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.

Impact of a Nurse Care Coordinator Supporting a Clinical Pharmacist Practitioner in Further Managing HCV-Infected Patients.

Patients undergoing chronic hepatitis C treatment require monitoring to ensure that treatment is both safe and effective. However, many of these patients are lost to follow-up. The aim of this study was to investigate the impact of implementing a Nurse Care Coordinator's role in a pharmacy-based collaborative team to enhance the care of hepatitis C-infected patients. This was a 6-month retrospective chart review from July 2018 to January 2019, where 116 patients receiving hepatitis C treatment were referred to the Nurse Care Coordinator for further management. The Nurse Care Coordinator provided more than a 5-fold increase in contact method by telephone call. Of the 116 referred hepatitis C-infected patients, 44.8% (n = 52) of patients were referred due to a missed post-treatment Week 12 follow-up appointment to assess for cure. The Nurse Care Coordinator successfully rescheduled 96.2% (50/52) of follow-up appointments to assess for cure; 90% (45/50) of those patients adhered to scheduled appointment; and 97.8% (44/45) of patients had undetectable hepatitis C virus RNA, indicating cure. The primary success rate of the intended Nurse Care Coordinator arrangement was 97.4% (n = 113), where 89.4% (101/113) of patients successfully adhered to the intervention. This study demonstrates the positive impact the Nurse Care Coordinator had in successfully re-engaging previously lost to follow-up patients back into clinic.

Outcomes of the use of infliximab biosimilars in rheumatology and gastroenterology clinics.

The originator infliximab product, Remicade, was approved by the US Food and Drug Administration in August 1998 for the management of Chron's disease. Since this time, several infliximab biosimilar agents have entered the market to introduce competition and lower costs for patients as well as health care systems. Clinical trials comparing infliximab biosimilars with the originator product have consistently demonstrated noninferiority, along with similar adverse effect profiles, leading to the approval of 3 additional biosimilars: Renflexis (infliximab-abda), Avsola (infliximab-axxq), and Inflectra (infliximab-dyyb). In 2021, the University of North Carolina rheumatology and gastroenterology outpatient clinics began an initiative to convert patients from the originator infliximab product to biosimilar agents Renflexis or Avsola based on market costs. Subsequently, a retrospective evaluation was conducted to analyze the clinical outcomes of patients that were switched to a biosimilar agent compared with those that were only ever using either the originator or biosimilar agent. A total of 180 patients were analyzed, of which half were prescribed a biosimilar as a result of the conversion initiative. Of these 90 patients, 79 (87.8%) were maintained on a single biosimilar agent without requiring a switch to an alternative infliximab product. We conclude that the effort to convert clinically stable patients to a biosimilar product resulted in a significant increase in biosimilar use within the health system. This is thought to have resulted in significant financial advantages both to our institution as well as patients, without sacrificing overall clinical control.