A fixed-dose combination (FDC) of three antiretroviral agents used as first-line therapy for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents. It is a generic version of the original regimen and is a cornerstone of public health programs in India under the National AIDS Control Organization (NACO) guidelines. It combines two nucleoside reverse transcriptase inhibitors (NRTIs) - Lamivudine and Stavudine - with one non-nucleoside reverse transcriptase inhibitor (NNRTI) - Nevirapine.
Adult: One tablet twice daily (approximately 12 hours apart). For Nevirapine-naïve patients: A lead-in period of 14 days with Nevirapine 200 mg once daily is recommended to reduce rash incidence, followed by 200 mg twice daily. This FDC is used only in the maintenance phase after the lead-in.
Note: Administer orally with or without food. Must be taken consistently at the same times each day to maintain viral suppression and prevent resistance. If a dose is missed by less than 6 hours, take it immediately and resume the normal schedule. If missed by more than 6 hours, 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, a critical step in viral replication. Lamivudine and Stavudine are nucleoside analogues that compete with natural nucleosides for incorporation into the growing viral DNA chain, causing chain termination. Nevirapine binds directly to a hydrophobic pocket on the p66 subunit of the reverse transcriptase enzyme, causing conformational change and non-competitive inhibition.
Pregnancy: Pregnancy Category C. Data from pregnancy registries show no clear increase in birth defects. Nevirapine is used in PMTCT protocols. However, the combination, especially Stavudine, is not the preferred first-line in pregnancy due to toxicity profile. Use only if benefit outweighs risk. Must be managed by a specialist. Nevirapine lead-in dose is NOT recommended in pregnancy.
Driving: Dizziness and fatigue have been reported. Patients should be cautioned about driving or operating machinery if they experience these effects.
| Rifampin / Rifampicin | Significantly decreases Nevirapine plasma levels (by ~20-55%) increasing risk of virological failure. Contraindicated in patients with higher CD4+ counts. In others, use with extreme caution and therapeutic drug monitoring. | Major |
| Ketoconazole, Itraconazole, Fluconazole | Increase Nevirapine plasma levels. Monitor for Nevirapine toxicity. | Moderate |
| Clarithromycin | Nevirapine decreases Clarithromycin levels; Clarithromycin increases Nevirapine levels. Consider alternative (Azithromycin) for MAC prophylaxis. | Moderate |
| Methadone | Nevirapine decreases Methadone plasma levels, potentially precipitating opioid withdrawal. Methadone dose may need increase. | Moderate |
| Oral Contraceptives (Ethinyl Estradiol) | Nevirapine may decrease hormone levels, reducing contraceptive efficacy. Use alternative or additional barrier methods. | Moderate |
| Other NRTIs (e.g., Zidovudine) | Stavudine and Zidovudine are antagonistic in vitro; avoid concomitant use. | Major |
| Ribavirin | Potential increased risk of lactic acidosis and hepatic toxicity when combined with NRTIs like Stavudine. Use with caution in HCV co-infection. | Moderate |
| Allopurinol | May increase risk of hypersensitivity reactions with Nevirapine. | Moderate |
Same composition (Lamivudine (150mg) + Stavudine (30mg) + Nevirapine (200mg)), different brands: