Combos

AbbVie, Enanta hep C combo looks stellar in CKD study as rivals hustle along the latest cures

There are a variety of combo therapies on the market now that can effectively cure the large majority of hepatitis C cases. But over the last few days we’ve been treated to a slate of new trials underscoring the efficacy of new combos that can root out out the virus in key pockets of patients, with investigators presenting new data at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

This morning AbbVie $ABBV and its partner Enanta $ENTA said that their combination of an NS3/4A protease inhibitor — Enanta’s glecaprevir (ABT-493) — and the NS5A pibrentasvir (ABT-530) achieved a near perfect score for curing hep C in patients with severe chronic kidney disease in the 12 weeks following treatment, SVR12.

EXPEDITION-4 is billed as a registration-level Phase III effort which enrolled 104 CKD patients, the latest in a long lineup of efforts to follow up on pioneering cures like Harvoni as developers look for new, faster ways to wipe out this disease among hard-to-treat patients. All but two of the patients in the study were effectively cured, and those two standouts failed for reasons other than the drug response.

A couple of days ago it was Merck’s turn to tout results for its triple for hep C, MK-3682B (MK-3682/grazoprevir/ruzasvir), which provided promising cure rates in three Phase II studies. Gilead has a triple combo of its own, as it watches its river of revenue from the franchise dwindle steadily from its peak torrent.

“Across the chronic hepatitis C treatment landscape, incredible progress has been made in a remarkably short amount of time, but there remains a need for more options, particularly for patients who do not achieve sustained virologic response with treatment regimens available today,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories.


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RAPS Regulatory Convergence 2017