In the Journals

Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret

Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

“A once-daily, pangenotypic regimen with shorter treatment durations for most HCV patient populations remains a high priority in the public health setting as it would simplify HCV treatment, potentially improving patient access to care and potentiating the global eradication of HCV,” Tarik Asselah, MD, PhD, from the Université Paris Diderot, AP-HP Hôpital Beaujon, France, and colleagues wrote. “Simple [direct-acting antiviral] regimens with high efficacy and tolerability, and with shorter treatment durations may improve patient adherence and reduce the burden of medical and diagnostic procedures, thereby increasing access to treatment.”

From Oct. 1, 2014, to Oct. 25, 2016, the researchers followed patients with HCV genotype 2, 4, 5, or 6 who were treated with Mavyret (glecaprevir/pibrentasvir, AbbVie) for 8 or 12 weeks.

In the ENDURANCE-2 study – which included 202 patients with genotype 2 – 195 of 196 treatment-naive patients achieved SVR (95% CI, 98.5-100) with no virologic failures. For the six patients with sofosbuvir-based treatment experience, the rate was 99.5% with no virologic failure.

The ENDURANCE-4 study included 76 patients with genotype 4, 26 patients with genotype 5, and 19 patients with genotype 6. Overall, 120 of 121 patients achieved SVR (95% CI, 97.6-100) with no virologic failures.

Of the 145 patients with genotype 2 treated for 8 weeks in the SURVEYOR-II study, 142 achieved SVR (95% CI, 94.1-99.3) and two patients had virologic failure. Five of six patients with sofosbuvir-based treatment experience achieved SVR and 135 of 137 treatment-naive patients achieved SVR (95% CI, 96.5-100). The overall SVR rate for the patients with genotype 4 (n = 46), 5 (n = 2) or 6 (n = 10) was 93% (95% CI, 83.6-97.3) with no virologic failures.

Reasons for non-response among the three studies included the two patients with virologic relapse from the SURVEYOR-II study; missing data on one patient with genotype 2, two patients with genotype 4 and one patient with genotype 6; and one patient with genotype 2 and two patients with genotype 4 who discontinued treatment.

The most common adverse events, which occurred in 10% or less of the study populations, included headache and fatigue. One patient discontinued treatment due to ischemic attack related to Mavyret, one discontinued due to anxiety, and one discontinued due to dyspepsia.

“Some regimens containing HCV protease inhibitors have been associated with hepatotoxicity and gastrointestinal adverse event,” the researchers concluded. In contrast to these observations, the [Mavyret] regimen was well-tolerated, with a favorable safety profile regardless of treatment duration similar to that observed in the placebo-controlled arm. Clinically significant laboratory abnormalities, adverse events, and discontinuations due to adverse events were rare.” – by Talitha Bennett

Disclosure: Asselah reports he is a clinical investigator, speaker or consultant for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharp & Dohme and Roche. Please see the full study for the other authors’ relevant financial disclosures.

Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

“A once-daily, pangenotypic regimen with shorter treatment durations for most HCV patient populations remains a high priority in the public health setting as it would simplify HCV treatment, potentially improving patient access to care and potentiating the global eradication of HCV,” Tarik Asselah, MD, PhD, from the Université Paris Diderot, AP-HP Hôpital Beaujon, France, and colleagues wrote. “Simple [direct-acting antiviral] regimens with high efficacy and tolerability, and with shorter treatment durations may improve patient adherence and reduce the burden of medical and diagnostic procedures, thereby increasing access to treatment.”

From Oct. 1, 2014, to Oct. 25, 2016, the researchers followed patients with HCV genotype 2, 4, 5, or 6 who were treated with Mavyret (glecaprevir/pibrentasvir, AbbVie) for 8 or 12 weeks.

In the ENDURANCE-2 study – which included 202 patients with genotype 2 – 195 of 196 treatment-naive patients achieved SVR (95% CI, 98.5-100) with no virologic failures. For the six patients with sofosbuvir-based treatment experience, the rate was 99.5% with no virologic failure.

The ENDURANCE-4 study included 76 patients with genotype 4, 26 patients with genotype 5, and 19 patients with genotype 6. Overall, 120 of 121 patients achieved SVR (95% CI, 97.6-100) with no virologic failures.

Of the 145 patients with genotype 2 treated for 8 weeks in the SURVEYOR-II study, 142 achieved SVR (95% CI, 94.1-99.3) and two patients had virologic failure. Five of six patients with sofosbuvir-based treatment experience achieved SVR and 135 of 137 treatment-naive patients achieved SVR (95% CI, 96.5-100). The overall SVR rate for the patients with genotype 4 (n = 46), 5 (n = 2) or 6 (n = 10) was 93% (95% CI, 83.6-97.3) with no virologic failures.

Reasons for non-response among the three studies included the two patients with virologic relapse from the SURVEYOR-II study; missing data on one patient with genotype 2, two patients with genotype 4 and one patient with genotype 6; and one patient with genotype 2 and two patients with genotype 4 who discontinued treatment.

The most common adverse events, which occurred in 10% or less of the study populations, included headache and fatigue. One patient discontinued treatment due to ischemic attack related to Mavyret, one discontinued due to anxiety, and one discontinued due to dyspepsia.

“Some regimens containing HCV protease inhibitors have been associated with hepatotoxicity and gastrointestinal adverse event,” the researchers concluded. In contrast to these observations, the [Mavyret] regimen was well-tolerated, with a favorable safety profile regardless of treatment duration similar to that observed in the placebo-controlled arm. Clinically significant laboratory abnormalities, adverse events, and discontinuations due to adverse events were rare.” – by Talitha Bennett

Disclosure: Asselah reports he is a clinical investigator, speaker or consultant for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharp & Dohme and Roche. Please see the full study for the other authors’ relevant financial disclosures.