Clinical Trial

. 2016 Mar;10(2):310-9.

doi: 10.1007/s12072-015-9680-7. Epub 2015 Nov 26.

High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study

Tess Petersen¹, Kerry Townsend², Lori A Gordon^{3

4}, Sreetha Sidharthan¹, Rachel Silk^{1

5}, Amy Nelson⁵, Chloe Gross^{5

6}, Monica Calderón^{6

7}, Michael Proschan⁸, Anu Osinusi^{2

5

9}, Michael A Polis², Henry Masur¹, Shyam Kottilil^{10

11

12}, Anita Kohli^{1

6

13}

Affiliations

¹ Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
² Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
³ Clinical Center Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.
⁴ Xavier University of Louisiana, New Orleans, LA, USA.
⁵ Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
⁶ Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
⁷ Food and Drug Administration, Silver Spring, MD, USA.
⁸ Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.
⁹ Gilead Sciences Inc., Foster City, CA, USA.
¹⁰ Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. SKottilil@ihv.umaryland.edu.
¹¹ Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA. SKottilil@ihv.umaryland.edu.
¹² Division of Clinical Care and Research, Institute of Human Virology, N222, University of Maryland School of Medicine, 725 West Lombard St, Room S222, Baltimore, MD, 21201, USA. SKottilil@ihv.umaryland.edu.
¹³ Division of Hepatology, St. Josephs Hospital and Medical Center, Creighton University Medical School, Phoenix, AZ, USA.

PMID: 26612014
PMCID: PMC4778154
DOI: 10.1007/s12072-015-9680-7

Clinical Trial

High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study

Tess Petersen et al. Hepatol Int. 2016 Mar.

. 2016 Mar;10(2):310-9.

doi: 10.1007/s12072-015-9680-7. Epub 2015 Nov 26.

Authors

Affiliations

¹ Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
² Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
³ Clinical Center Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.
⁴ Xavier University of Louisiana, New Orleans, LA, USA.
⁵ Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
⁶ Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
⁷ Food and Drug Administration, Silver Spring, MD, USA.
⁸ Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.
⁹ Gilead Sciences Inc., Foster City, CA, USA.
¹⁰ Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. SKottilil@ihv.umaryland.edu.
¹¹ Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA. SKottilil@ihv.umaryland.edu.
¹² Division of Clinical Care and Research, Institute of Human Virology, N222, University of Maryland School of Medicine, 725 West Lombard St, Room S222, Baltimore, MD, 21201, USA. SKottilil@ihv.umaryland.edu.
¹³ Division of Hepatology, St. Josephs Hospital and Medical Center, Creighton University Medical School, Phoenix, AZ, USA.

PMID: 26612014
PMCID: PMC4778154
DOI: 10.1007/s12072-015-9680-7

Abstract

Background: As treatment for chronic hepatitis C (HCV) virus has evolved to all-oral, interferon-free directly acting antiviral (DAA) therapy, the impact of these improvements on patient adherence has not been described.

Methods: Medication adherence was measured in 60 HCV, genotype-1, treatment-naïve participants enrolled in a phase 2a clinical trial at the National Institutes of Health and community clinics. Participants received either ledipasvir/sofosbuvir (LDV/SOF) (90 mg/400 mg) (one pill) daily for 12 weeks, LDV/SOF + GS-9451 (80 mg/day) (two pills) daily for 6 weeks, or LDV/SOF + GS-9669 (500 mg twice daily; three pills, two in the morning, one in the evening) for 6 weeks. Adherence was measured using medication event monitoring system (MEMS) caps, pill counts and patient report.

Results: Overall adherence to DAAs was high. Adherence declined over the course of the 12-week treatment (p = 0.04). While controlled psychiatric disease or symptoms of depression did not influence adherence, recent drug use was a risk factor for non-adherence to 12-week (p = 0.01), but not 6-week regimens. Adherence as measured by MEMS was lower than by patient report.

Conclusions: Adherence to short courses of DAA therapy with 1-3 pills a day was excellent in an urban population with multiple risk factors for non-adherence.

Trial registration: ClinicalTrials.gov NCT01805882.

Keywords: Adherence; DAA; HCV; MEMS.

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Figures

**Fig. 1**
Study design and adherence visits

**Fig. 2**
Adherence to DAA regimens measured by MEMS, pill count, and patient report. *p < 0.05 versus MEMS

**Fig. 3**
Adherence to DAAs decreases with increasing pill burden. Adherence to DAA regimens declined with increasing pill burden (*first 6 weeks compared between arms)

**Fig. 4**
Adherence to DAAs declines over 12-week treatment course. Adherence between weeks 0–4, 98.1 ± 0.9 %, was significantly higher than adherence between weeks 8–12, 95.0 ± 1.2 %. for patients treated with 12 weeks of LDV/SOF

See this image and copyright information in PMC

References

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High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study

Affiliations

High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Research Materials

Miscellaneous