Health Related Quality of Life and Healthcare Resource Utilization in chronic HCV patients under the Glecaprevir/Pibrentasvir Regimen: Interim-Analysis of the Austrian CONFIRMATION Study

Background and Aim:

Glecaprevir/Pibrentasvir (NS3/4A protease inhibitor/NS5A inhibitor; coformulated GLE/PIB) is a pangenotypic RBV- and interferon-free HCV treatment. The aim of this first prospective multi-center post-marketing observational study (PMOS) in Austria is to describe in routine clinical practice the effectiveness, safety, clinical practice use, healthcare resource utilization (HCRU) and impact on health related quality of life (HRQoL) of the GLE/PIB regimen across a variety of patient populations: HCV genotype, cirrhotic/non-cirrhotic patients, elderly (≥65 years)/non-elderly (< 65 years), PWUD and non-drug users.

Methods:

Patients with chronic HCV genotypes 1 – 6 receiving G/P at the treating physician's discretion according to local clinical practice, international recommendations and/or local label were eligible for the PMOS. Effectiveness and safety were assessed by SVR12 (virologic response at 12 weeks post treatment) and AE reports; HCRU was determined by the number of PMOS visits/patient within their local clinical setting. For evaluation of HRQoL SF-36, work productivity and activity impairment (WPAI) Hep C, and fatigue severity score (FSS), patient reported outcomes (PRO) were assessed for patients with available data.

Results:

Of 75 included patients, 66 (88%), 7 (9.3%), and 2 (2.7%) received G/P for 8, 12, or 16 weeks, respectively. The SVR12 was 98.3% in this interim analysis (58/59, n/N). Overall, the mean (SD) number of HCRU visits/patient was 4.21 (0.97). In the PRO analysis at SVR12 visits, 20/55 (36.4%), 27/55 (49.1%) and 9/58 (15.5%) patients demonstrated significant improvement in their SF-36 physical (≥2.5 increase) and mental component scores (≥2.5 increase), and FSS (≥0.7 increase), respectively. G/P was well-tolerated with no G/P-related serious adverse events (SAEs) and a low rate of AEs (12.3%).

Tab. 1:

Demographics and Clinical Characteristics at Baseline

Characteristics	N = 75
Male	42 (56%)
Age (median, range), years < 65 years ≥65 years	49.67 (51; 19 – 82) 59 (78.7%) 16 (21.3%)
HCV genotype (GT)
1 1a 1b Unknown GT1-subtype	50 (66.7%) 28 (37.4%) 21 (28%) 1 (1.3%)
2	2 (2.6%)
3	20 (26.7%)
4,5,6	3 (4%)
HCV treatment-naïve (TN)	66 (88%)
Mode of HCV Infection
Contaminated needle or intravenous drug use (current/past)	26 (39.4%)
Blood product transfusion	14 (21.2%)
Vertical transmission or contact with infected individual	5 (7.5%)
Unknown	21 (31.8%)
Missing	9
Any Concomitant Medication	50 (66.7%)
Opiate Substitution
Yes	21 (32.8%)
No	43 (67.2%)
Missing	11
GLE/PIB treatment duration
8-weeks	66 (88%)
12-weeks	7 (9.3%)
16-weeks	2 (2.7%)
Cirrhosis Status
Liver Cirrhosis	7 (9.3%)
Illicit Drug Use
Yes	34 (53.1%)
Current	5 (7.8%)
Within past 12 months	3 (4.7%)
More than 12 months ago	26 (40.6%)
No	30 (46.9%)
Missing	11

Conclusion:

In this interim analysis, G/P treatment demonstrated high effectiveness and safety in everyday clinical practice setting, consistent with data from registrational trials. PRO analysis showed significant improvement in HRQoL in terms of SF-36 and FSS.