Patient‐reported outcomes of the Treatment and Prevention Study: A real‐world community‐based trial of direct‐acting antivirals for hepatitis C among people who inject drugs

Abstract Background Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. Methods HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). Results We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. Conclusions This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

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Patient‐Reported Outcomes 12 Months After Hepatitis C Treatment with Direct‐Acting Antivirals: Results from the PROP UP Study

Liver International ◽

10.1111/liv.14781 ◽

2021 ◽

Author(s):

Marina Serper ◽

Donna M. Evon ◽

Jipcy Amador ◽

Paul W. Stewart ◽

Souvik Sarkar ◽

...

Keyword(s):

Hepatitis C ◽

Patient Reported Outcomes ◽

Direct Acting Antivirals ◽

Hepatitis C Treatment ◽

Patient Reported ◽

Direct Acting

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The Impact Of Direct‐Acting Antivirals On Hepatitis C Viraemia Among People Who Inject Drugs In England; Real‐World Data 2011‐2018

Journal of Viral Hepatitis ◽

10.1111/jvh.13575 ◽

2021 ◽

Author(s):

Megan Bardsley ◽

Ellen Heinsbroek ◽

Ross Harris ◽

Sara Croxford ◽

Claire Edmundson ◽

...

Keyword(s):

Hepatitis C ◽

Real World ◽

People Who Inject Drugs ◽

Direct Acting Antivirals ◽

Real World Data ◽

World Data ◽

Direct Acting ◽

The Impact

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Hepatitis C Virus Treatment Access Among Human Immunodeficiency Virus and Hepatitis C Virus (HCV)-Coinfected People Who Inject Drugs in Guangzhou, China: Implications for HCV Treatment Expansion

Open Forum Infectious Diseases ◽

10.1093/ofid/ofw065 ◽

2016 ◽

Vol 3 (2) ◽

Cited By ~ 6

Author(s):

Carissa E. Chu ◽

Feng Wu ◽

Xi He ◽

Kali Zhou ◽

Yu Cheng ◽

...

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Social Workers ◽

People Who Inject Drugs ◽

Hiv Treatment ◽

Direct Acting Antivirals ◽

Hcv Treatment ◽

Treatment Access ◽

Immunodeficiency Virus ◽

Direct Acting

Abstract Background. Hepatitis C virus (HCV) treatment access among human immunodeficiency virus (HIV)/HCV-coinfected people who inject drugs is poor, despite a high burden of disease in this population. Understanding barriers and facilitators to HCV treatment uptake is critical to the implementation of new direct-acting antivirals. Methods. We conducted in-depth interviews with patients, physicians, and social workers at an HIV treatment facility and methadone maintenance treatment centers in Guangzhou, China to identify barriers and facilitators to HCV treatment. We included patients who were in various stages of HCV treatment and those who were not treated. We used standard qualitative methods and organized data into themes. Results. Interview data from 29 patients, 8 physicians, and 3 social workers were analyzed. Facilitators and barriers were organized according to a modified Consolidated Framework for Implementation Research schematic. Facilitators included patient trust in physicians, hope for a cure, peer networks, and social support. Barriers included ongoing drug use, low HCV disease knowledge, fragmented reimbursement systems, HIV exceptionalism, and stigma. Conclusions. Expanding existing harm reduction programs, HIV treatment programs, and social services may facilitate scale-up of direct-acting antivirals globally. Improving integration of ancillary social and mental health services within existing HIV care systems may facilitate HCV treatment access.

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