FDA approves Harvoni for new uses

November 16, 2015

FDA recently approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection – as well as in hepatitis C patients co-infected with HIV.

FDA recently approved Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection – as well as in hepatitis C patients co-infected with HIV.

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Gilead Sciences' Harvoni, first approved by FDA in October, 2014, to treat chronic HCV genotype 1, reached sales of around $3.3 billion in its most recent quarter. The controversial drug has also been criticized by lawmakers and others because of its cost: more than $94,000 for a 12-week treatment regimen.

FDA also approved Harvoni plus ribavirin (RBV) for 12 weeks as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.

Related:Harvoni could save US, Europe $3.2 billion

“Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure,” said Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead. “We are pleased that the Harvoni label and prescribing information now includes guidance for health care providers on its use in these important HCV patient populations.”

FDA’s supplemental new drug application (sNDA) approval for HCV genotypes 4-6 was supported by data from two open-label trials. One study found that 93 percent of those with genotype 4 and 93 percent of those with genotype 5 achieved SVR12 (sustained viral response). In the second study, ELECTRON-2, which evaluated Harvoni for 12 weeks in treatment-naïve or previously-treated patients with genotype 6 HCV infection with or without cirrhosis, 96 percent achieved SVR12.

The most common adverse events (in at least 10% of subjects) were asthenia (18%), headache (14%) and fatigue (10%).

Meanwhile, the sNDA approval for patients with HCV/HIV-1 co-infection was supported by data from the Phase 3 open-label ION-4 study, which evaluated Harvoni for 12 weeks for the treatment of genotypes 1 or 4 chronic HCV infection among patients co-infected with HIV. In this study, a significant 96% of patients achieved SVR12. The study included HCV treatment-naïve (45%) and treatment-experienced (55%) patients, including patients with compensated cirrhosis (20%).

The majority of patients were taking one of three HIV antiretroviral (ARV) regimens: tenofovir disoproxil fumarate (TDF) and emtricitabine with efavirenz (Atripla), raltegravir or rilpivirine (Complera).

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