Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice – Vie-KinD study


Autoři: María-Carlota Londoño aff001;  Mar Riveiro-Barciela aff002;  Adriana Ahumada aff004;  Raquel Muñoz-Gómez aff005;  Mercé Roget aff006;  María J. Devesa-Medina aff007;  Miguel Ángel Serra aff008;  Carmen A. Navascués aff009;  Carme Baliellas aff010;  Teresa Aldamiz-Echevarría aff011;  María L. Gutiérrez aff012;  Benjamín Polo-Lorduy aff013;  Isabel Carmona aff014;  Salvador Benlloch aff002;  Lucía Bonet aff016;  Javier García-Samaniego aff002;  Miguel Jiménez-Pérez aff018;  Senador Morán-Sánchez aff019;  Ángeles Castro aff020;  Manuel Delgado aff020;  Francisco Gea-Rodríguez aff002;  Ignacio Martín-Granizo aff022;  María Luisa Montes aff023;  Luís Morano aff024;  Manuel A. Castaño aff018;  Ignacio de los Santos aff025;  Montserrat Laguno aff026;  Juan Emilio Losa aff027;  Marta Montero-Alonso aff028;  Antonio Rivero aff029;  Cristina de Álvaro aff030;  Amanda Manzanares aff030;  Josep Mallolas aff026;  Guillermina Barril aff031;  Emilio González-Parra aff032;  Luisa García-Buey aff033
Působiště autorů: Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Barcelona, Spain aff001;  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Madrid, Spain aff002;  Liver Unit, Internal Medicine Department, Hospital Vall d'Hebron, Barcelona, Barcelona, Spain aff003;  Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Madrid, Spain aff004;  Department of Gastroenterology, Hospital General Universitario 12 de Octubre, Madrid, Madrid, Spain aff005;  Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain aff006;  Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Madrid, Spain aff007;  Digestive Medicine Service, Hospital Clínico Universitario de Valencia, Universidad de Valencia, Valencia, Spain aff008;  Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain aff009;  Liver Unit, Hospital de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain aff010;  Infectious Diseases-HIV Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain aff011;  Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain aff012;  Digestive Diseases Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Madrid, Spain aff013;  Digestive Disease Unit, Hospital Universitario Virgen Macarena, Sevilla, Sevilla, Spain aff014;  Department of Hepatology, Hospital Universitario y Politécnico La Fe, Valencia, Valencia, Spain aff015;  Department of Gastroenterology, Hospital Universitario Son Espases, Palma de Mallorca, Mallorca, Spain aff016;  Liver Unit, Hospital Universitario La Paz/IdiPaz, Madrid, Madrid, Spain aff017;  Hospital Regional Universitario de Málaga, Málaga, Spain aff018;  Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain aff019;  Complejo Hospitalario Universitario A Coruña, A Coruña, Spain aff020;  Department of Gastroenterology, Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain aff021;  Department of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff022;  HIV Unit, Hospital Universitario La Paz/IdiPaz, Madrid, Madrid, Spain aff023;  Infectious Disease Unit, Internal Medicine Department, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff024;  Department of Internal Medicine, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff025;  HIV Unit, Infectious Diseases Service, Hospital Clínic/IDIBAPS, Barcelona, Barcelona, Spain aff026;  Infectious Diseases Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain aff027;  Infectious Diseases Unit, Hospital Universitario y Politécnico La Fe, Valencia, Valencia, Spain aff028;  Infectious Diseases Unit, Hospital Universitario Reina Sofía de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain aff029;  Medical Department & Quality Assurance, ABBVIE, Madrid, Madrid, Spain aff030;  Nephrology Unit, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff031;  Nephrology Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Madrid, Spain aff032;  Liver Unit, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff033
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0221567

Souhrn

Background and aims

Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015.

Material and methods

Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records.

Results

Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision.

Conclusions

These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials.

Klíčová slova:

Adverse events – Cirrhosis – Co-infections – Glomerular filtration rate – Hepatitis C virus – Chronic kidney disease – Medical dialysis – Renal transplantation


Zdroje

1. Hepatitis C. World Health Organization. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/

2. Rodríguez-Tajes S, Dacal Y, Collazos C, Frías MC, Vidal Benede MJ, Jané M, et al. Estudio de prevalencia de infección por los virus de la hepatitis b y c en Cataluña. Gastroenterol Hepatol. 2017;40(Espec Congr 1):13

3. Fernández Bermejo M, Íñiguez Ovando R, Mata Romero P, Ferreira Nossa HC, Gómez Alonso B, Mateos Rodríguez JM, et al. Estudio de prevalencia de serología de hepatitis c en un área de salud con población Rural. Gastroenterol Hepatol. 2017;40(Espec Congr 1):95 doi: 10.1016/j.gastrohep.2015.12.011

4. Younossi Z, Park H, Henry L, Adeyemi A, Stepanova M. Extrahepatic Manifestations of Hepatitis C: A Meta-analysis of Prevalence, Quality of Life, and Economic Burden. Gastroenterology. 2016 Jun;150(7):1599–1608 doi: 10.1053/j.gastro.2016.02.039 26924097

5. Daltro-Oliveira R, Morais-de-Jesus M, Pettersen KM, Paraná R, Quarantini LC. Impact of sustained virologic response on quality of life in chronic HVC carriers. Ann Hepatol. 2013 May-Jun;12(3):399–407. 23619256

6. Dan AA, Martin LM, Crone C, Ong JP, Farmer DW, Wise T, et al. Depression, anemia and health-related quality of life in chronic hepatitis C. J Hepatol. 2006; 44(3):491–8. doi: 10.1016/j.jhep.2005.11.046 16427157

7. Alcázar R, Egocheaga MªI, Orte L, Lobos JMª, González Parra E, Álvarez Guisasola F, et al. Documento de consenso SEN-semFYC sobre la enfermedad renal crónica. Nefrología 2008; 28 (3) 273–282

8. Park H, Adeyemi A, Henry L, Stepanova M, Younossi Z. A meta-analytic assessment of the risk of chronic kidney disease in patients with chronic hepatitis C virus infection. J Viral Hepat. 2015;22(11):897–905 doi: 10.1111/jvh.12413 25904153

9. García-Agudo R, Aoufi-Rabih S, Barril-Cuadrado G. Estudio y seguimiento de la hepatitis C crónica en hemodiálisis: conclusiones del estudio SHECTS. Nefrologia Sup Ext 2013;4(3):33–7

10. Fabrizi F, Dixit V, Messa P. Impact of hepatitis C on survival in dialysis patients: a link with cardiovascular mortality? J Viral Hepat. 2012;19(9):601–607 doi: 10.1111/j.1365-2893.2012.01633.x 22863263

11. Bunchorntavakul C, Maneerattanaporn M, Chavalitdhamrong D. Management of patients with hepatitis C infection and renal disease. World J Hepatol. 2015 Feb 27;7(2):213–25 doi: 10.4254/wjh.v7.i2.213 25729476

12. Lin PH, Lai CC, Yang JL, Huang HL, Huang MS, Tsai MS, et al. Slow immunological progression in HIV-1 CRF07_BC-infected injecting drug users. Emerg Microbes Infect. 2013 Dec; 2(12): e83. doi: 10.1038/emi.2013.83 26038447

13. Clausen LN, Lundbo LF, Benfield T. Hepatitis C virus infection in the human immunodeficiency virus infected patient. World J Gastroenterol. 2014 Sep 14;20(34):12132–43 doi: 10.3748/wjg.v20.i34.12132 25232248

14. Tastan Bishop O. Chapter 4.3 –Hepatitis C and HIV Coinfection in Developing Countries. In: Hepatitis C in Developing Countries. Current and Future Challenges 2018, Pages 135–155. Available from: https://doi.org/10.1016/B978-0-12-803233-6.00012-6

15. Karageorgopoulos DE, Allen J and Bhagani S. Hepatitis C in human immunodeficiency virus co-infected individuals: Is this still a “special population”? World J Hepatol. 2015 Jul 28; 7(15): 1936–1952. doi: 10.4254/wjh.v7.i15.1936 26244068

16. Vachon ML, Dieterich DT. The era of direct-acting antivirals has begun: the beginning of the end for HCV? Semin Liver Dis. 2011 Nov;31(4):399–409. doi: 10.1055/s-0031-1297928 22189979

17. Colombo M. Interferon-free therapy for hepatitis C: The hurdles amid a golden era. Dig Liver Dis. 2015 Sep;47(9):727–33 doi: 10.1016/j.dld.2015.04.003 25937625

18. EASL Recommendations on Treatment of Hepatitis C 2018. Available from: https://www.journal-of-hepatology.eu/article/S0168-8278(18)31968-8/fulltext

19. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Patients with renal impairment. Available from: https://www.hcvguidelines.org/unique-populations/renal-impairment

20. Shuster DL, Menon R, Cohen DE, Khatri A. Effect of chronic kidney disease on the pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir in subjects with HCV genotype 1 infection. Hepatology. 2015;62(suppl. 1):744A.

21. Polepally AR, Badri P, Eckert D, Mensing S, Menon R. Effect of renal function on the pharmacokinetics of Ombitasvir/Paritaprevir/Ritonavir Dasabuvir and ribavirin in over 2000 subjects with HCV GT1 infection. Hepatology. 2015;62(suppl. 1):733A

22. Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, et al. Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology. 2016 Jun;150(7):1590–8. doi: 10.1053/j.gastro.2016.02.078 26976799

23. Vierling JM, Lawitz E, Rajender Reddy K, Cohen E, Kemmer N, Morelli G et al. RUBY-I: safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in adults with genotype 1 chronic hepatitis c virus (HCV) infection with severe renal impairment or end-stage renal disease. Hepatology 2016;64(suppl. 1);441A

24. Gane EJ, Sola R, Cohen E, Roberts SK, George J, Skoien R, et al. RUBY-II: Efficacy and Safety of a Ribavirin-Free Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir Regimen in Patients with Severe Renal Impairment or End-Stage Renal Disease and HCV Genotype 1a or 4 Infection. Hepatology 2016;64(suppl. 1);470A

25. https://www.niddk.nih.gov/health-information/health-communication-programs/nkdep/lab-evaluation/gfr/estimating/Pages/estimating.aspx)

26. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Available from: https://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf

27. Muñoz-Gómez R, Rincón D, Ahumada A, Hernández E, Devesa MJ, Izquierdo S, et al. Therapy with ombitasvir/paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus (HCV) infection in patients with severe renal impairment: A multicentre experience. J Viral Hepat. 2017 Jun;24(6):464–471. doi: 10.1111/jvh.12664 27976490

28. Schlabe S, Rockstroh JK. Advances in the treatment of HIV/HCV coinfection in adults. Expert Opin Pharmacother. 2018 Jan;19(1):49–64. doi: 10.1080/14656566.2017.1419185 29252031

29. Cotte L, Pugliese P, Valantin MA, Cuzin L, Billaud E, Duvivier C et al. Hepatitis C treatment initiation in HIV-HCV coinfected patients. BMC Infect Dis. 2016;16:345 doi: 10.1186/s12879-016-1681-1 27450098

30. Bischoff J, Mauss S, Cordes C, Lutz T, Scholten S, Moll A et al. Rates of sustained virological response 12 weeks after the scheduled end of direct-acting antiviral (DAA)-based hepatitis C virus (HCV) therapy from the National German HCV registry: does HIV coinfection impair the response to DAA combination therapy? HIV Med. 2018 Apr;19(4):299–307 doi: 10.1111/hiv.12579 29368456

31. Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch Met 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 Aug;2(8):e319–27 doi: 10.1016/S2352-3018(15)00114-9 26423374

32. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Patients with HIV/HCV coinfection. Available from: https://www.hcvguidelines.org/unique-populations/hiv-hcv

33. Welzel TM, Hinrichsen H, Sarrazin C, Buggisch P, Baumgarten A, Christensen S et al. Real-world experience with the all-oral, interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry. J Viral Hepat. 2017;24(10):840–849. doi: 10.1111/jvh.12708 28342229

34. Calleja JL, Crespo J, Rincón D, Ruiz-Antorán B, Fernandez I, Perelló C, et al. Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort. J Hepatol. 2017;66(6):1138–1148 doi: 10.1016/j.jhep.2017.01.028 28189751

35. Flisiak R, Pogorzelska J, Flisiak-Jackiewicz M.Hepatitis C: efficacy and safety in real life. Liver Int. 2017 Jan;37 Suppl 1:26–32.


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