Clinical pharmacy programmatic perspectives on use of direct-acting antivirals for acquired hepatitis C infection in solid organ transplant recipients

Abstract

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Purpose</jats:title> <jats:p>An institutional workflow developed by clinical pharmacists for initiation of directing-acting antiviral (DAA) therapy for patients who receive solid organ transplants from hepatitis C (HCV)–positive donors is described; programmatic challenges in providing pharmaceutical care to these patients are reviewed.</jats:p> </jats:sec> <jats:sec> <jats:title>Summary</jats:title> <jats:p>In recent years the introduction of new oral DAAs, coupled with faster screening of donor organs for HCV infection through use of a nucleic acid test (NAT), has facilitated transplants of organs from HCV-seropositive donors to HCV-seronegative recipients. The solid organ transplant program of a North Carolina health system began performing such transplants in December 2017. In the pharmacist-developed workflow, patients are initiated on DAA therapy in the outpatient clinic setting, and clinic pharmacists are consulted regarding drug selection. Prescriptions for DAA therapy are sent to an on-site specialty pharmacy, where pharmacists and pharmacy technicians work to obtain prior authorization and, if necessary, payment assistance through manufacturer-sponsored programs. The medical team is notified at the time of patient approval to begin treatment. Pharmacists provide counseling at the time of DAA therapy initiation and follow up with patients every 2 weeks to confirm adherence. As of June 2019, about 100 transplants of HCV NAT–positive organs had been performed (approximately 50% were kidney transplants; 15%, lung transplants; 20%, heart transplants; and 15%, liver transplants). Many challenges are encountered in the process of providing pharmaceutical care to this patient population, including challenges in patient selection and counseling, overcoming financial barriers and insurance restrictions, and coordinating with an internal specialty pharmacy to ensure timely delivery of medication to patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Within a solid organ transplantation program, clinical pharmacists and other pharmacy personnel can play vital roles in ensuring safe and effective DAA therapy for recipients of transplanted HCV NAT–positive organs.</jats:p> </jats:sec>

The Impact of Treatment Delay on Hepatitis C Liver Transplant Outcomes

“…There was no difference in median time to the first rejection episode between groups (24 days and 14.5 [10.3-18.5] days, respectively; P = .20). The severity of the first occurrence of BPAR, defined by median Banff grading, was statistically higher in the HCV-seronegative group compared to the HCV NATpositive group (6 [4.3-6] and 5 [4][5]), respectively; P = .04).…”

“…In addition, as many of the DAAs were not FDA approved for treatment post-transplant during the period of this study, insurance approval was a component that contributed to delays in initiation of treatment as noted in the electronic medical record. 5 Uniquely, there are major challenges with the Maryland All-Payer System model, through which Medicaid and many Medicare programs required Metavir fibrosis scores of F2 or higher until 2018, which greatly slowed the prior authorization process. 18 Altogether, these process implementations and pharmacy-driven protocols may lead to decreased time to HCV treatment initiation and better patient outcomes.…”

“…Pharmacists can play a vital role in assessing the appropriateness of therapy, navigating the often complex insurance authorization process and providing medication education and adherence assessments. 5 Additionally, there is limited guidance for clinical practice when patients experience a rejection episode prior to initiation of their HCV treatment. [6][7][8][9] Our study sought to compare 1-year graft and patient outcomes between HCV Nucleic Acid Amplification Test (NAT)-positive and HCVseronegative liver transplant recipients at a transplant center where pharmacists play a comprehensive role in medication therapy management.…”

A systematic review of direct acting antiviral therapies in hepatitis C virus‐negative liver transplant recipients of hepatitis C‐viremic donors

“…Despite favorable short-term outcomes, barriers to acceptance of HCV-viremic allografts have been reported, including a lack of understanding about HCV disease, the potential for disease transmission, access to DAA treatment, and management while on antiviral therapy (Table 4). [46][47][48] A literature review was conducted assessing the impact of clinician and patient attitudes on acceptance of HCV-viremic donors. 49 Common concerns identified included DAA treatment cost and efficacy, organ quality, risk of HCV transmission, and the stigma associated with HCV infection.…”

“…Transplant pharmacists play a key role in the successful utilization of DAA therapies in liver transplant recipients including determining patient readiness to initiate therapy, DAA selection, screening for drug–drug interactions, making recommendations regarding concomitant medications, providing patient education, and assisting/facilitating medication procurement 46,48,50,51 . Efforts to overcome challenges to timely DAA initiation require effective processes to navigate the complex DAA authorization process.…”