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HCV Research Round-up


Hepatitis C treatment options continue to be a vibrant field full of exciting research, including the following:

Genotype 3 of the hepatitis C virus (HCV) has remained harder-to-treat among the six main genotypes. New research presented at the 2016 AASLD conference now offers promising news for treating genotype 3. According to results from the C-ISLE study, a combination of Zepatier (grazoprevir/elbasvir) and Sovaldi (sofosbuvir) without ribavirin led to a cure in 96% of treatment-naïve patients and 97% of treatment-experienced patients with genotype 3 hepatitis C infection and liver cirrhosis. These excellent results were seen in the group of 100 patients enrolled in this study, none of whom discontinued treatment due to adverse effects.

Another previously unmet need of hepatitis C treatment has been for those who also have severe chronic kidney disease. AbbVie recently announced study results of a phase 3 study called EXPEDITION-4. In this study, patients with hepatitis C and severe chronic kidney disease were treated with a new investigational pan-genotype regimen of glecaprevir and pibrentasvir. After 12 weeks, 98% of patients (even those on dialysis) achieved sustained viral response (SVR). This study was also presented at the recent AASLD conference.

This glecaprevir/pibrentasvir combination has also been successfully tested in all major genotypes of hepatitis C patients who do not have cirrhosis, as well as treatment-naïve patients. Of these groups, nearly 98% achieve a high SVR rate after 8 weeks. This combination is on-track with the FDA, where it currently holds a Breakthrough Therapy Designation.

The pipeline of potential new HCV medications seems to be endless. Merck is also researching – it’s currently in phase 2 trials – a triple combination that shows high SVR for genotypes 1, 2, and 3. This combination is currently known as MK-3682B (MK-3682/grazoprevir/ruzasviv).

And, finally, to add one more piece of news: Gilead’s successful trials with a combination pan-genotype treatment (sofosbuvir, velpatasvir, and voxilaprevir) shows cure rates as high as 97% in difficult-to-treat populations. It continues to be a very bright future in the hepatitis C world.

Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy | www.bioplusrx.com
Sources

Highleyman L. Grazoprevir/elbasvir + sofosbuvir highly effective for hard-to-treat genotype 3 hepatitis C patients. Infohep.org November 14, 2016.

Press release. AbbVie’s glecaprevir/pibrentasvir (G/P) shows high SVR rates in chronic hepatitis C patients with severe chronic kidney disease. November 15, 2016.

Press release. Merck announces findings for investigational triple-combination chronic hepatitis C therapy showing high rates of sustained virologic response in people with genotypes 1, 2, or 3. November 13, 2016.

Press release. Gildead announces SVR12 rates from four phase 3 studies of a once-daily, fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir in treatment-naïve and treatment-experienced genotype 1-6 chronic HCV-infected patients. October 20, 2016.

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