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

Tess Petersen, Kerry Townsend, Lori A Gordon, Sreetha Sidharthan, Rachel Silk, Amy Nelson, Chloe Gross, Monica Calderón, Michael Proschan, Anu Osinusi, Michael A Polis, Henry Masur, Shyam Kottilil, Anita Kohli, Tess Petersen, Kerry Townsend, Lori A Gordon, Sreetha Sidharthan, Rachel Silk, Amy Nelson, Chloe Gross, Monica Calderón, Michael Proschan, Anu Osinusi, Michael A Polis, Henry Masur, Shyam Kottilil, Anita Kohli

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.

Figures

Fig. 1
Fig. 1
Study design and adherence visits
Fig. 2
Fig. 2
Adherence to DAA regimens measured by MEMS, pill count, and patient report. *p < 0.05 versus MEMS
Fig. 3
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
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

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