In Largest U.S. Hepatitis C Trial, Researchers Determine Weight-Based Dosing Is Key To Optimal Treatment
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
“These findings help define optimal therapy for U.S. hepatitis C patients,” says the study’s principal investigator, Dr. Ira M. Jacobson, the Vincent Astor Professor of Clinical Medicine at Weill Cornell Medical College and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “Our findings underscore that weight-based-dosed combination therapy is significantly more effective than the flat-dosed RBV regimen, especially in more difficult-to-treat patient groups, such as patients with genotype 1 and African-American patients. Patients being treated for hepatitis C should talk to their doctors to be sure they are receiving the most effective therapy.”
Reported in the same journal is a subanalysis of the WIN-R data that evaluates the efficacy of weight-based dosing among African-American participants with genotype 1 infection. Twice as many of these patients cleared the virus when treated with the weight-based RBV regimen vs. the flat dose (21% vs. 10%); a lower rate was shown in the general study population with genotype 1 HCV, 34% vs. 28.9%. (However, the fact that over 300 patients with an end of treatment response missed their 24-week, post-treatment follow-up appointment accounts for some treatment failures under a strict intent-to-treat analysis.)
“These results are particularly significant for African-Americans, a group with known lower rates of response to HCV therapy than reported in other ethnic groups. Weight-based dosing vs. flat dosing clearly showed the greatest therapeutic impact in this group,” says Dr. Jacobson.
“The study data strongly suggest adopting a 1400 mg/dose for patients who weigh more than 105 kg. In my opinion, the larger dose provides an opportunity for very heavy patients to have the same chance of cure as lighter patients without compromising safety,” says Dr. Jacobson.
Overall safety with weight-based dosing was similar to that of the flat 800 mg dose. There was no difference in the occurrence of serious adverse events in the entire group, as well as in the African-American group.
Hepatitis C
Hepatitis C is the most common blood-borne infection in America. It affects approximately 4 million people, or about one in every 50 adults, including a disproportionately high percentage of African-Americans. Chronic hepatitis C can cause cirrhosis, liver failure and liver cancer. It has been estimated that at least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a smaller percentage of patients with chronic disease develop liver cancer. Patients with chronic hepatitis C and related cirrhosis are 100 times more likely to develop liver cancer than uninfected persons. About half of all cases of primary liver cancer in the developed world are caused by hepatitis C, and hepatitis C-related liver disease is now the leading cause for liver transplants.
hepatitis c, liver disease, chronic disease
hepatitis c, liver disease, chronic disease
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