Interim results evaluate virologic response rates in HCV/HIV co-infected patients treated with faldaprevir

March 7, 2013

The first interim results in HCV/HIV co-infected patients from Boehringer Ingelheim’s ongoing hepatitis C (HCV) clinical trial program, HCVerso, have become available. These results, from the phase 3 trial STARTVerso 4, were presented recently at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

The first interim results in HCV/HIV co-infected patients from Boehringer Ingelheim’s  ongoing hepatitis C (HCV) clinical trial program, HCVerso, have become available. These results, from the phase 3 trial STARTVerso 4, were presented recently at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

The interim results from the phase 3 STARTVerso 4 study evaluated faldaprevir with pegylated interferon and ribavirin (PegIFN/RBV) for treatment of HCV/HIV co-infected patients.

They showed that the majority of co-infected patients (84%) maintained a virologic response through week 12 on-treatment for their HCV. Further, 80% of the HCV/HIV co-infected patients included in the trial achieved protocol defined early treatment success (ETS).

Based on the study design, these patients were eligible to be randomized to a shortened treatment duration (24 weeks vs 48 weeks). To achieve protocol defined ETS, patients needed to have hepatitis c virus levels below the limit of qualification after 4 weeks of treatment, and sustain that response through 8 weeks of treatment.

Results from another Boehringer Ingelheim study presented at CROI, investigating drug-drug interactions between faldaprevir and commonly used HIV medicines in healthy volunteers, informed the study design for the STARTVerso 4 study.

STARTVerso 4 is an open-label, sponsor blinded, phase 3 study assessing the efficacy and safety of the investigational oral protease inhibitor faldaprevir in combination with PegIFN/RBV. The study includes 308 individuals co-infected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy, and were either HIV treatment-naïve or being treated with ART. The study enrolled HCV genotype-1 patients, including patients with cirrhosis (17%). Patients were randomly assigned into 1 of 2 treatment groups:  

•   Group 1: 12 or 24 weeks of faldaprevir 240 mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV

•   Group 2: 24 weeks of faldaprevir 120 mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV

“None of the patients receiving antiretroviral therapy [ART] for their HIV experienced a loss of HIV viral suppression during the study period,” said Douglas Dieterich, MD, professor of medicine in the division of liver diseases and also director of continuing medical education in the department of medicine at Mount Sinai School of Medicine, New York, N.Y.

One in 4 people living with HIV are also co-infected with HCV, and according to the CDC, liver disease has now become the leading cause of non-AIDS-related deaths among people living with HIV.

“The STARTVerso 4 study is designed to help us better understand the investigational treatment regimen including faldaprevir with PegIFN/RBV in this important patient population,” Dr Dieterich told Formulary.

“Several factors influence the likelihood of treatment success in HCV mono-infected patients, including personal genetic makeup, viral genotype and stage of liver disease,” he said. “Co-infection with HIV contributes additional factors, including potential toxicities from interactions between HIV and HCV medications, that influence treatment decisions and outcomes. Evaluation of investigational treatment regimens for HCV in HCV/HIV co-infected patients is important to understand the potential for HCV treatment in this patient population.”

The early virologic response rates from STARTVerso 4 are encouraging and comparable to those in HCV mono-infected patients, especially given the inclusion of patients with cirrhosis, according to Dr Dieterich. “I’m looking forward to the final trial outcomes,” he said.

The most frequent adverse events (AEs) in STARTVerso 4 were nausea (37%), fatigue (33%), diarrhea (27%), headache (23%), and weakness (22%). Serious AEs were reported in 32 patients (10%), including 3 deaths. To date, 18 patients have discontinued study participation due to AEs. The safety results of this study were comparable to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies. No patient on ART experienced a loss of HIV viral suppression during the study period.



Hepatitis C is a blood-born infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007.