SOF/VEL/VOX safe, effective for rescue hepatitis C treatment
The combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is safe and effective as rescue therapy for hepatitis C patients in whom prior direct-acting antivirals (DAAs) had failed, a new study has found.
Researchers conducted a prospective, multicentre study on 137 patients (median age, 56 years; 75 percent male), who had experienced DAA failure. All participants received 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir contained in a fixed-dose tablet. The primary endpoint was sustained virological response after 12 weeks (SVR 12).
Excluding two patients who were lost to follow-up, 128 of the remaining 135 participants achieved SVR 12. The resulting rate was 95 percent. This was higher in those without cirrhosis, as compared to their cirrhotic counterparts (98 percent vs 89 percent; p=0.05).
SVR 12 rates did not vary according to Child-Turcotte-Pugh scores (p=0.19), the presence of hepatocellular carcinoma (p=0.07), coinfection with HIV (p=0.72) or a history of liver transplant (p=0.66).
On the other hand, 131 participants showed evidence of treatment-related adverse events. Of these, only 25 had mild adverse episodes, most common of which were headaches (36 percent) and asthenia (32 percent). None had to discontinue treatment due to side effects
One patient developed multicentric hepatocellular carcinoma and, after 8 weeks of treatment, had jaundice. The situation worsened quickly and the patient ultimately died before achieving SVR 12.