Pediatric and Adolescent Hepatitis C Care Cascade and Real-World Treatment Outcomes Utilizing an Integrated Health System Specialty Pharmacy Model.

Objectives: This study evaluated the cascade of care (CoC) and real-world efficacy of direct-acting antivirals (DAAs) for hepatitis C treatment in pediatric and adolescent patients utilizing an integrated health system specialty pharmacy (HSSP) to assist with medication selection, insurance approval, swallowing practice, initiation, and monitoring.

Methods: This single-center, retrospective, observational cohort study included chronic hepatitis C patients <18 years old evaluated by pediatric hepatologists at an academic health system between 1/1/2017 and 9/30/2022. The primary endpoint was sustained virologic response (SVR) ≥12 weeks following treatment completion in patients initiating DAAs. Secondary endpoints were CoC advancement, variables impacting DAA initiation, patient-reported side effects, and adherence. An ordinal logistic regression model assessed whether initiation time was associated with a patient's ability to swallow, prior authorization outcome, and medication availability to HSSP at referral. The odds ratio reflects the likelihood of a shift in time to initiation for a given group relative to its respective reference group.

Results: Of 98 patients evaluated by a hepatologist, 73 (75%) were referred to the HSSP. Loss to follow-up was the primary reason (88%; 22/25) for non-referral, most commonly (73%; 16/22) in those aged ≤5 years. Following HSSP referral, 88% (64/73) initiated DAA and 92% (59/64) of those achieved SVR. Time from HSSP referral to medication initiation was impacted by DAA availability [OR=41.47; 95% CI: 9.51, 180.87; p<0.001] and inability to swallow the dosage form at evaluation [OR=3.94; 95% CI: 1.56, 9.98; p=0.004]. Over half (53%; 34/64) of patients initiating DAA reported ≥1 adverse event; none discontinued treatment. Most (69%; 44/64) reported no missed doses.

Conclusion: The largest CoC drop-off occurred following initial clinic evaluation, primarily in children ≤5 years. Enhanced linkage to care efforts are needed in these patients. Conversely, nearly all patients referred to the HSSP were initiated on DAA, completed therapy, and achieved SVR.