Effectiveness and Safety of Interferon-Free Direct-Acting Antiviral Hepatitis C Virus Therapy in HIV/Hepatitis C Virus Coinfected Individuals: Results From a Pan-European Study.


Journal

Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005

Informations de publication

Date de publication:
01 02 2021
Historique:
received: 19 05 2020
accepted: 05 10 2020
pubmed: 21 10 2020
medline: 6 8 2021
entrez: 20 10 2020
Statut: ppublish

Résumé

To investigate the effectiveness, safety, and reasons for premature discontinuation of direct-acting antivirals (DAAs) in a diverse population of HIV/hepatitis C virus (HCV) coinfected individuals in Europe. All HIV/HCV coinfected individuals in the EuroSIDA study that started interferon free DAA treatment between January 6, 2014, and January 3, 2018, with ≥12 weeks of follow-up after treatment stop were included in this analysis. Sustained virological response (SVR) was defined as a negative HCV-RNA result ≥12 weeks after stopping treatment (SVR12). Logistic regression was used to explore factors associated with SVR12. 1042 individuals started interferon-free DAA treatment after 1/6/2014 and were included, 862 (82.2%) had a known response to treatment, and 789 [91.5%, 95% confidence interval (CI): 89.7 to 93.4] of which achieved SVR12. There were no differences in SVR12 across regions of Europe (P = 0.84). After adjustment, the odds of achieving SVR12 was lower in individuals that received sofosbuvir/simeprevir ± ribavirin (RBV) [adjusted odds ratio 0.21 (95% CI: 0.08 to 0.53)] or ombitasvir/paritaprevir/dasabuvir ± RBV [adjusted odds ratio 0.46 (95% CI: 0.22 to 1.00)] compared with sofosbuvir/ledipasvir ± RBV. Forty-three (4.6%) individuals had one or more components of their HCV regimen stopped early, most commonly because of toxicity (n = 14); of these 14, 11 were treated with ribavirin. Increased bilirubin was the most common grade 3 or 4 laboratory adverse event (n = 15.3%) and was related to treatment with atazanavir and ribavirin. Our findings from real-world data on HIV/HCV coinfected individuals across Europe show DAA treatment is well tolerated and that high rates of SVR12 can be achieved in all regions of Europe.

Identifiants

pubmed: 33079903
pii: 00126334-202102010-00020
doi: 10.1097/QAI.0000000000002541
doi:

Substances chimiques

Anilides 0
Antiviral Agents 0
Benzimidazoles 0
Cyclopropanes 0
Fluorenes 0
Lactams, Macrocyclic 0
Sulfonamides 0
ledipasvir, sofosbuvir drug combination 0
ombitasvir 2302768XJ8
Ribavirin 49717AWG6K
Interferons 9008-11-1
Proline 9DLQ4CIU6V
Simeprevir 9WS5RD66HZ
Valine HG18B9YRS7
paritaprevir OU2YM37K86
Sofosbuvir WJ6CA3ZU8B

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

248-257

Informations de copyright

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Déclaration de conflit d'intérêts

The authors have no conflicts of interest to disclose.

Références

World Health Organisation. Global health observatory data (GHO). Available at: https://www.who.int/gho/hiv/en/ . Accessed August 29, 2020.
Platt L, Easterbrook P, Gower E, et al. Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis. Lancet Infect Dis. 2016;16:797–808.
Graham CS, Baden LR, Yu E, et al. Influence of human immunodeficiency virus infection on the course of hepatitis C virus infection: a meta-analysis. Clin Infect Dis. 2001;33:562–569.
Arends JE, Lieveld FI, Boeijen LL, et al. Natural history and treatment of HCV/HIV coinfection: is it time to change paradigms? J Hepatol. 2015;63:1254–1262.
Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach—ed. Geneva, Switzerland: World Health Organization, 2016. Available at: https://www.who.int/hiv/pub/arv/arv-2016/en/ . Accessed March 23, 2019.
European AIDS Clinical Society Guidelines Version 9.1, 2018 Available at: http://www.eacsociety.org/files/2018_guidelines-9.1-english.pdf .
Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–1898. Accessed October 29, 2019.
Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017;67:263–271.
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370:211–221.
Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:714–725.
Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2:e319–e327.
Rockstroh JK, Lacombe K, Viani RM, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients coinfected with hepatitis C virus and human immunodeficiency virus type 1: the EXPEDITION-2 study. Clin Infect Dis. 2018;67:1010–1017.
Naggie S, Cooper C, Saag M, et al. Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:705–713.
Berenguer J, varez-Pellicer J, Martin PM, et al. Sustained virological response to interferon plus ribavirin reduces liver-related complications and mortality in patients coinfected with human immunodeficiency virus and hepatitis C virus. Hepatology. 2009;50:407–413.
Kovari H, Rauch A, Kouyos R, et al. Hepatitis C infection and the risk of non-liver-related morbidity and mortality in HIV-infected persons in the Swiss HIV cohort study. Clin Infect Dis. 2017;64:490–497.
Mocroft A, Lundgren J, Gerstoft J, et al. Clinical outcomes in persons coinfected with human immunodeficiency virus and hepatitis C virus: impact of hepatitis C virus treatment. Clin Infect Dis. 2019;70:2131–2140.
Combating Hepatitis B and C to Reach Elimination by 2030. Geneva, Switzerland: World Health Organization, 2016. Available at: https://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en/ . Accessed September 22, 2019.
Beguelin C, Suter A, Bernasconi E, et al. Trends in HCV treatment uptake, efficacy and impact on liver fibrosis in the Swiss HIV Cohort Study. Liver Int. 2018;38:424–431.
Berenguer J, Gil-Martin A, Jarrin I, et al. All-oral direct-acting antiviral therapy against hepatitis C virus (HCV) in human immunodeficiency virus/HCV-coinfected subjects in real-world practice: Madrid coinfection registry findings. Hepatology. 2018;68:32–47.
Bhattacharya D, Belperio PS, Shahoumian TA, et al. Effectiveness of all-oral antiviral regimens in 996 human immunodeficiency virus/hepatitis C virus genotype 1-coinfected patients treated in routine practice. Clin Infect Dis. 2017;64:1711–1720.
Piroth L, Wittkop L, Lacombe K, et al. Efficacy and safety of direct-acting antiviral regimens in HIV/HCV-co-infected patients—French ANRS CO13 HEPAVIH cohort. J Hepatol. 2017;67:23–31.
Boesecke C, Ingiliz P, Berger F, et al. Liver cirrhosis as a risk factor for direct-acting antiviral therapy failure in real-life hepatitis C virus/human immunodeficiency virus coinfection. Open Forum Infect Dis. 2017;4:ofx158.
Laut K, Kirk O, Rockstroh J, et al. The EuroSIDA study: 25 years of scientific achievements. HIV Med. 2020;21:71–83.
Mauss S, Pol S, Buti M, et al. Late presentation of chronic viral hepatitis for medical care: a consensus definition. BMC Med. 2017;15:92.
Grint D, Peters L, Rockstroh JK, et al. Liver-related death among HIV/hepatitis C virus-co-infected individuals: implications for the era of directly acting antivirals. AIDS. 2015;29:1205–1215.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. National Institute of Allergy and Infectious Diseases, US Department of Health and Human Services, 2017. Available at: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf . Accessed April 22, 2019.
European AIDS Clinical Society Guidelines Version 10.0, 2019 Available at: https://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html . Accessed March 23, 2020.
Prescribing Information for REBETOL, MERCK, 2020 Available at: https://www.merck.com/product/usa/pi_circulars/r/rebetol/rebetol_pi.pdf . Accessed February 10, 2020.
Prescribing Information for REYATAZ, Bristol-Myers Squibb, 2018 Available at: https://packageinserts.bms.com/pi/pi_reyataz.pdf . Accessed February 10, 2020.
Sulkowski MS, Eron JJ, Wyles D, et al. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. JAMA. 2015;313:1223–1231.

Auteurs

Sarah Amele (S)

Institute for Global Health, University College London, London, United Kingdom.

Lars Peters (L)

CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Alison Rodger (A)

Institute for Global Health, University College London, London, United Kingdom.

Jens Lundgren (J)

CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Jurgen Rockstroh (J)

Department of Internal Medicine, University Hospital Bonn, Bonn, Germany.

Raimonda Matulionyte (R)

Vilnius University, Faculty of Medicine, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.

Clifford Leen (C)

Western General Hospital, Edinburgh, United Kingdom.

Elzbieta Jabłonowska (E)

Wojewodzki Szpital Specjalistyczny, Lodz, Poland.

Lars Østergaard (L)

Aarhus Universitetshospital, Skejby, Denmark.

Sanjay Bhagani (S)

Royal Free and University College Medical School, London, United Kingdom.

Mario Sarcletti (M)

Medical University Innsbruck, Innsbruck, Austria.

Amanda Clarke (A)

Royal Sussex County Hospital, Brighton, United Kingdom.

Karolin Falconer (K)

Karolinska University Hospital, Stockholm, Sweden.

Gilles Wandeler (G)

Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.

Pere Domingo (P)

Hospital Sant Pau, Barcelona, Spain.

Fernando Maltez (F)

Hospital Curry Cabral, Lisbon, Portugal.

Mauro Zaccarelli (M)

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, Rome, Italy.

Nikoloz Chkhartisvili (N)

Infectious Diseases, AIDS & Clinical Immunology Research Center, Tbilisi, Georgia.

Janos Szlavik (J)

Szent Lásló Hospital, Budapest, Hungary.

Christoph Stephan (C)

JW Goethe University Hospital, Frankfurt, Germany.

Laurent Fonquernie (L)

Hospital Saint-Antoine, Paris, France; and.

Inka Aho (I)

Helsinki University Hospital, Helsinki, Finland.

Amanda Mocroft (A)

Institute for Global Health, University College London, London, United Kingdom.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH