Efficacy and Safety of Generic Fixed-Dose Combination of Stavudine, Lamivudine and Nevirapine (GPO-vir(cid:31)) in Advanced HIV Infection
Aneley Getahun MD, DTMH, MCTM*, Somsit Tansuphasawadikul MD**, Varunee Desakorn BSc, MPH, MSc*, Jittima Dhitavat MD, MSc, DPhil*, Punnee Pitisuttithum MB, BS, DTMH, FRCP*
Affiliation : * Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University ** Bamrasnaradura Infectious Disease Institute, Department of Disease Control, Nonthaburi
Objectives : To assess the efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and
nevirapine; GPO-vir(cid:31) in advanced HIV infection.
Materials and Methods : Open-label combined prospective and retrospective study involving 102 HIV infected
patients with baseline CD4cell count < 100 cells/mm3. All patients received GPO-vir(cid:31) 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/mm3 and 363,500 copies/ml, respectively.
At 48 weeks, the median CD4 cell count increased to191 cells/mm3 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(cid:31) 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.
Keywords : GPO-vir(cid:31), Generic fixed-dose combination, Advanced HIV disease, HAART, Thailand
