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News

Single vs combination therapy in primary biliary cirrhosis

Combination therapy of lamivudine and zidovudine improves necroinflammatory score, reduces bile duct injury and increases portal tracts with bile ducts, reports December's issue of the American Journal of Gastroenterology.

News image

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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."

American Journal of Gastroenterology; 2004: 99 (12): 2348
08 December 2004

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