Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2022 Jul 14;14(7):1541.
doi: 10.3390/v14071541.

Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)

Markus Cornberg  1 , Albrecht Stoehr  2 , Uwe Naumann  3 , Gerlinde Teuber  4 , Hartwig Klinker  5 , Thomas Lutz  6 , Hjördis Möller  7 , Dennis Hidde  8 , Kristina Lohmann  8 , Karl-Georg Simon  9
Affiliations
Observational Study

Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)

Markus Cornberg et al. Viruses. .

Abstract

Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.

Keywords: German Hepatitis C-Registry; direct-acting antiviral; glecaprevir/pibrentasvir; hepatitis C virus; real world evidence.

PubMed Disclaimer

Conflict of interest statement

Markus Cornberg has served as a consultant/advisory board member/investigator/speaker for AbbVie, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck/MSD, Novartis, Roche, Spring Bank Pharmaceuticals, and Swedish Orphan Biovitrum, and received research grants from Roche. Albrecht Stoehr has served as a speaker and advisory board member for AbbVie, Gilead, Janssen, Merck/MSD, Roche, and GSK/ViiV Healthcare. Uwe Naumann has served as a speaker/advisory board member for AbbVie, Gilead, Merck/MSD, Mundipharma, and GSK/ViiV Healthcare. Gerlinde Teuber has served as a speaker for AbbVie and BMS, and is on an advisory board for Janssen, Gilead, and Merck/MSD. Hartwig Klinker has served as a speaker and advisory board member for AbbVie, BMS, Gilead, Janssen, Merck/MSD, Pfizer, Shionogi, and GSK/ViiV Healthcare, and received research funding from AbbVie, Arrowhead, BMS, Gilead, Hector Foundation, Janssen, and Merck/MSD. Thomas Lutz received research funding from AbbVie, Gilead, GSK/ViiV Healthcare, Merck/MSD, and Heidelberg Immunotherpeutics. Hjördis Möller has no conflicts to disclose. Dennis Hidde and Kristina Lohmann are employees of AbbVie and may hold AbbVie stock or options. Karl-Georg Simon has served as a speaker/advisory board member for AbbVie, Falk, Gilead, Janssen, Merck/MSD, and Norgine.

Figures

Figure 1
Figure 1
SVR12 rates in the effectiveness population according to (A) HCV genotype and (B) key comorbidities and migrant status (primary effectiveness endpoint). Patients who discontinued GLE/PIB prematurely and achieved SVR12 were counted as virologic responders (n = 11). EP-mITT analysis excluded patients who discontinued GLE/PIB prematurely and did not achieve SVR12, and patients with HCV reinfection. n = 258 patients in the EP-ITT population were cirrhotic; 252 (97.7%) of these patients achieved SVR12. CIS, Commonwealth of Independent States (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan); EP, effectiveness population; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus; ITT, intention to treat; mITT, modified intention to treat; OST, opioid substitution therapy; PWUD (active), people who actively use drugs; SVR12, sustained virologic response at PTW12.
Figure 2
Figure 2
SVR12 rates among TN patients who received GLE/PIB according to cirrhosis status and treatment duration. CC, compensated cirrhosis; EP, effectiveness population; HCV, hepatitis C virus; ITT, intention to treat; mITT, modified intention to treat; TN, treatment-naïve; SVR12, sustained virologic response at PTW12.
Figure 3
Figure 3
SVR12 rates among TN patients who received GLE/PIB for 8 weeks according to (A) HCV genotype and (B) key comorbidities and migrant status. Patients who discontinued GLE/PIB prematurely and achieved SVR12 were counted as virologic responders (n = 11). EP-mITT analysis excluded patients who discontinued GLE/PIB prematurely and did not achieve SVR12, or patients with HCV reinfection. CIS, Commonwealth of Independent States (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan); EP, effectiveness population; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus; ITT, intention to treat; mITT, modified intention to treat; OST, opioid substitution therapy; PWUD (active), people who actively use drugs; SVR12, sustained virologic response at PTW12.
Figure 4
Figure 4
Percentage of patients with a clinically relevant improvement (≥2.5-point increase from baseline to PTW12) in (A) SF-36 physical component summary score and (B) SF-36 mental component summary score, according to key comorbidities and migrant status. CIS, Commonwealth of Independent States (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan); HIV, human immunodeficiency virus; OST, opioid substitution therapy; PTW, post-treatment week; PWUD (active), people who actively use drugs.
See this image and copyright information in PMC

References

    1. World Health Organization Global Progress Report on HIV, Viral Hepatitis and Sexually Transmitted Infections. 2021. [(accessed on 3 May 2022)]. Available online: https://www.who.int/publications/i/item/9789240027077.
    1. Polaris Observatory German HCV Infections. [(accessed on 11 May 2021)]. Available online: https://cdafound.org/dashboard/polaris/dashboard.html.
    1. World Health Organization Global Health Sector Strategy on Viral Hepatitis 2016–2021. [(accessed on 3 May 2022)]. Available online: https://apps.who.int/iris/handle/10665/246177.
    1. World Health Organization Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection. [(accessed on 3 May 2022)]. Available online: https://www.who.int/publications/i/item/9789241550345. - PubMed
    1. European Association for the Study of the Liver EASL recommendations on treatment of hepatitis C: Final update of the series. J. Hepatol. 2020;73:1170–1218. doi: 10.1016/j.jhep.2020.08.018. - DOI - PubMed

Publication types

LinkOut - more resources