Hepatitis C: Sofosbuvir/Ledipasvir Combination Treatment

Prof Eric Lawitz MD Vice President of Scientific and Research Development at The Texas Liver Institute Clinical professor of Medicine San Antonio University of Texas Health Science Center.MedicalResearch.com Interview with:
Prof Eric Lawitz MD
Vice President of Scientific and Research Development at The Texas Liver Institute
Clinical professor of Medicine
San Antonio University of Texas Health Science Center.

MedicalResearch.com: What are the main findings of the study?

Dr. Lawitz: Currently available treatments for HCV involve weekly injections of pegylated interferon and daily doses of oral antivirals that must be taken for up to a year.  These regimens are not only burdensome for patients, but are not always effective and can cause serious and debilitating side effects, including anemia. So there is a significant need for new tablet-based treatment regimens for HCV that eliminate interferon and ribavirin, are more effective, better tolerated and easier for patients to take.
The Phase 2 LONESTAR study evaluated an 8- or 12-week course of therapy with a fixed-dose combination tablet containing two investigational agents, sofosbuvir and ledipasvir. The combination tablet was given to patients either with or without ribavirin. The medicines were tested among HCV patients with genotype 1 HCV infection – the most difficult strain of the virus to treat. Some of these patients had cirrhosis of the liver, or had failed prior therapy with protease inhibitors, and are considered among the most challenging patients to cure of HCV.

In LONESTAR, 95 percent of patients new to HCV therapy who received 8 weeks of treatment with the sofosbuvir/ledipasvir tablet were HCV undetectable 12 weeks after the therapy ended. This means they are considered cured of HCV.  Similarly, 95 percent of patients who had failed prior therapy and who received 12 weeks of the combination tablet became HCV undetectable. The combination pill was well tolerated by patients, and no one discontinued therapy due to side effects.

MedicalResearch.com: Were any of the findings unexpected?

Dr. Lawitz: 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-based regimen – patients that currently have no approved treatment options for their HCV.  In LONESTAR, 95 percent of these difficult-to-treat patients were cured with the sofosbuvir/ledipasvir combination tablet – which is a very impressive result.

MedicalResearch.com:  What should clinicians and patients take away from your report?

Dr. Lawitz: The results of LONESTAR suggest that the sofosbuvir/ledipasvir combination tablet has the potential to offer HCV patients a significantly improved treatment regimen, irrespective of their treatment history or whether they have cirrhosis.  The combination tablet also has the potential to cure HCV much more rapidly than the current standard of care, and in a far more convenient form – just one pill taken once a day for as a little as 8 weeks.  So these are potentially highly significant results for the treatment of hepatitis C.

MedicalResearch.com:  What recommendations do you have for future research as a result of this study?

Dr. Lawitz: While the results of LONESTAR are very promising, as a Phase 2 study it only included 100 patients, which is a relatively small number.  Large-scale, Phase 3 studies are needed to confirm these findings. Three clinical trials of this size are now testing the sofosbuvir/ledipasvir combination tablet, and we should have results from all of these studies by early 2014.

Citation:

Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial
Prof Eric Lawitz MD,Prof Fred F Poordad MD,Phillip S Pang MD,Robert H Hyland DPhil,Xiao Ding PhD,Hongmei Mo PhD,William T Symonds PharmD,John G McHutchison MD,Fernando E Membreno MD
The Lancet – 5 November 2013
DOI: 10.1016/S0140-6736(13)62121-2

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