A new phase 2b trial shows promise in HCV treatment.
is a viral infection that impacts millions of people each year within the US. While often an acute, asymptomatic infection, it can lead to chronic issues. Unfortunately, there is no vaccine, and since 2010 it has seen a growing number of cases related to injection drug use. In the US, there was a rate of hepatitis C virus infection of 3,216 per 100,000 people in 2017. This grew from 2,138 per 100,000 people in 2013.
For those living with HCV infections, it can be treated with antiviral medication to help clear the virus from the body, which can often be done with 3 months of treatment. For those though, who develop chronic HCV infection, liver damage can occur. As a result, liver transplantation is one avenue of medical care, but this does not cure the patient of viral infection and still requires the use of antiviral medications.
As a result of this serious condition, researchers are continuously working to find treatments. For those HCV patients with severe renal impairments, there is an increasing need for safe and effective treatment options. Within the new Lancet Gastroenterology & Hepatology journal, researchers addressed the a multicenter, phase 2b, non-randomized open label study they performed testing sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in those patients with genotype 1 or 3 HCV.
The goal was to assess the safety and efficacy of using either of these 2 treatment approaches in those patients with stage 4-5 chronic kidney disease who were not undergoing dialysis.
Across multiple centers in the US and New Zealand, they studied 3 sequentially enrolled cohorts of patients with either genotype 1 or 3 HCV infection.
“In cohorts 1 and 2, patients received sofosbuvir (200 mg in cohort 1 and 400 mg in cohort 2) plus ribavirin 200 mg once per day for 24 weeks,” the authors wrote. “In cohort 3, 18 patients received ledipasvir combined with sofosbuvir (90 mg ledipasvir and 400 mg sofosbuvir) once per day for 12 weeks. The primary efficacy endpoint was the proportion of patients achieving sustained virological response 12 weeks after the end of treatment (SVR12).”
From October 2013 to October 2017, the investigators studied sofosbuvir plus ribavirin in a 20-patient cohort (10 in each cohort) then 18 patients in the ledipasvir plus sofosbuvir cohort. They found that 40% of the 10 patients in cohort 1 and 60% of those in cohort 2 achieved SVR12. For cohort 3, 100% achieved SVR12. For those experiencing adverse symptoms, most were mild or moderate and the most common was a headache (21%) or anemia. Of all the patients, 8 had serious adverse events, but none were treatment related.
Overall, the researchers underscore that within their phase 2b study, ledipasvir plus sofosbuvir for 3 months (12 weeks) of treatment proved to be not only effective, but also safe for those patients with genotype 1 HCV infection and stage 4-5 chronic kidney disease, but not undergoing dialysis. This study shows a promising future for the treatment protocol of ledipasvir plus sofosbuvir for 12 weeks in this patient population.