Faldaprevir, simeprevir show promise in HCV/HIV coinfected patients
ATLANTA — Two new protease inhibitors have shown potential in treating hepatitis C genotype 1 infection in patients coinfected with HIV, data from two studies presented at the 2013 Conference on Retroviruses and Opportunistic Infections suggest.
“Faldaprevir and simeprevir had similar [sustained virologic response] rates in coinfected patients as they did in mono-infected patients,” Douglas Dieterich, MD, of Mount Sinai School of Medicine in New York, said during a presentation. “The theme seems to be consistent, as there were similar data prevented last year on telaprevir and boceprevir. Although we have not yet achieved an interferon-free regimen for these patients, the numbers are encouraging.”
Dieterich presented results from an interim analysis of the STARTVerso 4 trial, in which faldaprevir (Boehringer Ingelheim) combined with pegylated interferon and ribavirin is being evaluated. Patients with HCV/HIV coinfection were randomly assigned to 120 mg faldaprevir once daily or 240 mg faldaprevir once daily. Patients who were receiving efavirenz-based ART were assigned the 240-mg dose, and patients receiving protease inhibitor-based ART were assigned the 120-mg dose.
The study included 308 patients: 78% were HCV treatment-naive and 22% had relapsed. At week 4, 83% of patients had HCV RNA levels below limit of quantification and 63% had levels below limit of detection. For treatment-naive patients, 80% were below limit of quantification and 60% were below level of detection. For relapsers, 91% were below limit of quantification and 74% were below level of detection.
At week 12, 88% of patients had HCV RNA below limit of quantification and 84% of patients had levels below limit of detection. Among treatment-naive patients, 86% were below limit of quantification and 82% were below level of detection. Among relapsers, 93% were below limit of quantification and 91% were below level of detection.
For patients not receiving ART, 64% of patients had HCV RNA levels below limit of detection at both weeks 4 and 12. For patients receiving ART, 63% had levels below limit of detection at week 4 and 85% had levels below limit of detection at week 12. The most common adverse events were nausea, fatigue and diarrhea, commonly associated with pegylated interferon/ribavirin treatment.
In the TMC435-C212 trial, simeprevir (Janssen) was evaluated in 104 HCV/HIV coinfected patients: 50 were treatment-naive and non-cirrhotic, 14 were relapsers, 10 were prior partial responders, 28 were null responders and four patients had cirrhosis (three were treatment-naive and one was a relapse). Dieterich presented the results of a 24-week interim analysis.
The treatment-naive, non-cirrhotic patients and the prior relapsers received 150 mg simeprevir once daily for 12 weeks and pegylated interferon and ribavirin for 24 or 48 weeks. The remaining patients received treatment for 48 weeks. Most patients were receiving ART.
Overall, the rapid virologic response rate was 66.3% in the intention-to-treat population. Among treatment-naive patients, the rate was 71.2%; among relapsers, the rate was 93.3%. Patients with a prior partial response had a rapid virologic response rate of 80%, and patients with a prior null response had a rate of 37%.
The SVR4 rate overall was 85.7%. Among treatment-naive patients, the rate was 84%; and among relapsers, the rate was 90%. The overall SVR12 rate was 76.9%. Among treatment-naive patients, the rate was 75%; and among relapsers, the rate was 80%.
Disclosure: Douglas Dieterich, MD, reports financial relationships with Achillion, Boehringer Ingelheim, Gilead, Idenix Pharmaceuticals, Janssen, Merck and Vertex.
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Dieterich D. #40LB.
Dieterich D. #154B.
Both presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta.