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

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