Meeting News Coverage

AGATE-I: '3-D Regimen' Plus Ribavirin Yields High Response in Genotype 4 HCV

SAN DIEGO — Once-daily treatment with Technivie with ribavirin produced 12-week sustained virologic response rates of nearly 100% in a cohort of patients with genotype 4 hepatitis C virus, according to findings presented at Digestive Disease Week 2016.

Tarek I. Hassanein, MD, of Southern California Liver Centers and Southern California Research Center in Coronado, Calif., presented findings for a cohort of patients with cirrhosis and genotype 4 disease.

Eligible participants in the ongoing, randomized, open-label trial were enrolled in Austria, Belgium, Canada, France, Germany, Greece, Italy and the United States.

Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) was co-formulated for a once-daily dose at 25 mg ombitasvir, 150 mg paritaprevir and 100 mg ritonavir with weight-based ribavirin. There were two treatment arms: arm A included 59 patients treated for 12 weeks and arm B included 61 patients treated for 16 weeks. “This was an intention-to-treat analysis,”

SVR12 rates were 97% for the 12-week group and 98% for the 16-week group. When the researchers conducted a sensitivity analysis that excluded patients who prematurely discontinued therapy, the rates were 98% for 12 weeks and 100% for 16 weeks.

There was one virologic failure in the 12-week arm. The patient was a prior non-responder to pegriba and Child-Pugh 6, according to Hassanein. “The patient had no baseline NS5A variants,” he said.

To that point, SVR12 in the full cohort was not impacted by NS5A variants, according to Hassanein.

Adverse event data indicated that there were no deaths. Serious adverse events were reported in four patients in each group. “Tolerance to the treatment and adverse events have been mostly mild to moderate in severity,” Hassanein said.  

Laboratory analysis indicated a slight drop in hemoglobin in some patients, but none discontinued therapy as a result. “They didn’t impact SVR rates in any way,” Hassanein said. – by Rob Volansky

Reference:

Asselah T, et al. Abstract #503. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Hassanein reports financial relationships with AbbVie, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Gilead Sciences, Idenix, Ikaria, Janssen, La Jolla Pharmaceuticals, Merck, NGM BioPharmaceuticals, Obalon, Ocera Therapeutics, Roche, Salix, Sundise, TaiGen, Takeda, Tobria, Vertex and Vital Therapies.

SAN DIEGO — Once-daily treatment with Technivie with ribavirin produced 12-week sustained virologic response rates of nearly 100% in a cohort of patients with genotype 4 hepatitis C virus, according to findings presented at Digestive Disease Week 2016.

Tarek I. Hassanein, MD, of Southern California Liver Centers and Southern California Research Center in Coronado, Calif., presented findings for a cohort of patients with cirrhosis and genotype 4 disease.

Eligible participants in the ongoing, randomized, open-label trial were enrolled in Austria, Belgium, Canada, France, Germany, Greece, Italy and the United States.

Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) was co-formulated for a once-daily dose at 25 mg ombitasvir, 150 mg paritaprevir and 100 mg ritonavir with weight-based ribavirin. There were two treatment arms: arm A included 59 patients treated for 12 weeks and arm B included 61 patients treated for 16 weeks. “This was an intention-to-treat analysis,”

SVR12 rates were 97% for the 12-week group and 98% for the 16-week group. When the researchers conducted a sensitivity analysis that excluded patients who prematurely discontinued therapy, the rates were 98% for 12 weeks and 100% for 16 weeks.

There was one virologic failure in the 12-week arm. The patient was a prior non-responder to pegriba and Child-Pugh 6, according to Hassanein. “The patient had no baseline NS5A variants,” he said.

To that point, SVR12 in the full cohort was not impacted by NS5A variants, according to Hassanein.

Adverse event data indicated that there were no deaths. Serious adverse events were reported in four patients in each group. “Tolerance to the treatment and adverse events have been mostly mild to moderate in severity,” Hassanein said.  

Laboratory analysis indicated a slight drop in hemoglobin in some patients, but none discontinued therapy as a result. “They didn’t impact SVR rates in any way,” Hassanein said. – by Rob Volansky

Reference:

Asselah T, et al. Abstract #503. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Hassanein reports financial relationships with AbbVie, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Gilead Sciences, Idenix, Ikaria, Janssen, La Jolla Pharmaceuticals, Merck, NGM BioPharmaceuticals, Obalon, Ocera Therapeutics, Roche, Salix, Sundise, TaiGen, Takeda, Tobria, Vertex and Vital Therapies.