Access to direct-acting antivirals for hepatitis C-negative transplant recipients receiving organs from hepatitis C-viremic donors.

PURPOSE: A barrier to using organs from hepatitis C virus (HCV)-viremic donors is the high cost of direct-acting antivirals (DAAs) and concerns about access for recipients after transplantation. The purpose of this study was to evaluate access, cost, and timing for HCV DAAs following transplantation. METHODS: This was a single-center, retrospective study of HCV-negative adult transplant recipients from June 2017 to December 2019 who received grafts from HCV-viremic and/or HCV-seropositive individuals and became HCV viremic after transplantation. RESULTS: Between June 2017 and December 2019, there were 60 HCV-negative transplant recipients who became viremic after receiving grafts from HCV-viremic or HCV-seropositive donors. Thirty-eight patients met the inclusion criteria (n = 25 with liver transplants, n = 6 with lung transplants, n = 4 with simultaneous liver and kidney transplants, and n = 3 with kidney transplants). Of these patients, 23 had commercial insurance, 13 had Medicare, and 2 had Medicaid. All patients ultimately received insurance coverage for treatment; however, 36 (95%) required prior authorization and 9 (24%) required appeals to obtain insurance coverage. The median time from DAA prescription to insurance approval was 6 days. The median time from transplantation to start of treatment was 29 days (range, 0-84 days). Patients with Medicaid insurance had a significantly longer time to insurance approval (31.5 vs 6 days, P = 0.007). The average out-of-pocket cost to patients was less than $10 a month after patient assistance. All patients who completed treatment and 12-week follow-up after treatment achieved a sustained virologic response (n = 36). CONCLUSION: In this study, all HCV-negative recipients who developed HCV following transplantation had access to DAA therapy, with the majority starting treatment in the first month after transplantation.

Hepatitis C Elimination in People With HIV Is Contingent on Closing Gaps in the HIV Continuum.

BACKGROUND: Bolstered by the high efficacy of hepatitis C virus (HCV) treatment, the World Health Organization has called for HCV elimination by 2030. People with HIV (PWH) have been identified as a population in which elimination should be prioritized. METHODS: We examined progress in HCV elimination through the HCV care continuum among patients infected with HIV/HCV receiving HIV care at Johns Hopkins Hospital in Baltimore, Maryland, United States. Patients with HIV care visits in at least 2 consecutive years were followed through December 15, 2018, for referral to HCV care, treatment initiation, and cure. RESULTS: Among 593 HIV/HCV-coinfected individuals, 547 (92%) were referred for HCV care, 517 (87%) were evaluated for HCV treatment, 457 (77%) were prescribed HCV treatment, 426 (72%) initiated treatment, and 370 (62%) achieved HCV cure. In multivariable analysis, advanced liver disease (hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.17-1.88) remained significantly positively associated with HCV treatment initiation. Conversely, being insured by state Medicaid (HR, 0.75; 95% CI, 0.61-0.92), having an HIV RNA >400 copies/mL (HR, 0.29; 95% CI, 0.18-0.49), and having missed 1%-24% (HR, 0.72; 95% CI, 0.54-0.97), 25%-49% (HR, 0.66; 95% CI, 0.49-0.89), and ≥50% of HIV care visits (HR, 0.39; 95% CI, 0.25-0.60) were significantly negatively associated with HCV treatment initiation. CONCLUSIONS: HCV infection can be eliminated in PWH. However, HCV elimination requires unrestricted access to HCV treatment and improved methods of retaining people in medical care.

High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center.

Hepatitis C virus (HCV) cure rates have been similar in patients with and without human immunodeficiency virus (HIV) coinfection; however, in the ION-4 study, black patients treated with ledipasvir/sofosbuvir (LDV/SOF) were significantly less likely to achieve cure (90%) compared to nonblack patients (99%). There are limited real-world data on the effectiveness of oral direct-acting antivirals (DAAs) in predominantly minority HIV/HCV coinfected populations. We analyzed HCV treatment outcomes among 255 HCV coinfected patients initiating DAAs between February 2014 and March 2016 in an urban clinic in Baltimore, Maryland. To facilitate adherence, patients received standardized HIV nurse/pharmacist support, which included nurse visits and telephone calls. Median age was 43 years, 88% were black, 73% male, 69% had a history of injection drug use, 45% a history of hazardous alcohol use, and 57% a comorbid psychiatric diagnosis. Median CD4 count was 577 (interquartile range, 397-820) cells/mm3 ; most (97%) were on antiretroviral therapy, had HIV RNA <20 copies/mL (87%), and were infected with HCV genotype 1 (98%). Over 60% had significant fibrosis (Fibrosis-4 Index score 1.45-3.25 [44%] and >3.25 [17%, cirrhosis]) and 30% were HCV treatment experienced. The majority of patients received LDV/SOF with or without ribavirin (91%) and were treated for 12 weeks. Overall, the sustained virological response rate was 97% (95% confidence interval [CI], 93-98) and did not vary by race (black, 96% [95% CI, 93-98]; nonblack, 97%, [95% CI, 83-99]), history of injection drug use, alcohol use, or psychiatric diagnosis. CONCLUSION: HCV treatment was highly effective among HIV-infected patients who received care within an integrated nurse/pharmacist adherence support program. These results suggest that race and psychosocial comorbidity may not be barriers to HCV elimination. (Hepatology 2017;66:1402-1412).

Improvement of guideline ß-blocker prescribing in heart failure: a cluster-randomized pragmatic trial of a pharmacy intervention.

BACKGROUND: Treatment with specific beta-blockers and doses recommended by guidelines is often not achieved in practice. We evaluated an intervention directed to the pharmacy to improve prescribing. METHODS AND RESULTS: We conducted a pragmatic cluster-randomized trial, where facilities (n = 12) with patients (n = 220) were the clusters. Eligible patients had a beta-blocker prescription that was not guideline concordant. Level 1 intervention included information to a pharmacist on facility guideline concordance. Level 2 also provided a list of patients not meeting guideline goals. Intervention and follow-up periods were each 6 months. Achievement of full concordance with recommendations was low (4%-5%) in both groups, primarily due to lack of tolerability. However, compared with level 1, the level 2 intervention was associated with 1.9-fold greater odds of improvement in prescribing (95% confidence interval [CI] 1.1-3.2). Level 2 patients also had greater odds of a higher dose (1.9, 95% CI 1.1-3.3). The intervention was aided by the patient lists provided, the electronic medical record system, and staff support. CONCLUSIONS: In actual practice, full achievement of guideline goals was low. However, a simple intervention targeting pharmacy moved patients toward guideline goals. As health care systems incorporate electronic medical records, this intervention should have broader feasibility.