Pan-Genotypic, Shorter Duration Regimens Future of Hep C Treatment

Upcoming pipeline trends for hepatitis C virus (HCV) infection include treatments that work across all viral genotypes and therapy courses of shorter duration, according to a presentation at the AMCP Managed Care & Specialty Pharmacy Annual Meeting (April 19-22,2016; San Francisco, CA).

HCV is classified into 6 genotypes, with ~75% of all patients having genotype 1, 15% having genotype 2, 10% having genotype 3, and 1–6% having genotype 4; genotypes 5 and 6 are exceptionally rare. Current therapies are typically approved for the treatment of infection with only one or two genotypes of HCV.

In the session “Specialty Pharmaceuticals in Development,” Aimee Tharaldson, PharmD, senior clinical consultant, emerging therapeutics, Express Scripts, discussed several drugs in the HCV pipeline that are pan-genotypic regimens and how their approval will impact the market.

According to the presentation, the once-daily fixed-dose combination sofosbuvir/velpatasvir (Gilead Sciences, Inc) for the treatment of chronic genotype 1-6 HCV infection is expected to receive a decision from the FDA regarding approval in late June 2016. Several other combination therapies currently in the pipeline—including ABT‐530/ABT‐493 (AbbVie), MK‐3682/elbasvir/grazoprevir (Merck), odalasvir/ACH‐3422 (Janssen), and GS‐9857/velpatasvir/ sofosbuvir (Gilead)—are also pan-genotypic but are not expected to be approved this year.

“There are going to be other competitors that are pan-genotypic in the near future but probably not until late 2017 or early 2018,” Dr Tharaldson said.

Dr Tharaldson also highlighted the growing trend of shorter HCV infection treatment regimens, mentioning that all products currently in the pipeline have 8- and 12-week treatment arms. Although there are no 4- or 6-week treatment regimens currently in the pipeline, Dr Tharaldson mentioned RG-101 (Regulus Therapeutics), a 4-week combination treatment that is still in the early phases of development. If this drug is approved, it would not be until 2019 or later.—FRMC Editor