Efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-vir) in advanced HIV infection.

Abstract

OBJECTIVES:

To assess the efficacy and safety of generic fixed-dose combination of stavudine, lamivudine and nevirapine; GPO-vir in advanced HIV infection.

MATERIAL AND METHOD:

Open-label combined prospective and retrospective study involving 102 HIV infected patients with baseline CD4 cell count < 100 cells/mm3. All patients received GPO-vir 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 to 191 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 < 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 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.

• Authors: Aneley Getahun, Somsit Tansuphasawadikul, Varunee Desakorn, Jittima Dhitavat, Punnee Pitisuttithum
• Journal: Journal of the Medical Association of Thailand = Chotmaihet thangphaet (J Med Assoc Thai) Vol. 89 Issue 9 Pg. 1472-8 (Sep 2006) ISSN: 0125-2208 [Print] Thailand
• PMID: 17100387 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Anti-HIV Agents
• Drug Combinations
• Drugs, Generic
• Reverse Transcriptase Inhibitors
• stavudine, lamivudine, nevirapine drug combination
• Lamivudine
• Nevirapine
• Stavudine

Topics

• Adult
• Anti-HIV Agents (therapeutic use)
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Drug Combinations
• Drugs, Generic (administration & dosage, therapeutic use)
• Female
• HIV Infections (blood, drug therapy, pathology)
• Humans
• Lamivudine (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Nevirapine (administration & dosage, therapeutic use)
• Prospective Studies
• Retrospective Studies
• Reverse Transcriptase Inhibitors (administration & dosage)
• Stavudine (administration & dosage, therapeutic use)
• Survival Analysis
• Thailand
• Viral Load