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Sovaldi shows high SVR12 in patients with HCV after transplant

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September 19, 2016

Sovaldi-based combination therapies led to 12-week sustained virologic response in nearly 93% of patients who were reinfected with hepatitis C virus and had severe fibrosis after receiving a liver transplant, according to findings published in Liver Transplantation.

“In the present cohort, we observed in a majority of our cirrhotic patients, an improvement of liver function, based on Child score, during antiviral therapy,” Jérôme Dumortier, MD, PhD, professor of gastroenterology and hepatology at Claude Bernard University Lyon 1, and colleagues wrote. “Our good virological results are probably related to the frequent use in our series of a combination of sofosbuvir and daclatasvir.”

To assess Sovaldi (sofosbuvir, Gilead Sciences)-based regimens for HCV recurrence in patients with stage 3 or 4 fibrosis after liver transplant (LT), Dumortier and colleagues performed a prospective multicenter study of 125 patients who had been treated from October 2013 to November 2014 as part of the CUPILT cohort. The median delay from transplant was 95.9 months, and the mean age of study patients was 59.4 years. Almost 80% of the cohort were men, 78.2% were infected by HCV genotype 1, and the mean HCV RNA was 6.1 log IU/mL. Sixty-four percent of patients previously failed post-LT antiviral therapy, including triple therapy with first-generation protease inhibitors in 15.2% of cases.

The primary combination regimen (73.6%) was sofosbuvir with Daklinza (daclatasvir, Bristol-Myers Squibb); ribavirin was used in 48% of patients.

In the cohort, 92.8% of patients demonstrated SVR after 12 weeks of treatment. Only seven patients failed treatment. During therapy, 25.6% of patients had serious adverse events, with infection being most common (8%). During treatment and follow-up, three patients were re-transplanted, and four died.

“Treatment of HCV recurrence after LT is a major goal and results have been impaired for a long time because of poor efficacy and high toxicity of [pegylated interferon/ribavirin], even in combination with first-generation protease inhibitors,” the researchers wrote. “[Sofosbuvir]-based regimens allow achievement in the vast majority of patients presenting HCV recurrence with severe fibrosis following LT. These promising results are likely to dramatically change the prognosis in this difficult-to-treat population.” – by Will Offit

Disclosure: Dumortier reports being a clinical investigator, speaker and/or consultant for Astellas Pharma, Gilead Sciences, Janssen Pharmaceuticals, Novartis and Roche. Please see the full study for a list of all other authors’ relevant financial disclosures.

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