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Abstract
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
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
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 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.
The 3rd IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
TuPe1.1C03
Suggested Citation
"DeJesusE., et al.
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.
Poster Exhibition:
The 3rd IAS Conference on HIV Pathogenesis and Treatment:
Abstract no.
TuPe1.1C03"
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