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Oral daclatasvir plus sofosbuvir highly effective in HCV patients
A once-daily oral regimen of daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients with hepatitis C genotype 1, 2 or 3 infections — even among those who previously failed to respond to protease inhibitors — according to study results published in The New England Journal of Medicine.
“This research paves the way for safe, tolerable and effective treatment options for the vast majority of those infected with hepatitis C,” study researcher Mark Sulkowski, MD, medical director of the Johns Hopkins Center for Viral Hepatitis and an Infectious Disease News Editorial Board member, said in a press release. “Standard treatments for the disease are going to improve dramatically within the next year, leading to unprecedented advances for the treatment of patients infected with the hepatitis C virus.”
Mark Sulkowski
The study evaluated the efficacy and safety of daclatasvir (Bristol-Myers Squibb) plus sofosbuvir (Sovaldi, Gilead Sciences) in 211 men and women aged 18 to 70 years who sought treatment at 18 medical centers across the United States and Puerto Rico for chronic HCV genotype 1, 2 or 3 infections.
Originally, untreated patients with HCV genotype 1 (n=44) and HCV genotypes 2 or 3 (n=44) were randomly assigned a daily dose of 60 mg daclatasvir plus 400 mg sofosbuvir, with or without ribavirin, for 24 weeks. The study researchers later included an additional 123 patients with HCV genotype 1 who were randomly assigned daclatasvir plus sofosbuvir, with or without ribavirin, for 12 or 24 weeks. These included 82 previously untreated patients and 41 patients who previously experienced virologic failure with HCV protease inhibitors.
Among patients with HCV genotype 1, 98% of those who were previously untreated and 98% of those who previously failed to respond to protease inhibitors had a sustained virologic response (SVR) at 12 weeks after the end of treatment. More specifically, SVR at week 12 was observed in 98% of patients with HCV subtype 1a and 100% in those infected with subtype 1b.
SVR at 12 weeks also was achieved by 92% of patients with HCV genotype 2 and 89% with HCV genotype 3.
Additionally, high SVR rates were observed among patients with and without the IL28B CC genotype (93% and 98%, respectively) and among patients who did and did not receive ribavirin (93% and 98%, respectively).
According to the researchers, the safety profile of the treatment compares favorably with that of peginterferon-based therapy. The most common adverse events included fatigue, headache and nausea.
“Our study shows that the combination of an NS5A inhibitor and an NS5B inhibitor was associated with high cure rates in a range of HCV-infected patients, including patients who had persistent HCV variants conferring resistance to protease inhibitors after unsuccessful treatment with telaprevir or boceprevir,” the researchers wrote.
Disclosure: The study was funded by Bristol-Myers Squibb and Pharmasset (Gilead). See the study for a full list of financial disclosures.
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Once again, this study demonstrates that a very high proportion of persons with chronic hepatitis C can be cured with minimal adverse events. The study by Sulkowski and colleagues shows that potent medications acting on two or more sites can cure even the most difficult-to-treat patients with genotype 1 chronic hepatitis C who failed prior treatment. Once again, the work underscores the value of testing to identify the approximately 1 million persons in the United States with chronic HCV infection but no knowledge of their status. Everyone born between 1945 and 1965 should have one test.
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