Date: 2015-02-26
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle .
Company: Gilead Sciences (USA - CA)
Product: Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg)
Action
mechanism: direct-acting antiviral agent/nucleotide analog. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication. Ledipasvir is a NS5A inhibitor. Harvoni® was approved by the FDA and Health Canada in October 2014 and by the European Union in November 2014. This is the first once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection in adults.
Disease: genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV
Therapeutic area: Infectious diseases
Country:
Trial
details: ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni® treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®).
Latest
news: * On February 26, 2015, Gilead Sciences announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data were presented in a late-breaker oral session (Session 152LB) at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle . ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®). SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. No patients discontinued Harvoni® due to an adverse event (AE). Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. The most common AEs reported were headache (25 percent), fatigue (21 percent) and diarrhea (11 percent). Harvoni® received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014 . Based on the ION-4 trial results, Gilead plans to file a supplemental New Drug Application with the FDA for Harvoni® to include the results from this study in the U.S. label. Harvoni® received marketing authorization in Europe in November 2014 , where data from a small study in HIV-HCV co-infected patients (ERADICATE) are included in the prescribing information.
