1. Sofosbuvir plus ledipasvir was effective in treating chronic hepatitis C virus (HCV) genotype 1 infection in patients who were not candidates for interferon and who suffered viral relapse after prior sofosbuvir-based treatment.
Evidence Rating Level: 2 (Good)
Study Rundown: Sofosbuvir, an NS5B inhibitor, is an alternative to interferon-based treatments for chronic hepatitis C virus (HCV) genotype 1 infections in patients who are not candidates for interferon, such as those with advanced liver disease. In the NIAID SPARE trial, some patients with viral relapse agreed to retreatment with daily oral sofosbuvir and ledipasvir. Ledipasvir is an NS5A inhibitor which may be effective against sofosbuvir-resistant S282T mutant HCV. The 14 patients enrolled had high baseline viral RNA loads, and half had advanced liver disease (one was infected with S282T HCV). By the 4th week of treatment with sofosbuvir plus ledipasvir, all patients were aviremic based on unquantifiable HCV RNA levels. There were no significant changes in hemoglobin levels or renal variables, with the exception of a patient with baseline grade 2 renal insufficiency who had a grade 3 event after taking amoxicillin for a dental procedure. All patients completed treatment, with only mild adverse events. Ultimately, this study is limited by its small sample size and lack of controls, but sofosbuvir plus ledipasvir shows promise for the treatment of chronic HCV genotype 1 infections in patients who are not candidates for interferon and suffer viral relapse after prior sofosbuvir-based treatment.
In-Depth [prospective cohort]: This study included 14 patients who relapsed after treatment with sofosbuvir plus ribavirin for chronic HCV genotype 1 infection, with combined daily oral doses of sofosbuvir and ledipasvir. The average age of the patients was 59 years, 93% were black, 93% were men, median BMI was 28.5, and 50% had advanced liver disease. The baseline HCV RNA levels were high (median 6.31 log IU/ml), with 11% having very high HCV RNA levels >800,000 log IU/ml and one patient had S282T HCV infection. By the 4th week, all patients had HCV RNA levels below the quantifiable limit, maintained through the 12th week of treatment and at 12 weeks after the completion of treatment. There were no serious adverse events and all patients completed treatment.
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