#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain


Autoři: José Manuel Sousa aff001;  Mercedes Vergara aff002;  Federico Pulido aff003;  Gloria Sánchez Antolín aff004;  Lander Hijona aff005;  Fernando Carnicer aff006;  Diego Rincón aff007;  Javier Salmerón aff008;  Beatriz Mateos-Muñoz aff009;  Antoni Jou aff010;  Benjamín Polo-Lorduy aff011;  Ángel Rubín aff012;  Ana Escarda aff013;  Patricia Aguilar aff014;  Teresa Aldamiz-Echevarría aff015;  Luisa García-Buey aff016;  José A. Carrión aff017;  Manuel Hernández-Guerra aff018;  Sonia Chimeno-Hernández aff019;  Nuria Espinosa aff020;  Rosa Mª Morillas aff021;  Raúl J. Andrade aff022;  Manuel Delgado aff023;  Adolfo Gallego aff024;  Marta Magaz aff025;  José María Moreno-Planas aff026;  Ángel Estébanez aff027;  Mikel Rico aff028;  Fernando Menéndez aff029;  Blanca Sampedro aff030;  Luís Morano aff031;  Sonia Izquierdo aff032;  José Manuel Zozaya aff033;  Manuel Rodríguez aff034;  Senador Morán-Sánchez aff035;  Sara Lorente aff036;  Ignacio Martín-Granizo aff037;  Miguel Ángel Von-Wichmann aff038;  Marcial Delgado aff039;  Amanda Manzanares aff040
Působiště autorů: Hepatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Sevilla, Spain aff001;  Hepatology Unit, Digestive Disease Department, Parc Taulí Sabadell Hospital Universitari, Sabadell, Barcelona, Spain, CIBERehd, Instituto Carlos III, Madrid, Spain aff002;  HIV Unit, Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain aff003;  Hepatology Department, Hospital Universitario Río Hortega, Valladolid, Valladolid, Spain aff004;  Hepatology Department, Hospital Universitario Araba, Vitoria-Gasteiz, Álava, Spain aff005;  Hepatology Department, Hospital General Universitario de Alicante, Alicante, Alicante, Spain aff006;  Hepatology Department, Hospital General Universitario Gregorio Marañón, CIBERehd and (UCM), Madrid, Spain aff007;  Hepatology Department, Complejo Hospitalario Universitario de Granada, Granada, Granada, Spain aff008;  Hepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain aff009;  HIV Clinical Unit, Internal Medicine Department and Fundació de la Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain aff010;  Hepatology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain aff011;  Hepatology Department, Hospital Universitario y Politécnico de La Fe, Valencia, Valencia, Spain aff012;  Hepatology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain aff013;  Digestive System Clinical Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía/Córdoba University, Córdoba, Spain aff014;  Infectious Diseases-HIV, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain aff015;  Hepatology Department, Hospital Universitario de La Princesa, Madrid, Spain aff016;  Liver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autonoma de Barcelona) Barcelona, Spain aff017;  Hepatology Department, Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain aff018;  Hepatology Department, Hospital Arnau de Vilanova, Valencia, Valencia, Spain aff019;  Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Infectious Diseases Research Group, Institute of Biomedicine of Seville (IBiS), University of Seville/CSIC,Sevilla, Spain aff020;  Liver Section, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, IGTP, Badalona, Barcelona, Spain, and CIBEREHD aff021;  Unidad de Gestión Clínica de Aparato Digestivo, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBE aff022;  Hepatology Department, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain aff023;  Hepatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain aff024;  Hepatology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain aff025;  Digestive System Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain aff026;  Hepatology Department, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain aff027;  Infectious Diseases Unit, Hospital Universitario La Paz, Madrid, Spain aff028;  Hepatology Department, Hospital Universitario Basurto, Bilbao, Vizcaya, Spain aff029;  Hepatology Department, Hospital Galdakao, Galdakao, Vizcaya, Spain aff030;  Infectious Diseases Unit, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff031;  Hepatology Department, Hospital Clínico San Carlos, Madrid, Spain aff032;  Hepatology Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain aff033;  Liver Unit, Division of Gastroenterology & Hepatology. Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain aff034;  Hepatology Department, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain aff035;  Hepatology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Zaragoza, Spain aff036;  Department of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff037;  Infectious Diseases Unit, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain aff038;  Infectious Diseases Unit, Hospital Regional Universitario de Málaga, Málaga, Spain aff039;  AbbVie Spain, S.L.U., Madrid, Spain aff040
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0225061

Souhrn

Aim

We describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain.

Material and methods

Data were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven “National HCV plan.” Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded.

Results

Overall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8–97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of −2.2% (90% CI, −4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin.

Conclusions

Our results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.

Klíčová slova:

Cirrhosis – Co-infections – Fibrosis – Hepatitis C virus – HIV infections – Spain – Spanish people


Zdroje

1. Polaris Observatory HCVC. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. The lancet Gastroenterology & hepatology. 2017;2(3):161–176.

2. World Health Organization. Hepatitis C. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c. Accessed 2018. 2018;doi.

3. Lavin AC, Perello C, Llerena S, Gomez M, Escudero MD, Rodriguez L, et al. Prevalence of hepatitis C in the spanish population. The prevhep study (ethon cohort). Journal of hepatology. 2017;66(1):S272.

4. Bruguera M, Forns X. [Hepatitis C in Spain]. Medicina clinica. 2006;127(3):113–117. doi: 10.1157/13090276 16828003

5. Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61(1):77–87. doi: 10.1002/hep.27259 25069599

6. Acero Fernandez D, Ferri Iglesias MJ, Buxo Pujolras M, Lopez Nunez C, Serra Matamala I, Queralt Moles X, et al. Changes in the epidemiology and distribution of the hepatitis C virus genotypes in North-Eastern Spain over the last 35 years. Gastroenterologia y hepatologia. 2018;41(1):2–11. doi: 10.1016/j.gastrohep.2017.09.004 29150360

7. Kim AY, Onofrey S, Church DR. An epidemiologic update on hepatitis C infection in persons living with or at risk of HIV infection. The Journal of infectious diseases. 2013;207 Suppl 1:S1–6.

8. Berenguer J, Rivero A, Jarrín I, Núñez MJ, Vivancos MJ, Crespo M, et al. Human Immunodeficiency Virus/Hepatitis C Virus Coinfection in Spain: Prevalence and Patient Characteristics. Open forum infectious diseases. 2016;3(2):ofw059. doi: 10.1093/ofid/ofw059 27186584

9. Chen SL, Morgan TR. The natural history of hepatitis C virus (HCV) infection. International journal of medical sciences. 2006;3(2):47–52. doi: 10.7150/ijms.3.47 16614742

10. European Association for the Study of the Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017;66(1):153–194. doi: 10.1016/j.jhep.2016.09.001 27667367

11. AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015;62(3):932–954. doi: 10.1002/hep.27950 26111063

12. Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. The New England journal of medicine. 2014;370(17):1604–1614. doi: 10.1056/NEJMoa1401561 24720679

13. Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. The New England journal of medicine. 2014;370(21):1983–1992. doi: 10.1056/NEJMoa1402338 24795200

14. Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016;64(2):301–307. doi: 10.1016/j.jhep.2015.10.005 26476290

15. Wyles D, Saag M, Viani RM, Lalezari J, Adeyemi O, Bhatti L, et al. TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir. The Journal of infectious diseases. 2017;215(4):599–605. doi: 10.1093/infdis/jiw597 28329334

16. Rockstroh JK, Orkin C, Viani RM, Wyles D, Luetkemeyer AF, Lazzarin A, et al. Safety and Efficacy of Ombitasvir, Paritaprevir With Ritonavir +/- Dasabuvir With or Without Ribavirin in Patients With Human Immunodeficiency Virus-1 and Hepatitis C Virus Genotype 1 or Genotype 4 Coinfection: TURQUOISE-I Part 2. Open forum infectious diseases. 2017;4(3):ofx154. doi: 10.1093/ofid/ofx154 28948180

17. Rodés Teixidor J, Albillos Martínez A, Butí ferret M, Crespo García J, Moreno González A, Zulaika Aristi D. Strategic Plan for Tackling Hepatitis C in the Spanish National Health System. Available at: http://www.easl.eu/medias/files/eu/PEAHC_v2_eng.pdf In: Affairs OotSfHaC, editor. Madrid: Ministry of health, Social Services and Equality; 2015.

18. European Medicines Agency (EMA). EPAR-Product Information Viekirax®. Available at: https://www.ema.europa.eu/en/documents/product-information/viekirax-epar-product-information_en.pdf. Accessed 2018.2015;doi.

19. European Medicines Agency (EMA). EPAR-Product Information Exviera®. Available at: https://www.ema.europa.eu/en/documents/product-information/exviera-epar-product-information_en.pdf. Accessed 2018. 2015.

20. Guías AEEH/SEIMC de manejo de la Hepatitis C. Available at: http://aeeh.es/wp-content/uploads/2017/06/consenso.pdf. Accessed 2018.2017;doi.

21. Calleja JL, Crespo J, Rincon D, Ruiz-Antoran B, Fernandez I, Perello 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

22. Abad S, Vega A, Hernandez E, Merida E, de Sequera P, Albalate M, et al. Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4. American journal of nephrology. 2017;45(3):267–272. doi: 10.1159/000454819 28166520

23. Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. The New England journal of medicine. 2014;370(17):1594–1603. doi: 10.1056/NEJMoa1315722 24720703

24. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. The New England journal of medicine. 2014;370(21):1973–1982. doi: 10.1056/NEJMoa1402869 24725237

25. Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014;147(2):359–365 e351.

26. Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015;385(9986):2502–2509. doi: 10.1016/S0140-6736(15)60159-3 25837829

27. Wedemeyer H, Craxi A, Zuckerman E, Dieterich D, Flisiak R, Roberts SK, et al. Real-world effectiveness of ombitasvir/paritaprevir/ritonavir+/-dasabuvir+/-ribavirin in patients with hepatitis C virus genotype 1 or 4 infection: A meta-analysis. Journal of viral hepatitis. 2017;24(11):936–943. doi: 10.1111/jvh.12722 28480525

28. 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. Journal of viral hepatitis. 2017;24(10):840–849. doi: 10.1111/jvh.12708 28342229

29. Flisiak R, Janczewska E, Lucejko M, Karpinska E, Zarebska-Michaluk D, Nazzal K, et al. Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir+/-dasabuvir+/-ribavirin in the AMBER, real-world experience study. Journal of viral hepatitis. 2018;25(11):1298–1305. doi: 10.1111/jvh.12945 29888828

30. Montes ML, Olveira A, Ahumada A, Aldamiz T, García-Samaniego J, Clemente A, et al. Similar effectiveness of direct-acting antiviral against hepatitis C virus in patients with and without HIV infection. AIDS (London, England). 2017;31(9):1253–1260.

31. Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, 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. The lancet HIV. 2015;2(8):e319–327. doi: 10.1016/S2352-3018(15)00114-9 26423374

32. Fried MD, Vierling AM, Gane E, Nevens F, Strasser S, Weiland O, et al. Safety of ABT-450/Ritonavir/Ombitasvir + Dasabuvir with or without Ribavirin in HCV genotype 1-infected patients: Results from phase 2 and 3 trials [abstract 1951]. AASLD 2014 Boston MA USA. 2014;doi.

33. Ferenci P, Buggisch P, Norris S, Kleine H, Charafeddine M, Crown E. Safety and effectiveness of ombitasvir/paritaprevir/ ritonavir and dasabuvir with ribavirin in HCV genotype 1 and 4-infected patients treated for 12 weeks: real world evidence from a global multicountry observational study. AASDLD. 2017;doi.


Článek vyšel v časopise

PLOS One


2019 Číslo 11
Nejčtenější tento týden
Nejčtenější v tomto čísle
Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

KOST
Koncepce osteologické péče pro gynekology a praktické lékaře
nový kurz
Autoři: MUDr. František Šenk

Sekvenční léčba schizofrenie
Autoři: MUDr. Jana Hořínková

Hypertenze a hypercholesterolémie – synergický efekt léčby
Autoři: prof. MUDr. Hana Rosolová, DrSc.

Svět praktické medicíny 5/2023 (znalostní test z časopisu)

Imunopatologie? … a co my s tím???
Autoři: doc. MUDr. Helena Lahoda Brodská, Ph.D.

Všechny kurzy
Kurzy Podcasty Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Zadejte e-mailovou adresu, se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.

Přihlášení

Nemáte účet?  Registrujte se

#ADS_BOTTOM_SCRIPTS#