Digestive Disease Week 1999 Annual Meeting

/ June 27th, 2012/ Posted in Conditions and Diseases / Comments Off on Digestive Disease Week 1999 Annual Meeting

Hepatitis C: Achieving Maximum Results Putting Combination Therapy for HCV into Practice

Interferon/ribavirin combination therapy may induce a sustained response in previous nonresponders to interferon monotherapy, including those with normal ALT levels and those with predictors of poor response. This was suggested by a recent investigator-initiated, randomized, prospective, controlled trial that assessed 24 versus 48 weeks of combination therapy with interferon 3 MU t.i.w. plus ribavirin 1,000 to 1,200 mg/day in nonresponders to interferon.

All patients were HCV RNA positive and had failed to respond to a minimum of 3 months of therapy with interferon alfa. Nonresponse was defined as a detectable level of HCV RNA at the end of 3 months of treatment. Patients with elevated alanine aminotransferase (ALT) levels and those with normal ALT levels were included in the trial. As of January 1, 1999, 124 nonresponders with a mean age of 44.6 years had been enrolled (64$ male). One hundred (81%) had an elevated ALT and 101 (81%) were infected with HCV genotype 1. Twenty-seven (22%) had cirrhosis.

On January 1, 1999, 108 patients had completed 24 weeks of treatment and 50 of these (46%) had undetectable HCV RNA after 24 weeks of treatment. Seventy participants completed 24 weeks of posttreatment follow-up. Twenty-six (37%) of these 70 patients had undetectable HCV RNA at the end of treatment. Of these 26 patients with an end-of-treatment response, 8 (31%) relapsed. Of the 70 participants who completed posttreatment follow-up, 18 (26%) had undetectable HCV RNA at the end of follow-up and were therefore defined as virologic sustained responders.

Of those with a sustained response at 24 weeks of follow-up, 28% were cirrhotic, 56% were genotype 1, and 56% had HCV RNA levels greater than 3 x 10 6 viral copies/mL. As expected, the sustained response rate was higher among patients with HCV genotypes other than genotype 1 than in patients with HCV genotype 1. Sustained response rates did not vary according to whether the patient’s ALT level was normal or elevated, and there was only a slight (not statistically significant) improvement in the sustained response rate with 48 weeks of treatment compared with 24 weeks. Complications and adverse effects ere typical of those seen in other populations treated with interferon/ribavirin.

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