1. Ledipasvir-sofosbuvir treatment was associated with rapid chronic hepatitis C (HCV) RNA suppression.
2. Ledipasvir-sofosbuvir treatment was generally well tolerated in kidney transplant patients.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Infection with chronic HCV virus is very common within kidney transplant recipients. About 10% of recipients in Western countries will be infected. Chronic HCV infection increases risk for end-stage renal disease and is associated with higher graft loss and mortality rates in transplant patients. While interferon regimens are typically used to treat HCV in non-transplant patients, these treatments are of limited use in transplant recipients due to increased risk for interferon-mediated graft rejection and low efficacy. Ledipasvir-sofosbuvir is a direct-acting antiviral agent that may be an alternate therapy for such patients. However, limited data is available regarding the safety and efficacy of this treatment. In this study, the authors aimed to evaluate both safety and efficacy of interferon and ledipasvir-sofosbuvir regimen in kidney transplant recipients with chronic genotype 1 or 4 HCV infection. The study is mainly limited due to its open-label design and exclusion of patients with HCV genotypes other than 1 or 4. Furthermore, as the study excluded patients with creatinine clearance less than 40 mL/min, the results cannot be applied to patients with more severe renal impairment. Overall, the study suggests that ledipasvir-sofosbuvir may form a safe and effective interferon-free regiment for treating HCV infection in kidney transplant recipients.
In-Depth [randomized control trial]: In this randomized, open-label study, the authors investigated the efficacy and safety of ledipasvir-sofosbuvir treatment. Patients were enrolled at 5 clinical sites in 4 European countries, were infected with chronic HCV genotype 1 or 4, and had received a kidney transplant at least 6 months prior to the first study visit. Patients with compensated cirrhosis were eligible for the study. The authors observed that following ledipasvir-sofosbuvir treatment, 100% of patients treated for 12 or 24 weeks had HCV RNA less than the lower limit of quantification 12 weeks after stopping the study drug (95%CI 94% to 100%). In terms of safety, the most frequent adverse events overall were headache (n = 22 [19%]), asthenia (n =16 [14%]), and fatigue (n = 11 [10%]). Serious adverse events occurred in 11% of the patient population (n = 13). In general, ledipasvir-sofosbuvir appeared to be an effective treatment with an acceptable safety profile.
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