WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with VIRAMUNE. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4 counts at initiation of therapy place patients at increased risk; women with CD4 counts >250 cells/mm3, including pregnant women receiving VIRAMUNE in combination with other antiretrovirals for the treatment of HIV infection, are at the greatest risk. However, hepatotoxicity associated with VIRAMUNE use can occur in both genders, all CD4 counts and at any time during treatment. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue VIRAMUNE and seek medical evaluation immediately [ see Warnings and Precautions ].
Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue VIRAMUNE and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with VIRAMUNE 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [ see Warnings and Precautions ].
Patients must be monitored intensively during the first 18 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart VIRAMUNE following severe hepatic, skin or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Published Studies Related to Viramune (Nevirapine)
Efficacy and safety of an extended nevirapine regimen in infant children of
breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1
transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. 
months... INTERPRETATION: Nevirapine prophylaxis can safely be used to provide protection
Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated. [2011.11.22]
OBJECTIVE:: Nevirapine and cotrimoxazole are associated with hematologic toxicities and skin-rash. Safety of their concurrent use for prophylaxis over extended periods among HIV-exposed uninfected infants has not been previously assessed. DESIGN:: Secondary data analysis of the 'HIV Prevention Trials Network-046 protocol' (version 2.0), a phase-III, randomized, placebo-controlled trial that assessed efficacy and safety of nevirapine prophylaxis against breast milk transmission of HIV-1... CONCLUSION:: Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash. Concurrent use beyond 6 months, however, needs to be evaluated.
Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. [2011.10]
BACKGROUND: Nevirapine (NVP) can be safely and effectively administered once-daily but has not been assessed in human immunodeficiency virus (HIV)-infected patients with tuberculosis (TB). We studied the safety and efficacy of once-daily NVP, compared with efavirenz (EFV; standard therapy); both drugs were administered in combination with 2 nucleoside reverse-transcriptase inhibitors... CONCLUSIONS: Compared with a regimen of didanosine, lamivudine, and EFV, a regimen of once-daily didanosine, lamivudine, and NVP was inferior and was associated with more frequent virologic failure and death. Clinical Trials Registration. NCT00332306.
Comparative effectiveness of continuing a virologically effective first-line boosted protease inhibitor combination or of switching to a three-drug regimen containing either efavirenz, nevirapine or abacavir. [2011.08]
OBJECTIVES: To compare virological effectiveness in patients who continued on a virologically successful first-line boosted protease inhibitor (PI)-containing combination antiretroviral therapy (cART) regimen or who switched to a PI-free cART including efavirenz, nevirapine or abacavir... CONCLUSIONS: Switching from a virologically successful first-line boosted PI-containing cART regimen to a non-nucleoside reverse transcriptase inhibitor-containing cART regimen containing either efavirenz or nevirapine is virologically safe, while switching to abacavir-containing cART should be avoided.
Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naive HIV-1-infected patients (the ARTEN study). [2011.07]
OBJECTIVES: Dyslipidaemic effects of antiretrovirals (ARVs) may contribute to increased cardiovascular risk (CR) in HIV-1-infected patients. The ARTEN (atazanavir/ritonavir on a background of tenofovir and emtricitabine vs. nevirapine on the same background, in naive HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naive HIV-1-infected patients. Lipid profiles and CR from baseline to week 48 are reported... CONCLUSIONS: In ARV-naive patients with low CR at the outset, NVP showed a potentially less atherogenic lipid profile compared with ATZ/r. (c) 2011 British HIV Association.
Clinical Trials Related to Viramune (Nevirapine)
Genotype Based Personalized Prescription of Nevirapine [Recruiting]
Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a
commonly prescribed component of highly active antiretroviral therapy(HAART) in developing
countries. This clinical trials is designed to determine the efficacy and the
cost-effectiveness of this approach in the developing countries setting.
NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national
universal health coverage. Information of the prescribed drug will be collected, and
monitoring for the compliance with the prescribed highly active antiretroviral therapy will
The primary objective of this study is to evaluate the reduction in incidences of NVP
associated cutaneous side effects by genotype based personalized prescription. The
volunteers will be monitored for any solicited and non-solicited adverse effects for 6
months after drug administration, with first 6 weeks intensive monitoring for cutaneous
adverse reactions. Laboratory safety profiles (Complete Blood Count(CBC), Alanine
transaminase(ALT), Aspartate transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct
bilirubin, total bilirubin, lactate dehydrogenase, alkaline phosphatase) will be assessed
during the intensive monitoring period (6 weeks).
Descriptive statistics will be used to evaluate the conduct of the study. Analysis
variables will include overall follow-up rate, drug compliance, and events of protocol
Laboratory and safety data will be presented using comparative statistics for each study
group and compared within and between groups using standard parametric or non-parametric
comparison tests, i. e., McNemar's test or paired t-test as appropriate.
Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse
reaction(SCAR) will be made with chi-square test. Variable that shown significant different
between the "standard of care" or control group and the "genetic test" or intervention group
will adjusted for the final analysis with Poisson logistic regression.
The overall rate of adverse events in all participants will be monitored whether the rate of
adverse events is lower than the predefined criteria. The extension of trial may be
considered based on the rate of adverse events.
An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease [Completed]
To provide access to Viramune and to evaluate the tolerance and safety of Viramune in
patients with progressive, symptomatic HIV disease who failed or are intolerant to currently
approved treatment for HIV-1 infection and who are unable to participate in another Viramune
controlled clinical trial and have a compelling need for anti-HIV treatment.
The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance [Recruiting]
The primary objective of this two-phase trial is as follows:
- To determine the elimination half-life of NVP in HIV positive pregnant women
receiving it as a single dose in labour in addition to the ZDV and 3TC with or without
seven days phenytoin (pilot PK phase)
- To determine NVP resistance in HIV positive pregnant women receiving it as a single
dose in labour in addition to ZDV and 3TC with or without seven days phenytoin (main
The secondary objectives of this two-phase trial are as follows:
- To determine the safety of single dose nevirapine with seven days phenytoin as a part
of ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part
of ARV prophylaxis for PMTCT
- To determine the HIV status of the infant
- To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin
on the newborn
Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases
development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients [Completed]
The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the
mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption
of nucleoside analogues.
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4. [Completed]
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin,
and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
Reports of Suspected Viramune (Nevirapine) Side Effects
Premature Baby (14),
Viral Load Increased (10),
Suicide Attempt (9),
LOW Birth Weight Baby (8),
Foetal Exposure During Pregnancy (8),
Trisomy 21 (8),
Abortion Spontaneous (7), more >>