HCV New Drugs

16 May 2017 

by Michael Haydock

In this report we summarize several notable highlights from this year’s EASL conference. Also included are key abstracts featuring commentary from Biomedtracker and Datamonitor Healthcare analysts including any changes in Likelihood of Approval (LOA), if applicable.

Summary  
As chronic hepatitis C virus (HCV) drug development approaches the end-game following the launch of the first pan-genotypic regimen, Epclusa (sofosbuvir/velpatasvir; Gilead), recent and upcoming advances in chronic hepatitis B virus (HBV) treatment emerged as an important focus of The International Liver Conference (ILC) 2017, the annual meeting of the European Association for the Study of the Liver (EASL), which took place in Amsterdam, the Netherlands, on 19–23 April 2017. Particular interest was paid to 96week safety data from pivotal studies of Vemlidy (tenofovir alafenamide [TAF]; Gilead), which Gilead hopes will drive its uptake in the face of imminent competition from generic versions of Viread (tenofovir disoproxil fumarate [TDF]; Gilead). Updated EASL guidelines for the management and treatment of chronic HBV were also released, which included a novel recommendation for the use of Vemlidy as a firstline agent in select patients, as well as a revised nomenclature for classifying the stages of chronic HBV infection. 

There was also considerable optimism regarding the potential of new modes of action in early-phase development for the treatment of HBV to improve upon the disappointingly low rates of hepatitis B surface antigen (HBsAg) loss observed after treatment with currently available therapies. While there are very limited efficacy data available for early-phase approaches, there was consensus during panel discussions of available data that combining currently approved nucleos(t)ide analogs (NAs) with novel agents, such as RNA interference, capsid assembly inhibitors, nucleic acid polymers, and immunostimulatory agents, represents a promising approach towards achieving “functional cure”.

Multiple abstracts for HCV therapies were also presented as AbbVie, Merck & Co, and Johnson & Johnson attempted to demonstrate differentiation in a highly-competitive market with few unmet needs remaining. AbbVie presented data from multiple Phase III studies which highlighted glecaprevir/pibrentasvir’s pan-genotypic efficacy in non-cirrhotic genotype 3 (GT-3) patients (ENDURANCE-3) and cirrhotic GT-1/2/4/5/6 patients (EXPEDITION-1), as well as its maintenance of competitive cure rates in direct-acting antiviral-experienced GT-1/4 patients (MAGELLAN-1) and posttransplant patients (MAGELLAN-2). Merck & Co presented data from the Phase II C-SURGE study in DAAexperienced patients which demonstrated that its triple combination of uprifosbuvir/grazoprevir/ruzasvir was an effective salvage regimen in DAA-experienced patients with resistance-associated substitutions, and future studies will investigate the regimen in both DAA-naïve and DAA-experienced patients. Finally, Johnson & Johnson suffered a setback as its triple combination of AL-335/odalasvir/simeprevir failed to demonstrate competitive efficacy in GT-3 patients, prompting the company to discontinue development for this subgroup and putting an end to the company’s hopes of marketing a pan-genotypic regimen. While AL-335/odalasvir/simeprevir is still being developed for the remaining GTs and could shorten treatment duration to just six weeks in non-cirrhotic GT-1 patients, it is likely that Johnson & Johnson will be forced to offer significant discounts to compensate for its late entry to the market.

2017 Post-EASL Report

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Source

https://pharmaintelligence.informa.com/resources/product-content/2017-post-easl-report