Tuesday, August 21, 2012

No benefit to ribavirin maintenance therapy in HCV patients after liver transplant

No benefit to ribavirin maintenance therapy in HCV patients after liver transplant

Calmus Y. J Hepatol. 2012;57:564-571.

Patients with HCV who underwent liver transplant did not benefit from maintenance therapy with ribavirin alone following treatment with ribavirin and peginterferon, according to recent results.

The study included 101 patients who had undergone liver transplant for end-stage, HCV-positive, HBsAg-negative liver disease. All participants had biopsy-proven chronic HCV and stage 1 fibrosis or higher, and had completed 12 months of combination therapy with peginterferon alpha-2a and ribavirin. Researchers randomized 78 participants to receive either ribavirin (n=41) or placebo (n=37) for an additional 12 months of maintenance therapy, with 6 months of follow-up.

During maintenance therapy and follow-up, the per-protocol rate of treatment response was 54.4% after 15 months from initiation of combination therapy, 47.9% after 18 months, 51.4% at 24 months and 47.3% after 30 months. At no point during maintenance therapy or follow-up did investigators observe a significant difference in response between the treated and placebo groups. Relapse rates were also similar between the groups at all evaluated time points.

No statistically significant difference was found between the groups regarding mean viral load, GGT levels, METAVIR activity or fibrosis scores. Transaminases levels decreased significantly among treated patients compared with placebo at this point (P=.034), but were similar between groups upon completion of follow-up.

Investigators found independent associations between SVR and basal creatinine levels (OR=5.53, 95% CI, 1.07-28.49 for levels over 130 ┬Ámol/L compared with below 130 ┬Ámol/L), patient weight (OR=0.23, 95% CI, 0.07-0.77 for patients weighing more than 70 kg compared with less than 70 kg) and a viral load reduction after 3 months of treatment (OR=8.67, 95% CI, 0.92-81.32).

“Our results clearly show that ribavirin alone has no effect on the virological response, assessed in terms of viral response or in terms of viral load,” the researchers wrote. “… These data are more than ever relevant today, since adding a protease inhibitor to [peginterferon alpha 2a] and ribavirin therapy may increase the side effects, such as anemia. In contrast, the use of ribavirin as maintenance therapy provides no additional benefit.”


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