Generic Sofosbuvir-based Direct-acting Antivirals in Hepatitis C Virus-infected Patients With Chronic Kidney Disease

Manoj Kumar; Suman L. Nayak; Ekta Gupta; Ashish Kataria; Shiv K. Sarin


Liver International. 2018;38(12):2137-2148. 

In This Article


Our study demonstrates that sofosbuvir used in full dose in combination with ribavirin or ledipasvir or daclatasvir (all used in generic versions) is highly effective for individuals with HCV infection and CKD including advanced CKD (CKD stage 4 or 5 with an e-GFR <30 mL/min or those on dialysis). Non-ribavirin-containing regimens (sofosbuvir/ledipasvir and sofisbuvir/dacltasvir) have good safety profile also.

The newer second-generation DAAs will become available (without significant renal elimination) and could eventually replace sofosbuvir in new multidrug regimens. Excellent results in ESRD patients have been reported using ombitasvir/paritaprevir/dasabuvir (3D) and grazoprevir/elbasvir combinations[31,32] The main limitation of these 2 combinations is their lack of efficacy in genotype 2 and 3 HCV infections and also their availability and cost (especially in low-income countries, till the time they become available at reasonable prices there). Also, for genotype 2 and 3, therapeutic options are still limited to sofosbuvir-based regimens. Randomized controlled studies are also needed comparing generic and branded DAAs to assess efficacy and safety of generic DAAs.