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

被引：6

作者：

Manuel Sousa, Jose ^{[1
]}

Vergara, Mercedes ^{[2
,3
]}

Pulido, Federico ^{[4
]}

Sanchez Antolin, Gloria ^{[5
]}

Hijona, Lander ^{[6
]}

Carnicer, Fernando ^{[7
]}

Rincon, Diego ^{[8
,9
]}

Salmeron, Javier ^{[10
]}

Mateos-Munoz, Beatriz ^{[11
]}

Jou, Antoni ^{[12
,13
]}

Polo-Lorduy, Benjamin ^{[14
]}

Rubin, Angel ^{[15
]}

Escarda, Ana ^{[16
]}

Aguilar, Patricia ^{[17
]}

Aldamiz-Echevarria, Teresa ^{[18
]}

Garcia-Buey, Luisa ^{[19
]}

Carrion, Jose A. ^{[20
]}

Hernandez-Guerra, Manuel ^{[21
]}

Chimeno-Hernandez, Sonia ^{[22
]}

Espinosa, Nuria ^{[23
]}

Morillas, Rosa Ma ^{[24
,25
]}

Andrade, Raul J. ^{[26
]}

Delgado, Manuel ^{[27
]}

Gallego, Adolfo ^{[28
]}

Magaz, Marta ^{[29
]}

Maria Moreno-Planas, Jose ^{[30
]}

Estebanez, Angel ^{[31
]}

Rico, Mikel ^{[32
]}

Menendez, Fernando ^{[33
]}

Sampedro, Blanca ^{[34
]}

Morano, Luis ^{[35
]}

Izquierdo, Sonia ^{[36
]}

Manuel Zozaya, Jose ^{[37
]}

Rodriguez, Manuel ^{[38
]}

Moran-Sanchez, Senador ^{[39
]}

Lorente, Sara ^{[40
]}

Martin-Granizo, Ignacio ^{[41
]}

Angel Von-Wichmann, Miguel ^{[42
]}

Delgado, Marcial ^{[43
]}

Manzanares, Amanda ^{[44
]}

机构：

[1] Hosp Univ Virgen del Rocio, Hepatol Dept, Seville, Spain

[2] Parc Tauli Sabadell Hosp Univ, Digest Dis Dept, Hepatol Unit, Barcelona, Spain

[3] Inst Carlos III, CIBERehd, Madrid, Spain

[4] Univ Complutense Madrid UCM, HIV Unit, Imas12, Hosp Univ 12 Octubre, Madrid, Spain

[5] Hosp Univ Rio Hortega, Hepatol Dept, Valladolid, Spain

[6] Hosp Univ Araba, Hepatol Dept, Vitoria, Alava, Spain

[7] Hosp Gen Univ Alicante, Hepatol Dept, Alicante, Spain

[8] Hosp Gen Univ Gregorio Maranon, Hepatol Dept, CIBERehd, Madrid, Spain

[9] UCM, Madrid, Spain

[10] Complejo Hosp Univ Granada, Hepatol Dept, Granada, Spain

[11] Hosp Univ Ramon y Cajal, Hepatol Dept, Madrid, Spain

[12] Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Internal Med Dept, HIV Clin Unit, Barcelona, Spain

[13] Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fundacio Lluita SIDA, Barcelona, Spain

[14] Hosp Univ Fdn Jimenez Diaz, Hepatol Dept, Madrid, Spain

[15] Hosp Univ & Politecn La Fe, Hepatol Dept, Valencia, Spain

[16] Hosp Univ Son Espases, Hepatol Dept, Palma De Mallorca, Spain

[17] Cordoba Univ, Hosp Univ Reina Sofia, Inst Maimonides Invest Biomed Cordoba IMIBIC, Digest Syst Clin Unit, Cordoba, Spain

[18] Hosp Gen Univ Gregorio Maranon IiSGM, Infect Dis HIV, Madrid, Spain

[19] Hosp Univ La Princesa, Hepatol Dept, Madrid, Spain

[20] UAB Univ Autonoma Barcelona Barcelona, Hosp del Mar, IMIM Hosp del Mar Med Res Inst, Gastroenterol Dept,Liver Sect, Barcelona, Spain

[21] Hosp Univ Canarias, Hepatol Dept, San Cristobal la Laguna, Santa Cruz De T, Spain

[22] Hosp Arnau Vilanova, Hepatol Dept, Valencia, Spain

[23] Univ Seville, Inst Biomed Seville IBiS, Clin Unit Infect Dis Microbiol & Prevent Med, CSIC,Infect Dis Res Grp, Seville, Spain

[24] Hosp Badalona Germans Trias & Pujol, Dept Gastroenterol, Liver Sect, IGTP, Barcelona, Spain

[25] CIBEREHD, Barcelona, Spain

[26] Univ Malaga, Hosp Univ Virgen de la Victoria, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Inst Invest Biomed Malaga IBIMA,Unidad Gest Clin, Malaga, Spain

[27] Complejo Hosp Univ A Coruna, Hepatol Dept, La Coruna, Spain

[28] Hosp Santa Creu & Sant Pau, Hepatol Dept, Barcelona, Spain

[29] Hosp Univ Puerta de Hierro Majadahonda, Hepatol Dept, Madrid, Spain

[30] Complejo Hosp Univ Albacete, Digest Syst Dept, Albacete, Spain

[31] Hosp Univ Marques de Valdecilla, Hepatol Dept, Santander, Cantabria, Spain

[32] Hosp Univ La Paz, Infect Dis Unit, Madrid, Spain

[33] Hosp Univ Basurto, Hepatol Dept, Bilbao, Vizcaya, Spain

[34] Hosp Galdakao, Hepatol Dept, Galdakao, Vizcaya, Spain

[35] Hosp Univ Alvaro Cunqueiro, Infect Dis Unit, Vigo, Pontevedra, Spain

[36] Hosp Clin San Carlos, Hepatol Dept, Madrid, Spain

[37] Complejo Hosp Navarra, Hepatol Dept, Pamplona, Navarra, Spain

[38] Hosp Univ Cent Asturias, Div Gastroenterol & Hepatol, Liver Unit, Oviedo, Asturias, Spain

[39] Hosp Gen Univ Santa Lucia, Hepatol Dept, Murcia, Spain

[40] Hosp Clin Univ Lozano Blesa, Hepatol Dept, Zaragoza, Spain

[41] Hosp Univ Alvaro Cunqueiro, Dept Gastroenterol, Vigo, Pontevedra, Spain

[42] Hosp Univ Donostia, Infect Dis Unit, Donostia San Sebastian, Gipuzkoa, Spain

[43] Hosp Reg Univ Malaga, Infect Dis Unit, Malaga, Spain

[44] AbbVie Spain SLU, Madrid, Spain

来源：

PLOS ONE | 2019年 / 14卷 / 11期

关键词：

TREATMENT-EXPERIENCED PATIENTS; GENOTYPE; INFECTION; ABT-450/R-OMBITASVIR; HCV; OMBITASVIR/PARITAPREVIR/RITONAVIR; PREVALENCE; RITONAVIR; SAFETY;

D O I：

10.1371/journal.pone.0225061

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：18

共 33 条

[1] 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
Abad, Soraya
Vega, Almudena
Hernandez, Eduardo
Merida, Evangelina
de Sequera, Patricia
Albalate, Marta
Macias, Nicolas
Milla, Monica
Lopez-Gomez, Juan M.
[J]. AMERICAN JOURNAL OF NEPHROLOGY, 2017, 45 (03) : 267 - 272
[2] Changes in the epidemiology and distribution of the hepatitis C virus genotypes in North-Eastern Spain over the last 35 years
Acero Fernandez, Doroteo
Ferri Iglesias, Maria Jose
Buxo Pujolras, Maria
Lopez Nunez, Carmen
Serra Matamala, Isabel
Queralt Moles, Xavier
Aldeguer Mante, Xavier
[J]. GASTROENTEROLOGIA Y HEPATOLOGIA, 2018, 41 (01): : 2 - 11
[3] 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
Andreone, Pietro
Colombo, Massimo G.
Enejosa, Jeffrey V.
Koksal, Iftihar
Ferenci, Peter
Maieron, Andreas
Muellhaupt, Beat
Horsmans, Yves
Weiland, Ola
Reesink, Henk W.
Rodrigues, Lino, Jr.
Hu, Yiran B.
Podsadecki, Thomas
Bernstein, Barry
[J]. GASTROENTEROLOGY, 2014, 147 (02) : 359 - +
[4] [Anonymous], 2018, HEP C
[5] [Anonymous], 2017, GUIAS AEEH SEIMC MAN
[6] Human Immunodeficiency Virus/Hepatitis C Virus Coinfection in Spain: Prevalence and Patient Characteristics
Berenguer, Juan
Rivero, Antonio
Jarrin, Inmaculada
Nunez, Maria J.
Vivancos, Maria J.
Crespo, Manel
Tellez, Maria J.
Domingo, Pere
Iribarren, Jose A.
Artero, Arturo
Marquez, Manuel
Santos, Ignacio
Moreno, Javier
Montero, Marta
Gonzalez-Garcia, Juan
[J]. OPEN FORUM INFECTIOUS DISEASES, 2016, 3 (02):
[7] Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study
Blach, Sarah
Zeuzem, Stefan
Manns, Michael
Altraif, Ibrahim
Duberg, Ann-Sofi
Muljono, David H.
Waked, Imam
Alavian, Seyed M.
Lee, Mei-Hsuan
Negro, Francesco
Abaalkhail, Faisal
Abdou, Ahmed
Abdulla, Maheeba
Abou Rached, Antoine
Aho, Inka
Akarca, Ulus
Al Ghazzawi, Imad
Al Kaabi, Saad
Al Lawati, Faryal
Al Namaani, Khalid
Al Serkal, Youssif
Al-Busafi, Said A.
Al-Dabal, Layla
Aleman, Soo
Alghamdi, Abdullah S.
Aljumah, Abdulrahman A.
Al-Romaihi, Hamad E.
Andersson, Monique I.
Arendt, Vic
Arkkila, Perttu
Assiri, Abdullah M.
Baatarkhuu, Oidov
Bane, Abate
Ben-Ari, Ziv
Bergin, Colm
Bessone, Fernando
Bihl, Florian
Bizri, Abdul R.
Blachier, Martin
Blasco, Antonio J.
Mello, Carlos E. Brandao
Bruggmann, Philip
Brunton, Cheryl R.
Calinas, Filipe
Chan, Henry L. Y.
Chaudhry, Asad
Cheinquer, Hugo
Chen, Chien-Jen
Chien, Rong-Nan
Choi, Moon Seok
[J]. LANCET GASTROENTEROLOGY & HEPATOLOGY, 2017, 2 (03): : 161 - 176
[8] Hepatitis C in Spain
Bruguera, Miguel
Forns, Xavier
[J]. MEDICINA CLINICA, 2006, 127 (03): : 113 - 117
[9] Chen Stephen L, 2006, Int J Med Sci, V3, P47
[10] Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus
Chung, Raymond T.
Davis, Gary L.
Jensen, Donald M.
Masur, Henry
Saag, Michael S.
Thomas, David L.
Aronsohn, Andrew I.
Charlton, Michael R.
Feld, Jordan J.
Fontana, Robert J.
Ghany, Marc G.
Godofsky, Eliot W.
Graham, Camilla S.
Kim, Arthur Y.
Kiser, Jennifer J.
Kottilil, Shyam
Marks, Kristen M.
Martin, Paul
Mitruka, Kiren
Morgan, Timothy R.
Naggie, Susanna
Raymond, Daniel
Reau, Nancy S.
Schooley, Robert T.
Sherman, Kenneth E.
Sulkowski, Mark S.
Vargas, Hugo E.
Ward, John W.
Wyles, David L.
[J]. HEPATOLOGY, 2015, 62 (03) : 932 - 954

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