Hepatic Fibrosis Measured by Elastography among People who Inject Drugs with Chronic HCV in Community Settings: The Tap Study

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Hepatic Fibrosis Measured by Elastography among People who Inject Drugs with Chronic HCV in Community Settings: The Tap Study. J.S. Doyle, P. Dietze, P. Desmond, D.M. Iser, M. Stoove, E. McBryde, P. Higgs, M.E. Hellard, A.J. Thompson. 16 April 2016: Viral hepatitis: Hepatitis C – Clinical (therapy). Journal of Hepatology, 2016 Vol 64-2. doi: 10.1016/S0168-8278(16)01526-9


Abstract

Background and aims
The HCV Treatment and Prevention (TAP) Study is a community-based trial involving people who inject drugs (PWID) using a networks-based approach to treatment. We describe fibrosis and drug taking behaviour prior to treatment among the first fifty participants.

Methods
Eligible PWID were those with chronic HCV mono-infection, who injected drugs in the same time and place with ≥1 person in the previous six months, and without significant medical or concomitant medication interactions to sofosbuvir/ledipasvir ±ribavirin therapy. Participants were recruited via mobile street-based vans or primary health clinics for PWID. Hepatic fibrosis was measured by transient elastography (FibroScan) and alcohol and other drug use was documented at screening. The study protocol (clinicaltrials.gov NCT02363517) requires participants with advanced fibrosis receive care at specialist-led clinics. Analysis after the first 50 participants recruited was pre-specified.

Results
Fifty-seven HCV-infected participants have been recruited. Median age at screening was 37 years (range 24–58), 37 (65%) were male, and 22 (37%) have HCV genotype-1 infection with median ALT 47 IU/L (IQR 39-88) and platelet count 217 cells/mm3 (IQR 186-278). The median number of injecting partners was 2 (range 1 to 14) and median duration of injecting 11 years (IQR 7–17). The most commonly used drugs were heroin (72%) injected median 3 (IQR 2–7) times weekly, and crystal methamphetamine (21%) injected median 2 (IQR 1–4) times weekly. Twenty-two (39%) participants are receiving opioid substitution therapy. In the previous month, 56% reported any alcohol consumption, of whom 28% drink more frequently than weekly and 37% consume >40g alcohol per drinking day.  Median liver stiffness was 5.4kPa (IQR 4.4–6.8). Thirteen (23%) participants had liver stiffness >7kPa, of whom 4 (7%) had stiffness >9.5 kPa and 3 (5%) had stiffness >12.5kPa. FIB4 score was <1.45 in 39 (68%) and >3.25 in 3 (5%) participants; APRI score was ≤0.5 in 25 (45%) and ≥2.0 in 1 (2%) participant. There were no associations between liver stiffness (>7 or >9.5kPa) and age, gender, duration of injecting, current injecting or alcohol use.

Conclusions
Advanced fibrosis was uncommon in this sample of PWID, suggesting that community-based therapy will be possible for the majority of PWID. We anticipate that targeting PWID and their social networks will prevent HCV transmission, and prevent liver morbidity by eliminating HCV before advanced fibrosis develops.

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