Drug combo effective for currently untreatable Hepatitis C

by Bruce Sylvester – taken from The Lancet – An investigative, single-pill combination drug shows efficacy for treating patients with the most difficult-to-treat types of hepatitis C, researchers reported on Nov. 5, 2013 in The Lancet.

Lead investigator Eric Lawitz, M.D. of the Texas Liver Institute in San Antonio said, “To our knowledge, this trial is the first to report data for cirrhotic genotype 1 hepatitis C patients who did not respond to prior treatment with a protease inhibitor regimen, a population without treatment options at present.   The results of this trial suggest that the fixed-dose combination of sofosbuvir and ledipasvir could offer patients a short, all-oral treatment that might be highly effective and safe in patients who tend not to respond well to existing therapies, including individuals with cirrhosis or black race, resistant strains of the virus, and those who have not responded to standard-of-care regimens that include protease inhibitors.”

As background, the authors noted that even though hepatitis C is often curable, different genetic strains of the virus respond differently to drugs, and many patients with genotype 1 hepatitis C, the most common strain of the virus in the United States and Europe, do not respond to existing treatments.  Untreatable patients are at increased risk of significant liver damage, and currently they have no further treatment options.

Researchers from the Texas Liver Institute and Gilead Sciences, Inc. recruited 100 subjects with genotype 1 hepatitis C virus who had either never been treated (60), or who had failed to respond to existing drugs (40).  Among the failed-responders, just over half (22 subjects, 55%) had developed cirrhosis.

All subjects received combination treatment with investigative sofosbuvir and ledipasvir. They were treated for either 8 weeks or 12 weeks. Some subjects received ribavirin as part of their regimen.

The subjects were stratified into different groups according to prior treatment, length of prior  treatment and use of ribavirin.

At 12 weeks after the end of combination drug therapy, almost all (97 subjects or 97%) of the subjects had achieved a sustained virological response (SVR), which is deemed a functional cure for hepatitis C, where the virus is eliminated and prevented from replicating.

About half of the subjects reported at least one adverse event, with the highest rates among the ribavirin-treated subjects.  No one discontinued treatment because of an adverse event.