U.S. veterans' experience with rebetron in a nonstudy environment: success or failure?

Abstract

The aim of this study is to report the clinical response observed in a U.S. veteran population with hepatitis C to combination therapy with Rebetron (interferon/ribavirin) outside of a controlled study environment. Ninety-nine consecutive patients with hepatitis C who met the approved guidelines for treatment were offered treatment with Rebetron. Ninety-four patients initiated therapy. All patients received formal instruction on the use of the drug, as well as the side effects and were instructed to report any side effects. Follow-up was scheduled twice a month for the first month, then monthly unless adverse events were observed. Ninety-four of 99 patients initiated therapy. Thirty-two patients were lost to follow-up or did not tolerate therapy. Ethnic distribution comprised 56 whites, 42 African Americans, one Hispanic. Of the 56 whites who started therapy, 39 completed treatment. Sustained viral response (SVR) for all genotypes was observed in 10 of 39 (26%). In the African American patients, 22 of 42 (52%) completed therapy, but a SVR was noted in none. The only Hispanic patient did not respond to therapy. In the veteran population, favorable factors associated with achieving SVR included having genotype other than 1, absence of cirrhosis, and ethnicity. Factors contributing to the low response rates were difficulty in adhering to therapy as well as a predominance of genotype 1. Using an intention-to-treat analysis, only 10% of veterans achieved SVR. These findings highlight the need to develop a multidisciplinary team to address the complexity of treating the veteran patient with hepatitis C.