WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKINREACTIONS
HEPATOTOXICITY:
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+ cell counts at initiation of therapy place patients
at increased risk; women with CD4+ cell
counts greater than 250 cells/mm3, including
pregnant women receiving VIRAMUNE in combination with other antiretrovirals
for the treatment of HIV-1 infection, are at the greatest risk. However,
hepatotoxicity associated with VIRAMUNE use can occur in both genders,
all CD4+ cell counts and at any time during
treatment. Hepatic failure has also been reported in patients without
HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of VIRAMUNE
for occupational and non-occupational PEP is contraindicated [see Contraindications ]. 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 ].
SKIN
REACTIONS:
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 ].
MONITORING:
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 clinical hepatitis, or transaminase elevations
combined with rash or other systemic symptoms, or following severe
skin rash or hypersensitivity reactions. In some cases, hepatic injury
has progressed despite discontinuation of treatment.
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VIRAMUNE SUMMARY
VIRAMUNE is the brand name for nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.
VIRAMUNE (nevirapine) is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
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NEWS HIGHLIGHTS
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. [2012]
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)
Pharmacokinetics Study on Nevirapine Resistance in Tanzania [Completed]
Primary
- pharmacokinetics of single dose nevirapine
- the effect of single dose carbamazepine on the pk of single dose nevirapine
- resistance against nevirapine before and after.
- follow-up on HIV status newborns
- relation between nevirapine levels in cord blood and plasma
Secondary
* safety of single dose nevirapine and nevirapine/carbamazepine
Hypothesis:
Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive
pregnant Tanzanian women by decreasing nevirapine half-life.
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children. [Completed]
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of
nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is
an open-label, multiple dose, non-randomized and cross-over study. Patients who have
completed the last visit of the PK trial (visit 7) can enter into an Optional Extension
Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR
becomes approved and is available by prescription in a given country; or, the patient
enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy
information will be collected.
Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting [Completed]
In resource-limited setting, concerns remain regarding the emergence of virologic failure
and high-level drug resistance mutations (DRM) during WHO recommended first-line
antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI)
based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study
hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a
NNRTI-based regimen with a low genetic barrier to resistance.
The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment-
naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP)
each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine
(3TC). The primary end point is the incidence of therapeutic (clinical and/or
virologic)failure by study week 24.
Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB [Completed]
The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin
vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and
to investigate whether Rifampicin co-administration in clinical practice leads to a
clinically relevant decrease of Nevirapine plasma concentrations in Indian patients
co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities
(especially hepatic).
VENICE Study Nevirapine Full Dose/Dose Escalation [Completed]
This study aims to compare the trough plasma concentrations of nevirapine after 7 days of
treatment at the full dose from baseline with dose escalation in patients taking efavirenz
who switch to nevirapine due to neuropsychiatric adverse reactions.
Reports of Suspected Viramune (Nevirapine) Side Effects
Pyrexia (20),
Rash (15),
Premature Baby (14),
Viral Load Increased (10),
Diarrhoea (10),
Suicide Attempt (9),
LOW Birth Weight Baby (8),
Foetal Exposure During Pregnancy (8),
Trisomy 21 (8),
Abortion Spontaneous (7), more >>
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Page last updated: 2013-02-10
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