June 18, 2014 – Regimen of ledipasvir and sofosbuvir provides high rates sustained virologic response in all treatment groups.
Although knowledge and treatment options regarding the hepatitis C virus (HCV) have improved drastically over the last few years, the current standard treatment of interferon alfa and weight-based ribavirin can cause a variety of unwanted side effects. A recent study has found that a regimen of ledipasvir and sofosbuvir provides an effective treatment for patients with HCV genotype one with less toxicity.
This multicenter, randomized, phase-3 study treated patients for 12 or 24 weeks with or without the use of ribavirin. The results showed that despite whether the patients’ treatment regimen included ribavirin, all treatment groups had rates of sustained virologic response (an efficacy measure for HCV that looks for the absence of the RNA HCV virus in blood serum) that exceeded 97 percent.
The study results were published in the May 15 edition of the New England Journal of Medicine and included contributions from the DCRI’s Andrew Muir, MD, MHS (pictured right). In this trial, rates of response were generally uniform, irrespective of baseline patient characteristics. In patients with cirrhosis, which has traditionally been difficult to treat with interferon-based therapy, there appeared to be no marked effect on rates of response and the safety profile. However, the study was not specifically designed or powered to formally compare response rates in patients with or without cirrhosis, so these results need to be further tested.
The results further suggested that regimens adding ribavirin or extending treatment to 12 weeks do not result in better response rates than a regimen of 8 weeks of ledipasvir-sofosbuvir. This could mean a shorter treatment regimen would be equally effective. The groups receiving ledipasvir-sofosbuvir plus ribavirin experienced side effects such as fatigue, insomnia, cough, pruritus, and anemia.