The nucleoside analogue FTC (emtricitabine), which was recently licensed in the US for the treatment of HIV as part of HAART, is safe and effective as a treatment for hepatitis B in HIV and hepatitis B virus coinfected patients, according to data presented by French investigators to the Second International AIDS Society Conference on HIV Pathogenesis and Treatment in Paris on July 16th.
Earlier studies have shown that FTC can achieve a reduction of approximately three log10 in hepatitis B monoinfected patients, and investigators studied the results of three studies using FTC in HIV-positive patients.
Three studies compared FTC to d4T in combination with 3TC and efavirenz; FTC with 3TC in combination with d4T and efavirenz, and examined the safety and efficacy of FTC when used with d4T and either the investigational NNRTI emivirine or abacavir.
These studies included 52 hepatitis B antigen-positive patients, and data on the 22 patients with detectable hepatitis B DNA at baseline. Treatment with FTC resulted in a reduction of hepatitis B DNA of 2.75 log10 after 48 weeks, with 56% having undetectable hepatitis B DNA. The d4T control group experienced an increase in hepatitis B DNA of 0.2 log10 (p<0.009 compared to FTC patients).
Equal numbers of FTC and control patients (33%) experienced severe or very severe side effects, and 23% discontinued in both arms because of adverse-events.
The investigators concluded that FTC was a safe and effective treatment for hepatitis B in HIV-positive patients.
Raffi F. et al.Anti-HBV activity of emtricitabine (FTC) in patients co-infected with HIV and hepatitis B virus. Antiretroviral Therapy 8 (suppl.1), abstract 215, 236, 2003.