Daclatasvir and Sovaldi (sofosbuvir) cured 86 percent to 90 percent of people with genotype 3 of hepatitis C virus (HCV) in the ALLY-3 trial. The Phase III, open-label, randomized study enrolled 152 people with genotype 3 of the virus, 101 of whom were treatment naive and 51 of whom were treatment experienced. All of the participants received Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir and Gilead Sciences’ nucleotide analog polymerase inhibitor Sovaldi, taking the drugs daily for 12 weeks. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
“Both treatment-naive and treatment-experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat,” David R. Nelson, MD, a professor of medicine at the University of Florida, said in a press release. “Genotype 3 is associated with a more rapid progression of disease and remains a challenge to the efficacy of even newer regimens. The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen.”
Ninety percent of the treatment-naive participants and 86 percent of the treatment-experienced participants achieved a sustained virologic response 12 weeks after completing treatment (SVR12, considered a cure).
The most frequent reported side effects, occurring in at least 5 percent of cases, included headache (20 percent), fatigue (19 percent), nausea (12 percent), diarrhea (8.6 percent), insomnia (6 percent), abdominal pain (5 percent) and painful joints (5 percent).
To read the press release, click here.
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