Safety of a Fosamprenavir/Ritonavir-containing Regimen Over 120 Weeks in HIV Positive Treatment-naïve Adults with or without hepatitis B and/or C Coinfection

A sub-analysis of HIV-1 infected therapy-naïve adults enrolled in SOLO (APV30002) and continuing in rollover study APV30005, with or without HBV (HepB sAg positive) and/or HCV coinfection (anti-HCV positive) at Baseline, was conducted to assess liver enzyme changes and adverse events (AEs) over 120 weeks of FPV (Lexiva®, Telzir®)/r) QD treatment.

322 subjects received fosamprenavir/ritonavir/FPV/r 1400mg/200mg QD and ABC+3TC BID in SOLO. Of those, 211 subjects completed ³48 weeks on FPV/r QD in SOLO and continued the regimen in APV30005. A review of ALT/ AST laboratory values and AEs was conducted.

Results

·  21% (45/211) were co-infected at Baseline (BL); 9% (20/211) HBV, 12% (26/211) HCV.

·  Median BL ALT (41 u/L vs. 26 u/L) and AST levels (40 u/L vs. 30 u/L) were higher in co-infected subjects (n=45) than those without co-infection (n=164), respectively.

·  After Week 48, three co-infected subjects experienced a new treatment-emergent Grade 3/4 ALT toxicity (Grade 3/4 AST, n=0).

·  Over 120 weeks, 44% (20/45) of co-infected subjects reported a grade 2-4 drug related AE, compared to 43% (71/164) of subjects without co-infection.

·  In the same period, the percentage of subjects reporting a drug-related serious AE was similar between groups: co-infected, 11% (5/45); without co-infection, 10% (16/164).

Conclusions

Subjects in both the co-infected and non co-infected groups who completed at least 120 weeks had a median decrease in ALT and AST. Incidence of AEs was comparable between co-infected subjects and those without co-infection. In co-infected subjects, minimal additional liver toxicity was observed with longer term FPV/r QD therapy.

Orlando Immunology Center, Orlando, Florida, United States of America, Wroclaw University School of Medicine, Wroclaw, Poland, Centro Hospitalar de Cascais-Hospital de Dia de Doencas Infecciosas, Cascais, Portugal, Hospital Universitario Doce de Octubre, Madrid, Spain, Clinica di Malattie Infettive e Tropicali, Bresica, Italy, GlaxoSmithKline R&D, Research Triangle Park, United States of America, GlaxoSmithKline R&D, Greenford, United Kingdom.

08/01/05

Reference
E DeJesus and others. Safety of a fosamprenavir/ritonavir (FPV/r) containing regimen over 120 weeks in HIV-1 infected therapy-naïve adults with or without hepatitis B (HBV) and/or C (HCV) co-infection. Abstract TuPe1.1C03 (poster). 3^rd IAS Conference on HIV Pathogenesis and Treatment. July 24-27, 2005. Rio de Janeiro, Brazil.