More Hepatitis C Therapies Are Still in the Pharma Pipeline

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.”

Drug May Help Harder-to-Treat Genotypes

These new drugs, says Honaker-Jackson, “may give us better efficacy against all the HCV [hepatitis C virus] genotypes, particularly harder-to-treat genotype 2 and 3, with reduced length of treatment. Of course, this will have to be balanced against the monthly regimen cost.” That aspect is critical. The go-to treatments — Harvoni (ledipasvir and sofosbuvir), Sovaldi (sofosbuvir) and Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) — have annual per-person price tags that generally range from $83,000 to $94,500. And while new entrant Zepatier (elbasvir and grazoprevir) — approved Jan. 28 — launched with a price of $54,600 per person per year, industry experts maintain that the lower price is on par with the net prices of Harvoni, Sovaldi and Viekira Pak after contracting rebates given to payers (SPN 2/16, p. 1).
“The most imminent expected arrival would be Gilead’s fixed-dose combination of sofosbuvir and velpatasvir,” say Christopher Pace, Ph.D., GlobalData’s director for infectious diseases, and Daian Cheng, Ph.D., the company’s analyst covering infectious diseases. “This drug is under FDA priority review for all HCV genotypes. Hence, if approved, it will potentially eliminate the need for determining HCV genotype upon diagnosis. On the other hand, genotype testing is routinely done at least in the U.S., and the benefit of removing it is uncertain. Nevertheless, this drug will strengthen Gilead’s already dominant hepatitis C portfolio, especially for genotypes other than GT1 and GT4, for which treatment from other providers are largely lacking.”
“At the end of the day, anything coming down the pike at this point must show something amazing” — perhaps in price or treatment of all genotypes, says Marie Hollowell, senior manager of syndicated research for Zitter Health Insights. If not, that drug is “coming in third or fourth” as far as treatment options go, similar to the rheumatoid arthritis class of therapies, she says.