AbbVie’s new hepatitis C treatment candidate, a one tablet combination of the investigational drugs glecaprevir and pibrentasvir, harnessed the infection in all patients who completed a Japanese study.
The treatment, which worked after eight weeks, is developed to speed up the time to clear the virus from the body, and is effective against all major virus genotypes. Patients with a sustained virologic response at 12 weeks after treatment (SVR12) were considered cured of hepatitis C.
The study was part of a Phase 3 open-label clinical trial (NCT02707952; CERTAIN-1), comparing glecaprevir/pibrentasvir to treatment with Technivie, a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir. The study included 158 patients with genotype 1 chronic hepatitis C but without cirrhosis. Among the 106 patients receiving the glecaprevir/pibrentasvir combo were 23 patients with the resistance-associated Y93H virus variant.
Patients who received glecaprevir/pibrentasvir were treated for eight weeks, while those on Technivie received 12 weeks of treatment. One patient in the glecaprevir/pibrentasvir group was lost to follow-up, but the remaining 105 patients, constituting 99 percent of the group, had a sustained virologic response at 12 weeks.
All patients in the active control group also had a sustained virologic response at 12 weeks. With that, the study met its main goal — showing that the glecaprevir/pibrentasvir combination was not inferior to 12 weeks of Technivie treatment.
“These initial data in GT1-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 Goethe University Hospital in Frankfurt, Germany, said in a 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 GT1-infected Japanese patients without cirrhosis.”
The data are the first to be released from a trial and will constitute the basis for regulatory approval of the glecaprevir/pibrentasvir treatment in Japan. The majority of hepatitis C patients in Japan, 70 percent, are infected with genotype 1, making the study group representative of the general population.
As chronic hepatitis C infection is more common as people age, the study also included a large proportion of patients older than 65.
“Due to patient characteristics and virological considerations, people living with hepatitis C virus in Japan have specific treatment challenges and needs,” said Michael Severino, MD, AbbVie’s executive vice president of research and development and chief scientific officer.
The second part of the trial explores the glecaprevir/pibrentasvir treatment in patients with genotypes 1-6 who have specific challenges, including compensated cirrhosis or chronic kidney disease. Patients who failed previous treatment with direct-acting antivirals were also included in this group. AbbVie has not yet concluded the results of the second part of the study.