From EveryDay Health News, http://www.everydayhealth.com/news/new-pill-late-stage-hepatitis-c-cures-95-percent/
The FDA has approved Zepatier, a new pill for hepatitis C that combines the two drugs elbasvir and grazoprevir.
In April 2015, the FDA designated the combo drug as a breakthrough therapy for patients with hepatitis C genotype 1 disease who have end-stage kidney disease and are on hemodialysis, and for patients with hepatitis C genotype 4. The breakthrough designation is intended to accelerate development and review of drugs that offer substantial improvement over existing therapies. The new pill is made by Merck.
Zepatier doesn’t require additional interferon treatments, which often come with difficult side effects — good news for patients with hepatitis C.
Investigators previously reported encouraging findings on Zepatier at the International Liver Congress in Vienna from phase-3 clinical trials to treat people with chronic hepatitis C infection. Cure rates of 92 to 99 percent were reported, depending on the history of the patient’s hepatitis C infection.
The set of three clinical trials, called C-EDGE, included several types of patients with hepatitis C: those who had never been treated for hepatitis C, patients who'd been treated with drugs but whose infections did not respond to treatment, and patients co-infected with HIV. Three different hepatitis C genotypes were included: genotype 1, which is the most common in the United States, genotype 4, and genotype 6. Patients with the advanced liver disease cirrhosis were included in the trials.
Shorter Treatments and a Good Safety Profile
“This combination achieves the high SVR [sustained viral response, or cure] in treatment-experienced patients with a 16-week duration, which is shorter than comparable treatment regimens currently available,” says David Bernstein, MD, chief of the division of hepatology at the North Shore University Hospital in Manhasset, New York. Dr. Bernstein attended the Vienna meeting but did not take part in the research studies.
“There were no red flags in regards to safety,” he says. “I feel that this regimen will be widely used by practitioners if it is made readily available.”
Common side effects reported by patients who took Zepatier without ribavirin include fatigue, headache, and nausea. And some of those taking Zepatier along with ribavirin also experienced side effects, including anemia and headache.
The drug is the third all-oral hepatitis C treatment on the market, along with AbbVie’s Viekira Pak and Gilead's Harvoni.
As is the case with all three of these newer treatment approaches, patients don't need to take them along with interferon, an older hepatitis C drug that can cause serious side effects, like anemia and debilitating depression.
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