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Harvoni Expands Dosing Recommendations
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Gilead Sciences, which manufactures Harvoni, recently expanded the drug’s label to include dosage recommendations for chronic hepatitis C virus genotypes 4, 5 and 6 infection, and hepatitis C virus and HIV-1 coinfection, according to the FDA.
Labeling for Harvoni (ledipasvir/sofosbuvir) also states that a 12-week regimen of ledipasvir/sofosbuvir plus ribavirin can be considered in previously treated genotype 1 patients with cirrhosis. The label further added drug-drug interaction information.
The use of ledipasvir/sofosbuvir in genotypes 4, 5 and 6 infection was evaluated during three open-label trials — Study 1119, ION-4 and ELECTRON-2. According to the FDA, the results indicated that 118 patients infected with genotypes 4, 5 and 6 who received a 12-week regimen of once daily ledipasvir/sofosbuvir had a similar safety profile vs. patients infected with chronic HCV genotype 1. At week 12, sustained virological response was 93% in Study 1119 (patients with genotypes 4 and 5), 96% in the ELECTRON-2 trial (patients with genotype 6) and 100% in the ION-4 study (patients with genotype 4).
The ION-4 trial also demonstrated similar safety outcomes in patients coinfected with HCV and HIV-1 who were receiving ART vs. patients with only HCV. The percentage of CD4+ cells in patients with HIV did not change; however, the median CD4+ count increased by 29 cells/mm³ after 12 weeks of therapy with ledipasvir/sofosbuvir.
In the SIRIUS trial, researchers assessed a combination of ledipasvir/sofosbuvir plus ribavirin. They randomly assigned patients with HCV genotype 1 and compensated cirrhosis who failed prior therapy to 12 weeks of ledipasvir/sofosbuvir/ribavirin or 24 weeks of ledipasvir/sofosbuvir. SVR at 12 weeks was 96% among patients treated with ledipasvir/sofosbuvir/ribavirin vs. 97% in patients treated for 24 weeks with ledipasvir/sofosbuvir.