Da Silva B, King M, Cernohous P, Brun S; International Conference on AIDS (15th : 2004 : Bangkok, Thailand).

Int Conf AIDS. 2004 Jul 11-16; 15: abstract no. MoPeB3285.

Abbott Laboratories, Abbott Park, Illinois, United States

Background: As concomitant hepatitis C (HCV) and/or hepatitis B (HepB) infection occurs commonly with HIV infection, efficacy, safety and tolerability of antiretroviral therapy (ART) in these patients (pts) is of interest. Methods: Safety, tolerability, and efficacy data through 48 weeks from 8 LPV/r clinical trials (n=819) were compared in pts with HCV and/or HepB co-infection (Hep+, n=132) vs. those without (Hep-, n=687). Similar comparisons were conducted through 5 years in a subset of pts (Hep+, n=11, Hep-, n=89). Results: Through 48 weeks (n=819): Grade 3 AST and ALT elevations (>5x upper limit of normal) were more common in Hep+ vs. Hep- pts (AST: 13% for Hep+, 3% for Hep-, relative risk [RR], 4.3, 95% CI, 2.3-8.0; ALT: 16% for Hep+, 5% for Hep-, RR, 3.1, 95% CI, 1.9-5.3; p<0.001 for each comparison). Rates were similar for HCV-only vs. HepB-only pts: (AST: 13% for HCV, 10% for HepB; ALT: 13% for HCV, 15% for HepB). Excluding AST/ALT increases, hepatic AEs of any severity or relationship to study drug occurred similarly in Hep+ (2%) vs. Hep- (2%) pts. There was no significant difference in deaths (Hep+: 2%, Hep-: 1%) or AEs leading to discontinuation (7% for each group). Risk of virologic failure through 48 weeks was not statistically significantly different for Hep+ vs. Hep- pts among ART-naive or PI-experienced pts. There was no significant difference for Hep+ vs. Hep- pts in mean change from baseline to 48 weeks in CD4 counts in ART-naive (Hep+: +211, Hep-: +220, p=0.68) or PI-experienced (Hep+: +82, Hep-: +112, p=0.17). Through 5 years: Similar results were observed, with a higher risk of AST/ALT elevations in Hep+ pts, but no significant differences in deaths, discontinuations, or virologic/immunologic response. Conclusions: With the exception of AST/ALT increases, safety, tolerability, and efficacy were comparable for Hep+ vs. Hep- pts treated with LPV/r through 48 weeks. Results were consistent in a subset treated for up to 5 years.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Alanine Transaminase
• Aspartate Aminotransferases
• Clinical Trials as Topic
• HIV Infections
• HIV Seropositivity
• Hepacivirus
• Hepatitis B
• Hepatitis C
• Humans
• Pyrimidinones
• Ritonavir
• Safety
• lopinavir

Other ID:

• GWAIDS0035371

UI: 102279587

From Meeting Abstracts