3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

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

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C03

DeJesus E.¹, Gladysz A.², Vera J.³, Pulido F.⁴, Carosi G.⁵, Garris C.⁶, Givens N.⁷, Yeo J.⁷, Felton M.^7
1Orlando Immunology Center, Orlando, Florida, United States of America, ²Wroclaw University School of Medicine, Wroclaw, Poland, ³Centro Hospitalar de Cascais-Hospital de Dia de Doencas Infecciosas, Cascais, Portugal, ⁴Hospital Universitario Doce de Octubre, Madrid, Spain, ⁵Clinica di Malattie Infettive e Tropicali, Bresica, Italy, ⁶GlaxoSmithKline R&D, Reasearch Triangle Park, United States of America, ⁷GlaxoSmithKline R&D, Greenford, United Kingdom

INTRODUCTION: 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 co-infection (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.

METHODS: 322 subjects received FPV/r 1400mg/200mg QD and ABC+3TC BID in SOLO. Of those, 211 subjects completed ≥48 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.

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Clinical | TuPe1.1C03 | Edwin Dejesus
Hepatitis viruses

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