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New Drugs for Hep C Await Approval in Europe


Two new pangenotypic drug combinations are awaiting approval for hepatitis C in Europe, and could also receive approval in the U.S. by the end of the year.

The European Medicines Agency’s (CHMP) scientific committee has expressed positive opinions of two new types of pangenotypic antiviral drug combinations for the use in treating hepatitis C, according to a recent report from aidsmap. The CHMP — similar to the United States’ Food and Drug Administration (FDA) — is pushing for these combinations to be approved for marketing by the European Commission, which is expected later this year. Once approved in Europe, it is expected that the United States will quickly seek FDA approval as well.

What are pangenotypic antiviral drugs?

Hep C has seven known genotypes, numbered 1 through 7. The most common among those living with the virus is genotype1, followed by types 3 and 2, respectively. Types 4, 5, 6, and 7 account for less than one percent of the hep C population. Also, many people with hep C carry more than one genotype of the virus, especially IV drug users and sex workers, or anyone who has had high amounts of exposure.

Pangenotypic antivirals are drugs that work against every genotype, but are more effective on certain types. In certain combinations, these drugs can be highly effective in combating hep C across all types, and these latest versions in Europe seeking approval have been some of the most effective yet. Pangenotypic products also simplify prescribing and treatment by removing the need for genotype testing and reducing the amount of meds that need to be taken.

What are the two new pangenotypic drug combos?

Maviret, a combination of the protease inhibitor glecaprevir and the inhibitor pibrentasvir, is recommended for approval as a treatment for hepatitis C genotypes 1 through 6. Maviret is manufactured by AbbVie.

Clinical trials of glecaprevir/pibrentasvir showed very high rates of sustained virologic response (97.5 percent across genotypes 1 through 6) and in harder to treat groups of people, such as those with genotype 3, severe kidney disease or compensated cirrhosis.

The second product, Vosevi, is a combination of the polymerase inhibitor sofosbuvir, the inhibitor velpatasvir and the protease inhibitor voxilaprevir. Like Maviret, Vosevi is dosed once-daily. Vosevi is manufactured by Gilead Sciences.

Vosevi is also recommended for approval as a treatment for hepatitis C genotypes 1-6. Clinical trials to support the approval of Vosevi showed that the combination cured 95 percent of people with and without cirrhosis, and 96 percent of people with genotype 3 infection and cirrhosis, one of the hardest patient groups to cure.

Sofosbuvir and velpatasvir are already approved as a combination product, Epclusa (also manufactured by Gilead), for the treatment of genotypes 1 through 6.

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