Impact of sofosbuvir and daclastavir on health-related quality of life in patients co-infected with hepatitis C and human immunodeficiency virus

Yunihastuti E., Amelia F., Hapsari A.I., Wicaksana B., Natali V., Widhani A., Sulaiman A.S., Karjadi T.H.

Allergy and Clinical Immunology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia/Ciptomangunkusumo Hospital, Diponegoro 71, Jakarta, Indonesia; HIV Integrated Services, Ciptomangunkusumo Hospital, Jakarta, Indonesia; Hepatobilliary Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia


Abstract

Background: We conducted a real-life study of health-related quality of life (HRQoL) transformation before and 12 weeks after sofosbuvir and daclatasvir therapy in HCV/HIV co-infected patients. Factors related to the significant changes of each HRQoL domain/item were also evaluated. Methods: A prospective study was performed in the HIV integrated clinic at Cipto Mangunkusumo Hospital, Jakarta. HCV/HIV co-infected patients who started sofosbuvir and daclatasvir from government free DAA program in 2017–2019. WHOQoL-HIV BREF and RAND SF-36 questionnaires were recorded at baseline and post-treatment week 12. Results: 145 patients with mean age of 37.8 years (SD = 4.2) were included in the analysis. Most of patients were male (89%), previous IVDU (89%), active smoker (50.4%) and non-cirrhosis (80%). SVR12 was achieved in 95.5% of patients. Sofosbuvir and daclatasvir treatments showed positive impacts on 2 domains and 2 other items of WHOQoL-HIV BREF and 2 domains and 1 item of SF-36. Predicting factors of significant increase in each domain/item were: male and normal body mass index (BMI) for level of independence (RR 4.01,95% CI 1.09–14.74 and 4.80,95% CI 1.79–12.81); higher HCV-RNA for overall perception of QoL (RR 0.42,95% CI 0.18–0.94); non-smoking status for overall perception of health (RR 0.32,95% CI 0.15–0.66); male and fibrosis stage 0–1 for general health (RR 6.21,95% CI 1.69–22.88 and 2.86,95% CI 1.16–7.00); and the use of NNRTI-based ART (RR 5.23, 95% CI 1.16–23.65). Spiritual/personal belief decline was predicted by non-smoking status (RR 0.46, 95% CI 0.23–0.95). Treatment success was not associated with any changes of HR-QoL domain/item. Conclusions: HCV/HIV co-infected patients were successfully treated with sofosbuvir and daclatasvir and experienced improvement of HRQoL 12 weeks after treatment completion. © 2021, The Author(s).

Daclastavir; HCV; Health-related quality of life; Hepatitis C; HIV; Sofosbuvir


Journal

Health and Quality of Life Outcomes

Publisher: BioMed Central Ltd

Volume 19, Issue 1, Art No 154, Page – , Page Count


Journal Link: https://www.scopus.com/inward/record.uri?eid=2-s2.0-85106964144&doi=10.1186%2fs12955-021-01777-x&partnerID=40&md5=2f9401a263635d553b2c13c95a895839

doi: 10.1186/s12955-021-01777-x

Issn: 14777525

Type: All Open Access, Gold, Green


References

Platt, L., Easterbrook, P., Gower, E., Al, E., Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis (2016) Lancet Infect Dis, 16, pp. 797-808. , PID: 26922272; Hernandez, M.D., Sherman, K., HIV/HCV coinfection natural history and disease progression, a review of the most recent literature (2011) Curr Opin HIV AIDS, 6, pp. 478-482; Smith, C.J., Ryom, L., Weber, R., Morlat, P., Pradier, C., Reiss, P., Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration (2014) Lancet, 384, pp. 241-248. , PID: 25042234; Croxford, S., Kitching, A., Desai, S., Kall, M., Edelstein, M., Skingsley, A., Mortality and causes of death in people diagnosed with HIV in the era of highly active antiretroviral therapy compared with the general population: an analysis of a national observational cohort (2017) Lancet public Heal, 2, pp. 35-46; Hernando, V., Perez-Cachafeiro, S., Lewden, C., Gonzalez, J., Segura, F., Oteo, J.A., All-cause and liver-related mortality in HIV positive subjects compared to the general population: differences by HCV co-infection (2012) J Hepatol, 57, pp. 743-751. , PID: 22709620; Martinello, M., Amin, J., Matthews, G.V., Dore, G.J., Prevalence and disease burden of HCV coinfection in HIV cohorts in the Asia pacific region: a systematic review and meta-analysis (2016) AIDS Rev, 18, pp. 69-80; Hepatitis C, , https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c; Chung, R.T., Baumert, T.F., Curing chronic hepatitis C—the arc of a medical triumph (2014) N Engl J Med, 370, pp. 1576-1578. , COI: 1:CAS:528:DC%2BC2cXnt1Grsrw%3D, PID: 24720678; Abutaleb, A., Sherman, K.E., A changing paradigm: management and treatment of the HCV/HIV-co-infected patient (2018) Hepatol Int, 12, pp. 500-509. , PID: 30238230; (2018) Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection, , WHO, Geneve; Bullinger, M., Quitmann, J., Quality of life as patient-reported outcomes: principles of assessment (2014) Dialogues Clin Neurosci, 16, pp. 137-145. , PID: 25152653; WHOQOL: Measuring Quality of Life, , https://www.who.int/healthinfo/survey/whoqol-qualityoflife/en/; Younossi, Z.M., Stepanova, M., Sulkowski, M., Naggie, S., Henry, L., Hunt, S., Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus (2016) J Viral Hepat, 23, pp. 857-865. , COI: 1:CAS:528:DC%2BC28XhslOqu7zL, PID: 27291391; Groen, W.G., Kuijpers, W., Oldenburg, H.S., Wouters, M.W., Aaronson, N.K., van Harten, W.H., Supporting lung cancer patients with an interactive patient portal: feasibility study (2017) JMIR Cancer, 3. , PID: 28790025; Muragundi, P., Tumkur, A., Shetty, R., Naik, A., Health-related quality of life measurement (2012) J Young Pharm, 4, p. 54. , PID: 22523462; Younossi, Z.M., Henry, L., Systematic review: patient-reported outcomes in chronic hepatitis C—the impact of liver disease and new treatment regimens (2015) Aliment Pharmacol Ther, 41, pp. 497-520. , COI: 1:CAS:528:DC%2BC2MXitlKrsrw%3D, PID: 25616122; Younossi, Z.M., Stepanova, M., Nader, F., Jacobson, I.M., Gane, E., Nelson, D., Patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens (2014) Hepatology, 59, pp. 2161-2169. , COI: 1:CAS:528:DC%2BC2cXovFagsb8%3D, PID: 24710669; Stepanova, M., Nader, F., Cure, S., Bourhis, F., Hunt, S., Younossi, Z., Patients’ preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens (2014) Aliment Pharmacol Ther, 40, pp. 676-685. , COI: 1:CAS:528:DC%2BC2cXhtlyms7rI, PID: 25040192; Younossi, Z.M., Stepanova, M., Feld, J., Zeuzem, J., Jacobson, I., Agarwal, K., Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: results from ASTRAL-1 placebo-controlled trial (2016) J Hepatol, 65, pp. 33-39. , COI: 1:CAS:528:DC%2BC28XmtValuro%3D, PID: 26956698; Younossi, Z.M., Stepanova, M., Sulkowski, M., Foster, G.R., Reau, N., Mangia, A., Ribavirin-free regimen with sofosbuvir and velpatasvir is associated with high efficacy and improvement of patient-reported outcomes in patients with geno- types 2 and 3 chronic hepatitis C: results from Astral-2 and -3 clinical trials (2016) Clin Infect Dis, 63, pp. 1042-1048. , PID: 27444413; Pereira, M., Fialho, R., Assessment of factors associated with the quality of life of patients living with HIV/HCV co-infection (2016) J Behav Med, 39, pp. 767-781. , PID: 27506910; Goñi-Esarte, S., Juanbeltz, R., Martínez-Baz, I., Castilla, J., Miguel, R.S., Herrero, J.I., Long-term changes on health-related quality of life in patients with chronic hepatitis C after viral clearance with direct-acting antiviral agents (2019) Rev Esp Enfermedades Dig, 111, pp. 445-452; Scheiner, B., Schwabl, P., Steiner, S., Bucsics, T., Chromy, D., Aichelburg, M.C., Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease (2016) Medicine, 95, pp. 1-8. , COI: 1:CAS:528:DC%2BC28XhtFOhtL3N; (2018) Progress Report on Access to Hepatitis C Treatment. Focus on Overcoming Access Barriers: Experiences of Selected Countries, , https://www.who.int/hepatitis/publications/hep-c-access-report-2018/en/; Bifano, M., Hwang, C., Oosterhuis, B., Hartstra, J., Grasela, D., Tiessen, R., Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir (2013) Antivir Ther, 18, pp. 931-940. , COI: 1:CAS:528:DC%2BC2cXltFWgurY%3D, PID: 23963204; Truong, T.N., Laureillard, D., Lacombe, K., Thi, H.D., Hanh, P.P.T., Xuan, L.T.T., High proportion of HIV-HCV coinfected patients with advanced liver fibrosis requiring hepatitis C treatment in Haiphong, Northern Vietnam (2016) PLoS ONE, 11, pp. 1-13; (2002) World Health Organization. WHOQOL-HIV Instrument Users Manual; Ware, J.E., Gandek, B., Overview of the SF-36 health survey and the international quality of life assessment (IQOLA) project (1998) J Clin Epidemiol, 51, pp. 903-912. , PID: 9817107; Muhammad, N.N., Shatri, H., Djoerban, Z., Abdullah, M., Uji kesahihan dan keandalan kuesioner World Health Organization Quality of Life-HIV Bref dalam bahasa indonesia untuk mengukur kualitas hidup pasien HIV/AIDS (2017) J Penyakit Dalam Indones, 4, p. 112; Salim, S., Yamin, M., Alwi, I., Setiati, S., Validity and reliability of the Indonesian version of SF-36 quality of life questionnaire on patients with permanent pacemakers (2017) Acta Medica Indones, 49, pp. 10-16; Astoro, N.W., Djauzi, S., Djoerban, Z., Prodjosudjadi, W., Quality of life of HIV patients and influential factors (2007) Acta Med Indones, 39, pp. 2-7. , PID: 17297202; Bonkovsky, H.L.W.J., Reduction of health-related quality of life in chronic hepatitis C and improvement with interferon therapy. The Consensus Interferon Study Group (1999) Hepatology, 29, pp. 264-270. , COI: 1:CAS:528:DyaK1MXjslWmtQ%3D%3D, PID: 9862876; Torriani, F.J., Rodriguez-Torres, M., Rockstroh, J.K., Lissen, E., Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV- infected patients (2004) N Engl J Med, 351, pp. 438-450. , COI: 1:CAS:528:DC%2BD2cXmtFalu7k%3D, PID: 15282351; Younossi, Z.M., Stepanova, M., Sulkowski, M., Wyles, D., Kottilil, S., Hunt, S., Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: the ASTRAL-5 study (2017) Liver Int, 37, pp. 1796-1804. , COI: 1:CAS:528:DC%2BC2sXhvVeqtrbN, PID: 28470938; Saeed, S., Strumpf, E.C., Walmsley, S.L., Rollet-Kurhajec, K., Pick, N., Martel-Laferrière, V., How generalizable are the results from trials of direct antiviral agents to people coinfected with HIV/HCV in the real world? (2016) Clin Infect Dis, 62, pp. 919-926. , COI: 1:CAS:528:DC%2BC1cXitVGqt70%3D, PID: 26743093; Yeung, M.W., Young, J., Moodie, E., Rollet-Kurhajec, K.C., Schwartzman, K., Greenaway, C., Changes in quality of life, healthcare use, and substance use in HIV/hepatitis C coinfected patients after hepatitis C therapy: a prospective cohort study (2015) HIV Clin Trials, 16, pp. 100-110. , PID: 25972048; Saeed, S., Moodie, E.E.M., Strumpf, E., Gill, J., Wong, A., Cooper, C., Real-world impact of direct acting antiviral therapy on health-related quality of life in HIV/Hepatitis C co-infected individuals (2018) J Viral Hepat, 25, pp. 1507-1514. , COI: 1:CAS:528:DC%2BC1cXitl2jurzO, PID: 30141236; Bakiono, F., Ouédraogo, L., Sanou, M., Samadoulougou, S., Kirakoya-Samadoulougou, P.W.L.G.F., Robert, A., Quality of life in people living with HIV: A cross-sectional study in Ouagadougou, Burkina Faso (2014) Springerplus, 3; Nobre, N., Pereira, M., Roine, R.P., Sintonen, H., Sutinen, J., Factors associated with the quality of life of people living with HIV in Finland (2017) AIDS Care, 29, pp. 1074-1078. , PID: 28110552; Arjun, B.Y., Unnikrishnan, B., Ramapuram, J.T., Thapar, R., Mithra, P., Kumar, N., Factors influencing quality of life among people living with HIV in Coastal South India (2015) J Int Assoc Provid AIDS Care, 16, pp. 247-253. , PID: 26251226; Tesfay, A., Gebremariam, A., Gerbaba, M., Abrha, H., Gender differences in health related quality of life among people living with HIV on highly active antiretroviral therapy in Mekelle Town, Northern Ethiopia (2015) Biomed Res Int; Tesemma, A.L., Abate, M.G., Abebo, Z.H., Madebo, W.E., Determinants of poor quality of life among adults living with HIV and enrolled in highly active antiretroviral therapy at public health facilities of Arba Minch Town Administration in Southern Ethiopia (2019) HIV AIDS, 11, pp. 387-394; de Munter, J.S., Tynelius, P., Ahlström, G., Rasmussen, F., The bidirectional association between body weight and mobility disability: a population-based cohort (2016) Disabil Health J, 9, pp. 632-637. , PID: 27528493; Norrbäck, M., Tynelius, P., Ahlström, G., Rasmussen, F., The association of mobility disability and obesity with risk of unemployment in two cohorts from Sweden (2019) BMC Public Health, 19, p. 347. , PID: 30922278; Thein, H.-H., Butler, T., Krahn, M., Rawlinson, W., Levy, M.H., Kaldor, J.M., The effect of hepatitis C virus infection on health-related quality of life in prisoners (2006) J Urban Heal, 83, pp. 275-288; Toghianifar, N., Najafian, J., Pooya, A., Rabiei, K., Eshrati, B., Anaraki, J., Association of smoking status with quality of life in a cross-sectional population-based sample of iranian adults: Isfahan healthy heart program (2012) Asia-Pacific J Public Heal, 24, pp. 786-794; Krosnick, J.A., Malhotra, N., Mo, C.H., Bruera, E.F., Chang, L.C., Pasek, J., Perceptions of health risks of cigarette smoking: a new measure reveals widespread misunderstanding (2017) PLoS ONE, 12, pp. 1-23. , COI: 1:CAS:528:DC%2BC1cXnsFKlurw%3D; Bailey, Z.D., Slopen, N., Albert, M., Williams, D.R., Multidimensional religious involvement and tobacco smoking patterns over 9–10 years: a prospective study of middle-aged adults in the United States (2015) Soc Sci Med, 138, pp. 128-135. , PID: 26093070; Ghouri, N., Atcha, M., Sheikh, A., Influence of Islam on smoking among Muslims (2006) BMJ Clin Res, 332, p. 291; Campo, R.E., Cohen, C., Grimm, K., Shangguan, T., Maa, J., Seekins, D., Switch from protease inhibitor- to efavirenz-based antiretroviral therapy improves quality of life, treatment satisfaction and adherence with low rates of virological failure in virologically suppressed patients (2010) Int J STD AIDS, 21, pp. 166-171. , COI: 1:STN:280:DC%2BC3c7ntV2htA%3D%3D, PID: 20215619; Younossi, Z.M., Stepanova, M., Omata, M., Mizokami, M., Walters, M., Hunt, S., Quality of life of Japanese patients with chronic hepatitis C treated with ledipasvir and sofosbuvir (2016) Medicine, 95, pp. 1-7; Younossi, Z.M., Stepanova, M., Afdhal, N., Kowdley, K.V., Zeuzem, S., Henry, L., Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir (2015) J Hepatol, 63, pp. 337-345. , COI: 1:CAS:528:DC%2BC2MXoslCnurk%3D, PID: 25795586; Ichikawa, T., Miyaaki, H., Miuma, S., Taura, N., Motoyoshi, Y., Akahoshi, H., Hepatitis C virus-related symptoms, but not quality of life, were improved by treatment with direct-acting antivirals (2018) Hepatol Res, 48, pp. 232-239. , COI: 1:CAS:528:DC%2BC1cXisVOqsbg%3D; Pereira, L., De, M.J., Barreto, M., Lima, C., Maria, M., Pires, A., Treatment with sofosbuvir and daclatasvir (with or without ribavirin) improves patient reported outcomes in hepatitis C (2018) Osong Public Heal Res Perspect, 9, pp. 50-58; Younossi, Z.M., Stepanova, M., Esteban, R., Jacobson, I., Zeuzem, S., Sulkowski, M., Superiority of interferon-free regimens for chronic hepatitis C (2017) Medicine (Baltimore), 96. , COI: 1:CAS:528:DC%2BC2sXislKrurw%3D; Younossi, Z.M., Stepanova, M., Feld, J., Zeuzem, S., Sulkowski, M., Foster, G.R., Sofosbuvir and velpatasvir combination improves patient-reported outcomes for patients with HCV infection, without or with compensated or decompensated cirrhosis (2017) Clin Gastroenterol Hepatol, 15, pp. 421-431. , COI: 1:CAS:528:DC%2BC28XitFKru7zE, PID: 27847279; Doyle, J.S., Grebely, J., Spelman, T., Alavi, M., Matthews, G., Thompson, A.J., Quality of life and social functioning during treatment of recent hepatitis C infection: a multi-centre prospective cohort (2016) PLoS ONE, 11, pp. 1-16. , COI: 1:CAS:528:DC%2BC28XivVGguro%3D

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