Amazing! The 8-week cure rate of abbvie hepatitis C new compound is as high as 99%

Source: on January 9, 2017, abbvie announced the first-line results of the phase III certain-1 study of glecaprevir / pibrentasvir (g / P, abt-493 / abt-530, NS3A / NS5A) 300mg / 120mg in Japanese patients with genotype 1 chronic hepatitis C The certain-1 study is a phase III multicenter study that evaluated the efficacy, safety, and pharmacokinetics of the g / P combination in patients with hepatitis C in Japan Subgroup 1 is an open label, randomized, and positive control study It mainly recruited patients with genotype 1 hepatitis C who did not receive direct antiviral drugs (DAAS) and did not have cirrhosis Patients without y93h mutation associated with drug resistance were randomly divided into 2:1 groups and given g / P for 8 weeks and ofombitasvir / paritaprevir / ritonavir (obv / PTV / R) for 12 weeks All 23 patients with y93h mutation were treated with g / P for 8 weeks The main end point of the study was the safety and non inferiority of g / P compared with obv / PTV / R Subgroup 2 is an open label, non randomized study, mainly including some gene 1-6 hepatitis C patients with more difficult treatment, including those with compensatory cirrhosis (child Pugh a), chronic kidney disease and hepatitis C patients who were not cured by previous DAAS drugs The results showed that the proportion of patients who achieved 12 week sustained virological response (svr12) was 99% (n = 105 / 106) in 106 patients without cirrhosis and y93h mutation The only patient who did not receive svr12 was due to data loss due to loss of access Another 23 patients with y93h mutation achieved svr12 after 8 weeks of g / P treatment "Genotype 1 HCV infection is the most common type of hepatitis C in Japan," said Stefan zeuzem, Ph.D., University of Goth hospital Through the certain-1 study, we observed for the first time that the combination of g / P for 8 weeks achieved a super high cure rate in Japanese patients with genotype 1 hepatitis C without cirrhosis Japan is one of the countries with high incidence of hepatitis C in the world There are about 1 million patients with hepatitis C, 60% - 70% of them are genotype 1 hepatitis C The infection rate of hepatitis C increased with the age of, and the patients enrolled in the certain-1 study were also the most representative patients over 65 years old in Japan Abbvie expects to provide a virological cure with a shorter treatment cycle for most hepatitis C patients with genotype 1-6 In Japan, abbvie has conducted additional clinical studies based on the epidemiological characteristics of hepatitis C patients, and the above results are also the first disclosure of data of its g / P clinical project in Japan.