Efficacy of a generic fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) in Thai HIV-infected patients.

ABSTRACT

BACKGROUND: GPO-VIR, fixed-dose combination of stavudine 30/40 mg, lamivudine 150 mg, and nevirapine 200 mg are widely used in Thailand. OBJECTIVE: Determine the efficacy and tolerability of GPO-VIR in naive HIV-infected patients. MATERIAL AND METHOD: Primary outcome was the time of initiation to achieve the goal of therapy, which was HIV RNA < 50 copies/mL or 50% increased of CD4 cell count. Ninety patients were eligible for the present study. Mean +/- SD age was 35 +/- 7 years and 51% were male. Median baseline CD4 and HIV RNA were 52 cells/ mm3 and 280,000 (5.4 log10) copies/mL, respectively. Sixty-two (69%) patients had previous opportunistic infections. RESULTS: In a median follow-up period of 15 weeks, 49 (54%) patients achieved the goal of therapy. The probability of goal achievement showed that 12-, 24-, 36- and 48- weeks success rates were 8.5% [95% confidence interval (CI) 3.9-18.0%], 62.7% (95% CI 50.8-74.6%), 80.0% (95% CI 67.3-90.1%), and 93.3% (95% CI 76.3-99.4%), respectively. The median success time to achieve the goal was 21 weeks. Eleven (12%) patients needed to discontinue GPO-VIR because of adverse drugs reaction. CONCLUSION: GPO-VIR may be one of the antiretroviral regimens for HIV-infected patients in Thailand and other resource-limited countries. Its efficacy is good in patients with advanced HIV infection.