New pangenotypic hepatitis C drug combinations recommended for approval in the European Union

Two new pangenotypic direct-acting antiviral combinations have received positive opinions from the scientific committee of the European Medicines Agency (the CHMP) and should receive European Union marketing approval in the next few months, manufacturers announced last week.

Drugs submitted for approval in the European Union must be approved by the CHMP before receiving marketing approval from the European Commission.

Pangenotypic treatments are suitable for all genotypes of hepatitis C. Pangenotypic products may simplify prescribing and treatment enrolment by removing the need for genotype testing and simplifying treatment. But, in settings where genotype testing is easily available, other considerations may be important for simplifying treatment, especially equal efficacy across different patient groups.

Glossary

cirrhosis

Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

compensated cirrhosis

The earlier stage of cirrhosis, during which the liver is damaged but still able to perform most of its functions. 

virologic response

Reduction in viral replication in response to treatment, especially achievement of an undetectable viral load.

 

antiviral

A drug that acts against a virus or viruses.

cure

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a person’s body, or permanently control the virus and render it unable to cause disease. A ‘sterilising’ cure would completely eliminate the virus. A ‘functional’ cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness. 

Maviret, a combination of the NS3/NS4 protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir, is recommended for approval as a treatment for hepatitis C genotypes 1-6. Maviret is manufactured by AbbVie.

Clinical trials of glecaprevir/pibrentasvir showed very high rates of sustained virologic response (97.5% across genotypes 1-6) 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 NS5B polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir and the NS3/NS4 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% of people with and without cirrhosis, and 96% 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, for the treatment of genotypes 1-6.

Final details of the duration of treatment with each product will be available when full marketing approval is granted by the European Commission later this year. Vosevi is expected to receive US marketing approval by August 2017 and Maviret is also undergoing US review.