FDA Approves First Combination Pill 'Harvoni' to Treat Hepatitis C

First Posted: Oct 14, 2014 06:24 AM EDT

The U.S. FDA panel has given a nod to Harvoni, the first combination pill to treat chronic hepatitis C virus.

In the latest announcement, the U.S. Food and Drug Administration revealed that it had approved the first combination pill - 'Harvoni' (ledipasvir and sofosbuvir) - to treat chronic hepatitis C virus (HCV) genotype 1 infection. Apart from this, Harvoni is the first approved regimen that does not need administration with interferon or ribavirin, the two FDA-drugs that is used to treat HCV infection.

Both the drugs present in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is an approved HCV drug marketed under the brand name Sovaldi. Harvoni also has a new drug called ledipasvir.

"With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens."

The newly-approved drug is the third drug that is sanctioned by FDA in the last year to treat chronic HCV infection. Prior to this, it was approved by Olysio in November 2013 and Sovaldi December 2013.

Hepatitis C is a viral disease that triggers inflammation of the liver that further leads to reduced liver function or in worst cases liver failure. Most of those infected with HCV display no symptoms of the disease until the liver damage becomes evident and this migt take decades.

Some of those with chronic HCV infection develop scarring and poor liver function over several years that can also lead to complications like bleeding, jaundice, fluid accumulation in the abdomen, infections and liver cancer.

The Centers for Disease Control and Prevention claim that over 3.2 million Americans are infected with HCV and without treatment 15-30 percent of them develop cirrhosis.

The safety and efficacy of the drug was tested in three different clinical trials that involved 1,518 participants who had not received any treatment earlier for their infection or had not responded to their previous treatment including participants with cirrhosis.

The participants were randomly assigned to receive Harvoni with or without ribavirin. These trials were basically designed to measure whether the HCV was longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response (SVR)), indicating the participants HCV infection had been cured.

In the first trail, 94 of the subjects who got Harvoni for eight weeks and 96 percent of them who did not receive Harvoni for 12 weeks had achieved SVR. In the second trial, 99 percent of them with and without cirrhosis also achieved SVR after 12 weeks. In the third trial, 94 percent of the, receiving Harvoni for 12 weeks and 99 percent of them who received Harvoni for 24 weeks achieved SVR.

The most common side effects noticed was fatigue and headache.

The drug was marketed by Gilead, based in California.

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