Randomised controlled trial conducted in injecting equipment provision sites to compare the effectiveness of different hepatitis C treatment regimens in people who inject drugs: A Direct obserVed therApy versus fortNightly CollEction study for HCV treatment—ADVANCE HCV protocol study

Abstract

IntroductionHepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. Over 85% of individuals who have HCV in Scotland became infected following injecting drug use. Since people who inject drugs (PWID) are the main source of new infections, theoretical modelling has suggested that treatment of HCV infection in PWID may effectively reduce HCV prevalence and accomplish elimination. This protocol describes a clinical trial delivering HCV treatment within injecting equipment provision sites (IEPS) in Tayside, Scotland.Methods and analysisPWID attending IEPS are tested for HCV and, if they are chronically infected with HCV and eligible, invited to receive treatment within the IEPS. They are randomised to one of three treatment regimens; daily observed treatment, treatment dispensed every 2 weeks and treatment dispensed every 2 weeks together with an adherence psychological intervention (administered before treatment begins). The primary outcome is comparison of the rate of successful treatment (SVR12) in each treatment group. Secondary analyses include assessment of adherence, reinfection rates, viral resistance to treatment and interaction of the treatment with illicit drugs.Ethics and disseminationThe ADVANCE (A Direct obserVed therApy versus fortNightly CollEction) HCV trial was given favourable opinion by East of Scotland Research Ethics Committee (LR/17/ES/0089) prior to commencement.Trial registration numbersEuropean Clinical Trials Database (EudraCT) (2017-001039-38) and ClinicalTrials.gov (NCT03236506).

Evaluating and communicating hepatitis C cascades of care data in Tayside, Scotland: A journey towards elimination

“…This may be attributed to their quick transition from interferon‐based treatments to DAAs in 2015 and universal access to treatment provided for virtually all those infected. Tayside has utilized innovative testing and treatment pathways, some of which are located within community pharmacies and harm‐reduction centres, to widen access to services at each stage of the cascade 13‐15 . As in many settings, there are continuing challenges in providing services to those that are hardest to reach, such as those that frequently relocate or those that may not regularly engage with healthcare services.…”

Patient Centeredness in Hepatitis C Direct-Acting Antiviral Treatment Delivery to People Who Inject Drugs: A Scoping Review

“…Eleven studies co-located HCV treatment point of care with other services. These services included primary care services [36,41,42], homeless primary care services [26], SAM clinics [41,43,44], harm reduction centers [45][46][47], public health services [48], and HIV clinics [49].…”

“…Clinical Visits Follow-up support to ensure adherence was the most addressed component within this dimension (19 studies). This follow-up was offered by providers [31,33,37,39,40,42,43,45,46,48,[50][51][52]58] as well as peer support groups [26,53,56]. One study triaged the patients into different levels of support according to their risk of non-adherence and patients who did not complete treatment were offered intensive follow-up home visits by peers [57].…”

Hepatitis C Virus Infection in Persons Who Inject Drugs in the Middle East and North Africa: Intervention Strategies

“…These two medications had limited efficacy and numerous side effects; a systematic review and meta-analysis estimated that only 25% of patients with chronic HCV infection were treated with these therapies [ 9 ]. The cure rate associated with DAAs is approximately 98% [ 10 ], which is much higher than the 50% cure rate associated with interferon-based therapy [ 11 ]. Now that the potency of HCV treatment has improved, the focus has shifted to expanding access to treatment and decreasing HCV-associated morbidity and mortality.…”