Abacavir Plus Lamivudine Safe in HIV-Hepatitis Coinfected Patients: Presented at

[Guest guest]

Abacavir Plus Lamivudine Safe in HIV-Hepatitis Coinfected Patients:

Presented at IAS-HIV

By Charlene Laino

RIO DE JANEIRO, BRAZIL -- July 27, 2005 -- Treatment-naive patients

with HIV who have hepatitis B and/or hepatitis C coinfection appear

to tolerate well a highly active antiretroviral therapy regimen that

combines abacavir plus lamivudine.

Henry Zhao, PhD, principal statistician, GlaxoKline Research

and Development, Research Triangle Park, North Carolina, presented

the findings here on July 26th at the 3rd International AIDS Society

Conference on HIV Pathogenesis and Treatment (IAS-HIV).

The fixed-dose combination of abacavir (Ziagen) and lamivudine

(Epivir) was developed to reduce pill burden and dosing frequency in

HIV-infected patients, Dr. Zhao said.

The objective of the present analysis was to assess the safety and

tolerability of the combination treatment in patients coinfected

with hepatitis B and/or hepatitis C, which may increase the risk of

liver toxicity associated with antiretroviral therapy, Dr. Zhao

said.

The analysis used data from 4 large, randomized clinical trials

using abacavir plus lamivudine once or twice daily in combination

with efavirenz or protease inhibitors.

Of 1985 patients included in the analysis, 389 were coinfected with

hepatitis B and/or hepatitis C. The baseline demographics and

disease characteristics were comparable between these patients and

1596 patients without coinfection.

By week 48, 71% of 389 patients with coinfection and 71% of 1596

patients without coinfection reported grade 2 to 4 adverse events (P

=.9). Similarly, 70% of subjects with coinfection and 71% of

patients without confection reported drug-related adverse events (P

=.6).

New grade 2 to 4 alanine transaminase (ALT) elevations were observed

in 10.5% of coinfected patients and 1.3% of patients not infected.

Grade 2 to 4 aspartate aminotransferase (AST) elevations were seen

in 8.5% and 1.3% of patients, respectively.

" While ALT and AST elevations were more common in coinfected

participants, this was most likely due to the natural course of

hepatitis B and hepatitis C infection, " Dr. Zhao noted.

GlaxoKline funded the study.

[Presentation title: 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) Co-infection. Abstract TuPe1.1C16]