A fixed-dose combination (FDC) of three antiretroviral agents: two nucleoside reverse transcriptase inhibitors (NRTIs) - Lamivudine and Zidovudine, and one non-nucleoside reverse transcriptase inhibitor (NNRTI) - Nevirapine. This combination forms a cornerstone of first-line antiretroviral therapy (ART) for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents in India, as per the National AIDS Control Organization (NACO) guidelines. It is a complete regimen in a single tablet, promoting adherence.
Adult: One tablet (Lamivudine 150mg + Zidovudine 300mg + Nevirapine 200mg) orally, twice daily. IMPORTANT: Initiate with a 14-day lead-in period of Nevirapine 200mg once daily (using separate tablet) plus Lamivudine 150mg + Zidovudine 300mg twice daily. After 14 days, switch to the combined tablet twice daily if no rash or other toxicity.
Note: Can be taken with or without food. To improve tolerability, taking with food may be advised. Must be swallowed whole with water. Adherence to the twice-daily schedule is critical to prevent viral resistance. If a dose is missed within 6 hours of the scheduled time, take it immediately. If >6 hours late, skip the dose and take the next one at the regular time. Do not double the dose.
This combination inhibits the reverse transcriptase enzyme of HIV-1 via two distinct mechanisms, preventing the conversion of viral RNA into DNA and thus halting viral replication. Lamivudine and Zidovudine are nucleoside analogues that act as competitive substrates for reverse transcriptase, causing chain termination upon incorporation into the growing viral DNA strand. Nevirapine binds directly to a hydrophobic pocket on the reverse transcriptase enzyme, causing allosteric conformational changes that inhibit its RNA- and DNA-dependent polymerase activities.
Pregnancy: Pregnancy Category C (US FDA). Used in pregnancy for maternal health and PMTCT. NACO guidelines include it in first-line ART for pregnant women. Nevirapine-associated hepatotoxicity risk may be higher in pregnant women with CD4 >250. Benefits often outweigh risks. Register with the Antiretroviral Pregnancy Registry.
Driving: May cause dizziness, fatigue, and headache. Patients should not drive or operate machinery if they experience these effects.
| Rifampin/Rifampicin | Decreases Nevirapine plasma levels by ~50-60%, leading to treatment failure. CONTRAINDICATED. | High |
| Ketoconazole, Itraconazole, Fluconazole (high dose) | Increases Nevirapine levels. Monitor for nevirapine toxicity. | Moderate |
| Clarithromycin | Decreased levels of both drugs. Consider alternative like Azithromycin. | Moderate |
| Methadone | Nevirapine decreases methadone levels, potentially precipitating opioid withdrawal. Methadone dose may need increase. | Moderate |
| Oral Contraceptives (Ethinyl Estradiol) | Nevirapine decreases levels, reducing contraceptive efficacy. Use alternative/barrier methods. | Moderate |
| Other CYP3A4 substrates (e.g., Simvastatin, Atorvastatin) | Nevirapine may decrease their levels, reducing efficacy. | Moderate |
| Ribavirin | Increased risk of lactic acidosis with Zidovudine. Avoid concomitant use. | High |
| Valproic Acid | May increase Zidovudine levels. Monitor for Zidovudine toxicity. | Moderate |
| Ganciclovir, Interferon-alpha, other myelosuppressants | Additive risk of hematological toxicity (anemia, neutropenia) with Zidovudine. | High |
Same composition (Lamivudine (150mg) + Zidovudine (300mg) + Nevirapine (200mg)), different brands: