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Academic Medicine | clinical trials | Infectious Disease

NEJM Reports on 2 New Drugs for Hepatitis C

Last week’s NEJM delivered an intriguing, imperfect article on a new approach to treating hepatitis C (HCV). The paper’s careful title, Pre­lim­inary Study of Two Antiviral Agents for Hepatitis C Genotype 1, seems right. The analysis, with 17 authors listed, traces the response of 21 people with hepatitis C (HCV) who got two new anti-​​​​viral agents, with or without older drugs, in a clinical trial spon­sored by Bristol-​​​​Meyers Squibb.

The 21 study par­tic­i­pants all had chronic infection by HCV genotype 1, a strain that’s common in North America and rel­a­tively resistant to standard treatment. All sub­jects were between 18 and 70 years old, with a mea­surable level of HCV RNA in the blood, no evi­dence of cir­rhosis, and no response to prior HCV treatment (according to cri­teria detailed in the paper). In the trial, 11 patients received a com­bi­nation regimen of daclatasvir (60 mg once daily, by mouth) and asunaprevir (600 mg, twice daily by mouth) alone; the other 10 patients took the exper­i­mental drugs

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