When the FDA in May 2011 approved the first two protease inhibitors to treat hepatitis C — Merck & Co., Inc.’s Victrelis (boceprevir) and Vertex Pharmaceuticals Inc.’s Incivek (telaprevir) — those were the first new drugs for the condition in years (SPN 5/11, p. 1). They were also the first hepatitis C oral therapies and offered fewer side effects and shortened treatment regimens. But since that time, a handful of next-generation drugs offering even higher cure rates, shorter regimens, fewer and less-severe side effects, and effectiveness in multiple genotypes essentially rendered Victrelis and Incivek obsolete. So much so, in fact, that both Merck and Vertex have pulled their respective therapies off the U.S. market (SPN 9/14, p. 1; 2/15, p. 6). With more hepatitis C drugs still in the pipeline, are there drugs coming down the pike that are expected to have a similar impact? While that seems unlikely given the current drugs’ effectiveness (SPN 2/16, p. 1), there are still some treatments that payers should keep an eye on.
According to Marsha Honaker-Jackson, Pharm.D., clinical director at Benevere Specialty Pharmacy, “several companies have interesting compounds in various phases of clinical trials. Gilead [Sciences, Inc.] has two DAA [i.e., direct-acting antiviral] regimens in clinical trials that are worth watching: a pan-genotypic NS5B/NS5A inhibitor combination (sofosbuvir/velpatasvir) and a pan-genotypic NS5B/NS5A/NS3 protease inhibitor combination (sofosbuvir/velpatasvir/GS-9857). AbbVie [Inc.] has a pan-genotypic NS5A/direct-acting protease inhibitor combination (ABT-530/ABT-493) currently in clinical trial as well. [Bristol-Myers Squibb Co.] has a three-drug regimen (daclatasvir/asunaprevir/beclabuvir) in clinical trial used in combination with Sovaldi/RBV [ribavirin,] evaluating efficacy in a very short treatment duration.”