Weight-Based HCV Therapy Brings Better Outcomes

May 2nd, 2007    Posted by: Dr. Cox

NEW YORK, Oct. 2 — Giving bigger ribavirin doses to heavier hepatitis C patients appears to result in better outcomes, especially for African Americans, researchers here said.Action Points
Explain to interested patients that the combination of ribavirin and pegylated interferon alfa-2b has been a standard treatment since 2001, but there has been controversy over how to choose the best dose of ribavirin.

Note that this study suggests that giving ribavirin based on weight appears to produce better outcomes than a single flat dose for all patients.

The finding, from a prospective randomized trial of more than 5,000 treatment-naïve patients, supports the idea of so-called true weight-based dosing of ribavirin, in combination with pegylated interferon alfa-2b, according to Ira M. Jacobson, M.D., of Weill Cornell Medical College, and colleagues.

The combination of the two drugs has been used to treat HCV infection since 2001, with ribavirin given at 1,000 mg a day for patients who weigh less than 75 kg and 1,200 for those who weigh 75 kg or more, Dr. Jacobson and colleagues reported in the October issue of Hepatology.

But in this study, patients were randomized to a flat dose of 800 mg/day, regardless of weight, or to one of several doses adjusted for weight — 800 mg for patients weighing less than 65 kg, 1,000 mg for patients from 65 to 85 kg, 1,200 mg for those from 85 to 105 kg, and 1,400 mg for patients from 105 to 125 kg.

Patients with genotypes G1, G4, G5, and G6 were treated for 48 weeks and followed for another 24. The primary endpoint was sustained virologic response, defined as less than 125 IU per milliliter of serum of HCV viral RNA, at the end of follow-up.

Patients with genotypes G2 and G3 — regarded as easier to treat than the other types — were treated for 24 or 48 weeks.

The study showed that patients in the weight based-arm did better, with a sustained virologic response of 44.2% compared to 40.5% for those in the flat-dose arm. The difference was significant at P=0.008.

Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P

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