Source: Spine  |  Posted 10 years ago

Interferon plus a reduced - rather than standard - daily dose of ribavirin is well tolerated and effective in hepatitis C patients who are previous nonresponders or relapsers to interferon alone.

Therapy with the combination of ribavirin and interferon-[]a[], compared to either drug alone, leads to improved rates of response in patients with chronic hepatitis C.

However, the optimal dose of ribavirin has never been established, although side effects often mandate downward dose adjustment or cessation of therapy.

Researchers in this study sought to determine whether 600 mg ribavirin per day would prove as efficacious as 1000 mg to 1200 mg/day when combined with interferon (three million units thrice weekly) in patients previously treated with standard interferon who had failed to respond or had relapsed.

This was a multicentre study in Massachusetts and Connecticut, United State, led by Herbert L. Bonkovsky and colleagues from The University of Massachusetts Medical School.

Study participants were 69 patients with chronic hepatitis C and compensated liver disease: 45 were men (24 women), 65 were Caucasian, 48 were infected with genotype one hepatitis C virus.

Thirty-five were randomly assigned to receive 600 mg ribavirin/day (group A), and the other 34 received 1000 mg (people 75 kg or less body wt) or 1200 mg/day (more than 75 kg body wt) (group B).

The two groups were well matched for demographic and laboratory features at baseline.

In both groups, mean serum levels of alanine aminotransferase (ALT) and hepatitis C viral (HCV) RNA levels fell promptly and remained significantly lower than at baseline throughout 24 weeks of therapy.

There was no significant difference in mean levels of ALT or HCV RNA during therapy or at the end of follow-up (24 weeks after cessation of therapy).

At the end of 24 weeks of post-therapy follow-up, 12 patients in each group had undetectable HCV RNA in serum, whereas 11 (31 percent) in group A and 9 (26.5 percent) in group B had normal serum ALT levels.

Study found the lower doses of ribavirin (group A) were better tolerated.

Thus, in previous nonresponders or relapsers to interferon alone, combination therapy with interferon-[]a[]_2b (three MU thrice weekly) plus 600 mg ribavirin/day is tolerated better and is as effective as interferon plus higher (standard) doses of ribavirin (1000mg to 1200 mg/day).