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Reuters Health Information (2013-11-04): High cure rates seen with Merck oral hepatitis drugs: study

Drug & Device Development

High cure rates seen with Merck oral hepatitis drugs: study

Last Updated: 2013-11-04 18:38:26 -0400 (Reuters Health)

(Reuters) - A combination of two oral hepatitis C treatments developed by Merck & Co led to high cure rates in previously untreated patients, researchers say.

The treatments tested with and without the older drug ribavirin led to cure rates of 96% to 100%, according to interim data from a small midstage clinical trial presented Sunday at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington, DC.

The results appear to confirm Merck will be competitive in the crowded race to develop interferon-free treatments for hepatitis C, assuming they are repeated in larger studies that include more difficult to treat patient populations, such as those not helped by prior therapy.

The 65-patient, 3-arm study tested MK-5172, a protease inhibitor, combined with MK-8742 from a highly promising new class of drugs called NS5A inhibitors for 12 weeks of treatment.

Based on data available at the time the interim results were released, 55 of 56 patients who completed the therapy were considered to be cured of the virus which is transmitted through infected blood from sources such as infected hypodermic needles or blood transfusions.

Patients who have no detectable levels of the virus in their blood 12 weeks after completing 12 weeks of treatment were deemed to have a sustained virologic response.

In the arm of the study that did not include the older oral medicine ribavirin, all 11 patients who completed therapy with MK-5172 and the higher 50 mg dose of MK-8742 taken once a day achieved SVR at 12 weeks.

All 12 patients who began that arm of the study had HCV genotype 1b, which is prevalent in Europe and Japan. It is considered somewhat easier to treat than genotype 1a, the most common form of the virus seen in the United States, which may require a third drug in the regimen to achieve similarly high cure rates.

The other two arms - one testing 50 mg of MK-8742 and one using 20 mg - did include ribavirin given twice a day.

With the lower dose of the NS5A inhibitor, all 21 patients who completed therapy were deemed cured. In the group that received the higher dose in the three-drug combination, 23 of 24, or 96%, reached SVR at 12 weeks. About three quarters of the patients in those arms were genotype 1a.

Of the 65 patients in the study, only one had experienced a relapse of the virus.

"We are encouraged by these preliminary data for the combination of MK-5172 and MK-8742. It's a one-two punch with both arms equally strong," said Eliav Barr, head of infectious diseases for Merck.

SHORTER TREATMENT DURATION

Current standard treatment regimens for hepatitis C take 24 or 48 weeks and includes injected interferon, which causes miserable flu-like symptoms that lead many patients to avoid or discontinue treatment.

Several companies are developing new all-oral combinations that in clinical trials have cut treatment duration to 12 weeks for many patients while significantly increasing cure rates from about 75% with current drugs.

Ultimately, physicians would like to also see regimens that do not require ribavirin, which has its own side effect issues, including anemia and rash.

It is believed that tens of thousands of hepatitis C patients have delayed treatment while awaiting the new drugs expected to start reaching the market next year.

Gilead Sciences is widely seen as being in the lead with a safe and effective all-oral combination, with Bristol-Myers-Squibb and AbbVie close behind.

Gilead recently won an approval recommendation from a U.S. Food and Drug Administration advisory panel for its highly regarded sofosbuvir.

Some analysts believe the market for all-oral hepatitis C treatments could reach $20 billion as many more people get tested for the virus, given the very high cure rates, shorter treatment durations and tolerable side effects.

The Merck drugs were well tolerated with no serious adverse side effects reported. The most common side effects were fatigue, headache and nausea.

Merck plans to expand the Phase II trial to about 400 additional patients, testing its drugs with and without ribavirin, and including those also infected with the HIV virus, those with cirrhosis and patients who have failed to be cured by prior treatments. It is also looking at a regimen of only 8 weeks in previously untreated patients that would include ribavirin.

 
 
 
 
                 
 
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