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Digestive Diseases and Sciences

, Volume 63, Issue 12, pp 3228–3232 | Cite as

Lack of Patient Compliance in Real-World Practice Negatively Affects Sustained Viral Response Rates to Direct Acting Agent Therapy for Hepatitis C

  • Mary Caitlin MarshallEmail author
  • Jorge L. Herrera
Original Article

Abstract

Objective

To assess the true efficacy of direct acting antiviral (DAA) therapy in real-world clinical practice, taking into account those patients that do not complete therapy or the necessary follow-up to establish sustained viral response (SVR).

Methods

Retrospective data collection of 261 genotype 1 HCV-infected patients, treatment naïve or treatment experienced, treated with ledipasvir/sofosbuvir combination therapy at an academic medical center. All patients received individualized teaching and counseling prior to starting therapy stressing importance of compliance with laboratory monitoring and treatment completion. Intention to treat SVR rates (ITT-SVR) and per-protocol SVR rates (PP-SVR) were calculated. Chi-squared test was used to compare the number of subjects lost to follow-up in the treatment-naïve vs. treatment-experienced groups. Characteristics of noncompliant patients were compared to compliant patients.

Results

ITT-SVR rates for the entire cohort were 74%, significantly lower than the 95% PP-SVR rate for the compliant patients (p < 0.001). ITT-SVR was lower in treatment-naïve patients compared to treatment-experienced patients (68% vs. 86%). Among the entire cohort, 22% of patients either discontinued therapy prematurely (7%) or did not return for SVR assessment (15%). Failure to complete therapy or return for SVR assessment was statistically more common among treatment-naïve patients compared to treatment-experienced patients (28% vs. 11%, p = 0.0016).

Conclusions

There is a significant rate of noncompliance among patients treated with DAA in real-world clinical practice despite pre-treatment education efforts. The ITT-SVR rates observed in clinical practice were significantly lower than those reported by clinical trials, and this difference was most pronounced among treatment-naïve patients.

Keywords

HCV genotype 1 Real world Ledipasvir/sofosbuvir Noncompliance 

Notes

Author’s contribution

Both authors contributed to the planning and conduct of the study, the collection and interpretation of the data, the drafting of the manuscript, and the review of the final manuscript. Both authors have reviewed and approved this final manuscript submitted for publication.

Compliance with ethical standards

Conflict of interest

Dr. Jorge L. Herrera is a member of the speaker’s bureau of Gilead Sciences Inc., and Abbvie Inc. Dr. Mary Caitlin Marshall has no competing interests.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of MedicineUniversity of South Alabama College of MedicineMobileUSA
  2. 2.Division of GastroenterologyUniversity of South Alabama College of MedicineMobileUSA
  3. 3.Internal Medicine DepartmentUSA Medical CenterMobileUSA

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