Efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-vir) in advanced HIV infection
Getahun, A.; Tansuphasawadikul, S.; Desakorn, V.; Dhitavat, J.; Pitisuttithum, P.
Journal of the Medical Association of Thailand 89(9): 1472-1478
2006
ISSN/ISBN: 0125-2208 PMID: 17100387 Document Number: 2630
Objectives: To assess the efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and nevirapine; GPO-vir (R) in advanced HIV infection.Material and Method: Open-label combined prospective and retrospective study involving 102 HIV infected patients with baseline CD4cell count < 100 cells/mm(3). All patients received GPO-vir (R) for 48 weeks. The CD4 cell count and plasma viral load (pVL) was measured at 48 weeks.Results: The median baseline CD4 cell count and pVL were 13 cells/mm(3) and 363,500 copies/ml, respectively. At 48 weeks, the median CD4 cell count increased to 191 cells/mm(3) and 63.7% in intention-to treat and 82.3% in on-treatment analysis had pVL < 50 copies/ml. There was no significant difference in pVL between patients with baseline pVL > 100, 000 or <= 100, 000 copies/ml (p = 0.312). The incidence of hepatotoxicity, rash and peripheral neuropathy was 4.9%, 14.7% and 6.9%, respectively.Conclusion: GPO-vir (R) was well tolerated and effective in increasing CD4 cell count and suppressing plasma viremia in advanced HIV infection during the 48 weeks follow-up period.
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