Long-Term Safety Study of Fosamprenavir-Containing Regimens in HIV-1–Infected Patients. Issue 5 (September 2013)

• Record Type: Journal Article
• Authors: Wood, Robin; Gathe, Joseph C.; Givens, Naomi; Sedani, Sangeeta; Cheng, Katharine; Sievers, Jörg
• Is Part Of: HIV clinical trials. Volume 14:Issue 5(2013)
• Page Start: 183
• Page End: 191
• Publication Date: 2013-09
• Subjects: fosamprenavir -- long-term safety -- protease inhibitors; HIV Infections -- Chemotherapy -- Periodicals; AIDS (Disease) -- Chemotherapy -- Periodicals; HIV Infections -- Research -- Periodicals; AIDS (Disease) -- Research -- Periodicals; 616.979206105
• DOI: 10.1310/hct1405-183
• Languages: English
• ISSNs: 1528-4336

Abstract

Abstract : Background: Safety and efficacy of the protease inhibitor fosamprenavir (FPV) ± ritonavir (r) was evaluated in 3 pivotal 48-week phase III studies. A follow-on study provides long-term data on FPV-based regimens.Methods: International, multicenter, uncontrolled open-label study APV30005 provided FPV as part of combination therapy to HIV-1–infected patients aged ≥13 years who had participated in previous FPV and amprenavir studies. Regimens included FPV/r 1400/200 mg once daily, FPV/r 700/100 mg twice daily, or FPV 1400 mg twice daily. Safety and efficacy were evaluated every 12 weeks, including incidence and frequency of adverse events and laboratory abnormalities, plasma HIV-1 RNA levels, CD4+ cell counts, and frequency of HIV disease progression. Because this was a nonrandomized, observational study, no significance testing was performed.Results: Overall, 753 patients were enrolled. The most common reasons for premature discontinuation were lost to follow-up (88 [12%]) and insufficient viral load response (69 [9%]). The majority of patients had >192 weeks exposure to FPV, with 53 patients exposed for more than 8 years. Drug-related grade 2-4 adverse events were reported for 250 patients (33%), with the majority reported in the first 48 weeks of the study. Most commonly reported grade 3/4 laboratory parameters were increased lipase, triglycerides, and elevated liver enzymes. The observed proportions of patients with plasma HIV-1 RNA levels <50 copies/mL remained >70% from week 48 onwards.Conclusions: Extended treatment of up to 8 years with FPV-containing regimens revealed no new safety concerns and was associated with sustained antiviral responses.