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

Mercedes Vergara; José Antonio Carrión Rodríguez; J. M. Sousa; F. Pulido; G. S. Antolín; L. Hijona; F. Carnicer; D. Rincón; J. Salmerón; B. Mateos-Muñoz; A. Jou; B. Polo-Lorduy; Á. Rubín; Ana Escarda; Patricia Aguilar-Melero; T. Aldámiz-Echevarría; L. García-Buey; M. Hernández-Guerra; S. Chimeno-Hernández; N. Espinosa; Rosa Ma. Morillas Cunill; R. J. Andrade; M. Delgado; Adolfo Gallego; Marta Magaz; J. M. Moreno-Planas; Á. Estébanez; M. Rico; F. Menéndez; B. Sampedro; Luis Enrique Morano Amado; S. Izquierdo; José M Zozaya; Manuel Rodríguez; Senador Morán-Sánchez; S. Lorente; I. Martín-Granizo; M. Á. Von-Wichmann; M. Delgado; A. Manzanares

doi:10.1371/journal.pone.0225061

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

Mercedes Vergara, José Antonio Carrión Rodríguez, J. M. Sousa, F. Pulido, G. S. Antolín, L. Hijona, F. Carnicer, D. Rincón, J. Salmerón, B. Mateos-Muñoz, A. Jou, B. Polo-Lorduy, Á. Rubín, Ana Escarda, Patricia Aguilar-Melero, T. Aldámiz-Echevarría, L. García-Buey, M. Hernández-Guerra, S. Chimeno-Hernández, N. EspinosaRosa Ma. Morillas Cunill, R. J. Andrade, M. Delgado, Adolfo Gallego, Marta Magaz, J. M. Moreno-Planas, Á. Estébanez, M. Rico, F. Menéndez, B. Sampedro, Luis Enrique Morano Amado, S. Izquierdo, José M Zozaya, Manuel Rodríguez, Senador Morán-Sánchez, S. Lorente, I. Martín-Granizo, M. Á. Von-Wichmann, M. Delgado, A. Manzanares

Department of Medicine

Research output: Contribution to journal › Article › Research › peer-review

4 Citations (Scopus)

Abstract

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.

Original language	English
Journal	PLoS ONE
Volume	14
Issue number	11
DOIs	https://doi.org/10.1371/journal.pone.0225061
Publication status	Published - 2019

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Vergara, M., Carrión Rodríguez, J. A., Sousa, J. M., Pulido, F., Antolín, G. S., Hijona, L., Carnicer, F., Rincón, D., Salmerón, J., Mateos-Muñoz, B., Jou, A., Polo-Lorduy, B., Rubín, Á., Escarda, A., Aguilar-Melero, P., Aldámiz-Echevarría, T., García-Buey, L., Hernández-Guerra, M., Chimeno-Hernández, S., ... Manzanares, A. (2019). 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. PLoS ONE, 14(11). https://doi.org/10.1371/journal.pone.0225061

@article{b91f0d69fec7460295dafb895fec2b81,

title = "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",

abstract = "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.",

author = "Mercedes Vergara and {Carri{\'o}n Rodr{\'i}guez}, {Jos{\'e} Antonio} and Sousa, {J. M.} and F. Pulido and Antol{\'i}n, {G. S.} and L. Hijona and F. Carnicer and D. Rinc{\'o}n and J. Salmer{\'o}n and B. Mateos-Mu{\~n}oz and A. Jou and B. Polo-Lorduy and {\'A}. Rub{\'i}n and Ana Escarda and Patricia Aguilar-Melero and T. Ald{\'a}miz-Echevarr{\'i}a and L. Garc{\'i}a-Buey and M. Hern{\'a}ndez-Guerra and S. Chimeno-Hern{\'a}ndez and N. Espinosa and {Morillas Cunill}, {Rosa Ma.} and Andrade, {R. J.} and M. Delgado and Adolfo Gallego and Marta Magaz and Moreno-Planas, {J. M.} and {\'A}. Est{\'e}banez and M. Rico and F. Men{\'e}ndez and B. Sampedro and {Morano Amado}, {Luis Enrique} and S. Izquierdo and Zozaya, {Jos{\'e} M} and Manuel Rodr{\'i}guez and Senador Mor{\'a}n-S{\'a}nchez and S. Lorente and I. Mart{\'i}n-Granizo and Von-Wichmann, {M. {\'A}.} and M. Delgado and A. Manzanares",

year = "2019",

doi = "10.1371/journal.pone.0225061",

language = "English",

volume = "14",

number = "11",

}

Vergara, M, Carrión Rodríguez, JA, Sousa, JM, Pulido, F, Antolín, GS, Hijona, L, Carnicer, F, Rincón, D, Salmerón, J, Mateos-Muñoz, B, Jou, A, Polo-Lorduy, B, Rubín, Á, Escarda, A, Aguilar-Melero, P, Aldámiz-Echevarría, T, García-Buey, L, Hernández-Guerra, M, Chimeno-Hernández, S, Espinosa, N, Morillas Cunill, RM, Andrade, RJ, Delgado, M, Gallego, A, Magaz, M, Moreno-Planas, JM, Estébanez, Á, Rico, M, Menéndez, F, Sampedro, B, Morano Amado, LE, Izquierdo, S, Zozaya, JM, Rodríguez, M, Morán-Sánchez, S, Lorente, S, Martín-Granizo, I, Von-Wichmann, MÁ, Delgado, M & Manzanares, A 2019, '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', PLoS ONE, vol. 14, no. 11. https://doi.org/10.1371/journal.pone.0225061

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. / Vergara, Mercedes; Carrión Rodríguez, José Antonio; Sousa, J. M. et al.
In: PLoS ONE, Vol. 14, No. 11, 2019.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - 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

AU - Vergara, Mercedes

AU - Carrión Rodríguez, José Antonio

AU - Sousa, J. M.

AU - Pulido, F.

AU - Antolín, G. S.

AU - Hijona, L.

AU - Carnicer, F.

AU - Rincón, D.

AU - Salmerón, J.

AU - Mateos-Muñoz, B.

AU - Jou, A.

AU - Polo-Lorduy, B.

AU - Rubín, Á.

AU - Escarda, Ana

AU - Aguilar-Melero, Patricia

AU - Aldámiz-Echevarría, T.

AU - García-Buey, L.

AU - Hernández-Guerra, M.

AU - Chimeno-Hernández, S.

AU - Espinosa, N.

AU - Morillas Cunill, Rosa Ma.

AU - Andrade, R. J.

AU - Delgado, M.

AU - Gallego, Adolfo

AU - Magaz, Marta

AU - Moreno-Planas, J. M.

AU - Estébanez, Á.

AU - Rico, M.

AU - Menéndez, F.

AU - Sampedro, B.

AU - Morano Amado, Luis Enrique

AU - Izquierdo, S.

AU - Zozaya, José M

AU - Rodríguez, Manuel

AU - Morán-Sánchez, Senador

AU - Lorente, S.

AU - Martín-Granizo, I.

AU - Von-Wichmann, M. Á.

AU - Delgado, M.

AU - Manzanares, A.

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

U2 - 10.1371/journal.pone.0225061

DO - 10.1371/journal.pone.0225061

M3 - Article

C2 - 31714950

SN - 1932-6203

VL - 14

JO - PLoS ONE

JF - PLoS ONE

IS - 11

ER -