In a new study published in the New England Journal of Medicine, lead investigator Marc Bourliere, MD, from the Hospital Saint Joseph in Marseilles, and his colleagues conducted 2 phase 3 clinical trials to explore treatment options for those chronically infected with hepatitis C (HCV) who have had no success with DAA therapy.

Dr. Bourliere et al’s first trial, POLARIS-1, involved 300 patients with HCV genotype 1 who had previously received a drug combination containing an NS5A inhibitor. Half of the patients received a combination of sofosbuvir, a nucleotide polymerase inhibitor, velpatasvir, an NS5A inhibitor, and voxilaprevir, a protease inhibitor, once a day for 3 months. The remaining 150 patients received a placebo for the same period.

In the second clinical trial, POLARIS-4, patients with HCV genotypes 1, 2 or 3 who had been given a DAA regimen without an NS5A inhibitor were assigned to either receive a 3-drug cocktail, consisting of sofosbuvir, velpatasvir, and voxilaprevir, or a 2-drug cocktail, only consisting of sofosbuvir and velpatasvir, for 12 weeks.

In POLARIS-1, the results were very promising, with 96% of the patients receiving sofosbuvir, velpatasvir, and voxilaprevir achieving SVR. This is compared to 0% of patients achieving SVR in the placebo group. In POLARIS-4, 98% of patients receiving the 3-drug cocktail achieved SVR while 90% of those receiving only sofosbuvir and velpatasvir achieved SVR. The authors note that the most common side effects of the therapy were fatigue, nausea, diarrhea, and headaches. However, less than 1% of patients discontinued treatment due to the severity of the side effects.

Overall, Dr. Bourliere and his colleagues conclude that administering sofosbuvir, velpatasvir, and voxilaprevir for 12 weeks to patients who had previously failed treatment with DAAs resulted in high SVR rates. This study provides hope to those who have not had success with DAA therapy. Dr. Bourliere is quoted in a press release as saying, “we have other options even if you fail the first treatments.”