Reuters Health Information (2012-04-04): Abbott hepatitis C combo impressive in small study
Drug & Device Development
Abbott hepatitis C combo impressive in small study
Last Updated: 2012-04-04 18:58:22 -0400 (Reuters Health)
(Reuters) - A combination of experimental oral hepatitis C treatments being developed by Abbott Laboratories led to cure rates of more than 90% in previously untreated patients, according to data from a small mid-stage study.
The data, to be presented at a major European liver meeting later this month, put Abbott firmly in the crowded race to produce a short duration, interferon-free treatment regimen for hepatitis C.
"This demonstrates unprecedented cure rates for the most common form of hepatitis C infection. And we were able to achieve those rates with only a 12-week duration of therapy," said Scott Brun, Abbott's divisional vice president for infectious disease development.
Abstracts of studies to be presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona were made available on Wednesday.
"At EASL it's going to be very clear that we've reached a really transformational moment for patients with HCV (hepatitis C virus)," Brun said.
The Phase II trial of previously untreated patients, known as Co-Pilot, combined Abbot's protease inhibitor ABT-450 boosted by ritonavir with its polymerase inhibitor ABT-333 and ribavirin, a drug that is part of all current hepatitis C regimens.
Patients received the combination therapy for 12 weeks and were checked 24 weeks later for signs of the virus in the blood to determine if there was a sustained virologic response (SVR). An SVR at 24 weeks after completing treatment is considered to reflect a cure.
Eighteen of the 19 patients (95%) who received a 250 mg dose of ABT-450 as part of their combination achieved an SVR, as did 13 of 14 patients (93%) who got a 150 mg dose.
In a third arm of the study that involved patients who had failed treatment with interferon and ribavirin, eight of 17 patients, or 47%, achieved an SVR.
Abbott is also testing a drug from a promising class known as NS5A inhibitors in various all-oral combinations that it believes may improve cure rates for prior non-responders.
"For a first step it's very encouraging," Brun said of the new data in non-responders. "If you're able to add the potent NS5A inhibitor into the mix we think there's the potential to do even better and that's currently under study."
There were no serious side effects seen in the study, with the most common side effects fatigue, nausea and headache.
The treatment of hepatitis C took a major leap forward last year with the approvals of new drugs from Vertex Pharmaceuticals Inc and Merck & Co that led to far-higher cure rates with the potential for shorter treatment durations than interferon and ribavirin, which had to be taken for 48 weeks and cured only about 40% of patients.
Vertex's Incivec led to cure rates as high as 80% in previously untreated patients. But both new drugs must be taken with interferon and ribavirin, and the shortest treatment regimen is currently 24 weeks, with many patients still requiring 48 weeks.
Far larger trials will be needed to confirm the efficacy and safety of the Abbott drugs, and the company said it is on track to begin pivotal Phase III testing in early 2013.
But the data Abbott will present at EASL this month clearly signals that it intends to be a major player in the field.