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. This medication plays a critical role in comprehensive antiretroviral therapy (ART) regimens, offering a well-established option for treatment-naïve and certain treatment-experienced individuals. Clinical use requires strict adherence to dosing guidelines and monitoring protocols to maximize efficacy and manage potential risks.

Features

• Active ingredient: nevirapine 200 mg
• Available in immediate-release tablets and oral suspension formulations
• Bioavailability not significantly affected by food intake
• Metabolized primarily by the cytochrome P450 system (CYP3A4 and CYP2B6 isoenzymes)
• Plasma half-life of approximately 25-30 hours in adults
• Demonstrated efficacy in reducing HIV-1 RNA levels in clinical trials

Benefits

• Potent suppression of HIV-1 replication through non-competitive inhibition of reverse transcriptase
• Established long-term viral load reduction in combination therapy regimens
• Convenient twice-daily dosing after initial lead-in period
• Demonstrated efficacy in preventing maternal-to-child HIV transmission
• Well-characterized safety profile with extensive clinical experience
• Available in pediatric formulation for treatment of children aged 15 days and older

Common use

Viramune is primarily used as part of combination antiretroviral therapy for the treatment of HIV-1 infection. It is typically prescribed for treatment-naïve adults with CD4+ cell counts below 250 cells/mm³ for women and below 400 cells/mm³ for men to reduce the risk of hepatic events. The medication is also utilized in certain prevention protocols, including the prevention of maternal-to-child transmission during labor and delivery when other antiretroviral options are not available. Clinical decision-making should always consider individual patient factors, including baseline viral load, CD4+ count, and potential drug interactions.

Dosage and direction

Adults: Initiate with 200 mg once daily for the first 14 days (lead-in period), then increase to 200 mg twice daily. This gradual escalation helps identify patients at risk for serious skin reactions and hepatic events.

Pediatric patients: Dosage is based on body surface area or body weight. For patients aged 15 days through 12 years: initial dose of 150 mg/m² once daily for first 14 days, then increase to 150 mg/m² twice daily. Maximum dose should not exceed 200 mg twice daily.

Administration: Tablets may be taken with or without food. Oral suspension should be shaken gently before use and administered using an appropriate measuring device.

Precautions

• Hepatotoxicity: Severe, life-threatening hepatotoxicity has occurred, including fatal hepatic necrosis. Monitor hepatic function regularly, especially during first 18 weeks.
• Skin reactions: Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Discontinue immediately if severe skin reactions occur.
• Resistance: Use in combination with other antiretroviral agents to reduce risk of resistance development.
• Immune reconstitution syndrome: Inflammatory response to opportunistic infections may occur during initial treatment phase.
• Fat redistribution: Long-term antiretroviral therapy may cause fat redistribution and metabolic abnormalities.
• Laboratory monitoring: Regular monitoring of liver function tests, CD4+ counts, and viral load is essential.

Contraindications

• Moderate to severe hepatic impairment (Child-Pugh Class B or C)
• History of hypersensitivity reaction to nevirapine
• Use as part of occupational and non-occupational post-exposure prophylaxis regimens
• Concomitant use with drugs highly dependent on CYP3A4 for clearance with narrow therapeutic indices
• Patients who developed serious skin reactions or hepatic events during previous nevirapine therapy

Possible side effects

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

Less common (1-10%): Elevated liver enzymes, diarrhea, abdominal pain, myalgia

Serious (<1%): Severe hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions, drug reaction with eosinophilia and systemic symptoms (DRESS)

Laboratory abnormalities: Increased ALT, AST, GGT; decreased neutrophil count

Drug interaction

• CYP3A4 inhibitors: Ketoconazole, itraconazole, and other strong inhibitors may increase nevirapine concentrations
• CYP3A4 inducers: Rifampin, rifabutin, and other inducers may decrease nevirapine efficacy
• Hormonal contraceptives: Nevirapine may decrease ethinyl estradiol and norethindrone concentrations
• Methadone: Nevirapine may decrease methadone levels, potentially requiring dosage adjustment
• Other antiretrovirals: Complex interactions possible with protease inhibitors and other NNRTIs
• Warfarin: Monitoring of anticoagulant effect recommended

Missed dose

If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose to make up for a missed dose. Consistent adherence is critical to maintain viral suppression and prevent development of resistance.

Overdose

There is limited experience with nevirapine overdose. Reported cases have included edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, and vomiting. 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. Hemodialysis may be of limited value due to high protein binding and extensive metabolism.

Storage

Store at 15°C to 30°C (59°F to 86°F). Keep tablets in original container with dessicant and keep tightly closed. Protect from light and moisture. Oral suspension should be stored at 2°C to 8°C (36°F to 46°F) until dispensed; after dispensing, store at room temperature and use within 3 months. Keep all medications out of reach of children and pets.

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. Always follow the prescribing information provided with the medication and consult appropriate clinical guidelines. The prescribing physician should be aware of the most current safety information and monitoring recommendations.

Reviews

Clinical trial data: Multiple randomized controlled trials have demonstrated virological efficacy of nevirapine-containing regimens. The 2NN study showed similar efficacy between nevirapine and efavirenz in treatment-naïve patients. Long-term follow-up data support durable viral suppression in appropriate patient populations.

Real-world evidence: Cohort studies have confirmed the effectiveness of nevirapine in routine clinical practice, particularly in resource-limited settings. Treatment success is highly dependent on proper patient selection, adherence to monitoring protocols, and management of potential adverse events.

Expert consensus: Guidelines from major HIV treatment organizations continue to include nevirapine as a recommended option in certain clinical scenarios, particularly when other NNRTIs or integrase inhibitors are not suitable or available.