Telemedicine HCV Treatment in Department of Corrections Results in High SVR in Era of Direct-acting Antivirals

Taseen A. Syed; Reena Cherian; Shawn Lewis; Richard K. Sterling

Disclosures

J Viral Hepat. 2020;28(1):209-212. 

In This Article

Materials and Methods

Patient Selection and Study Design

In the early 2015, the Virginia DOC, in conjunction with Virginia Commonwealth University (VCU), developed a telemedicine HCV referral and treatment protocol following AASLD-IDSA's guidelines. The initiation for referral for HCV treatment was made by the Virginia DOC. Patients were preselected by DOC and then referred to the telemedicine clinic to determine appropriateness for therapy. All treated patients were HCV ribonucleic acid (RNA) positive with compensated liver disease. Liver disease severity was assessed by FIB-4 and/or vibration-controlled transient elastography (VCTE) using published cut-offs.[6,7] Those with advanced fibrosis, stages 3–4 defined by FIB-4 ≥ 3.25 and/or VCTE ≥ 9.5 kPa underwent ultrasound to exclude hepatocellular carcinoma (HCC) prior to starting DAA. Demographic, clinical, and laboratory data and prior treatment status (naive or experienced) were collected at time of the initial visit. We excluded those with end-stage liver disease (MELD > 12), HCC, significant comorbidities, <9 months remaining on their sentence to ensure completion of therapy or had recent alcohol or drug use or tattoos (risk of reinfection). HIV coinfection was included as long as the CD4 count was > 100 cells/mm3 and HIV RNA undetectable. HBV-coinfected individuals were also treated as long as the HBV DNA was suppressed.

Treatment Protocol

Treatment followed the updated AASLD-IDSA's guidelines. Patients were evaluated via telemedicine prior to starting treatment. After determining appropriateness and duration for HCV treatment, a prescription was filled by VCU Pharmacy Services mailed to the patient's facility. Laboratory tests (hepatic panel, complete blood count, basic metabolic panel and HCV RNA) were obtained at weeks 4, 8 and 12, and patients were then seen at weeks 5, 9 and 13 to discuss results, and at 12 weeks after completion of therapy for SVR. A variety of DAAs were used for HCV treatment as indicated following the AASLD-IDSA guidelines for each GT at the time treatment was initiated. Ribavirin was used early on in our treatment in conjunction with DAAs to help reduce relapse in all those with cirrhosis. All treatment facilities had 24-hour nursing, and thus, treatment was under direct supervision by DOC healthcare staff. The purpose of telemedicine visits was to document compliance, tolerance, side effects, duration and response of treatment. Adherence and compliance were documented at each visit from both DOC facility staff and patient.

Statistical Analysis

This was a retrospective analysis of our HCV treatment database of patients treated with DAAs June 2015 through December 2019. We excluded those in our early experience treated with sofosbuvir/declatasvir (n = 8) or sofosbuvir/ribavirin (n = 11), and those re-treated with sofosbuvir/velpatasvir/voxilaprevir (n = 7) after they failed an initial DAA regimen. The primary outcome was SVR-12 (undetectable HCV RNA 12 weeks after completing therapy). Continuous variables were expressed as mean (±SD) or median (interquartile range) and nominal variables as percentage. Differences among the treatment regimens and durations were compared across demographic and clinical (gender, race, fibrosis level, GT, duration, ribavirin use and HIV coinfection) variables by univariate analysis. A P-value of <.05 was considered statistically significant. Any factors identified with P < .02 on univariate analysis were included in a multivariate model to identify any independent factors associated with SVR-12. This analysis was approved by the VCU institutional review board for the study of human subjects. All analyses were performed using JMP 15 (Cary, NC).

processing....