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

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.

• Authors: 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
• Journal: Hepatology international (Hepatol Int) Vol. 10 Issue 2 Pg. 310-9 (Mar 2016) ISSN: 1936-0541 [Electronic] United States
• PMID: 26612014 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents

Topics

• Administration, Oral
• Antiviral Agents (administration & dosage)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Hepatitis C, Chronic (drug therapy)
• Humans
• Male
• Medication Adherence
• Middle Aged
• Treatment Outcome
• Urban Population