Access to hepatitis C direct-acting antiviral therapy in hepatitis C-positive donor to hepatitis C-negative recipient solid-organ transplantation in a real-world setting.

BACKGROUND: Emerging data supports expanding the solid organ donor pool with transplantation from hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant in a real-world setting. METHODS: This single-center, retrospective study evaluated DAA access rates, time to first dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing an integrated specialty pharmacy process. RESULTS: Among 91 patients, all accessed DAAs through prescription insurance (97%) or patient assistance programs (3%). Of those who received DAAs through insurance, only 65% received approval on initial insurance submission. Median time from transplant to first dose was 45d [IQR 34-66]. The on-site specialty pharmacy was used by 69% of patients. Copay assistance programs reduced the median monthly patient cost from $1914 [range $7-7536] to $0 [range $0-5]. CONCLUSION: Our findings indicate that access to DAAs in donor-derived HCV post-transplant is achievable and affordable; however, significant added administrative efforts may be required for insurance approval as well as obtaining copay assistance, which is a limited resource.

Incidence and Impact of Persistent Viremia on SVR Rates in Patients Receiving Direct-Acting Antiviral Therapy.

Rates of persistent viremia (PV) while on direct-acting antiviral therapy were low (5.7%) in a real-world cohort of 983 patients. High sustained virologic response rates were achieved both in patients with PV (92.9%) and those with rapid virologic response (96.5%), without significant differences.

Expanding Heart Transplant in the Era of Direct-Acting Antiviral Therapy for Hepatitis C.

Importance: For patients awaiting heart transplant, hepatitis C-positive donors offer an opportunity to expand the donor pool, shorten wait times, and decrease wait-list mortality. While early reported outcomes among few heart transplant recipients have been promising, knowledge of 1-year outcomes in larger cohorts of patients is critical to shared decision-making with patients about this option. Objective: To better define the association of hepatitis C-positive donors with heart transplant volumes, wait-list duration, the transmission and cure of donor-derived hepatitis C, and morbidity and mortality at 1 year. Design, Setting, and Participants: This was a prospective, single-center observational study of 80 adult (age 18 years or older) patients who underwent heart transplant using hearts from hepatitis C-positive donors between September 2016 and April 2019 at a large academic medical center. Among donors, who were considered hepatitis C-positive if results from hepatitis C antibody and/or nucleic acid testing were positive, 70 had viremia and 10 were seropositive but did not have viremia. Follow-up was available through May 15, 2019. Comparisons were drawn with patients who underwent transplant with hearts from hepatitis C-negative donors during the same period. Exposures: In addition to standard posttransplant management, transplant recipients who developed donor-derived hepatitis C infection were treated with direct-acting antivirals. Main Outcomes and Measures: The main outcomes included wait-list duration and 1-year survival in all patients, and for those who developed donor-derived hepatitis C, the response to direct-acting antiviral treatment. Results: Of 80 patients, 57 (71.3%) were men, 55 (68.7%) were white, and 17 (26.3%) were black; the median age at transplant was 54.5 years (interquartile range, 46-62 years). Following consent to accept hearts from hepatitis C-exposed donors, the median days to heart transplant was 4 (interquartile range, 1-18). No recipients of donors with negative nucleic acid testing results (10 [12.5%]) developed donor-derived hepatitis C. Of 70 patients who were recipients of donors with positive nucleic acid testing results, 67 (95.7%) developed donor-derived hepatitis C over a median follow-up of 301 days (interquartile range, 142-617). Treatment with direct-acting antivirals was well tolerated and yielded sustained virologic responses in all treated patients. Within the cohort with infection, 1-year patient survival was 90.4%, which was not significantly different compared with the cohort without infection or with patients who received transplants from hepatitis C-negative donors during the same period. Conclusions and Relevance: In the era of direct-acting antivirals, hepatitis C-positive donors are a viable option to expand the donor pool, potentially reducing wait-list duration and mortality. In heart transplant recipients with donor-derived hepatitis C, infection is well-tolerated and curable, and 1-year survival is equivalent to that in recipients of hepatitis C-negative donors.

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities.

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments' continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients, and shed light on pharmacists' vital role in patient care. This insightful and real-world experience is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies.

Building a Hepatitis C Clinical Program: Strategies to Optimize Outcomes.

PURPOSE OF REVIEW: An increasing number of specialists and non-specialists are developing clinical programs to treat and cure hepatitis C virus (HCV). The goal of this paper is to evaluate and describe optimal strategies to improve outcomes related to HCV care delivery. RECENT FINDINGS: Screening and diagnosis of HCV should be guided by established recommendations. Given the recognized disparity in HCV diagnosis and linkage to care, a multi-modal approach involving care coordination and technology resources should be used to improve patient engagement. Access to HCV treatment may be optimized through systematic documentation, prior authorization, and appeal processes. Treatment monitoring should emphasize medication adherence, side effect and drug interaction management, as well as elimination of practical barriers. Finally, post-treatment engagement to promote liver health and reduce the risk of complications or reinfection maximizes the benefit of HCV treatment. SUMMARY: The landscape of HCV treatment has evolved from a specialist-driven model with few patients qualifying for treatment to an opportunity for non-specialists and other providers to provide curative therapies in most patients. Innovative practice models that employ a multidisciplinary approach will likely improve screening, diagnosis, engagement, and treatment outcomes.

Early outcomes using hepatitis C-positive donors for cardiac transplantation in the era of effective direct-acting anti-viral therapies.

BACKGROUND: Given the shortage of suitable donor hearts for cardiac transplantation, and the favorable safety and efficacy of current agents used to treat hepatitis C virus (HCV), our institution recently piloted transplantation of select patients using HCV-positive donors. METHODS: Between September 2016 and March 2017, 12 HCV-naive patients and 1 patient with a history of treated HCV underwent heart transplantation (HT) using hearts from HCV-positive donors after informed consent. Patients who acquired HCV were referred to hepatology and treated with direct-acting anti-viral therapies (DAAs). Data collection and analysis were performed with institutional review board approval. RESULTS: At the time of HT, mean age of recipients was 53 ± 10 years, and 8 patients (61.5%) were on left ventricular assist device support. After consent to consider an HCV-positive heart, mean time to HT was 11 ± 12 days. Nine of 13 patients (69%) developed HCV viremia after transplant, including 8 who completed DAA treatment and demonstrated cure, as defined by a sustained virologic response 12 weeks after treatment. One patient died during Week 7 of his treatment due to pulmonary embolism. DAAs were well tolerated in all treated patients. CONCLUSIONS: In the era of highly effective DAAs, the use of HCV-positive donors represents a potential approach to safely expand the donor pool. Additional follow-up is needed to elucidate long-term outcomes.

Advancing Patient Care Through Specialty Pharmacy Services in an Academic Health System.

BACKGROUND: With the rapid growth of specialty pharmacies, including those within academic health systems, pharmacists have the opportunity to improve patient care through the management of specialty medications. Specialty pharmacists within academic health systems are uniquely positioned to overcome restrictions to medication access, financial constraints, and provider burdens that often lead to obstacles for patients to start and maintain necessary treatments. The Vanderbilt Specialty Pharmacy (VSP) model at Vanderbilt University Medical Center (VUMC) provides an example of a patient-centered, collaborative care prototype that places pharmacists directly into specialty clinics to assist with comprehensive management of patients on specialty medications. PROGRAM DESCRIPTION: VSP integrates specialty pharmacy services within existing specialty clinics based on the needs of each individual clinic. Each clinic is staffed with at least 1 clinical pharmacist and 1 pharmacy technician. The pharmacist is integrally involved in medication selection, initiation, and monitoring. The specialty pharmacy team ensures appropriate medication access and cost, provides extensive medication education, ensures patients are adherent to treatment, and coordinates care between patients and providers using the electronic medical record. OBSERVATIONS: Integration of pharmacists within specialty clinics at VUMC benefits providers, the health system, and patient care. This model has demonstrated decreased provider and clinic burden, decreased time to medication approval and initiation, excellent patient and provider satisfaction, substantial patient cost savings, optimal medication adherence, and overall improved continuity of care for patients on specialty medications. Since its inception in 2011, VSP has integrated 24 clinical pharmacists and 17 pharmacy technicians into 20 specialty clinics, with continued quarterly growth. IMPLICATIONS: The VSP model advances the role of pharmacists in managing patients on specialty medications in collaboration with providers. The integrated collaborative approach as presented by VSP represents a best practices model for those establishing and advancing specialty pharmacy services within academic health systems. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Study concept and design were principally contributed by Bagwell and Newman, along with the other authors. Lee took the lead in data collection, along with Carver, Bagwell, Kelley, and Newman. Data interpretation was performed by Carver, Kelley, Lee, and Bagwell, with assistance from Newman. The manuscript was written by Bagwell, Carver, Kelley, and Lee and revised primarily by Bagwell, along with the other authors.