Safety and efficacy of once daily ledipasvir/sofosbuvir fixed-dose combination in patients with chronic hepatitis C

ABSTRACT

Introduction: During the past couple of years, the regulatory authorities have approved seven new direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C (CHC). In 2014, the US FDA approved the fixed dose combination of ledipasvir (LDV) plus sofosbuvir (SOF) for the treatment of genotype (GT) 1 HCV and the European Commission Granted its marketing authorization to treat patients with GT1 and 4. This regimen showed outstanding rates of virologic response along with a favorable safety profile with a very low rate of both virologic failure and treatment discontinuation.

Areas covered: In this review, we sought to review the pharmacokinetics, clinical efficacy and safety profile pertaining to LDV/SOF combination in treatment of CHC with special emphasis on phase III clinical trials.

Expert opinion: In all phase III trials, the 12-week course of this new interferon (IFN)-sparing regimen has delivered high virologic cure rates among patient with GT1 and 4 both treatment-naïve and – experienced Data about its effectiveness in patients under 18 years of age, end-stage renal disease and patients with significant other organ involvement are eagerly awaited.

KEYWORDS:

• Ledipasvir
• sofosbuvir
• hepatitis C
• safety
• efficacy

Declaration of Interest

P Andreone has received research support from Roche, MSD and Gilead. Has also acted on advisory committees for Roche, MSD, Janssen Cilag, Abbvie, Boehringer Ingelheim, Gilead SC and Bristol-Myers Squibb. N Gamal has received a grant from A.Ri.A.E. (Associazione per la Ricerca ed Assistenza in Epatologia). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.