Aiming for HCV elimination - Optimizing DAA therapy by characterisation of patients lost to follow up (LTFU) in a large real world setting - Data from the German Hepatitis C-Registry (DHC-R)

Background and aims Prevention, diagnosis and linkage to care are key factors to reach the goal of HCV elimination especially in vulnerable patient groups. A full course of direct acting antivirals (DAA) leads to HCV-cure in more than 90 % of patients chronically infected. Simplifying all aspects associated with DAA treatment may facilitate access in particular for vulnerable patient groups. To characterise patients who went lost-to-follow-up (LTFU) before end of treatment (EOT) might help to identify those in need for alternative access strategies to DAA therapy.

Method The DHC-R is a national multicentre real-world registry currently including about 17,700 patients recruited by more than 250 centres. Data were analysed as of Jan 01, 2020. The present analysis of patients with LTFU before and after EOT in comparison to patients with data on sustained virological response (SVR) 12/24 weeks after EOT (modified Intention-to-treat population, mITT) is based on 7,898 patients (ITT) treated with GLE/PIB, SOF/LDV, SOF/VEL, SOF/VEL/VOX and GZR/EBR (± ribavirin). LTFU before EOT was defined as reported lost before treatment was ended as scheduled, LTFU after EOT as lost after a full course of therapy without SVR12/24 data.

Results In total, 11.5 % (908/7,898) of the patients were reported as lost: 432 patients were lost before and 476 patients were lost after EOT. Thus, 6,990 were included in the mITT analysis. The overall SVR rates were 86 % (6,823/7,898) and 98 % (6,823/6,990) in the ITT and mITT analysis, respectively. In multivariate regression analysis (Table 1), being male or of younger age and having a history of drug abuse and/or an opioid substitution therapy (OST) has been associated with a higher risk of LTFU before and after EOT, HIV/HCV co-infected and patients with psychiatric disorders do have a lower risk of LTFU.

Conclusion It is known that patients lost after EOT have a high probability of achieving SVR. In this analysis, we identified patient groups with a higher risk of LTFU before end of treatment. In the setting of good tolerability and high effectiveness of DAA therapy, alternative treatment approaches tailored to the target group such as less intense monitoring or in contrast, directly observed treatment (DOT) should be considered.

Publication History

Article published online:
07 September 2021