Single-Center Retrospective Review of Standard Versus Minimal Monitoring for Hepatitis C Direct Acting Antiviral Therapy.

Background: Highly effective direct acting antiviral (DAA) therapies have transformed the landscape of Hepatitis C Virus (HCV) treatment. However, there continues to be limited data regarding the efficacy and safety of required in-person clinic visits (standard monitoring) versus completely telehealth clinic visits (minimal monitoring) during HCV therapy, which could delay practice adoption.

Objectives: This study aimed to assess the rates of undetectable HCV RNA in sustained viral load 12 weeks after therapy (SVR12) in standard versus minimal monitoring approaches during DAA.

Methods: A 12-month, single-center retrospective cohort study was conducted in treatment-naïve HCV-infected adults who received DAA therapy between 5/1/2020-4/30/2021. The standard monitoring group had > 1 in-person clinic visit with HCV RNA lab monitoring during DAA treatment. The minimal monitoring group had entirely telehealth visits without HCV RNA lab monitoring during treatment. Both groups received telephonic touchpoints throughout DAA treatment from a Clinical Pharmacist Practitioner and Nurse Care Coordinator. The primary outcome was SVR12.

Results: From May 2020 to April 2021, 133 HCV patients met inclusion criteria and were treated with DAA (Standard n=56; Minimal: n=77), with no differences in baseline demographics. Overall, total encounters during DAA treatment remained significantly higher in the standard versus minimal monitoring group (Standard: 2.1 ± 0.8, vs MInimal: 1.7 ± 0.9; p <0.01). Although minimal monitoring had higher loss to follow-up rates (Standard: 7.1% vs Minimal: 18.2%; p=0.06), the modified intention-to-treat analysis showed no differences in SVR between standard versus minimal monitoring approaches (Standard: 98.1%, n=51 vs Minimal: 95.3%, n=60; p=0.41).

Conclusions: This single-center retrospective cohort study demonstrated that minimal monitoring during HCV treatment was as effective in achieving SVR cure rates as standard monitoring. Eliminating required in-person clinic visits during DAA therapy alongside a collaborative approach may play a major role in overcoming barriers to HCV care in select patients.