1
Manosuthi, W	1
Anwikar, SR	1
Bandekar, MS	1
Smrati, B	1
Pazare, AP	1
Tatke, PA	1
Kshirsagar, NA	1
Li, ZC	1
Li, HJ	1
Dai, LL	1
Gao, YQ	1
Cai, WP	1
Li, HY	1
Huang, XJ	1
Zhang, T	1
Wu, H	1
Snijdewind, IJ	1
Smit, C	1
Godfried, MH	2
Nellen, JF	1
de Wolf, F	3
Boer, K	2
van der Ende, ME	3
Chang, HM	1
Tsai, HC	1
Lee, SS	1
Wann, SR	1
Chen, YS	1
Dong, BJ	1
Zheng, Y	1
Hughes, MD	1
Frymoyer, A	1
Verotta, D	1
Lizak, P	1
Sawe, F	1
Currier, JS	1
Lockman, S	1
Aweeka, FT	1
Minniear, TD	1
Zeh, C	1
Polle, N	1
Masaba, R	1
Oyaro, B	1
Akoth, B	1
Ndivo, R	1
Angira, F	1
Mills, LA	1
Thomas, TK	1
Sharma, AM	1
Li, Y	2
Novalen, M	1
Hayes, MA	1
Zuniga, I	1
Biot, M	1
Ford, NP	1
Rasschaert, F	1
Agbaji, O	1
Thio, CL	1
Meloni, S	1
Graham, C	1
Muazu, M	1
Nimzing, L	1
Idoko, J	1
Sankalé, JL	1
Ekong, E	1
Murphy, R	1
Kanki, P	1
Hawkins, C	1
Zhang, C	1
Wang, W	1
Zhou, M	1
Han, Y	1
Xie, J	1
Qiu, Z	1
Guo, F	1
Wang, H	1
Ghanem, KG	1
Li, T	1
Phillips, E	1
Bartlett, JA	2
Sanne, I	2
Lederman, MM	2
Hinkle, J	2
Rousseau, F	2
Dunn, D	1
Pavlos, R	1
James, I	1
Mallal, SA	1
Haas, DW	3
Chan, J	1
Núñez, M	1
González-Requena, D	1
González-Lahoz, J	1
Pulido, F	1
Torralba, M	1
Knudtson, E	1
Para, M	1
Boswell, H	1
Fan-Havard, P	1
Kontorinis, N	1
Dieterich, DT	2
Law, WP	1
Dore, GJ	1
Duncombe, CJ	1
Mahanontharit, A	1
Boyd, MA	1
Ruxrungtham, K	1
Lange, JM	4
Phanuphak, P	1
Cooper, DA	1
Ena, J	1
Amador, C	1
Benito, C	1
Fenoll, V	1
Pasquau, F	1
Becker, S	1
Robinson, PA	2
Love, J	1
Stern, JO	1
Baylor, MS	1
Johann-Liang, R	1
Rodríguez Guardado, A	1
Maradona Hidalgo, JA	1
Asensi Alvarez, V	1
Cartón Sánchez, JA	1
Wooltorton, E	1
Mackie, NE	1
Fidler, S	1
Tamm, N	1
Clarke, JR	1
Back, D	1
Weber, JN	1
Taylor, GP	2
Negredo, E	2
Moltó, J	1
Muñoz-Moreno, JA	1
Pedrol, E	1
Ribera, E	1
Viciana, P	1
Galindos, MJ	1
Miralles, C	1
Rodriguez Fumaz, C	1
Puig, J	1
Gel, S	1
Rodríguez, E	1
Videla, S	1
Ruiz, L	1
Clotet, B	2
Shahar, E	1
Krivoy, N	1
Weltfriend, S	1
Pollack, S	1
Aranzabal, L	1
Casado, JL	1
Moya, J	1
Quereda, C	1
Diz, S	1
Moreno, A	2
Moreno, L	1
Antela, A	1
Perez-Elias, MJ	1
Dronda, F	1
Marín, A	1
Hernandez-Ranz, F	1
Moreno, S	1
de Maat, MM	1
Beijnen, JH	2
Schellens, JH	1
Mulder, JW	1
Thorne, C	1
Newell, ML	1
Timmermans, S	1
Tempelman, C	1
Nellen, J	1
Dieleman, J	1
Sprenger, H	1
Schneider, ME	1
De Requena, DG	1
Jiménez-Nácher, I	1
Kappelhoff, BS	1
van Leth, F	1
MacGregor, TR	1
Baraldi, E	1
Montella, F	1
Uip, DE	1
Thompson, MA	1
Russell, DB	1
Huitema, AD	1
Girault, V	1
Lyons, F	1
Hopkins, S	1
Kelleher, B	1
McGeary, A	1
Sheehan, G	1
Geoghegan, J	1
Bergin, C	1
Mulcahy, FM	1
McCormick, PA	1
Drummond, NS	1
Vilar, FJ	1
Naisbitt, DJ	1
Hanson, A	1
Woods, A	1
Park, BK	1
Ritchie, MD	1
Motsinger, AA	1
Donahue, JP	1
Erdem, H	1
Raffanti, S	1
Rebeiro, P	1
George, AL	1
Kim, RB	2
Haines, JL	1
Sterling, TR	1
Andersen, JW	1
Wilkinson, GR	1
Ingram, CD	1
Shaw, A	1
Walubo, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Optimal Combination Therapy After Nevirapine Exposure[NCT00089505]	Phase 3	745 participants (Actual)	Interventional	2006-11-30	Completed
A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols[NCT00411983]		10,000 participants (Anticipated)	Observational	2002-11-30	Recruiting
Hepatic Safety of Currently Used Antiretroviral Regimens in HIV-infected Patients With Chronic Hepatitis B and/or Hepatitis C Under Real Life Conditions: The HEPAVIR HEPATIC SAFETY Cohort.[NCT01908660]		192 participants (Actual)	Observational [Patient Registry]	2007-01-31	Completed
A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants[NCT00076791]	Phase 1	66 participants (Actual)	Interventional	2004-03-31	Completed
Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine/Didanosine or Zidovudine/Di[NCT00109590]	Phase 2	175 participants (Actual)	Interventional	2006-06-30	Completed
EuroSIDA Prospective Observational Cohort Study on Clinical and Virological Outcome of European Patients Infected With HIV[NCT02699736]		23,000 participants (Actual)	Observational [Patient Registry]	1994-01-31	Enrolling by invitation
Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV[NCT00051090]		0 participants (Actual)	Interventional		Withdrawn
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.

Intervention	participants (Number)
NVP/NVP	6
NVP/LPV_r	4
NoNVP/NVP	19
NoNVP/LPV_r	26

The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Experienced Virologic Failure or Died.

Intervention	participants (Number)
NVP/NVP	15
NVP/LPV_r	0
NoNVP/NVP	35
NoNVP/LPV_r	0

Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality

Intervention	participants (Number)
NVP/NVP	32
NVP/LPV_r	10
NoNVP/NVP	42
NoNVP/LPV_r	50

Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.

CD4 Count Change From Randomization

Intervention	participants (Number)
NVP/NVP	20
NoNVP/NVP	51

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.

Percent of Participants Who Experienced Virologic Failure or Died

Intervention	cells/mm^3 (Median)
	Week 48 CD4 count change from randomization	Week 96 CD4 count change from randomization
NoNVP/LPV_r	172	256
NoNVP/NVP	172	223
NVP/LPV_r	201	278
NVP/NVP	191	291

Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month

Intervention	Percent of participants (Number)
	week 48 percent of virologic failure or death	week 96 percent of virologic failure or death
NoNVP/LPV_r	14	20
NoNVP/NVP	14	17
NVP/LPV_r	4	12
NVP/NVP	23	31

Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry

Intervention	percent of participants (Number)
	week 48 percent of full adherence in past month	week 96 percent of full adherence in past month
NoNVP/LPV_r	86	87
NoNVP/NVP	90	93
NVP/LPV_r	88	95
NVP/NVP	89	94

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.

Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry

Intervention	weeks (Number)
	5th percentile	10th percentile	25th percentile
NVP/LPV_r	60	84	NA
NVP/NVP	12	12	60

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.

Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)

Intervention	weeks (Number)
	5th percentile	10th percentile	25th percentile
NoNVP/LPV_r	12	36	132
NoNVP/NVP	24	36	NA

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).

Intervention	ug*hr/mL (Median)
Within 72 Hrs Ppm	99.7
At Day 30 Ppm	NA

Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .

Intervention	ug/mL (Median)
Within 72 Hrs Ppm	10.78
At Day 30 Ppm	12.96

Median HIV-1 Viral Load at 24 Weeks Postpartum in Women

Number of Women With Grade >=3 Events After Start of Study Treatment

Intervention	ug/mL (Median)
Within 72 Hrs Ppm	11.2
At Day 30 Ppm	NA

Intervention	log10 copies/mL (Median)
Arm A : LPV/r x 7d	4.3
Arm B : no LPV/r	3.9
Arm C: LPV/r x 30d	4.0

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included. (NCT00109590)
Timeframe: After start of study Treatment (postpartum)

Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).

Intervention	participants (Number)
Arm A : LPV/r x 7d	2
Arm B : no LPV/r	0
Arm C: LPV/r x 30d	2

Resistance Mutations in HIV Infected Infants

Intervention	ug/mL (Median)
Within 72 Hrs Ppm	6.08
At Day 30 Ppm	9.17

Resistance mutations as identified by consensus sequencing or OLA (NCT00109590)
Timeframe: 24 weeks postpartum

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma

Intervention	participants (Number)
Arm B : no LPV/r	0
Arm C: LPV/r x 30d	0

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: at Day 10 or Week 6 postpartum.

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry

Intervention	percent of participants (Number)
Arm A : LPV/r x 7d	3.6
Arm B : no LPV/r	7.1
Arm C : LPV/r x 30d	5.3

The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).

Intervention	percent of participants (Number)
Arm A: LPV/r x 7d	4.9
Arm B: no LPV/r	9.5
Arm C : LPV/r x 30d	7.0

The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: within 8 weeks postpartum.

Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.

Intervention	percent of participants (Number)
Arm A : LPV/r x 7d	7.1
Arm B : no LPV/r	12.5
Arm C: LPV/r x 30d	5.3

Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation. (NCT00109590)
Timeframe: within 72 weeks postpartum

The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.

Intervention	participants (Number)
	OLA in plasma samples	OLA in PBMC
Arm A : LPV/r x 7d	0	0
Arm B : no LPV/r	0	0
Arm C: LPV/r x 30d	0	1

(NCT00109590)
Timeframe: At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).

Article	Year
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans. Drug discovery today, 2016, Volume: 21, Issue:4 Topics: Chemical and Drug Induced Liver Injury; Databases, Factual; Drug Labeling; Humans; Pharmaceutical Pr	2016
HLA-allelotype associations with nevirapine-induced hypersensitivity reactions and hepatotoxicity: a systematic review of the literature and meta-analysis. Pharmacogenetics and genomics, 2015, Volume: 25, Issue:4 Topics: Case-Control Studies; Chemical and Drug Induced Liver Injury; Ethnicity; Genetic Association Studies	2015
Hepatotoxicity associated with long- versus short-course HIV-prophylactic nevirapine use: a systematic review and meta-analysis from the Research on Adverse Drug events And Reports (RADAR) project. Drug safety, 2009, Volume: 32, Issue:2 Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injur	2009
Noncirrhotic portal hypertension associated with didanosine: a case report and literature review. Japanese journal of infectious diseases, 2012, Volume: 65, Issue:1 Topics: Aged, 80 and over; Antiretroviral Therapy, Highly Active; Ascites; Chemical and Drug Induced Liver I	2012
NNRTI hepatotoxicity: efavirenz versus nevirapine. Journal of HIV therapy, 2002, Volume: 7 Suppl 2 Topics: Alkynes; Anti-HIV Agents; Benzoxazines; Chemical and Drug Induced Liver Injury; Cyclopropanes; Hepat	2002
Toxicity of non-nucleoside analogue reverse transcriptase inhibitors. Seminars in liver disease, 2003, Volume: 23, Issue:2 Topics: Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemical and Drug Ind	2003
Hepatotoxicity associated with nevirapine use. Journal of acquired immune deficiency syndromes (1999), 2004, Apr-15, Volume: 35, Issue:5 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Clinical Trials as Topic; Female; HIV Infec	2004
The safety of antiretroviral drugs in pregnancy. Expert opinion on drug safety, 2005, Volume: 4, Issue:2 Topics: Abnormalities, Drug-Induced; Acidosis, Lactic; Anemia; Animals; Anti-Retroviral Agents; Chemical and	2005
The safety of antiretroviral drugs in pregnancy. Expert opinion on drug safety, 2005, Volume: 4, Issue:2 Topics: Abnormalities, Drug-Induced; Acidosis, Lactic; Anemia; Animals; Anti-Retroviral Agents; Chemical and	2005
The safety of antiretroviral drugs in pregnancy. Expert opinion on drug safety, 2005, Volume: 4, Issue:2 Topics: Abnormalities, Drug-Induced; Acidosis, Lactic; Anemia; Animals; Anti-Retroviral Agents; Chemical and	2005
The safety of antiretroviral drugs in pregnancy. Expert opinion on drug safety, 2005, Volume: 4, Issue:2 Topics: Abnormalities, Drug-Induced; Acidosis, Lactic; Anemia; Animals; Anti-Retroviral Agents; Chemical and	2005
[The treatment of HIV infection]. Presse medicale (Paris, France : 1983), 2005, Nov-19, Volume: 34, Issue:20 Pt 2 Topics: Adenine; Anti-Retroviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; Clinical Trials	2005
Efavirenz and nevirapine in HIV-1 infection : is there a role for clinical pharmacokinetic monitoring? Clinical pharmacokinetics, 2007, Volume: 46, Issue:2 Topics: Algorithms; Alkynes; Anti-HIV Agents; Benzoxazines; Chemical and Drug Induced Liver Injury; Cyclopro	2007
Liver toxicity induced by non-nucleoside reverse transcriptase inhibitors. The Journal of antimicrobial chemotherapy, 2007, Volume: 59, Issue:3 Topics: Alanine Transaminase; Alkynes; Anti-HIV Agents; Aspartate Aminotransferases; Benzoxazines; Chemical	2007
Once-daily nevirapine dosing: a pharmacokinetics, efficacy and safety review. HIV medicine, 2007, Volume: 8, Issue:1 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Tolerance; Exanthema; HIV Infections;	2007
Is it safe to switch between efavirenz and nevirapine in the event of toxicity? The Lancet. Infectious diseases, 2007, Volume: 7, Issue:11 Topics: Alkynes; Benzoxazines; Chemical and Drug Induced Liver Injury; Cross Reactions; Cyclopropanes; Drug	2007
Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts. HIV medicine, 2008, Volume: 9, Issue:4 Topics: Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Drug Therapy,	2008
Nevirapine-induced hepatitis: a case series and review of the literature. The AIDS reader, 2001, Volume: 11, Issue:7 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; Humans; Liver Function Tests	2001
[U.S. warns on some use of anti-AIDS drug]. Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2001, Volume: 121, Issue:9 Topics: Acquired Immunodeficiency Syndrome; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Humans;	2001

Article	Year
Livolin ameliorates elevations in alanine transaminase in HIV infected patients commencing highly active antiretroviral therapy. African journal of medicine and medical sciences, 2012, Volume: 41, Issue:4 Topics: Adult; Alanine Transaminase; Alkaline Phosphatase; Anti-HIV Agents; Antiretroviral Therapy, Highly A	2012
Concomitant use of nonnucleoside analogue reverse transcriptase inhibitors and rifampicin in TB/HIV type 1-coinfected patients. AIDS research and human retroviruses, 2008, Volume: 24, Issue:7 Topics: Adult; Alkynes; Antibiotics, Antitubercular; Antiretroviral Therapy, Highly Active; Benzoxazines; Ch	2008
Strategies for nevirapine initiation in HIV-infected children taking pediatric fixed-dose combination "baby pills" in Zambia: a randomized controlled trial. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2010, Nov-01, Volume: 51, Issue:9 Topics: Alanine Transaminase; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Aspartate Aminotransfe	2010
Hepatotoxicity in patients co-infected with tuberculosis and HIV-1 while receiving non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy and rifampicin-containing anti-tuberculosis regimen. The Southeast Asian journal of tropical medicine and public health, 2011, Volume: 42, Issue:3 Topics: Adult; Alkynes; Antibiotics, Antitubercular; Benzoxazines; Chemical and Drug Induced Liver Injury; C	2011
Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women. AIDS (London, England), 2012, Apr-24, Volume: 26, Issue:7 Topics: Adult; Africa South of the Sahara; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Dru	2012
The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China: a change in national treatment guidelines may be warranted. Journal of acquired immune deficiency syndromes (1999), 2013, Apr-15, Volume: 62, Issue:5 Topics: Adult; Alanine Transaminase; Aspartate Aminotransferases; Bilirubin; CD4 Lymphocyte Count; Chemical	2013
Associations between HLA-DRB10102, HLA-B5801, and hepatotoxicity during initiation of nevirapine-containing regimens in South Africa. Journal of acquired immune deficiency syndromes (1999), 2013, Feb-01, Volume: 62, Issue:2 Topics: Adult; Alanine Transaminase; Anti-HIV Agents; Aryl Hydrocarbon Hydroxylases; Aspartate Aminotransfer	2013
Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral therapy, 2004, Volume: 9, Issue:3 Topics: Adenine; Adult; Anti-HIV Agents; CD4 Lymphocyte Count; CD4-CD8 Ratio; Chemical and Drug Induced Live	2004
Highly active antiretroviral treatment containing efavirenz or nevirapine and related toxicity in the TREAT Asia HIV Observational Database. Journal of acquired immune deficiency syndromes (1999), 2006, Dec-01, Volume: 43, Issue:4 Topics: Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemical and Drug Ind	2006
Safety of nevirapine in pregnancy. HIV medicine, 2007, Volume: 8, Issue:1 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Exanthema	2007
Risk of discontinuation of nevirapine due to toxicities in antiretroviral-naive and -experienced HIV-infected patients with high and low CD4+ T-cell counts. Antiviral therapy, 2007, Volume: 12, Issue:3 Topics: Adult; Anti-HIV Agents; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Argentina; CD	2007
Safety of switching to nevirapine-based highly active antiretroviral therapy at elevated CD4 cell counts in a resource-constrained setting. Journal of acquired immune deficiency syndromes (1999), 2007, Aug-15, Volume: 45, Issue:5 Topics: Adult; Alkynes; Antiretroviral Therapy, Highly Active; Benzoxazines; CD4 Lymphocyte Count; Chemical	2007
Discontinuation of nevirapine because of hypersensitivity reactions in patients with prior treatment experience, compared with treatment-naive patients: the ATHENA cohort study. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2008, Mar-15, Volume: 46, Issue:6 Topics: Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Cohort Studies	2008
Spanish study looks at the effect of nevirapine on the liver. TreatmentUpdate, 2001, Volume: 13, Issue:3 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; HIV Infections; Humans; Liver; Live	2001

Article	Year
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species. Chemical research in toxicology, 2010, Volume: 23, Issue:1 Topics: Animals; Chemical and Drug Induced Liver Injury; Cluster Analysis; Databases, Factual; Humans; MEDLI	2010
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development. Toxicological sciences : an official journal of the Society of Toxicology, 2010, Volume: 118, Issue:2 Topics: Animals; ATP Binding Cassette Transporter, Subfamily B, Member 11; ATP-Binding Cassette Transporters	2010
FDA-approved drug labeling for the study of drug-induced liver injury. Drug discovery today, 2011, Volume: 16, Issue:15-16 Topics: Animals; Benchmarking; Biomarkers, Pharmacological; Chemical and Drug Induced Liver Injury; Drug Des	2011
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). PLoS computational biology, 2011, Volume: 7, Issue:12 Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da	2011
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds. Chemical research in toxicology, 2012, Oct-15, Volume: 25, Issue:10 Topics: Chemical and Drug Induced Liver Injury; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme	2012
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification. Drug metabolism and disposition: the biological fate of chemicals, 2012, Volume: 40, Issue:12 Topics: Animals; ATP Binding Cassette Transporter, Subfamily B, Member 11; ATP-Binding Cassette Transporters	2012
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. Toxicological sciences : an official journal of the Society of Toxicology, 2013, Volume: 136, Issue:1 Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily	2013
Prevalence of ABCC3-1767G/A polymorphism among patients with antiretroviral-associated hepatotoxicity. Molecular genetics & genomic medicine, 2020, Volume: 8, Issue:6 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; Humans; Male; Middle Aged; M	2020
HBV, HCV, and HBV/HCV co-infection among HIV-positive patients in Hunan province, China: Regimen selection, hepatotoxicity, and antiretroviral therapy outcome. Journal of medical virology, 2018, Volume: 90, Issue:3 Topics: Adult; Alkynes; Anti-Retroviral Agents; Benzoxazines; CD4 Lymphocyte Count; Chemical and Drug Induce	2018
Determinants of anti-retroviral regimen changes among HIV/AIDS patients of east and west Wollega zone health institutions, Oromia region, west Ethiopia: a cross-sectional study. BMC pharmacology & toxicology, 2018, 06-05, Volume: 19, Issue:1 Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injury; Cros	2018
Clinical and genetic factors associated with increased risk of severe liver toxicity in a monocentric cohort of HIV positive patients receiving nevirapine-based antiretroviral therapy. BMC infectious diseases, 2018, Nov-12, Volume: 18, Issue:1 Topics: Adult; Anti-HIV Agents; Anti-Retroviral Agents; Chemical and Drug Induced Liver Injury; Drug Therapy	2018
Occurrence of CYP2B6 516G>T polymorphism in patients with ARV-associated hepatotoxicity. Molecular genetics & genomic medicine, 2019, Volume: 7, Issue:4 Topics: Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Chemical and Drug Induced Liver Injury; Cyclopropanes	2019
Low risk of liver toxicity using the most recently approved antiretroviral agents but still increased in HIV-hepatitis C virus coinfected patients. AIDS (London, England), 2013, Apr-24, Volume: 27, Issue:7 Topics: Alkynes; Anti-HIV Agents; Atazanavir Sulfate; Benzoxazines; CD4 Lymphocyte Count; Chemical and Drug	2013
The impact of HBV or HCV infection in a cohort of HIV-infected pregnant women receiving a nevirapine-based antiretroviral regimen in Malawi. BMC infectious diseases, 2014, Apr-04, Volume: 14 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Coinfection; Female; Hepatitis B; He	2014
[Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy]. Enfermedades infecciosas y microbiologia clinica, 2016, Volume: 34, Issue:1 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Cross-Sectional Studies; Female; HIV Infect	2016
Proteomic analysis of serum and urine of HIV-monoinfected and HIV/HCV-coinfected patients undergoing long term treatment with nevirapine. Disease markers, 2014, Volume: 2014 Topics: Alanine Transaminase; Anti-HIV Agents; Biomarkers; Blood Proteins; Chemical and Drug Induced Liver I	2014
The Combination of Anti-CTLA-4 and PD1-/- Mice Unmasks the Potential of Isoniazid and Nevirapine To Cause Liver Injury. Chemical research in toxicology, 2015, Dec-21, Volume: 28, Issue:12 Topics: Animals; Antibodies, Monoclonal; Chemical and Drug Induced Liver Injury; Disease Models, Animal; Fem	2015
Transcriptional profiling suggests that Nevirapine and Ritonavir cause drug induced liver injury through distinct mechanisms in primary human hepatocytes. Chemico-biological interactions, 2016, Aug-05, Volume: 255 Topics: Anti-HIV Agents; Cell Culture Techniques; Cells, Cultured; Chemical and Drug Induced Liver Injury; D	2016
Hepatotoxicity in patients prescribed efavirenz or nevirapine. European journal of medical research, 2008, Jul-28, Volume: 13, Issue:7 Topics: Adult; Alkynes; Benzoxazines; CD4-Positive T-Lymphocytes; Chemical and Drug Induced Liver Injury; Cy	2008
The spectrum of liver diseases in HIV infected individuals at an HIV treatment clinic in Kampala, Uganda. African health sciences, 2008, Volume: 8, Issue:1 Topics: Anti-HIV Agents; Antitubercular Agents; Chemical and Drug Induced Liver Injury; Comorbidity; Female;	2008
Long-term follow-up of nevirapine-treated patients in a single-centre cohort. HIV medicine, 2009, Volume: 10, Issue:8 Topics: Adult; Alanine Transaminase; Anti-Retroviral Agents; Aspartate Aminotransferases; CD4 Lymphocyte Cou	2009
Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure. AIDS (London, England), 2009, Nov-27, Volume: 23, Issue:18 Topics: Anti-HIV Agents; Anti-Retroviral Agents; Chemical and Drug Induced Liver Injury; Female; HIV Infecti	2009
Lack of increased hepatotoxicity in HIV-infected pregnant women receiving nevirapine compared with other antiretrovirals. AIDS (London, England), 2010, Jan-02, Volume: 24, Issue:1 Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Chemical and Drug Indu	2010
Nevirapine-induced hepatotoxicity and pharmacogenetics: a retrospective study in a population from Mozambique. Pharmacogenomics, 2010, Volume: 11, Issue:1 Topics: Alleles; Anti-HIV Agents; Aryl Hydrocarbon Hydroxylases; ATP Binding Cassette Transporter, Subfamily	2010
Outcomes and safety of concomitant nevirapine and rifampicin treatment under programme conditions in Malawi. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2010, Volume: 14, Issue:2 Topics: Adolescent; Adult; Anti-HIV Agents; Antibiotics, Antitubercular; Chemical and Drug Induced Liver Inj	2010
Nevirapine-associated early hepatotoxicity: incidence, risk factors, and associated mortality in a primary care ART programme in South Africa. PloS one, 2010, Feb-17, Volume: 5, Issue:2 Topics: Adult; Alanine Transaminase; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Chemical a	2010
Hepatotoxicity and effectiveness of a Nevirapine-based antiretroviral therapy in HIV-infected patients with or without viral hepatitis B or C infection in Cameroon. BMC public health, 2010, Mar-01, Volume: 10 Topics: Adult; Anti-HIV Agents; Cameroon; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Coho	2010
Incidence and risk factors of severe adverse events with nevirapine-based antiretroviral therapy in HIV-infected women. MTCT-Plus program, Abidjan, Côte d'Ivoire. BMC infectious diseases, 2010, Jun-24, Volume: 10 Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injur	2010
Nevirapine-associated hepatotoxicity was not predicted by CD4 count ≥250 cells/μL among women in Zambia, Thailand and Kenya. HIV medicine, 2010, Volume: 11, Issue:10 Topics: Adolescent; Adult; Alanine Transaminase; Aspartate Aminotransferases; CD4 Lymphocyte Count; Chemical	2010
[Nevirapine related hepatotoxicity: the prevalence and risk factors in a cohort of ART naive Han Chinese with AIDS]. Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology, 2010, Volume: 18, Issue:9 Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; Anti-Retroviral Agents; Asian People; Chemica	2010
Discontinuation rate of nevirapine-based highly active antiretroviral therapy. AIDS research and human retroviruses, 2012, Volume: 28, Issue:1 Topics: Adult; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Chemical and Drug Induced Liver	2012
HAART induced adverse drug reactions: a retrospective analysis at a tertiary referral health care center in India. The International journal of risk & safety in medicine, 2011, Volume: 23, Issue:3 Topics: Alkynes; Anemia; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemical and Drug Induced Live	2011
Liver injury in HIV-1-infected patients receiving non-nucleosides reverse transcriptase inhibitors-based antiretroviral therapy. Chinese medical journal, 2010, Volume: 123, Issue:24 Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; Antiretroviral Therapy, Highly Active; Chemic	2010
Hcv coinfection, an important risk factor for hepatotoxicity in pregnant women starting antiretroviral therapy. The Journal of infection, 2012, Volume: 64, Issue:4 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Cohort Studies; Coinfection; Drug Th	2012
Rash, hepatotoxicity and hyperbilirubinemia among Kenyan infants born to HIV-infected women receiving triple-antiretroviral drugs for the prevention of mother-to-child HIV transmission. The Pediatric infectious disease journal, 2012, Volume: 31, Issue:11 Topics: Adult; Aging, Premature; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Eruptions; Fe	2012
Bioactivation of nevirapine to a reactive quinone methide: implications for liver injury. Chemical research in toxicology, 2012, Aug-20, Volume: 25, Issue:8 Topics: Animals; Antibodies; Aryl Hydrocarbon Hydroxylases; Chemical and Drug Induced Liver Injury; Cytochro	2012
Nevirapine- and efavirenz-associated hepatotoxicity under programmatic conditions in Kenya and Mozambique. International journal of STD & AIDS, 2012, Volume: 23, Issue:6 Topics: Adult; Alkynes; Analysis of Variance; Anti-HIV Agents; Benzoxazines; Chemical and Drug Induced Liver	2012
Impact of hepatitis C virus on HIV response to antiretroviral therapy in Nigeria. Journal of acquired immune deficiency syndromes (1999), 2013, Feb-01, Volume: 62, Issue:2 Topics: Adult; Alanine Transaminase; Alkynes; Anti-Retroviral Agents; Benzoxazines; Chemical and Drug Induce	2013
Hepatotoxicity after prophylaxis with a nevirapine-containing antiretroviral regimen. Annals of internal medicine, 2002, Jul-16, Volume: 137, Issue:2 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; HIV Infections; Humans; Nevirapine; Occupat	2002
Short communication: interactions between nevirapine plasma levels, chronic hepatitis C, and the development of liver toxicity in HIV-infected patients. AIDS research and human retroviruses, 2003, Volume: 19, Issue:3 Topics: Alanine Transaminase; Anti-HIV Agents; Antibodies, Viral; Antiretroviral Therapy, Highly Active; Che	2003
Drug rash with eosinophilia and systemic symptoms syndrome and renal toxicity with a nevirapine-containing regimen in a pregnant patient with human immunodeficiency virus. Obstetrics and gynecology, 2003, Volume: 101, Issue:5 Pt 2 Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injur	2003
Risk of severe hepatotoxicity associated with antiretroviral therapy in the HIV-NAT Cohort, Thailand, 1996-2001. AIDS (London, England), 2003, Oct-17, Volume: 17, Issue:15 Topics: Adult; Alkynes; Anti-Retroviral Agents; Benzoxazines; Chemical and Drug Induced Liver Injury; Cyclop	2003
Risk and determinants of developing severe liver toxicity during therapy with nevirapine-and efavirenz-containing regimens in HIV-infected patients. International journal of STD & AIDS, 2003, Volume: 14, Issue:11 Topics: Adult; Alanine Transaminase; Alcoholism; Alkynes; Anti-HIV Agents; Benzoxazines; Chemical and Drug I	2003
Liver toxicity in epidemiological cohorts. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2004, Mar-01, Volume: 38 Suppl 2 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Cohort Studies; Humans; Multivariate Analys	2004
Drug-induced liver injury associated with the use of nonnucleoside reverse-transcriptase inhibitors. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2004, Mar-01, Volume: 38 Suppl 2 Topics: Adult; Chemical and Drug Induced Liver Injury; Female; HIV Infections; Humans; Liver; Liver Diseases	2004
[Assessment of nevirapine liver toxicity in patients with HIV and HVC coinfection]. Medicina clinica, 2004, Mar-06, Volume: 122, Issue:8 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; Hepatitis C, Chronic; HIV In	2004
HIV drug nevirapine (Viramune): risk of severe hepatotoxicity. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2004, Mar-30, Volume: 170, Issue:7 Topics: Alanine Transaminase; Anti-HIV Agents; Aspartate Aminotransferases; Chemical and Drug Induced Liver	2004
Clinical implications of stopping nevirapine-based antiretroviral therapy: relative pharmacokinetics and avoidance of drug resistance. HIV medicine, 2004, Volume: 5, Issue:3 Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Chemical and Drug Indu	2004
Nevirapine warning. AIDS patient care and STDs, 2004, Volume: 18, Issue:4 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; HIV Infections; Humans; Nevirapine;	2004
Severe leukopenia associated with mild hepatotoxicity in an HIV carrier treated with nevirapine. Japanese journal of infectious diseases, 2004, Volume: 57, Issue:5 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; HIV Infections; Humans; Leuk	2004
Influence of liver fibrosis on highly active antiretroviral therapy-associated hepatotoxicity in patients with HIV and hepatitis C virus coinfection. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2005, Feb-15, Volume: 40, Issue:4 Topics: Adult; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemical and D	2005
Chronic hepatotoxicity after long-term antiretroviral treatment including nevirapine. The Journal of infection, 2005, Volume: 50, Issue:3 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Chronic Disease; HIV Infections; Hum	2005
Nelfinavir and nevirapine side effects during pregnancy. AIDS (London, England), 2005, May-20, Volume: 19, Issue:8 Topics: Adult; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Case-Control Studies; CD4 Lymp	2005
Changes in nevirapine plasma concentrations over time and its relationship with liver enzyme elevations. AIDS research and human retroviruses, 2005, Volume: 21, Issue:6 Topics: Adult; Alanine Transaminase; Anti-HIV Agents; Aspartate Aminotransferases; Chemical and Drug Induced	2005
Are adverse events of nevirapine and efavirenz related to plasma concentrations? Antiviral therapy, 2005, Volume: 10, Issue:4 Topics: Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Central Nervous System Diseases; Chemical and Drug In	2005
Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy. HIV medicine, 2006, Volume: 7, Issue:4 Topics: Adolescent; Adult; Anti-HIV Agents; Anti-Retroviral Agents; CD4 Lymphocyte Count; Chemical and Drug	2006
Drug-specific T cells in an HIV-positive patient with nevirapine-induced hepatitis. Antiviral therapy, 2006, Volume: 11, Issue:3 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; HIV Seropositivity; HIV-1; Humans; M	2006
Drug transporter and metabolizing enzyme gene variants and nonnucleoside reverse-transcriptase inhibitor hepatotoxicity. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2006, Sep-15, Volume: 43, Issue:6 Topics: Adult; Alkynes; Anti-HIV Agents; Aryl Hydrocarbon Hydroxylases; Benzoxazines; Case-Control Studies;	2006
Pharmacogenetics of nevirapine-associated hepatotoxicity: an Adult AIDS Clinical Trials Group collaboration. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2006, Sep-15, Volume: 43, Issue:6 Topics: Adult; Anti-HIV Agents; Aryl Hydrocarbon Hydroxylases; Case-Control Studies; Chemical and Drug Induc	2006
RAT CYP3A and CYP2B1/2 were not associated with nevirapine-induced hepatotoxicity. Methods and findings in experimental and clinical pharmacology, 2006, Volume: 28, Issue:7 Topics: Administration, Oral; Alanine Transaminase; Animals; Anti-HIV Agents; Aryl Hydrocarbon Hydroxylases;	2006
Nevirapine versus efavirenz in 742 patients: no link of liver toxicity with female sex, and a baseline CD4 cell count greater than 250 cells/microl. AIDS (London, England), 2006, Nov-14, Volume: 20, Issue:17 Topics: Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; CD4 Lymphocyte Count;	2006
Clinical toxicity of highly active antiretroviral therapy in a home-based AIDS care program in rural Uganda. Journal of acquired immune deficiency syndromes (1999), 2007, Apr-01, Volume: 44, Issue:4 Topics: Acquired Immunodeficiency Syndrome; Adult; Aged; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, H	2007
Nodular regenerative hyperplasia: a new serious antiretroviral drugs side effect? AIDS (London, England), 2007, Jul-11, Volume: 21, Issue:11 Topics: Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injur	2007
Safety issues about nevirapine administration in HIV-infected pregnant women. Journal of acquired immune deficiency syndromes (1999), 2007, Jul-01, Volume: 45, Issue:3 Topics: Adult; Anti-HIV Agents; Bilirubin; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Con	2007
Analysis of severe hepatic events associated with nevirapine-containing regimens: CD4+ T-cell count and gender in hepatitis C seropositive and seronegative patients. Drug safety, 2007, Volume: 30, Issue:12 Topics: Adult; Alanine Transaminase; Anti-HIV Agents; Aspartate Aminotransferases; CD4 Lymphocyte Count; Che	2007
Risk of side effects associated with the use of nevirapine in treatment-naïve patients, with respect to gender and CD4 cell count. HIV medicine, 2008, Volume: 9, Issue:1 Topics: Anti-HIV Agents; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Exanthema; Female; HI	2008
Nevirapine-associated toxicity in Niger. HIV medicine, 2008, Volume: 9, Issue:1 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Epidemiologic Methods; Exanthema; Fe	2008
Nevirapine-induced side effects in pregnant women: experience of a Brazilian university hospital. The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases, 2007, Volume: 11, Issue:6 Topics: Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Drug Eruptions	2007
Incidence of nevirapine-associated hepatitis in an antenatal clinic. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2008, Volume: 98, Issue:2 Topics: Adult; Alanine Transaminase; Ambulatory Care Facilities; Chemical and Drug Induced Liver Injury; Fem	2008
Spectrum of adverse events after generic HAART in southern Indian HIV-infected patients. AIDS patient care and STDs, 2008, Volume: 22, Issue:4 Topics: Adult; Anemia; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Chemica	2008
Nevirapine-induced hepatitis treated with corticosteroids? AIDS (London, England), 1998, Jun-18, Volume: 12, Issue:9 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; Glucocorticoids; HIV Infecti	1998
Late onset hepatitis and prolonged deterioration in hepatic function associated with nevirapine therapy. International journal of STD & AIDS, 2000, Volume: 11, Issue:5 Topics: Anti-HIV Agents; Biopsy; Chemical and Drug Induced Liver Injury; HIV Infections; Humans; Liver; Male	2000
[Hepatitis and nevirapine]. Medicina clinica, 2000, Apr-22, Volume: 114, Issue:15 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Female; Humans; Male; Middle Aged; N	2000
Europe warned of side effects. AIDS patient care and STDs, 2000, Volume: 14, Issue:7 Topics: Chemical and Drug Induced Liver Injury; Drug Eruptions; Europe; HIV Infections; Humans; Liver Failur	2000
Severe hepatic and cutaneous adverse effects with nevirapine. Prescrire international, 2000, Volume: 9, Issue:48 Topics: Chemical and Drug Induced Liver Injury; Humans; Nevirapine; Oxazines; Reverse Transcriptase Inhibito	2000
Adverse effects associated with use of nevirapine in HIV postexposure prophylaxis for 2 health care workers. JAMA, 2000, Dec-06, Volume: 284, Issue:21 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Female; H	2000
Nevirapine should not be prescribed for needlestick injuries. BMJ (Clinical research ed.), 2001, Jan-20, Volume: 322, Issue:7279 Topics: Acquired Immunodeficiency Syndrome; Acute Disease; Anti-HIV Agents; Chemical and Drug Induced Liver	2001
Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000. MMWR. Morbidity and mortality weekly report, 2001, Jan-05, Volume: 49, Issue:51-52 Topics: Adult; Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Eruptions; Female; HIV Infectio	2001
Revised nevirapine insert. AIDS patient care and STDs, 2001, Volume: 15, Issue:2 Topics: Anti-HIV Agents; Chemical and Drug Induced Liver Injury; Drug Labeling; Humans; Nevirapine	2001
Jaundice and hepatocellular damage associated with nevirapine therapy. The American journal of gastroenterology, 2001, Volume: 96, Issue:5 Topics: Adult; Chemical and Drug Induced Liver Injury; HIV Infections; Humans; Jaundice; Male; Middle Aged;	2001
Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: role of hepatitis C and B infections. Hepatology (Baltimore, Md.), 2002, Volume: 35, Issue:1 Topics: Adult; Alanine Transaminase; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Aspart	2002
Optimal treatment of nevirapine-associated hepatotoxicity remains uncertain. The AIDS reader, 2001, Volume: 11, Issue:11 Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Drug Induced Liver Injur	2001
[Hepatotoxicity with antiretroviral therapy. The liver is affected as well]. MMW Fortschritte der Medizin, 2002, Apr-09, Volume: 144 Suppl 1 Topics: Acquired Immunodeficiency Syndrome; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical	2002
Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. The Journal of infectious diseases, 2002, Jul-01, Volume: 186, Issue:1 Topics: Adult; Alanine Transaminase; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Chemical and Dr	2002

nevirapine and Acute Liver Injury, Drug-Induced