Direct-acting antivirals for hepatitis C

Predictors of early discontinuation in the real world

Marina Amaral De Ávila Machado, Cristiano Soares De Moura, Marina Klein, Kevin Winthrop, Bruce Carleton, Michal Abrahamowicz, Jordan Feld, Jeffrey R. Curtis, Marie Eve Beauchamp, Sasha Bernatsky

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The treatment for hepatitis C virus (HCV) infection has evolved over time, and direct-acting antivirals (DAA) have revolutionized HCV therapy. OBJECTIVES: To (a) assess early treatment discontinuation and (b) identify predictors of early discontinuation in a cohort of patients receiving second-generation DAAs. METHODS: We identified HCV patients newly prescribed simeprevir/sofosbuvir (SIM/SOF), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ ritonavir+dasabuvir (OPrD), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/ grazoprevir (EBR/GZR), and glecaprevir/pibrentasvir (GLE/PIB) between 2014 and 2017. Early discontinuation was defined as duration of therapy less than 8 weeks. Multivariable logistic regression was performed to evaluate the association of drug regimens and potential predictive factors to early discontinuation. RESULTS: We identified 26,098 DAA-treated patients: 67.8% with LDV/SOF, 9.9% with OPrD, 8.5% with SIM/SOF, 7.8% with SOF/VEL, 5.2% with EBR/ GZR, and 0.8% with GLE/PIB. With approval of new therapies in 2016 and 2017, use of OPrD, LDV/SOF, and SIM/SOF declined substantially. At baseline, there was some heterogeneity of past HCV drug use and comorbidity across groups; patients on SIM/SOF had the highest frequency of previous interferon, cirrhosis, and decompensated cirrhosis. Most HCV patients received therapy for 8-12 weeks; fewer patients went through 16-week and 24-week therapy courses. Early discontinuation rates (95% CI) were 7.1% (6.0-8.2) for SIM/SOF, 3.2% (2.9-3.5) for LDV/SOF, 9.6% (8.5-10.7) for OPrD, 3.1% (2.3-3.8) for SOF/VEL, 4.2% (3.1-5.3) for EBR/GZR, and 2.5% (0.3-4.7) for GLE/PIB. In multivariable analyses, versus OPrD, patients starting other drug regimens were less likely to discontinue therapy early. Early discontinuation was more common in women, patients with baseline anemia, and Medicare and Medicaid patients. CONCLUSIONS: These real-world data confirm low rates of early discontinuation in users of second-generation DAAs. Future research focusing on socioeconomic and sex/gender issues may help further optimize care for patients with HCV.

Original languageEnglish (US)
Pages (from-to)697-704
Number of pages8
JournalJournal of Managed Care and Specialty Pharmacy
Volume25
Issue number6
DOIs
StatePublished - Jan 1 2019

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Hepatitis C
Ritonavir
Antiviral Agents
Viruses
Hepacivirus
Therapeutics
Pharmaceutical Preparations
Fibrosis
Sofosbuvir
Interferons
Logistics
Medicaid
Virus Diseases
Interpersonal Relations
Medicare
ABT-267
ABT-333
ABT-450
Simeprevir
Comorbidity

ASJC Scopus subject areas

  • Pharmacy
  • Pharmaceutical Science
  • Health Policy

Cite this

De Ávila Machado, M. A., De Moura, C. S., Klein, M., Winthrop, K., Carleton, B., Abrahamowicz, M., ... Bernatsky, S. (2019). Direct-acting antivirals for hepatitis C: Predictors of early discontinuation in the real world. Journal of Managed Care and Specialty Pharmacy, 25(6), 697-704. https://doi.org/10.18553/jmcp.2019.25.6.697

Direct-acting antivirals for hepatitis C : Predictors of early discontinuation in the real world. / De Ávila Machado, Marina Amaral; De Moura, Cristiano Soares; Klein, Marina; Winthrop, Kevin; Carleton, Bruce; Abrahamowicz, Michal; Feld, Jordan; Curtis, Jeffrey R.; Beauchamp, Marie Eve; Bernatsky, Sasha.

In: Journal of Managed Care and Specialty Pharmacy, Vol. 25, No. 6, 01.01.2019, p. 697-704.

Research output: Contribution to journalArticle

De Ávila Machado, MA, De Moura, CS, Klein, M, Winthrop, K, Carleton, B, Abrahamowicz, M, Feld, J, Curtis, JR, Beauchamp, ME & Bernatsky, S 2019, 'Direct-acting antivirals for hepatitis C: Predictors of early discontinuation in the real world', Journal of Managed Care and Specialty Pharmacy, vol. 25, no. 6, pp. 697-704. https://doi.org/10.18553/jmcp.2019.25.6.697
De Ávila Machado, Marina Amaral ; De Moura, Cristiano Soares ; Klein, Marina ; Winthrop, Kevin ; Carleton, Bruce ; Abrahamowicz, Michal ; Feld, Jordan ; Curtis, Jeffrey R. ; Beauchamp, Marie Eve ; Bernatsky, Sasha. / Direct-acting antivirals for hepatitis C : Predictors of early discontinuation in the real world. In: Journal of Managed Care and Specialty Pharmacy. 2019 ; Vol. 25, No. 6. pp. 697-704.
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T1 - Direct-acting antivirals for hepatitis C

T2 - Predictors of early discontinuation in the real world

AU - De Ávila Machado, Marina Amaral

AU - De Moura, Cristiano Soares

AU - Klein, Marina

AU - Winthrop, Kevin

AU - Carleton, Bruce

AU - Abrahamowicz, Michal

AU - Feld, Jordan

AU - Curtis, Jeffrey R.

AU - Beauchamp, Marie Eve

AU - Bernatsky, Sasha

PY - 2019/1/1

Y1 - 2019/1/1

N2 - BACKGROUND: The treatment for hepatitis C virus (HCV) infection has evolved over time, and direct-acting antivirals (DAA) have revolutionized HCV therapy. OBJECTIVES: To (a) assess early treatment discontinuation and (b) identify predictors of early discontinuation in a cohort of patients receiving second-generation DAAs. METHODS: We identified HCV patients newly prescribed simeprevir/sofosbuvir (SIM/SOF), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ ritonavir+dasabuvir (OPrD), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/ grazoprevir (EBR/GZR), and glecaprevir/pibrentasvir (GLE/PIB) between 2014 and 2017. Early discontinuation was defined as duration of therapy less than 8 weeks. Multivariable logistic regression was performed to evaluate the association of drug regimens and potential predictive factors to early discontinuation. RESULTS: We identified 26,098 DAA-treated patients: 67.8% with LDV/SOF, 9.9% with OPrD, 8.5% with SIM/SOF, 7.8% with SOF/VEL, 5.2% with EBR/ GZR, and 0.8% with GLE/PIB. With approval of new therapies in 2016 and 2017, use of OPrD, LDV/SOF, and SIM/SOF declined substantially. At baseline, there was some heterogeneity of past HCV drug use and comorbidity across groups; patients on SIM/SOF had the highest frequency of previous interferon, cirrhosis, and decompensated cirrhosis. Most HCV patients received therapy for 8-12 weeks; fewer patients went through 16-week and 24-week therapy courses. Early discontinuation rates (95% CI) were 7.1% (6.0-8.2) for SIM/SOF, 3.2% (2.9-3.5) for LDV/SOF, 9.6% (8.5-10.7) for OPrD, 3.1% (2.3-3.8) for SOF/VEL, 4.2% (3.1-5.3) for EBR/GZR, and 2.5% (0.3-4.7) for GLE/PIB. In multivariable analyses, versus OPrD, patients starting other drug regimens were less likely to discontinue therapy early. Early discontinuation was more common in women, patients with baseline anemia, and Medicare and Medicaid patients. CONCLUSIONS: These real-world data confirm low rates of early discontinuation in users of second-generation DAAs. Future research focusing on socioeconomic and sex/gender issues may help further optimize care for patients with HCV.

AB - BACKGROUND: The treatment for hepatitis C virus (HCV) infection has evolved over time, and direct-acting antivirals (DAA) have revolutionized HCV therapy. OBJECTIVES: To (a) assess early treatment discontinuation and (b) identify predictors of early discontinuation in a cohort of patients receiving second-generation DAAs. METHODS: We identified HCV patients newly prescribed simeprevir/sofosbuvir (SIM/SOF), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ ritonavir+dasabuvir (OPrD), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/ grazoprevir (EBR/GZR), and glecaprevir/pibrentasvir (GLE/PIB) between 2014 and 2017. Early discontinuation was defined as duration of therapy less than 8 weeks. Multivariable logistic regression was performed to evaluate the association of drug regimens and potential predictive factors to early discontinuation. RESULTS: We identified 26,098 DAA-treated patients: 67.8% with LDV/SOF, 9.9% with OPrD, 8.5% with SIM/SOF, 7.8% with SOF/VEL, 5.2% with EBR/ GZR, and 0.8% with GLE/PIB. With approval of new therapies in 2016 and 2017, use of OPrD, LDV/SOF, and SIM/SOF declined substantially. At baseline, there was some heterogeneity of past HCV drug use and comorbidity across groups; patients on SIM/SOF had the highest frequency of previous interferon, cirrhosis, and decompensated cirrhosis. Most HCV patients received therapy for 8-12 weeks; fewer patients went through 16-week and 24-week therapy courses. Early discontinuation rates (95% CI) were 7.1% (6.0-8.2) for SIM/SOF, 3.2% (2.9-3.5) for LDV/SOF, 9.6% (8.5-10.7) for OPrD, 3.1% (2.3-3.8) for SOF/VEL, 4.2% (3.1-5.3) for EBR/GZR, and 2.5% (0.3-4.7) for GLE/PIB. In multivariable analyses, versus OPrD, patients starting other drug regimens were less likely to discontinue therapy early. Early discontinuation was more common in women, patients with baseline anemia, and Medicare and Medicaid patients. CONCLUSIONS: These real-world data confirm low rates of early discontinuation in users of second-generation DAAs. Future research focusing on socioeconomic and sex/gender issues may help further optimize care for patients with HCV.

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