Investigational HCV regimen highly effective in Japanese genotype-1 patients

Eight weeks of treatment with an investigational, ribavirin-free regimen of glecaprevir and pibrentasvir resulted in high rates of 12-week sustained virologic response in non-cirrhotic Japanese patients with chronic hepatitis C genotype 1 infection, AbbVie announced.

The regimen, for which AbbVie recently submitted an NDA for all HCV genotypes, combines two antiviral agents — 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor — taken as three oral tablets once-daily.

“These initial data in [genotype 1]-infected patients, which is the most common type of hepatitis C in Japan, may help to further advance our understanding on how we care for patients in this country,” Stefan Zeuzem, MD, chief of the department of medicine at the Goethe University Hospital in Frankfurt, Germany, said in the press release. “In the CERTAIN-1 study with the [glecaprevir/pibrentasvir] regimen, we see for the first time that 8 weeks of treatment achieved high cure rates in these [genotype 1]-infected Japanese patients without cirrhosis.”  

To evaluate the safety, efficacy and pharmacokinetics of this regimen in Japanese adults, investigators performed a phase 3 multicenter study comparing 8 weeks of glecaprevir/pibrentasvir with 12 weeks of ombitasvir/paritaprevir/ritonavir (Viekira Pak in the U.S.; Viekirax in Japan) in patients with chronic HCV genotype 1.

Overall, 105 of 106 patients (99%) without cirrhosis and without the Y93H variant achieved SVR12.

“The only patient in whom SVR12 was not documented in this intent-to-treat population was lost to follow-up,” according to the press release. “All 23 patients with the Y93H variant were assigned to the [glecaprevir/pibrentasvir] arm and achieved SVR12.”

The primary endpoint of noninferiority was met; 8 weeks of glecaprevir/pibrentasvir was noninferior to 12 weeks of Viekirax (100% SVR12; n = 52).

Further, in a randomized, open label, active-controlled sub-analysis (substudy 1), evaluating glecaprevir/pibrentasvir-treated genotype 1 patients without cirrhosis who had not received previous treatment with direct-acting antivirals, no patients discontinued treatment due to adverse events, and the most common adverse events were nasopharyngitis and pruritis.

The study also includes a non-randomized, open label sub-analysis (substudy 2), evaluating genotype 1 to 6 HCV patients with Child-Pugh A compensated cirrhosis, chronic kidney disease, previous DAA failure and other treatment challenges.

Additional data will be shared at a future scientific meeting, according to the press release.

Disclosures: The researchers report no relevant financial disclosures.

Eight weeks of treatment with an investigational, ribavirin-free regimen of glecaprevir and pibrentasvir resulted in high rates of 12-week sustained virologic response in non-cirrhotic Japanese patients with chronic hepatitis C genotype 1 infection, AbbVie announced.

The regimen, for which AbbVie recently submitted an NDA for all HCV genotypes, combines two antiviral agents — 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor — taken as three oral tablets once-daily.

“These initial data in [genotype 1]-infected patients, which is the most common type of hepatitis C in Japan, may help to further advance our understanding on how we care for patients in this country,” Stefan Zeuzem, MD, chief of the department of medicine at the Goethe University Hospital in Frankfurt, Germany, said in the press release. “In the CERTAIN-1 study with the [glecaprevir/pibrentasvir] regimen, we see for the first time that 8 weeks of treatment achieved high cure rates in these [genotype 1]-infected Japanese patients without cirrhosis.”  

To evaluate the safety, efficacy and pharmacokinetics of this regimen in Japanese adults, investigators performed a phase 3 multicenter study comparing 8 weeks of glecaprevir/pibrentasvir with 12 weeks of ombitasvir/paritaprevir/ritonavir (Viekira Pak in the U.S.; Viekirax in Japan) in patients with chronic HCV genotype 1.

Overall, 105 of 106 patients (99%) without cirrhosis and without the Y93H variant achieved SVR12.

“The only patient in whom SVR12 was not documented in this intent-to-treat population was lost to follow-up,” according to the press release. “All 23 patients with the Y93H variant were assigned to the [glecaprevir/pibrentasvir] arm and achieved SVR12.”

The primary endpoint of noninferiority was met; 8 weeks of glecaprevir/pibrentasvir was noninferior to 12 weeks of Viekirax (100% SVR12; n = 52).

Further, in a randomized, open label, active-controlled sub-analysis (substudy 1), evaluating glecaprevir/pibrentasvir-treated genotype 1 patients without cirrhosis who had not received previous treatment with direct-acting antivirals, no patients discontinued treatment due to adverse events, and the most common adverse events were nasopharyngitis and pruritis.

The study also includes a non-randomized, open label sub-analysis (substudy 2), evaluating genotype 1 to 6 HCV patients with Child-Pugh A compensated cirrhosis, chronic kidney disease, previous DAA failure and other treatment challenges.

Additional data will be shared at a future scientific meeting, according to the press release.

Disclosures: The researchers report no relevant financial disclosures.