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 na□ve 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.