Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life.

Journal: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

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Affiliated Institutions:  Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil Manguinhos, Rio de Janeiro, RJ, -, Brazil. thiago.torres@ini.fiocruz.br. Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA, USA. DLH Corporation, Bethesda, MD, USA. Hospital Nossa Senhora da Conceicao, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil. Thai Red Cross AIDS Research Center, Center of Excellence in Tuberculosis, Faculty of Medicine, HIV-NAT, Chulalongkorn University, Bangkok, Thailand. Joint Clinical Research Centre, Kampala, Uganda. Clinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. Family Centre for Research with Ubuntu, Stellenbosch University, Cape Town, South Africa. Boston Medical Center, Boston, MA, USA. Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Av Brasil Manguinhos, Rio de Janeiro, RJ, -, Brazil. Massachusetts General Hospital, Boston, MA, USA. Denver Health Medical Center, Denver, CO, USA. Duke University School of Medicine, Durham, NC, USA. Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Abstract summary 

Direct-acting antivirals (DAA) are highly effective for the management of HCV disease. This study aims to evaluate changes in health-related quality of life (HQoL) among people with HCV who were treated with DAAs using a minimal monitoring (MINMON) approach.ACTG A5360 was a multicenter, international (Brazil, South Africa, Thailand, Uganda, and USA) trial to assess the feasibility and efficacy of MINMON approach in people with HCV. We measured HQoL using EQ-5D-3L at baseline, sustained virological evaluation visit, week 48 and week 72, and described using EQ-5D summary index (ranges:0-1) and visual analog scale (VAS) score (ranges 0-100). We used paired T-tests to evaluate the change in EQ-5D summary and multivariable linear regression for changes in VAS scores.Overall, 394 individuals were included; most did not have cirrhosis (360; 91%) or problematic alcohol use (278; 71%). We found HQoL improvements for participants from Brazil and Thailand, but not for the USA. Participants reported high rates of pain/discomfort and anxiety/depression, with decreases over time only for Brazil. Factors associated with larger improvements in VAS scores included: cirrhosis at baseline, and non-use or problematic use of other substances (apart from tobacco/marijuana) compared to non-problematic use.We found HQoL improvements among people with HCV following DAA treatment with variability across countries. Our findings reinforce the importance of DAA treatment, especially among those with advanced HCV disease. Continuous mental health care including depression and substance use support should be offered to individuals after HCV treatment.NCT03512210 (22-Oct-2018) Direct-acting antivirals are highly effective for the management of hepatitis C disease. Recent studies have shown that hepatitis C treatment with direct-acting antivirals has a positive impact on quality of life. However, no studies have assessed quality of life among individuals starting direct-acting antivirals treatment across multiple countries representing high-, middle- and low-income settings. In this study, we evaluated changes in health-related quality of life among people with hepatitis C who were treated with direct-acting antivirals using a simplified treatment delivery and offering minimal in-person monitoring. We found quality of life improvements among persons with hepatitis C after direct-acting antivirals treatment, with differences across countries. Although direct-acting antivirals treatment works well and should be available to all persons with hepatitis C, we found that participants with cirrhosis (liver damage) had higher improvements in quality of life, reinforcing the importance of starting treatment among people with advanced hepatitis C. We also found high rates of anxiety and depression, pointing to the importance of adding mental health care and support to infectious diseases services.

Authors & Co-authors:  Torres Thiago S TS Saha Pooja T PT Smeaton Laura L Wimbish Chanelle C Kliemann Dimas Alexandre DA Avihingsanon Anchalee A Kityo Cissy C Bennet Jaclyn Ann JA Van Schalkwyk Marije M Linas Benjamin B Nunes Estevao Portela EP Robbins Gregory K GK Wyles David D Naggie Susanna S Sulkowski Mark M Cardoso Sandra Wagner SW Solomon Sunil S

Study Outcome 

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Statistics
Citations :  WHO (2024, September 4). Global hepatitis report 2024: Action for access in low-and middle-income countries. https://www.who.int/publications/i/item/9789240091672
Authors :  17
Identifiers
Doi : 10.1007/s11136-025-03922-1
SSN : 1573-2649
Study Population
Male,Female
Mesh Terms
Other Terms
Cirrhosis;Direct-acting antivirals;HIV;Health-related quality of life;Hepatitis C;Mental health
Study Design
Study Approach
Country of Study
Uganda
Publication Country
Netherlands