Real-life effectiveness of direct-acting antiviral treatment among chronic hepatitis C infected opioid substituted patients in Germany
Patients in opioid substitution treatment (OST) are often chronically infected with hepatitis C. Real life data on the effectiveness of direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C among these patients are highly relevant to inform health policy makers, clinicians and patients, but comparativly rare. While first data from the German Hepatitis C-Registry on the effectiveness and safety of DAAs for the treatment of chronic hepatitis C among OST patients were recently published, data on patient-reported outcome measures are still missing.
The aim of this prospective cohort study was to evaluate the effectiveness, safety and patient reported outcome measures of DAA treatment among OST patients with chronic hepatitis C in Germany. Effectiveness was defined as sustained virological response at week 12 after end of treatment (SVR12). Further outcome measures include patients` adherence and patient reported outcome measures like functioning, treatment satisfaction, health status and health-related quality of life.
Effectiveness and safety analyses will be conducted as intention-to-treat (ITT) as well as per protocol (PP) analyses. The ITT sample was defined as the number of patients starting treatment (first dose), whereas the PP sample includes only patients with complete data for SVR12.
Inclusion criteria were patients with genotype 1-6, with or without HIV/HCV-coinfection, at least 18 years or older who are in OST for at least 3 months. Both, treatment naïve and treatment-experienced (non-responder/relapser) patients were included. All patients had to be eligible for treatment with DAAs according to the respective summary of product.
At all 326 OST patients with chronic hepatitis C were included. The data analyses are not finished yet, but preliminary clinical outcome data on effectiveness and safety of 162 patients with genotype 1 and 3 are available. The majority of these patients are male (75,9%), substituted with methadone (63,1%) or buprenorphine (20,0%) and in average 44,5 years old. 54,3% of the patients are infected with HCV genotype 1, 4,3% are HIV/HCV co-infected and about one out of five (21,6%) patient was treatment experienced. Patients were mainly treated with sofosbuvir based (83,3%) treatment protocols, most often for 8 (24,1%) or 12 weeks (72,8%). Within the course of the study at all 7 patients dropped out, mainly (5 patients) after the end of DAA treatment. 16 patients (9,9%) and 34 patients (21,0%) reported adverse events until week 4 and between week 4 and end of treatment, respectively. As the data analysis is still ongoing, data on the sustained virologic response are only available for the PP sample. Of those patients with test results at week 12 after end of treatment (N=140), 134 (95,7%) achieved a sustained virologic response.
Considering the prevalence of adverse events and the low drop-out rates as well the high SVR rates in the PP sample the preliminary analyses of this study indicate that DAA treatment results in high SVR rates among OST patients in Germany. At the conference outcome data of all patients will be presented including data on patient-reported outcomes and data for the ITT sample.