Preliminary reports suggest that patients with primary biliary cirrhosis have evidence of human betaretrovirus infection.
Dr Mason and colleagues from Birmingham in England designed a study to determine whether antiviral therapy impacts on the disease process.
The researchers conducted two consecutive open-labeled, nonrandomized, 1-yr pilot studies.
The first study examined the effects of lamivudine 150 mg/day. The second looked at Combivir combination therapy using lamivudine 150 mg and zidovudine 300 mg twice a day.
In total, the research team recruited 11 primary biliary cirrhosis patients in each study.
|A larger placebo-controlled trial is required to assess whether antiviral therapy impacts the disease process|
|American Journal of Gastroenterology|
The team entered 7 patients into both studies, and withdrew 1 patient from each study due to side effects.
On evaluation of liver biopsies before and after lamivudine therapy, the researchers were able to show a 4-5 increase in necroinflammatory score, a 1-1.5 elevation in bile duct injury and all with little change in the percentage of portal tracts with bile ducts (50-52%).
None of the patients in the lamivudine study normalized alkaline phosphatase.
The investigators carried out a histological assessment following Combivir therapy which revealed a 6 to 4 improvement in necroinflammatory score, a 3 to 1 reduction in bile duct injury, and a 45-75% increase in portal tracts with bile ducts.
The researchers found that in the Combivir cohort, 5 patients normalized alkaline phosphatase and 4 developed normal AST, ALT, and alkaline phosphatase.
Dr Mason concluded, "Histological and biochemical endpoints were achieved in the Combivir pilot study suggesting a larger placebo-controlled trial is required as a proof of principle to assess whether antiviral therapy impacts the primary biliary cirrhosis disease process."