Safety of Abacavir + Lamivudine-based HAART in ART-naïve HIV Positive Subjects with and without Hepatitis B and/or Hepatitis C Coinfection

HIV infection has been associated with increases in HBV-related morbidity and mortality and accelerated HCV-related liver damage. Conversely, HBV and/or HCV co-infection may increase the risk of liver toxicity from antiretroviral therapy (ART).

Data from ART-naïve, HIV-infected subjects participating in 4 large, randomized clinical trials using abacavir/ABC (Ziagen) + lamivudine/3TC (Epivir) [ABC+3TC] once daily (QD) or twice daily (BID) in combination with efavirenz/ EFV (Sustiva) or protease inhibitors (PI) were used for this analysis.

Safety data over >48 weeks of ART for patients with HBV (baseline positive HBV-sAg) and/or HCV (baseline positive anti-HCV) co-infection were compared to those of subjects without co-infection.

Descriptive statistics were summarized for subjects with and without HBV and/or HCV co-infection.

Results

·  The percentage of subjects with HBV and/or HCV co-infection was 15 to 25% in these 4 large clinical trials using ABC+3TC.

·  Of 1985 subjects participating, 389 (20%) were HBV and/or HCV co-infected.

·  Baseline demographics and disease characteristics were comparable between subjects with and without (1596 subjects) HBV/HCV co-infection.

·  The overall incidence of adverse events (AEs) was not different between the two groups [emphasis added-Ed]

·   The percentages of subjects reporting grade 2-4 AEs through 48 weeks were 71% (275/389) of subjects with vs. 71% (1135/1596) of subjects without co-infection (p=0.9 by two sided Fisher's exact test).

·  Similarly, the percentages of subjects reporting treatment emergent AEs were also comparable: 70% (272/389) of subjects with vs. 71% (1135/1596, p= 0.6, two-sided Fischer's exact test) without co-infection.

The authors conclude that in subjects treated with ABC+3TC based HAART, there was no significant difference in the incidence and/or type of AEs, grade 2-4 AEs or treatment emergent AEs, regardless of whether subjects were HBV and/or HCV co-infected or not.

In addition, the incidence of specific adverse events in co-infected subjects did not differ between subjects taking ABC QD and those taking ABC BID.

GlaxoSmithKline R&D, Research Triangle Park, North Carolina, USA.

08/01/05

Reference
H Zhao and others. Safety of Abacavir (ABC)+Lamivudine (3TC)-based HAART in ART-Naïve HIV-Infected Subjects With and Without Hepatitis B (HBV) and/or Hepatitis C (HCV) Coinfection. Abstract TuPe1.1C16 (poster). 3^rd IAS Conference on HIV Pathogenesis and Treatment. July 24-27, 2005. Rio de Janeiro, Brazil.