In the Journals

Faldaprevir Yields High SVR in Relapsers with HCV Genotype 1

Treatment with faldaprevir plus pegylated interferon alfa-2b and ribavirin was efficacious among patients with hepatitis C virus genotype 1 infection who relapsed on a prior treatment regimen with PEG-IFN a-2b and ribavirin, according to published findings.

“These data support results from other trials with second-generation protease inhibitors, indicating that high response rates can be achieved and early measurement of on-treatment response allows modification of the regimen, which improves tolerability and cost-effectiveness,” Graham R. Foster, PhD, professor of medicine, department of Hepatology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, and colleagues wrote.

Nonresponders to previous therapy with placebo were enrolled in the STARTVerso 1 through 3 clinical trials (n = 118) and were assigned a treatment regimen of 240 mg of faldaprevir (Boehringer Ingelheim) plus PEG-IFN a-2b and weight-based ribavirin for 24 weeks. They were treated in two cohorts: prior relapsers (n = 43) and prior nonresponders (null responders, partial responders and patients with breakthrough; n = 75). If any patient failed treatment at 24 weeks, they continued treatment with PEG-IFN a-2b and ribavirin through 48 weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment.

Overall, SVR12 rates were 95.3% among prior relapsers (95% CI, 89.1-100) and 54.7% among prior nonresponders (95% CI, 43.4-65.9). Early treatment success rates were also higher in prior relapsers (97.7% vs. 65.3%).

In addition, a higher number of prior nonresponders had baseline HCV RNA greater than 800,000 IU/mL (80%) compared with prior relapsers (58%) and a non-CC IL28B genotype (91% vs. 70%).

Adverse events were similar among the groups and led to 3% of patients discontinuing treatment. The most common adverse events were anemia (13%), nausea (10%) and hyperbilirubinemia (9%).

The adverse event profile was consistent with the known safety profile of faldaprevir, according to the research.

The researchers concluded: “Faldaprevir plus [PEG-IFN a-2b and ribavirin] achieved clinically meaningful SVR12 rates in patients who failed [PEG-IFN a-2b and ribavirin] in a prior trial, with response rates higher among prior relapsers than among prior nonresponders.” – by Melinda Stevens

Disclosure: Foster reports consulting for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Idenix, Merck, Novartis and Regulus. Please see the full study for a list of all other authors’ relevant financial disclosures.

Treatment with faldaprevir plus pegylated interferon alfa-2b and ribavirin was efficacious among patients with hepatitis C virus genotype 1 infection who relapsed on a prior treatment regimen with PEG-IFN a-2b and ribavirin, according to published findings.

“These data support results from other trials with second-generation protease inhibitors, indicating that high response rates can be achieved and early measurement of on-treatment response allows modification of the regimen, which improves tolerability and cost-effectiveness,” Graham R. Foster, PhD, professor of medicine, department of Hepatology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, and colleagues wrote.

Nonresponders to previous therapy with placebo were enrolled in the STARTVerso 1 through 3 clinical trials (n = 118) and were assigned a treatment regimen of 240 mg of faldaprevir (Boehringer Ingelheim) plus PEG-IFN a-2b and weight-based ribavirin for 24 weeks. They were treated in two cohorts: prior relapsers (n = 43) and prior nonresponders (null responders, partial responders and patients with breakthrough; n = 75). If any patient failed treatment at 24 weeks, they continued treatment with PEG-IFN a-2b and ribavirin through 48 weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment.

Overall, SVR12 rates were 95.3% among prior relapsers (95% CI, 89.1-100) and 54.7% among prior nonresponders (95% CI, 43.4-65.9). Early treatment success rates were also higher in prior relapsers (97.7% vs. 65.3%).

In addition, a higher number of prior nonresponders had baseline HCV RNA greater than 800,000 IU/mL (80%) compared with prior relapsers (58%) and a non-CC IL28B genotype (91% vs. 70%).

Adverse events were similar among the groups and led to 3% of patients discontinuing treatment. The most common adverse events were anemia (13%), nausea (10%) and hyperbilirubinemia (9%).

The adverse event profile was consistent with the known safety profile of faldaprevir, according to the research.

The researchers concluded: “Faldaprevir plus [PEG-IFN a-2b and ribavirin] achieved clinically meaningful SVR12 rates in patients who failed [PEG-IFN a-2b and ribavirin] in a prior trial, with response rates higher among prior relapsers than among prior nonresponders.” – by Melinda Stevens

Disclosure: Foster reports consulting for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Idenix, Merck, Novartis and Regulus. Please see the full study for a list of all other authors’ relevant financial disclosures.