Darvoni is a pangenotypic cure for Hepatitis C which combines 400 mg of the pangenotyic NS5B inhibitor Sofosbuvir with 60 mg of the pangenotypic NS5A inhibitor Daclatasvir in a convenient once a day single tablet formulation. There is no need to take Sofosbuvir and Daclatasvir separately.
In clinical trials this combination provides cure for over 90% of all patients, 95% for most patients, and for some patient groups perfect 100% have been reported.
This powerful combination is the only one recommended by EASL, AASLD and IDSA to treat all genotypes of HCV.
Key Clinical Trials of Sofosbuvir + Daclatasvir
ALLY-2: In the ALLY-2 trial, treatment-naive and treatment-experienced patients with HCV genotype 1-4 and HIV coinfection received daclatasvir and sofosbuvir. The treatment-naive patients received either 12 weeks (n=101) or 8 weeks (n=50) of therapy; approximately 10% of the treatment-naive patients had cirrhosis. For the treatment-naive patients with genotype 1 infection, the SVR12 rates were 96% with 12 weeks of therapy. The SVR12 responses in treatment-naive patients with genotype 1 and cirrhosis were 89% (8 of 9) in the 12-week arm.
A1444040: The AI444040 trial had multiple treatment arms of daclatasvir and sofosbuvir, with or without ribavirin. Enrollment included treatment-naive and treatment-experienced patients with genotype 1 and treatment-naive with genotype 2 or 3. Patients received either a 12- or 24-week treatment course, with or without ribavirin. For the treatment-naive genotype 1 patients treated with a 12-week course of daclatasvir plus sofosbuvir, with or without ribavirin, 80 (98%) of 82 achieved an SVR12.
ALLY-3: The phase 3 ALLY-3 trial enrolled 152 patients with genotype 3 infection (101 treatment-naive and 51 treatment experienced). All patients received a 12-week course of the oral regimen of daclatasvir (60 mg once daily) plus sofosbuvir (400 mg once daily). Patients with compensated cirrhosis were allowed in the trial. Overall, SVR12 was achieved in 84 (89%) of 94 of the treatment-naive patients (97% in those without cirrhosis and 58% on those with cirrhosis).
At the AASLD November 2014 the following a large trial of Sofosbuvir + Daclatasvir in patients with advanced liver disease was reported.
The check the expected SVR rate and optimal treatment duration please use this decision support tool.