J&J firms up efficacy data on hep C triple combo
- Updated results of an ongoing Phase 2a study carried out by Janssen subsidiary Alios BioPharma showed all patients who received a triple therapy of AL-335, odalasvir and Olysio (simperevir) had undetectable levels of hepatitis C virus sustained 12 weeks after finishing treatment.
- Efficacy was seen even in the cohort of patients who were given the combo over six weeks, underscoring the potential of the therapy to be a speedier alternative to current hepatitis C drugs on the market.
- Development will continue with a once-daily dose of odalasvir (25 mg), AL-335 (800 mg) and Olysio (75 mg) for treatment durations of both six and eight weeks. The Phase 2a study will continue to assess the combination in patients with or without compensated cirrhosis and HCV genotype 3 infections.
Duration of treatment is likely to become one of the main levers of competition in the hepatitis C market, as fewer untreated patients begin treatment with the wave of potentially curative treatments approved over the past several years.
The Phase 2a study showed efficacy across the board after six or eight weeks of treatment, compared to the standard 12-week regimen for Gilead’s Sovaldi (sofosbuvir), Merck’s Zepatier (elbasvir and grazoprevir) and Gilead’s Harvoni (ledipasvir and sofosbuvir).
Length of treatment canhave an impact on adherence. An analysis of Sovaldi real world data by CVS suggested an 8% discontinuation rate during the 12-week treatment course, four-fold higher than that seen in clinical trials. A six- or eight-week regimen could improve adherence rates.
Merck's launch of Zepatier has signaled a potential pricing battle in the costly market for hepatitis C drugs. Gilead's Sovaldi and Harvoni, along with AbbVie’s Viekira Pak command high list prices, and so the entry of Zepatier at $54,600 for a 12-week regimen has stepped up jockeying for market share. All treatments have proven high efficacy in the most common hepatitis C patient populations, meaning competition down the road could revolve around different levers.
Gilead is also testing a combination therapy with shorter treatment durations.
The updated study results also gave further detail on the one serious adverse event reported in clinical testing. A patient receiving all three drugs experienced a Mobitz Type 1 2nd degree atrioventricular block, which was judged to be "probably related" to odalasvir and "possibly related" to AL-335 and Oylsio. The patient discontinued treatment of all three drugs, but did not need to receive any other intervention and eventually achieved a viral response.
Johnson & Johnson signed its deal with Achillion in May 2015 lining up a potential $1.1 billion to gain acess to Achillion's hepatitis C compound odalasvir. AL-335 came from Alios, and Olysio (simeprevir) was developed through a collaboration between Swedish company Medivir and Janssen (J&J).
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