Interferon plus 3TC for people with HIV/HBV coinfection

Treatments for patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses, the study authors note.

The resulting strategy of continued use of nucleoside and nucleotide analogues is associated with the risk of resistance and unknown long-term safety implications.

Researchers compared the effectiveness and safety of once-weekly 180 μg peginterferon alfa-2a plus placebo, peginterferon alfa-2a plus 100 mg daily lamivudine, and lamivudine alone in 177, 179, and 181 HBeAg-negative chronic hepatitis B patients, respectively.

After 24 weeks of follow-up, researchers found a significantly higher percentage of patients taking peginterferon monotherapy or combination therapy, compared to lamivudine alone, had normalisation of alanine aminotransferase levels or HBV DNA levels below 20,000 copies/mL (peginterferon monotherapy: 59 percent and 43 percent, respectively; peginterferon plus lamivudine: 60 percent and 44 percent; lamivudine alone: 44 percent and 29 percent). Sustained HBV DNA suppression rates to below 400 copies/mL occurred among 19 percent of patients taking peginterferon monotherapy; 20 percent taking combination therapy; and 7 percent taking lamivudine alone.

Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon arms; no such clearance occurred in the group given only lamivudine. Patients taking lamivudine had fewer adverse events – including pyrexia, fatigue, myalgia and headache – than did patient groups taking peginterferon.

Patients had significantly higher rates of response, sustained for 24 weeks after cessation of therapy, with peginterferon alfa-2a than with lamivudine. “The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates,” the researchers concluded.

Marcellin P, Lau GKK, Bonino F et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. New England Journal of Medicine (09.16.04) Vol. 351; No. 12: P. 1206-1217.