VIENNA — A real-world analysis of Mavyret for hepatitis C showed patients with key comorbidities such as psychiatric disorders and substance abuse achieved high rates of sustained virologic response with improvements in patient-reported outcomes, according to a presentation at the International Liver Congress 2019.
“We have seen phase 3 data and, recently, real-world data with excellent efficacy and safety of [Mavyret]; still we have an interest in real-world data because some subgroups may have been underrepresented in clinical trials, ... particularly patient subgroups that are key to achieving HCV elimination goals,” Markus Cornberg, MD, from the Hannover Medical School, Germany, said in his presentation.
Cornberg presented data from the German Hepatitis C-Registry, which included 1,242 patients with genotypes 1 through 6, 84% of whom were treatment-naive without cirrhosis. Because of the low rate of cirrhosis in the cohort, patients received an 8-week course of Mavyret (glecaprevir/pibrentasvir, AbbVie).
Approximately half of the cohort included patients with psychiatric disorders, history of alcohol abuse, active drug use, those on opioid substitution therapy and/or those with HIV coinfection, for whom “treatment is sometimes deferred,” Cornberg said.
Intention-to-treat SVR by 12 weeks was 97% including 100% in 11 patients with active drug use. Two patients experienced reinfection, one treatment-naive patient with genotype 3 without cirrhosis relapsed, and 13 patients discontinued treatment due to adverse events. The researchers determined three cases of serious adverse events possibly related to treatment, which represented less than 1% of the cohort. Excluding non-virologic failure, the modified SVR was 99.5%.
“If you have this high treatment efficacy, it is somehow redundant to look at subgroups, but you can see there are no major differences among the different genotypes, patients with no cirrhosis and cirrhotics. Astonishingly, all patients with cirrhosis achieved SVR,” he said.
At baseline, patients with comorbidities had similar physical component scores based on the SF-36 survey but significantly lower mental health scores (P < .05 for alcohol abuse and P < .001 for psychiatry disorders and OST).
At the end of the study, SF-36 physical component scores improved by 2.5 or more in patients with psychiatric disorders, alcohol abuse and those on OST.
“Patients on OST and those with psychiatric disorders showed the greatest improvements in mental component scores, which may be relevant for this cohort,” Cornberg concluded. – by Talitha Bennett
Cornberg M. Abstract GS-07. Presented at: International Liver Congress; April 10-14, 2019; Vienna, Austria.
Disclosures: The German Hepatitis C-Registry is financially supported by AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck Sharp & Dohme, and Roche Pharma. Cornberg has participated in advisory committees/review panels for AbbVie, Biogen, BMS, Gilead, Janssen-Cilag, Merck Sharp & Dohme (MSD), Roche and Spring Bank and has carried out speaking/teaching engagements for AbbVie, BMS, Falk, Gilead, Janssen-Cilag, MSD and Roche. He is on the data safety management board for Janssen-Cilag and has received research support/grants from Roche.