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| Does antiretroviral therapy affect patients with primary biliary cirrhosis? | |
| By Kathryn Blair | |
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"Our studies show that the biochemical improvements correspond to the commencement of therapy. However, the biochemical improvements were modest," Dr. Mason said. He is Associate Professor of Medicine, University of Alberta, Edmonton. Fifteen patients with PBC enrolled in two separate pilot studies conducted at the Ochsner Clinic Foundation, New Orleans, LA, in collaboration with investigators at University Hospital Birmingham, U.K. Eleven patients received Lamivudine 150mg/d (seven patients in this group were subsequently treated with Combivir), and eleven received Combivir (Lamivudine 150mg and Zidovudine 300 mg) b.i.d. "The drugs were well-tolerated," said Dr. Mason. Only one patient in the Lamivudine group discontinued therapy due to elevated amylase and abdominal pains. Describing the biochemical response of the Lamivudine group as somewhat disappointing, he noted that none of the Lamivudine patients normalized their alkaline phosphatase, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) levels. Five Combivir patients, however, normalized their alkaline phosphatase levels, and four normalized their alkaline phosphatase, ALT, and AST levels. Of these four, three patients relapsed and the other demonstrated normal hepatic biochemistry two years after discontinuing Combivir. The effect of the therapies on inflammation was also measured. "With the Lamivudine patients there was no improvement in inflammatory score, and if anything things got worse," Dr. Mason said. At 12 months, Lamivudine patients demonstrated higher Ishak inflammatory scores (4 to 5, p = 0.20), while Combivir patients showed a two-point reduction in inflammatory score (6 to 4, p < 0.01). Lamivudine patients showed little change in portal triads with bile ducts (50 per cent to 52 per cent, p = 0.20), while Combivir patients showed a 30 per cent increase (45 per cent to 75 per cent, p < 0.05). "We found
that patients treated with Combivir had a good response to antiretroviral
therapy," said Dr. Mason. He noted that larger, placebo-controlled
studies are warranted. The next study in which he will participate
will involve the University of Alberta; the University Hospital
Birmingham; the Mayo Clinic; and other U.S. centres.
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