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Efficacy of a Generic Fixed-Dose Combination of Stavudine, Lamivudine and Nevirapine (GPO-VIR(cid:31)) in Thai HIV-Infected Patients

Sasisopin Kiertiburanakul MD*, Sirinat Khongnorasat MD*, Sasivimol Rattanasiri PhD**, Somnuek Sungkanuparph MD*

Affiliation : * Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University ** Clinical Epidemiology Unit, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Background : GPO-VIR(cid:31), 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(cid:31) in na(cid:31)ve HIV-infected patients.
Materials and Methods : 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(cid:31) because of adverse drugs reaction.
Conclusion : GPO-VIR(cid:31) 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.

Keywords : GPO-VIR, Nevirapine, Antiretroviral therapy, HIV, Thailand


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