Gilead Sciences, a company focused on delivering treatments for patients with a wide range of diseases including Hepatitis C, recently announced the results from its Phase 3 study called ION-4, a trial that is examining the efficacy of a drug called Harvoni (ledipasvir 90mg/sofosbuvir 400mg) to treat patients suffering from genotypes 1 or 4 chronic hepatitis C virus (HCV) infection that also have HIV.
The study is an open-label multi center trial that, apart from efficacy, is also looking into the safety and tolerability of treatment with Harvoni for a period of 12 weeks in a total of 335 patients with HCV genotype 1a (75%), 1b (23%) or 4 (2%) and HIV-1 co-infection. The ION-4 trial involved HCV treatment-naïve (45%) and treatment-experienced (55%) patients, and also patients with compensated cirrhosis (20%), whose HIV was suppressed with one of three HIV antiretroviral (ARV) regimens namely, Atripla (tenofovir/emtricitabine/efavirenz), tenofovir/emtricitabine/raltegravir or Complera (tenofovir/emtricitabine/rilpivirine).
According to a recent news release, results from the study revealed that after the 12 weeks therapy (SVR12) a total of 321 HCV patients (96%) attained a continued virologic response, with no differences in rates found regarding HCV treatment status, presence or absence of cirrhosis, or ARV regimen. From the 14 patients that did not attain SVR12, the researchers observed that two patients suffered from virologic failure during treatment, 10 experienced virologic relapse after the treatment, one died due to causes not associated with the study and one was lost to follow up.
Nearly 3.2 million Americans suffer from chronic hepatitis C. Hepatitis C is a condition that progressively destroys the liver, leading to life-altering and possibly fatal complications, such as liver cancer and the need for liver transplants. In addition to severe liver damage, untreated hepatitis C can lead to Type 2 diabetes, thyroid disease and rheumatologic disorders. Since the discovery of the virus, treating patients with hepatitis C has been a challenge and for several years, the only available options were found to be ineffective for many patients with the condition and often difficult to tolerate. In clinical practice, the initial treatment options for hepatitis C involve up to a year of interferon injections and ribavirin tablets every week, causing side events including nausea, depression, severe reductions in certain blood cells and flu-like symptoms. In October 2014, the FDA approved Harvoni for patients with the most common form of hepatitis C in the United States (genotype 1).