New Hep C Cures Cover All Genotypes

The European Medicines Agency’s Committee for Medicinal Products for Human Use—similar to the U.S. Food and Drug Administration—is pushing for two new antiviral drug combinations to be approved by the European Commission. The decision, which is expected later this year will likely be followed by requests for FDA approval as well.

These two combinations are curative treatments considered “pangenotypic drugs,” which means they work on all genotypes of hepatitis C. There are six or seven known genotypes and the Centers for Disease Control and Prevention reports “more than 50 subtypes of HCV.” Genotype 1 is most common in the U.S., accounting for 74 percent of hep C diagnoses. According to hep magazine, only four people around the world have been identified with genotype 7, while genotypes 4, 5, and 6 account for less than 1 percent of those living with hep C. That leaves 25 percent represented by genotypes 2 and 3. It is also possible to have a super infection with multiple genotypes of the virus.

While pangenotypic antivirals work against every genotype, they are often more effective on particular ones. In combinations, these drugs can be highly effective in combating hep C across all types, and these new drugs have had particular success in that regard.

According to the CDC, viral genotyping is necessary in treating hep C because of the number of different genotypes, but advocates argue the success of pangenotypic meds may remove the need for genotype testing. That could simplify diagnosis and speed up the time needed to get those with hep C into care and cured of the disease.

The two pangenotypic treatments seeking approval as curative treatment for hepatitis C genotypes 1 through 6 are Maviret and Vosevi, both once-daily medications. Manufactured by AbbVie, Maviret is a combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir.

Clinical trials of glecaprevir/pibrentasvir showed very high rates of sustained virologic response with 97.5 percent cured across genotypes 1 through 6, including for those harder to treat—those with genotype 3, severe kidney disease, or compensated cirrhosis.

Manufactured by Gilead Sciences, the second product, Vosevi, is a combination of the NS5B polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/NS4 protease inhibitor voxilaprevir. Sofosbuvir and velpatasvir are already approved as a combination product, Epclusa (also manufactured by Gilead), for the treatment of genotypes 1 through 6.

Clinical trials of Vosevi showed that the combination cured 95 percent of people with and without cirrhosis, and lead to continued viral suppression in 96 percent of people with genotype 3 infection and cirrhosis (one of the hardest groups to cure).