Viramune (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. It is specifically formulated to reduce viral load and increase CD4+ cell counts in adults and pediatric patients. As a cornerstone of many antiretroviral regimens, Viramune offers a well-established efficacy and safety profile when administered under appropriate clinical supervision. This medication requires careful adherence to dosing protocols, particularly during the initial lead-in period, to minimize the risk of severe adverse reactions.

Features

• Contains nevirapine as the active pharmaceutical ingredient
• Available in immediate-release 200 mg tablets and oral suspension (50 mg/5 mL)
• Dosed once daily for the first 14 days, then twice daily thereafter
• Demonstrated efficacy in treatment-naïve and treatment-experienced patients
• Compatible with many other antiretroviral agents
• Requires baseline and periodic monitoring of hepatic function

Benefits

• Significantly reduces HIV-1 RNA viral load
• Increases CD4+ T-cell counts, supporting immune reconstitution
• Well-tolerated long-term therapy with a predictable side effect profile
• Convenient oral dosing supports regimen adherence
• Established clinical data from extensive use in diverse patient populations
• May be used as part of simplified maintenance therapy in virologically suppressed patients

Common use

Viramune is primarily used as part of combination antiretroviral therapy for the treatment of HIV-1 infection. It is indicated for use in both treatment-naïve and treatment-experienced patients, though its use is generally reserved for those without prior NNRTI exposure due to potential cross-resistance. The medication is commonly paired with nucleoside reverse transcriptase inhibitors (NRTIs) such as lamivudine or tenofovir, and may be used in various regimen configurations based on individual patient factors and resistance testing results.

Dosage and direction

Adults: The recommended initiation dose is one 200 mg tablet (or 10 mL oral suspension) once daily for the first 14 days (lead-in period). If no rash or other significant toxicity is observed, increase to one 200 mg tablet twice daily or 10 mL oral suspension twice daily.

Pediatric patients: Dosage is based on body surface area (BSA) or body weight. For patients 15 days and older: 150 mg/m² once daily for first 14 days, then 150 mg/m² twice daily thereafter (maximum dose 200 mg twice daily). Alternatively: 4 mg/kg once daily for first 14 days, then 7 mg/kg twice daily for patients 2 months to 8 years, or 4 mg/kg twice daily for patients 8 years and older.

All patients must undergo baseline assessment of hepatic function before initiation and frequent monitoring during the first 18 weeks of therapy.

Precautions

Viramune carries a boxed warning for severe, life-threatening hepatotoxicity and skin reactions. Hepatic failure resulting in transplantation or death has been reported. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions with organ dysfunction, have occurred.

Patients should be closely monitored during the first 18 weeks of therapy, with particular attention to signs or symptoms of hepatitis or skin reactions. Liver function tests should be performed at baseline, prior to dose escalation, and at two-week intervals for the first month, then monthly for the first 18 weeks, and periodically thereafter.

Women with CD4+ cell counts greater than 250 cells/mm³ are at considerably higher risk of hepatic events. Viramune should generally not be initiated in women with CD4+ cell counts greater than 250 cells/mm³ unless the benefit clearly outweighs the risk.

Contraindications

Viramune is contraindicated in patients with:

• Moderate or severe (Child-Pugh Class B or C) hepatic impairment
• History of hypersensitivity to nevirapine or any component of the formulation
• Previous experience with Viramune-associated hepatic events or severe skin reactions
• Concomitant use with drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events

Possible side effects

Common (≥10%): Rash (including maculopapular eruptions), headache, nausea, fatigue, fever, abnormal liver function tests

Less common (1-10%): Hepatitis, increased transaminases, vomiting, diarrhea, abdominal pain, myalgia

Rare (<1%): Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions (including drug reaction with eosinophilia and systemic symptoms), hepatic failure, arthralgia, granulocytopenia

The rash associated with Viramune is usually mild to moderate, maculopapular, and occurs primarily within the first 6 weeks of therapy. Approximately 16% of patients experience rash of any severity, with 7% discontinuing therapy due to rash.

Drug interaction

Nevirapine is a moderate inducer of CYP3A4 and may decrease plasma concentrations of drugs metabolized by this pathway. Significant interactions include:

• Antiretroviral agents: Reduced concentrations of atazanavir, fosamprenavir, lopinavir, indinavir, saquinavir, and maraviroc
• Anticonvulsants: Reduced concentrations of carbamazepine, clonazepam, and ethosuximide
• Antimycobacterials: Reduced concentrations of clarithromycin and rifabutin
• Benzodiazepines: Reduced concentrations of diazepam
• Calcium channel blockers: Reduced concentrations of diltiazem, nifedipine, verapamil
• Immunosuppressants: Reduced concentrations of cyclosporine, tacrolimus, sirolimus
• Methadone: May decrease methadone concentrations, potentially leading to opioid withdrawal
• Warfarin: May decrease warfarin concentrations

Concomitant use with other hepatotoxic drugs may increase the risk of hepatic events.

Missed dose

If a dose is missed, patients should take it as soon as they remember. If it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the next dose to make up for a missed dose. Consistent adherence is critical to maintaining virologic suppression and preventing the development of resistance.

Overdose

There is limited experience with Viramune overdose. Cases of nevirapine overdose up to 800-1800 mg per day for up to 15 days have been reported. Symptoms may include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. There is no specific antidote for nevirapine overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. Charcoal may be used to aid removal of unabsorbed drug. Nevirapine is extensively metabolized and is unlikely to be significantly removed by dialysis.

Storage

Store Viramune tablets at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Store the oral suspension at 2-8°C (36-46°F). Do not freeze. Keep container tightly closed. Dispense oral suspension in original container. Use within 30 days of first opening. Keep out of reach of children.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be thoroughly familiar with the complete prescribing information, including boxed warnings, before initiating therapy with Viramune. Patients should be counseled on the importance of adherence and recognition of potential adverse effects.

Reviews

Clinical trials have demonstrated Viramune’s efficacy in reducing viral load and increasing CD4+ cell counts when used as part of combination antiretroviral therapy. In the INCAS trial, 51% of patients receiving nevirapine-containing regimens achieved viral loads below 400 copies/mL at 52 weeks compared to 12% in the control group. The 2NN study showed similar efficacy between nevirapine and efavirenz in treatment-naïve patients, though with different safety profiles.

Real-world evidence supports Viramune’s long-term efficacy and tolerability in appropriately selected patients. Many clinicians value its once-daily dosing option after the initial lead-in period and its generally favorable lipid profile compared to some protease inhibitors. However, the requirement for careful monitoring, particularly during the initial treatment period, is consistently emphasized in clinical experience.

Patient-reported outcomes often note satisfaction with the dosing convenience after the initial period, though some report challenges with the twice-daily dosing schedule. The potential for rash and hepatic events remains a concern that requires diligent patient education and monitoring.