FDA Expands Indications for Two Hepatitis C Drugs

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.

“Hepatitis C infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited,” Norbert Bischofberger, Gilead’s executive vice president of research and development and chief scientific officer said in the release. “We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile.”

The FDA decision was based on data that Gilead submitted in a supplemental new drug application involving Phase 2 open-label clinical trials. The studies evaluated Harvoni for 12 and 24 weeks in combination with ribavirin in patients who had never been treated for HCV, as well as treatment-experienced patients with HCV genotype 1 and 4 who had liver transplants or decompensated liver disease, the release states.

Earlier this month, the pharmaceutical company Bristol-Myers Squibb also received FDA approval for expanded use of its hepatitis C drug called Daklinza (daclatasvir) in combination with Sovaldi (with or without ribavirin) to treat chronic HCV genotypes 1 and 3 patients coinfected with HIV-1 and post-liver-transplant patients with HCV recurrence, according to a company release. The label also allows for treatment of HCV genotype 1 patients with compensated or decompensated cirrhosis and genotype 3 patients with decompensated cirrhosis, the release states.

Daklinza’s efficacy and safety were evaluated in one Phase 3 clinical trial involving post-liver-transplant patients and patients with advanced cirrhosis and another in patients who were coinfected with HIV.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” Chris Boerner, who heads up Bristol-Myers Squibb US commercial division said in the release. “HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”