Evaluation of and implications for a novel hepatitis C e-consult direct-to-treatment pilot program

A Hepatitis C (HCV) e-Consult Direct-To-Treatment (DTT) program managed by midlevel providers was developed at the Veteran Affairs Greater Los Angeles Healthcare System (VAGLAHS) which provided remote referral and, in some, remote management of HCV. DTT patients were more likely to be initiated on HCV treatment compared to standard of care (SOC), lending support for similar programs of remote engagement in HCV care.

patients without clinical cirrhosis, fibrosis, substance abuse disorder, alcohol use disorder, malignancy, mental health disorders, chronic obstructive pulmonary disease, or heart disease were eligible for inclusion.Endpoints included HCV treatment initiation (yes/no), HCV treatment completion (yes/no), SVR12 (defined by ≥ 10 weeks post-treatment), and the number of HCV treatment-related clinic visits.Outcomes were compared between Veterans who initiated treatment via DTT and patients who were ineligible for DTT and referred to standard of care.Descriptive statistics, t-tests, and chi-squared tests were used.
Achievement of SVR12 was based upon patients who completed SVR12 labs.Of those who completed treatment but did not reach SVR12, one patient had virologic failure, while 24 missed their lab collection.Adverse events were reported common events, evaluated based on the patients' HCV clinical treatment notes.These included headache, nausea, fatigue, diarrhea, weight loss, insomnia, suppressed appetite, and itchy redness and burning on lower extremities.Only one person discontinued HCV treatment due to adverse events.

Ethics approval and consent to participate
The study was approved by the local institutional review board (IRB) at VAGLAHS, and all study activities were carried out in accordance with the relevant guidelines.Informed consent was waived by the VAGLAHS IRB due to the retrospective nature of this investigation.

Discussion
This retrospective chart review evaluated a historical HCV e-consult DTT program with the aim of comparing clinical outcomes of patients who initiated HCV treatment via DTT versus SOC practices.Veterans eligible for DTT were more likely to initiate DAA therapy than those who were not.There was also a trend towards shorter time to HCV treatment initiation in patients who initiated via DTT as compared to ineligible patients who were referred to specialists.HCV treatment completion and SVR12 rates were similar for both groups, but the DTT group had fewer face-to-face clinic visits during HCV treatment.
To our knowledge, this is the first evaluation of a program which referred patients directly to a remote online evaluation system (HCV e-consult DTT program) with subsequent successful HCV treatment initiation and completion by midlevel providers, highlighting a potential model for other integrated healthcare systems.There exist other telehealth programs that have been demonstrated to be effective for HCV treatment [12][13][14][15] .Of particular note, at the VA, one study found that sites that offered video conferencing between primary care providers and people living with HCV as part of the HCV VA-ECHO program had higher treatment initiation rates than sites that did not offer this 16 .However, this program and others did not utilize the same e-consult DTT model reported here.The novelty of the e-consult DTT program lies in the potential for reduced time between HCV diagnosis and treatment.Furthermore, this DTT program has implications for pandemic-era losses in screening, linkage to care, and treatment initiation.The COVID-19 pandemic saw reduced HCV screening and treatment across all populations; telehealth interventions can close this gap by offering safer, more convenient healthcare alternatives for people affected by the pandemic.
We report SVR12 rates of 95% with this program.Other programs that have implemented remote linkage to care and/or treatment have found similar success, with SVR rates between 93.3-98.5% [17][18][19] .However, these programs differed from the model described here in a few important ways.Linkage to care and treatment were either not managed or not exclusively managed by midlevel practitioners [17][18][19] , they did not take place in integrated healthcare systems 18,19 , and some exclusively evaluated people who inject drugs (PWID) 18,19 .
This cohort was evaluated 7 years ago; as such, there have been advances in telehealth outreach and technology since.Moving forward, these data are important due to their demonstration of the effectiveness of telehealth and DTT interventions in a time when these programs were less prevalent.The success of the program in linking Veterans to care and achieving SVR underlines the utility of telehealth programs with midlevel providers, particularly as specialists are often less accessible.Additionally, it is important to note that, now that telehealth programs are more established, those with substance abuse and alcohol abuse disorders are more likely to be given the opportunity to be treated via electronic means.
Limitations include a limited sample size and short study timeframe.Second, this study was completed at a single healthcare facility with Veterans; thus, results may not be applicable to other populations.The study also did not evaluate patient acceptance of the program or include any quality of life indices.Those who received treatment via SOC were likely a disparate population compared to those referred through DTT.With regards to the higher proportion of DTT patients initiating therapy, it is possible that those referred to standard of care had more comorbidities, requiring more diagnostic evaluation that delayed care.Future research could evaluate clinical outcomes in patients with similar baseline characteristics who initiated treatment via DTT versus SOC.
As compared to SOC, the HCV e-consult DTT program managed by midlevel practitioners required fewer visits for patients to achieve similar SVR12 rates, results which may have important cost-saving and post-pandemic-era safety ramifications.Overall, our findings lend support for this e-consult program in other integrated healthcare systems.