In the Journals

8-weeks Mavyret therapy effective regardless of patient characteristics

Hepatitis C treatment with Mavyret for 8 weeks had an overall sustained virologic response rate of 98% regardless of baseline patient or viral characteristics in a cohort of patients with genotypes 1 through 6, according to a recently published study.

“According to recent United States and European guidelines, the majority of approved regimens for patients with HCV infection without cirrhosis have treatment durations of 12 weeks or more,” Massimo Puoti, MD, from the Ospedale Niguarda Cà Granda, Milan, Italy, and colleagues wrote. “Shorter treatment durations have been associated with improved adherence, which may benefit difficult-to-treat populations, such as prisoners, psychiatric patients, and injection drug users.”

Puoti and colleagues gathered data from nine phase 2 and phase 3 clinical trials to determine the efficacy of 8 vs. 12 weeks of Mavyret (glecaprevir/pibrentasvir, AbbVie) and any baseline factors that may impact the rate of SVR.

The analysis included 2,041 patients with HCV genotype 1, 2, 3, 4, 5 or 6 without cirrhosis who received glecaprevir/pibrentasvir between Sept. 8, 2014, and Oct. 10, 2016, for either 8 weeks (n = 965) or 12 weeks (n = 1,076). Most patients (59%) had plasma HCV RNA higher than 1 million IU/mL at baseline, 11% had stage 3 fibrosis, and 16% of those treated for 8 weeks and 2% treated for 12 weeks were coinfected with HIV-1.

The SVR rates were 98% (95% CI, 96.6-98.5) for 8 weeks and 99% (95% CI, 97.6-99.1) for 12 weeks, which were not significantly different. After the researchers excluded patients with non-virologic failure, the SVR rates for the modified subgroup were 99.1% (95% CI, 98.2-99.5) for 8 weeks and 99.6% (95% CI, 99-99.9) for 12 weeks.

Subgroup analysis showed that SVR rates were similarly high for patients treated with either 8 weeks or 12 weeks regardless of variables including race, HCV treatment experience, HIV-1 coinfection, fibrosis stage, viral load, proton-pump inhibitor use, history of injection drug use or presence of baseline polymorphisms in NS3 or NS5A resistance-associated substitutions.

Further subgroup analysis of those who received treatment for 8 weeks showed no virologic failures in patients older than 65 years, those with BMI of 30 kg/m2 or higher, those using concomitant PPIs, those with HIV-1 coinfection, or among black patients.

“A pangenotypic regimen that combines the high efficacy expected from DAA-based therapies with a treatment duration of 8 weeks has the potential advantages of reducing treatment burden and simplifying treatment algorithms,” the researchers concluded. “Specifically, a pangenotypic option without restrictions may eliminate the need for genotyping and other baseline assessments (eg, resistance-associated polymorphisms), which may not be available in resource-limited settings.” – by Talitha Bennett

Disclosure: Puoti reports he is a temporary advisory board member or speaker at events for AbbVie, Bristol-Myers Squibb, Boehringer, Ingelheim, Janssen, Gilead, Merck Sharp & Dohme and Roche; and received research support from Gilead and Merck Sharp & Dohme. Please see the full study for the other authors’ relevant financial disclosures.

Hepatitis C treatment with Mavyret for 8 weeks had an overall sustained virologic response rate of 98% regardless of baseline patient or viral characteristics in a cohort of patients with genotypes 1 through 6, according to a recently published study.

“According to recent United States and European guidelines, the majority of approved regimens for patients with HCV infection without cirrhosis have treatment durations of 12 weeks or more,” Massimo Puoti, MD, from the Ospedale Niguarda Cà Granda, Milan, Italy, and colleagues wrote. “Shorter treatment durations have been associated with improved adherence, which may benefit difficult-to-treat populations, such as prisoners, psychiatric patients, and injection drug users.”

Puoti and colleagues gathered data from nine phase 2 and phase 3 clinical trials to determine the efficacy of 8 vs. 12 weeks of Mavyret (glecaprevir/pibrentasvir, AbbVie) and any baseline factors that may impact the rate of SVR.

The analysis included 2,041 patients with HCV genotype 1, 2, 3, 4, 5 or 6 without cirrhosis who received glecaprevir/pibrentasvir between Sept. 8, 2014, and Oct. 10, 2016, for either 8 weeks (n = 965) or 12 weeks (n = 1,076). Most patients (59%) had plasma HCV RNA higher than 1 million IU/mL at baseline, 11% had stage 3 fibrosis, and 16% of those treated for 8 weeks and 2% treated for 12 weeks were coinfected with HIV-1.

The SVR rates were 98% (95% CI, 96.6-98.5) for 8 weeks and 99% (95% CI, 97.6-99.1) for 12 weeks, which were not significantly different. After the researchers excluded patients with non-virologic failure, the SVR rates for the modified subgroup were 99.1% (95% CI, 98.2-99.5) for 8 weeks and 99.6% (95% CI, 99-99.9) for 12 weeks.

Subgroup analysis showed that SVR rates were similarly high for patients treated with either 8 weeks or 12 weeks regardless of variables including race, HCV treatment experience, HIV-1 coinfection, fibrosis stage, viral load, proton-pump inhibitor use, history of injection drug use or presence of baseline polymorphisms in NS3 or NS5A resistance-associated substitutions.

Further subgroup analysis of those who received treatment for 8 weeks showed no virologic failures in patients older than 65 years, those with BMI of 30 kg/m2 or higher, those using concomitant PPIs, those with HIV-1 coinfection, or among black patients.

“A pangenotypic regimen that combines the high efficacy expected from DAA-based therapies with a treatment duration of 8 weeks has the potential advantages of reducing treatment burden and simplifying treatment algorithms,” the researchers concluded. “Specifically, a pangenotypic option without restrictions may eliminate the need for genotyping and other baseline assessments (eg, resistance-associated polymorphisms), which may not be available in resource-limited settings.” – by Talitha Bennett

Disclosure: Puoti reports he is a temporary advisory board member or speaker at events for AbbVie, Bristol-Myers Squibb, Boehringer, Ingelheim, Janssen, Gilead, Merck Sharp & Dohme and Roche; and received research support from Gilead and Merck Sharp & Dohme. Please see the full study for the other authors’ relevant financial disclosures.