Viramune: Advanced NNRTI Therapy for HIV-1 Management

Viramune

Viramune

Viramune is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Viramune is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS, and should not be used to prevent HIV.
Product dosage: 200mg
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Synonyms

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 in antiretroviral therapy (ART), Viramune targets the reverse transcriptase enzyme, critical for viral replication. Its established efficacy and well-characterized safety profile make it a trusted option in comprehensive HIV management strategies under appropriate medical supervision.

Features

  • Active ingredient: Nevirapine 200 mg
  • Formulation: Immediate-release tablets and oral suspension
  • Mechanism: Binds directly to reverse transcriptase, inhibiting RNA- and DNA-dependent DNA polymerase activities
  • Bioavailability: >90% following oral administration
  • Half-life: Approximately 45 hours (allowing for once or twice daily dosing after initial lead-in)
  • Metabolism: Hepatic, primarily via cytochrome P450 isozymes (CYP3A4 and CYP2B6)

Benefits

  • Effectively suppresses HIV-1 replication, leading to sustained viral load reduction
  • Contributes to immune reconstitution as evidenced by increased CD4+ cell counts
  • Convenient dosing regimen after initial titration period supports adherence
  • Demonstrated long-term efficacy in treatment-naïve and experienced patients
  • Available in multiple formulations for flexible administration across age groups
  • Compatible with many backbone NRTI combinations in ART regimens

Common use

Viramune is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is commonly used as part of initial therapy in treatment-naïve adults and children over 15 days old, as well as in treatment-experienced patients where resistance testing supports its use. The medication is typically incorporated into regimens containing two nucleoside reverse transcriptase inhibitors (NRTIs), forming a complete triple-drug antiretroviral regimen. Viramune may be particularly appropriate for patients who cannot tolerate or have contraindications to other NNRTIs or integrase strand transfer inhibitors.

Dosage and direction

Adults: Initiate with 200 mg once daily for 14 days (lead-in period), then increase to 200 mg twice daily if no rash or hepatic events occur. The lead-in period reduces frequency of rash.

Pediatric patients: Dosage based on body surface area or body weight. For patients 15 days to 8 years: 4 mg/kg once daily for 14 days, then 7 mg/kg twice daily. For patients 8 years and older: 4 mg/kg once daily for 14 days, then 4 mg/kg twice daily (maximum 400 mg daily).

Administration: May be taken with or without food. Tablets should be swallowed whole; oral suspension should be shaken well before use. Dosage adjustment required in patients with moderate to severe hepatic impairment. Not recommended for patients with severe renal impairment requiring dialysis.

Precautions

Hepatotoxicity: Severe, life-threatening, and in some cases fatal hepatotoxicity has occurred, particularly during the first 18 weeks of therapy. Monitor hepatic function regularly.

Skin reactions: Severe skin reactions, including Stevens-JJohnson syndrome and toxic epidermal necrolysis, have been reported. Discontinue immediately if severe rash or rash accompanied by constitutional symptoms appears.

Immune reconstitution syndrome: Inflammatory response to opportunistic infections may occur during initial treatment phase.

Fat redistribution: Long-term antiretroviral therapy has been associated with redistribution/accumulation of body fat.

Laboratory monitoring: Regular monitoring of liver function tests (ALT, AST, bilirubin) and CD4+ cell counts is essential, especially during initial 18 weeks.

Contraindications

  • Moderate or severe (Child-Pugh Class B or C) hepatic impairment
  • History of hypersensitivity reaction to nevirapine
  • Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens
  • Co-administration with rifampin-containing regimens for tuberculosis treatment
  • Patients with CD4+ cell counts ≥250 cells/mm³ (women) or ≥400 cells/mm³ (men) unless benefit clearly outweighs risk

Possible side effects

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

Less common (1-10%): Fever, abdominal pain, diarrhea, myalgia, increased cholesterol levels

Serious (<1%): Severe hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions, immune reconstitution inflammatory syndrome

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

Drug interaction

Contraindicated combinations: Rifampin, rifapentine, St. John’s wort (Hypericum perforatum) - significant decrease in nevirapine concentrations

Significant interactions:

  • Ketoconazole: Markedly reduces ketoconazole concentrations; alternative antifungal recommended
  • Methadone: Decreases methadone levels; may require methadone dosage adjustment
  • Hormonal contraceptives: May decrease contraceptive efficacy; alternative non-hormonal methods recommended
  • Other CYP3A4 substrates: May alter concentrations of drugs metabolized by CYP3A4 (e.g., calcium channel blockers, immunosuppressants)
  • Other antiretrovirals: Potential interactions with protease inhibitors; monitor therapeutic concentrations

Missed dose

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

Overdose

Limited experience with nevirapine overdose. Symptoms may include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. There is no specific antidote. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. Charcoal administration may be used to eliminate unabsorbed drug. Nevirapine is extensively metabolized and unlikely to be eliminated by dialysis.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep container tightly closed. Protect from light and moisture. Keep out of reach of children. Do not use after expiration date printed on packaging. Oral suspension should not be frozen.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Viramune should only be used under the supervision of a qualified healthcare provider experienced in the treatment of HIV infection. Treatment decisions should be based on individual patient characteristics, including viral load, CD4+ count, resistance testing, and comorbid conditions. Patients should not alter their dosage or discontinue medication without consulting their healthcare provider. Full prescribing information including boxed warnings should be reviewed before initiation of therapy.

Reviews

“Viramune has been a reliable component of our antiretroviral regimens for appropriate patients. The established safety profile with careful monitoring and convenient dosing schedule makes it a valuable option in our therapeutic arsenal.” - Infectious Disease Specialist, 15 years experience

“In our pediatric HIV clinic, the oral suspension formulation has been particularly useful for younger patients. While we maintain vigilant monitoring during the initial treatment phase, the long-term outcomes have been generally favorable.” - Pediatric HIV Specialist

“After the critical initial 18-week period, most of my patients on Viramune-containing regimens have maintained viral suppression with good tolerability. The twice-daily dosing after lead-in supports adherence better than some more frequent dosing regimens.” - HIV Clinical Pharmacist