German researchers need more data before they can decide whether the hepatitis drug combo sofosbuvir/velpatasvir (Epclusa/Gilead Sciences) is better than earlier antivirals for all genotypes of hepatitis C virus.
German researchers looking for proof of the effectiveness of the drug combo sofosbuvir/velpatasvir (Epclusa/Gilead Sciences) found the studies submitted by the manufacturer proved it offered “a hint of added benefit” in only two of 10 subindications.
Their findings are in a report from the German Institute for Quality and Efficiency in Health Care.
The direct-acting antiviral combination got US Food and Drug Administration approval in June 2016 as the “first all-oral, pan-genotypic, single table regimen for the treatment of adults with genotype 1 to 6 chronic hepatitis C virus (HCV) infection."
Patients should be without cirrhosis or with compensated cirrhosis. It can also be taken in combination with ribavirin for patients who have decompensated cirrhosis.
In Germany, the drug was approved in July. The German Institute for Quality and Efficiency in Health Care then sought to see whether the combo has an added benefit for patients.
They looked at gentotypes one through six and the status of liver disease.
They found “considerable added benefit” in patients with genotype 2, a “hint of non-quantifiable added benefit” in genotype 3.
In patients with HCV genotype 2, there was a slight improvement in morbidity for men taking the combination product but not in women.
Both sexes had lessened fatigue and psychiatric disorders, the researchers found.
In patients with HCV gentotype 3, the new drug did better in sustained virologic response and “hints of lesser harm” in that there were fewer reports of adverse events.
But “no conclusions were possible for other outcomes.”
The researchers said the drug manufacturer had not submitted enough data for the institute to assess whether Epclusa for genotype 1 infections and for patients without cirrhosis with genotype 4.
“For the remaining four subindications, the manufacturer submitted data on the new drug combination but not on the corresponding appropriate comparator therapies,” so the researchers could not determine whether Epclusa was better than earlier DAAs.
“Overall an added benefit of sofosbuvir/velpatasvir in comparison with the appropriate comparator therapies is not proven for eight of ten subindications,” they concluded, “There is a hint of an added benefit in two subindications.”