Faldaprevir (BI 201335) for the treatment of hepatitis C in patients co-infected with HIV

Abstract

Chronic HCV infection affects 130–170 million individuals worldwide and there are currently 34 million people living with HIV/AIDS. The aim of treatment of HCV is the elimination of the virus (sustained virological response). With development of drugs that specifically target HCV replication, direct-acting agents, sustained virological response rates have dramatically changed for genotype 1 infections. Challenges in the use of direct-acting agents in patients with HIV/HCV co-infection include the potential for drug–drug interactions between HIV and HCV drugs, additional drug toxicities and the need for therapy with IFN-α. Faldaprevir (FDV), previously known as BI 201335, is a second-wave HCV NS3/4A protease inhibitor with highly potent in vitro activity against HCV GT-1a/1b and improved pharmacokinetics suitable for once-daily dosing. FDV is currently in Phase III development. This article will review the pharmacology and pharmacodynamics of FDV, the efficacy and safety of the drug and explore possible future developments in the management of chronic hepatitis C infection, focusing on HIV/HCV co-infected patients.

Keywords::

• faldaprevir
• hepatitis C
• HIV
• treatment

Financial & competing interests disclosure

JK Rockstroh has received honoraria for consulting or speaking at educational events from Abbvie, Bionor, Boehringer Ingelheim, BMS, Gilead, Janssen, Merck, Novartis, Roche, Tibotec, Vertex and ViiV. NL Laufer has received honoraria for speaking at educational events from Merck. 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.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Faldaprevir (FDV), previously known as BI 201335, is a second-wave HCV NS3/4A protease inhibitor with highly potent in vitro activity against HCV GT-1a/1b and improved pharmacokinetics suitable for once-daily dosing. It is currently in Phase III development.

• There is an ongoing Phase III study (STARTVerso4) assessing the efficacy and safety of FDV in combination with pegylated interferon and ribavirin in HIV/HCV co-infected patients.

• In HIV/HCV co-infected patients both in treatment-naïve and treatment-experienced patients, rates of sustained virological response were higher when FDV was added to standard therapy of pegylated interferon and ribavirin.

• The most significant adverse events associated with FDV treatment were nausea, fatigue, diarrhea and headache.

Notes