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FDA Expands Indications for Two Hepatitis C Drugs

Two medications now have FDA approval for expanded use as hepatitis C treatment, including the treatment of patients with different types of advanced liver disease and those coinfected with HIV.

The Food and Drug Administration has given two drug companies approval to expand the use of their hepatitis C regimens to include treating patients with different types of advanced liver disease, and those coinfected with HIV.

If left untreated chronic infection of the hepatitis C virus can inflame and seriously damage the liver and even lead to liver cancer or the need for a liver transplant. Health officials estimate that there are roughly 3 million people in the United States who are infected with the blood borne virus.

While great strides have been made in the last few years in development of more effective hepatitis C drugs, options have been more limited for those with the virus who also have advanced liver disease or HIV. These expanded label indications widen options for those patients whose disease complications make their conditions more difficult to treat, officials from both drug companies said.

The most recent FDA label update is for Harvoni, a Gilead Sciences fixed-dose drug that combines Sovaldi (known generically sofosbuvir) and ledipasvir. The label change expands the patient population to include HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis, according to a statement from Gilead.

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