New Chronic Hepatitis C, Genotype 1 Infection Drug Approved By FDA

New Chronic Hepatitis C, Genotype 1 Infection Drug Approved By FDA

Harvoni FDA approvalApproval for a new chronic hepatitis C (HCV) treatment, genotype 1 infection in adults, was recently announced by the U.S. Food and Drug Administration (FDA). The drug — Harvoni® (ledipasvir/sofosbuvir) — is manufactured by Gilead Sciences.

Harvoni represents the first FDA-approved oral combination therapy for HCV treatment. Previous treatments for HCV required administration with pegylated interferon (the addition of PEG makes interferon last longer in the body) or ribavirin (blocks viral RNA synthesis and viral mRNA capping). Harvoni® is the first interferon- and ribavirin-free treatment for HCV. Its efficacy was established in chronic hepatitis C patients enrolled in three Phase 3 studies, ION-1, ION-2 and ION-3.

Nezam Afdhal, MD, the director of hepatology at Beth Israel Deaconess Medical Center, a professor of medicine at Harvard Medical School, both in Boston, and a principal investigator for the clinical trials of Harvoni commented, “By providing high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States.”

Harvoni® is a once-a-day, fixed-dose treatment for HCV that combines two therapeutic components — ledipasvir (which inhibits hepatitis C virus NS5A protein, a key factor for HCV RNA replication) and sofosbuvir (which inhibits the RNA polymerase with which the virus replicates its RNA). The Harvoni® treatment period depends on the patient’s medical history, cirrhosis status, and baseline viral load, and can be administrated for eight, twelve, or twenty-four weeks.

The FDA granted Harvoni® priority review and breakthrough therapy designation. These are given to new drugs still in the investigation phase, but that may introduce major advances in treatment over available therapies.

HCV is a viral disease estimated to affect approximately 3.2 million Americans, according to Centers for Disease Control and Prevention. HCV is a liver disease, usually asymptomatic, that leads to scarring of the liver and ultimately cirrhosis. Eventually, some cirrhosis patients will develop liver failure and liver cancer.



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