Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir.

Abstract

OBJECTIVE:

As the treatment of hepatitis C virus (HCV) infection has evolved to directly acting antiviral agents, the impact of these directly acting antiviral-only regimens on improving adherence to HCV treatment in HIV/HCV coinfected populations has not been evaluated. The study compared adherence to ledipasvir/sofosbuvir (LDV/SOF) in HCV monoinfected and HIV/HCV coinfected individuals.

DESIGN:

Adherence was measured from participants in two phase 2 open-label studies (NCT01805882 and NCT01878799).

METHODS:

HCV treatment-naive, genotype 1 study individuals [HCV monoinfected participants (N = 20) and HIV/HCV coinfected participants, antiretroviral untreated (N = 13) or on combination antiretroviral therapy (N = 37)] were treated with LDV (90 mg) and SOF (400 mg) administered as one tablet once daily for 12 weeks. Adherence was measured using three tools: medication event monitoring system cap, pill count, and patient report.

RESULTS:

Participants were predominately African American (83%) and male (73%), with a median age of 59 years. Participants had prompt HCV viral load decline and high adherence rates (97 ± 0.5% by medication event monitoring system). Participant adherence decreased significantly from early (baseline week 4) as compared with late (weeks 8-12) in therapy in all three groups - HCV monoinfected (P = 0.01), HIV/HCV antiretroviral untreated (P = 0.02), and HIV/HCV antiretroviral treated participants (P = 0.01).

CONCLUSION:

Adherence to LDV/SOF in this urban population was high and comparable between HCV monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.

• Authors: Kerry Townsend, Tess Petersen, Lori A Gordon, Anita Kohli, Amy Nelson, Cassie Seamon, Chloe Gross, Lydia Tang, Anu Osinusi, Michael A Polis, Henry Masur, Shyam Kottilil
• Journal: AIDS (London, England) (AIDS) Vol. 30 Issue 2 Pg. 261-6 (Jan 2016) ISSN: 1473-5571 [Electronic] England
• PMID: 26691547 (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
• Benzimidazoles
• Fluorenes
• ledipasvir
• Sofosbuvir

Topics

• Antiviral Agents (administration & dosage)
• Benzimidazoles (administration & dosage)
• Coinfection (drug therapy)
• Female
• Fluorenes (administration & dosage)
• HIV Infections (complications)
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Male
• Medication Adherence
• Middle Aged
• Sofosbuvir (administration & dosage)
• Urban Population