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Treatment options FDA approves new drug to treat hepatitis C

Portsmouth Herald - 8/13/2017

EXETER - Last week, the Food and Drug Administration approved the use of a new drug for treating all forms of hepatitis C in eight weeks, improving treatment options for patients with the disease.

Dr. Arthur Yan of Core Gastroenterology in Exeter said it's a great new treatment option, and it also serves as a reminder that the Centers for Disease Control recommends that all baby boomers be tested for the disease.

"It can lie dormant for 20-30 years, but untreated can result in cirrhosis of the liver," said Yan. "Many people are not even aware they have it. Some people are beginning to present with cirrhosis."

People in the baby boomer age range should particularly seek testing if they lived their early life with certain risks, including drug or alcohol use.

Hepatitis can also be transmitted through sexual activity.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 million to 3.9 million people in the United States have chronic HCV.

Some patients who suffer from chronic HCV infection over many years may have jaundice (yellowish eyes or skin) and complications, such as bleeding, fluid accumulation in the abdomen, infections, liver cancer and death.

Last week the FDA approved Mavyret, a combination of two hepatitis drugs, glecaprevir and pibrentasvir, to treat adults with chronic hepatitis C virus genotypes 1-6, in patients who do not yet have cirrhosis of the liver, including patients with kidney disease and those who are on dialysis.

"It is a breakthrough drug," said Yan. "Of course, it will take some time to go through the process before we can start prescribing it."

Mavyret is the first treatment of eight weeks' duration approved for all HCV genotypes in adult patients without cirrhosis who have not been previously treated. Previously, the standard course of treatment was 12 weeks or more, sometimes as long as a year.

"Combo drugs are available," sad Yan. "This one, to treat all genotypes and in eight weeks, offers great promise." Yan said the drug offers new hope for patients whose treatment has failed with other treatment protocols.

According to a press release from the FDA, the safety and efficacy of Mavyret were evaluated during clinical trials enrolling about 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis.

Results of the trials demonstrated that 92 percent to 100 percent of patients who received Mavyret for eight, 12 or 16 weeks' duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients' infection had been cured.

"Those are pretty good numbers," sad Yan. "Nine studies and 2,300 people is good test parameter."

Yan said having one drug for all genotypes could drive down the cost of treatment for hepatitis.

According to the FDA, the most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea. It is not recommended for patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

The FDA reported that using Mavyret poses some risk of reactivation on patients with hepatitis B. Doctors should screen for the disease before beginning treatment with Mavyret. The FDA granted approval of Mavyret to AbbVie Inc., a pharmaceutical company in Chicago.