Publications by authors named "Janaki Amin"

149 Publications

Opportunities to enhance linkage to hepatitis C care among hospitalised people with recent drug dependence in New South Wales, Australia: A population-based linkage study.

Clin Infect Dis 2021 Jun 9. Epub 2021 Jun 9.

The Kirby Institute, UNSW Sydney, Sydney, Australia.

Background: People who inject drugs are at greater risk of hepatitis C virus (HCV) infection and hospitalisation, yet admissions are not utilised for HCV treatment initiation. We aimed to assess the extent to which people with HCV notification, including those with evidence of recent drug dependence, are hospitalised while eligible for direct-acting antiviral (DAA) therapy, and treatment uptake according to hospitalisation in the DAA era.

Methods: We conducted a longitudinal, population-based cohort study of people living with HCV in the DAA era (March 2016-December 2018) through analysis of linked databases in New South Wales, Australia. Kaplan Meier estimates were used to report HCV treatment uptake by frequency, length, and cause-specific hospitalisation.

Results: Among 57,467 people, 14,938 (26%) had evidence of recent drug dependence, 50% (n=7,506) of whom were hospitalised while DAA eligible. Incidence of selected cause-specific hospitalisation was highest for mental health-related (15.84 per 100 person-years [PY]), drug-related (15.20 per 100PY), and injection-related infectious disease (9.15 per 100PY) hospitalisations, and lowest for alcohol use disorder (4.58 per 100PY) and liver-related (3.13 per 100PY). 65% (n=4,898) of those hospitalised had been admitted >2 times and 46% (n=3,437) were hospitalised >7 days. By the end of 2018, DAA therapy was lowest for those hospitalised >2 times, for >7 days, and those whose first admission was for injection-related infectious disease, mental health disorders, and drug-related complications.

Conclusions: Among people who have evidence of recent drug dependence, frequent hospitalisation-particularly mental health, drug, and alcohol admissions-presents an opportunity for engagement in HCV care.
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http://dx.doi.org/10.1093/cid/ciab526DOI Listing
June 2021

Adherence to daily HIV Pre-exposure prophylaxis in a large-scale implementation study in New South Wales, Australia.

AIDS 2021 Jun 4. Epub 2021 Jun 4.

The Kirby Institute, UNSW Sydney, NSW Department of Health Systems and Populations, Macquarie University, NSW Ministry of Health, NSW Government, NSW Westmead Clinical School, Sydney University, NSW AIDS Council New South Wales, NSW Sydney Sexual Health Centre, Sydney, NSW North Coast HIV/Sexual Health Services, Lismore, NSW Sexual Health Service, Sydney Local Health District Sydney and Sydney Medical School, University of Sydney, Sydney, NSW, Australia.

Objectives: To examine patterns of long-term PrEP adherence and its association with HIV seroconversion in NSW, Australia.

Design: Population-based HIV PrEP implementation study.

Methods: EPIC-NSW was an open-label study of daily oral PrEP which recruited participants from March 2016 to April 2018. Adherence was measured using dispensing records. PrEP discontinuation was defined as a ≥120-day period without PrEP coverage. Long-term adherence patterns were identified using group-based trajectory modelling.

Results: Participants dispensed at least once (n = 9586) were almost all male (98.5%), identified as gay (91.3%), with a median age of 34 years (range: 18-86). Of the 6460 (67.4%) participants who had at least nine-months of follow-up since first dispensing, 1942 (30.1%) discontinued. Among these, 292 (15.0%) restarted later. Four distinct groups were identified ('Steep decline' in adherence (15.8%), 'Steady decline' (11.6%), 'Good adherence' (37.4%), and 'Excellent adherence' (35.2%)). Older (p < 0.001) and gay-identified (p < 0.001) participants were more likely to have higher adherence, so were those living in postcodes with a higher proportion of gay-identified male residents (p < 0.001). Conversely, those who at baseline reported recent crystal methamphetamine use and had a recent diagnosis of sexually transmitted infection (STI) had lower adherence (p < 0.001). Overall HIV incidence was 0.94 per 1000 person-years (95%CI: 0.49-1.81; n = 9) and was highest in the 'steep decline' group (5.45 per 1000 person-years; p = 0.001).

Conclusions: About 15% of participants stopped PrEP during study follow-up and were at increased risk of HIV infection. They were more likely to be younger and report a recent STI or methamphetamine use prior to PrEP initiation.
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http://dx.doi.org/10.1097/QAD.0000000000002970DOI Listing
June 2021

Evaluation of hepatitis C treatment-as-prevention within Australian prisons (SToP-C): a prospective cohort study.

Lancet Gastroenterol Hepatol 2021 Jul 7;6(7):533-546. Epub 2021 May 7.

The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia. Electronic address:

Background: Limited empirical evidence exists for the effectiveness of hepatitis C virus (HCV) treatment-as-prevention. The Surveillance and Treatment of Prisoners with hepatitis C (SToP-C) study aimed to assess the effect of HCV treatment-as-prevention in the prison setting.

Methods: SToP-C was a prospective study, including a before-and-after analysis, within a cohort of people incarcerated in two maximum-security prisons (male) and two medium-security prisons (one male, one female) in New South Wales, Australia. All prison inmates aged at least 18 years were eligible for enrolment. After HCV testing, participants were monitored for risk behaviours and HCV infection, among three sub-populations: uninfected (HCV antibody-negative); previously infected (HCV antibody-positive, HCV RNA-negative); and infected (HCV antibody and HCV RNA-positive). Uninfected participants were followed up every 3-6 months to detect HCV primary infection and previously infected participants were followed up every 3-6 months to detect re-infection. Participants with HCV infection were assessed for treatment, initially standard-of-care treatment (administered by prison health services) from 2014 to mid-2017, then direct-acting antiviral (DAA) treatment scale-up from mid-2017 onwards (12 weeks of sofosbuvir plus velpatasvir, administered through SToP-C). Participants were followed up until study closure in November, 2019. The primary study outcome was HCV incidence before and after DAA treatment scale-up among participants at risk of HCV primary infection or re-infection. This study is registered with ClinicalTrials.gov, NCT02064049.

Findings: Between Oct 30, 2014, and Sept 30, 2019, 3691 participants were enrolled in the SToP-C study. 719 (19%) participants had detectable HCV RNA, 2240 (61%) were at risk of primary HCV infection, and 725 (20%) were at risk of re-infection at baseline. DAA treatment was initiated in 349 (70%) of 499 eligible participants during the treatment scale-up period. The HCV incidence analysis comprised 1643 participants at risk of HCV infection or re-infection during longitudinal follow-up (median age 33 years [IQR 27-42]; 1350 [82%] male). 487 (30%) of 1643 participants reported injecting drugs in prison. HCV incidence decreased from 8·31 per 100 person-years in the pre-treatment scale-up period to 4·35 per 100 person-years in the post-treatment scale-up period (incidence rate ratio [IRR] 0·52 [95% CI 0·36-0·78]; p=0·0007). The incidence of primary infection decreased from 6·64 per 100 person-years in the pre-treatment scale-up period to 2·85 per 100 person-years in the post-treatment scale-up period (IRR 0·43 [95% CI 0·25-0·74]; p=0·0019), whereas the incidence of re-infection decreased from 12·36 per 100 person-years to 7·27 per 100 person-years (0·59 [0·35-1·00]; p=0·050). Among participants reporting injecting drugs during their current imprisonment, the incidence of primary infection decreased from 39·08 per 100 person-years in the pre-treatment scale-up period to 14·03 per 100 person-years in the post-treatment scale-up period (IRR 0·36 [95% CI 0·16-0·80]; p=0·0091), and the incidence of re-infection decreased from 15·26 per 100 person-years to 9·34 per 100 person-years (0·61 [0·34-1·09]; p=0·093). The adjusted analysis (adjusted for age, Indigenous Australian ethnicity, duration of stay in prison, previous imprisonment, injecting drug use status, and prison site) indicated a significant reduction in the risk of HCV infection between the pre-DAA treatment scale-up and post-DAA treatment scale-up periods (adjusted hazard ratio 0·50 [95% CI 0·33-0·76]; p=0·0014).

Interpretation: DAA treatment scale-up was associated with reduced HCV incidence in prison, indicative of a beneficial effect of HCV treatment-as-prevention in this setting. These findings support broad DAA treatment scale-up within incarcerated populations.

Funding: Australian National Health and Medical Research Council Partnership Project Grant and Gilead Sciences.
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http://dx.doi.org/10.1016/S2468-1253(21)00077-7DOI Listing
July 2021

Parent engagement with the New South Wales child health home-based record: A cross-sectional survey and a retrospective chart review.

Child Care Health Dev 2021 Apr 19. Epub 2021 Apr 19.

Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.

Background: In 2018, World Health Organization endorsed universal use of home-based records to improve care for mothers, pregnant women, newborns and children. New South Wales (NSW), Australia has had universal use of a child health home-based record since 1988, with the first major update in 2013. Since the update, limitedbelief is sufficient for constituting evidence has been collected about factors influencing parent use of the record. This study aims to examine parent engagement with the record and whether it is influenced by child's first-born status and Parent Evaluation of Development Status (PEDS) outcome.

Method: A survey of 202 parent-child pairs and a review of 20 record books were conducted in NSW, Australia. Odds ratio (OR) at 95% confidence interval (CI) and .05 level of significance, bivariate and multivariate logistic regressions were conducted to examine the influence of first-born status, child's PEDS outcome and other parent-child characteristics on parent engagement with the record.

Results: Parents engaged with the home-based record by taking it for routine checks (80.7%), writing (74.8%) or reading (75.8%) information. Parents of first-born children were more than three times likely to take the record book for routine checks compared with parent of later-born children (adjusted OR [AOR] = 3.70, 95% CI 1.12-12.20). Similarly, parents of children with low PEDS level of risk were significantly less likely to read information in the record book compared with parents of children with high risk (AOR = 0.28, 95% CI 0.08-0.98). Parent record input through direct observation significantly decreased from 85% at 1-month to 60% at 12-month postnatal. Data about at least one vaccination event were recorded in all the record books examined, while 85% had all recommended vaccinations recorded.

Conclusion: Parents valued/engaged regularly with a child health home-based record, and the record may be a useful tool for early detection and monitoring of child developmental concerns. Therefore, continued promotion of the use of child health home-based record appears to play an important role in improving child health and development.
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http://dx.doi.org/10.1111/cch.12871DOI Listing
April 2021

High levels of prevention-effective adherence to HIV pre-exposure prophylaxis (PrEP): An analysis of sub-study data from the EPIC-NSW trial.

J Acquir Immune Defic Syndr 2021 Apr 1. Epub 2021 Apr 1.

Kirby Institute, UNSW Sydney Centre for Social Research in Health, UNSW Sydney Sydney Medical School - Westmead, University of Sydney Western Sydney Sexual Health Centre Macquarie University Department of Sexual Health Medicine and Sexual Assault Medical Service, Sydney Local Health District Central Clinical School, Sydney Medical School, University of Sydney East Sydney Doctors Sydney Sexual Health Centre.

Background: Pre-exposure prophylaxis (PrEP) prevents HIV infection but relies on good adherence at times of risk, termed 'prevention-effective adherence'. Most studies assess adherence without reference to sexual behaviour, making it challenging to determine if poor adherence coincides with HIV risk.

Setting: We examined data from a behavioural sub-study of a large-scale PrEP implementation trial in New South Wales, Australia.

Methods: Trial participants completed optional, brief quarterly surveys, reporting number of pills taken and sexual behaviour with male partners for each day of the 'last full week' before each survey. Condomless sex (CLS) was defined as 'higher risk' for HIV when with HIV-positive men with detectable/unknown viral loads or unknown HIV status men. Adequate PrEP protection was defined as ≥4 pills for participants assigned male sex at birth and ≥6 pills for participants assigned female sex at birth (including transgender men).

Results: Of 9596 participants dispensed PrEP, 4401 completed baseline and ≥1 follow-up survey. Participants reported on 12399 'last full weeks'; 7485 weeks (60.4%) involved CLS, and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS. There were 103 weeks in which participants did not have adequate PrEP protection and had higher risk CLS: 4.1% of higher risk CLS-weeks (n=103/2521), 1.4% of all CLS-weeks (n=103/7485), and 0.8% of all observed weeks (n=103/12399).

Conclusions: In a large PrEP trial, prevention-effective adherence to PrEP was very high at 99%. Our findings illustrate the importance of measuring pill-taking and sexual behaviour in the same period so that prevention-effective adherence can be better estimated.
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http://dx.doi.org/10.1097/QAI.0000000000002691DOI Listing
April 2021

Predictors of parent use of a child health home-based record and associations with long-term child health/developmental outcomes: Findings from the Longitudinal Study of Australian Children from 2004 to 2016.

J Pediatr Nurs 2021 Feb 16. Epub 2021 Feb 16.

Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW 2109, Australia.

Purpose: This study aims to examine predictors of parent use of a child health home-based record and associations with child health/developmental outcomes.

Design And Methods: Data for this study was obtained from a nationally representative study of Australian children from 2004 to 2016. The current study focuses on the kindergarten cohort of the Longitudinal Study of Australian Children, which enrolled children at the ages of 4-5 years. Logistic regression was used to analyse the data using Odds Ratio (OR) at 95% Confidence Interval (CI) and p-value of 0.05.

Results: A total of 4983 parent-child pairs participated at the beginning of the study in 2004, which reduced to 3089 (62%) by 2016. The most significant predictor of home-based record use was co-parenting, with single parents less likely to use the record (Adjusted OR = 0.633-95%CI:0.518-0.772). Similarly, child up-to-date immunisation was 31% higher among parents who used the record (OR = 1.313-95%CI:1.049-1.644). Children without a home-based record had increased odds of having various health/developmental concerns (p < 0.05).

Conclusion: The findings suggest that using a home-based record may have a long-term impact on child health and development. It is also possible that home-based records are more likely to be used by parents of relatively healthy children. Further work is needed to consider if home-based records need to be modified for parents of children with health/development problems.

Practice Implications: Nurses and other primary care providers at forefront of family health should ensure proper use of child health home-based records as well as promote its use by parents and caregivers of children.
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http://dx.doi.org/10.1016/j.pedn.2021.02.002DOI Listing
February 2021

Comparison of Trends in Rates of Sexually Transmitted Infections Before vs After Initiation of HIV Preexposure Prophylaxis Among Men Who Have Sex With Men.

JAMA Netw Open 2020 12 1;3(12):e2030806. Epub 2020 Dec 1.

Kirby Institute, University of New South Wales Sydney, Sydney, New South Wales, Australia.

Importance: There have been concerns that HIV preexposure prophylaxis (PrEP) may be associated with increases in sexually transmitted infections (STIs) because of subsequent reductions in condom use and/or increases in sexual partners.

Objective: To determine trends in STI test positivity among high-risk men who have sex with men (MSM) before and after the start of HIV PrEP.

Design, Setting, And Participants: A before-after analysis was conducted using a subcohort of a single-group PrEP implementation study cohort in New South Wales, Australia (Expanded PreEP Implementation in Communities in New South Wales [EPIC-NSW]), from up to 1 year before enrollment if after January 1, 2015, and up to 2 years after enrollment and before December 31, 2018. STI testing data were extracted from a network of 54 sexual health clinics and 6 primary health care clinics Australia-wide, using software to deidentify, encrypt, and anonymously link participants between clinics. A cohort of MSM dispensed PrEP for the first time during the study, with 2 or more STI tests in the prior year and who tested during follow-up, were included from the EPIC-NSW cohort of HIV-negative participants with high-risk sexual behavior. Data analysis was performed from June to December 2019.

Exposures: Participants were dispensed coformulated tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP.

Main Outcomes And Measures: The main outcome was STI, measured using test positivity, defined as the proportion of participants testing positive for an STI at least once per quarter of follow-up. Outcomes were calculated for Chlamydia trachomatis and Neisseria gonorrhoea by site of infection (anorectal, pharyngeal, urethral, or any) and for syphilis.

Results: Of the EPIC-NSW cohort of 9709 MSM, 2404 were included in the before-after analysis. The mean (SD) age of the participants was 36 (10.4) years, and 1192 (50%) were Australia-born. STI positivity was 52% in the year after PrEP (23.3% per quarter; 95% CI, 22.5%-24.2% per quarter) with no significant trend (mean rate ratio [RR] increase of 1.01 per quarter [95% CI, 0.99-1.02]; P = .29), compared with 50% positivity in the year prior to PrEP (20.0% per quarter [95% CI, 19.04%-20.95% per quarter]; RR for overall STI positivity, 1.17 [95% CI, 1.10-1.24]; P < .001), with an increase in quarterly STI positivity (mean RR of 1.08 per quarter, or an 8% increase per quarter [95% CI, 1.05-1.11]; P < .001; RR, 0.93 [95% CI, 0.90-0.96]; P < .001). Findings were similar when stratified by specific STIs and anatomical site.

Conclusions And Relevance: STI rates were high but stable among high-risk MSM while taking PrEP, compared with a high but increasing trend in STI positivity before commencing PrEP. These findings suggest the importance of considering trends in STIs when describing how PrEP use may be associated with STI incidence.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.30806DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7758809PMC
December 2020

High hepatitis C treatment uptake among people with recent drug dependence in New South Wales, Australia.

J Hepatol 2021 Feb 12;74(2):293-302. Epub 2020 Sep 12.

The Kirby Institute, UNSW Sydney, Sydney, Australia.

Background & Aims: High HCV treatment uptake among people at most risk of transmission is essential to achieve elimination. We aimed to characterise subpopulations of people with HCV based on drug dependence, to estimate direct-acting antiviral (DAA) uptake in an unrestricted treatment era, and to evaluate factors associated with treatment uptake among people with recent drug dependence.

Methods: HCV notifications in New South Wales, Australia (1995-2017) were linked to opioid agonist therapy (OAT), hospitalisations, incarcerations, HIV notifications, deaths, and prescription databases. Drug dependence was defined as hospitalisation due to injectable drugs or receipt of OAT, with indicators in 2016-2018 considered recent. Records were weighted to account for spontaneous clearance. Logistic regression was used to analyse factors associated with treatment uptake among those with recent drug dependence.

Results: 57,467 people were estimated to have chronic HCV throughout the DAA era. Treatment uptake was highest among those with recent (47%), compared to those with distant (38%), and no (33%) drug dependence. Among those with recent drug dependence, treatment was more likely among those with HIV (adjusted odds ratio [aOR] 1.71; 95% CI 1.24-2.36), recent incarceration (aOR 1.10; 95% CI 1.01-1.19), and history of alcohol use disorder (aOR 1.22; 95% CI 1.13-1.31). Treatment was less likely among women (aOR 0.78; 95% CI 0.72-0.84), patients of Indigenous ethnicity (aOR 0.75; 95% CI 0.69-0.81), foreign-born individuals (aOR 0.86; 95% CI 0.78-0.96), those with outer-metropolitan notifications (aOR 0.90; 95% CI 0.82-0.98), HBV coinfection (aOR 0.69; 95% CI 0.59-0.80), and >1 recent hospitalisation (aOR: 0.91; 95% CI 0.84-0.98).

Conclusions: These data provide evidence of high DAA uptake among people with recent drug dependence, including those who are incarcerated. Enhancing this encouraging initial uptake among high-risk populations will be essential to achieve HCV elimination.

Lay Summary: To facilitate HCV elimination, those at highest risk of infection and transmission are a treatment priority. This study shows the successes of Australia's universal provision of DAA therapy in reducing the barriers to treatment which have historically persisted among people who inject drugs. Despite higher DAA therapy uptake among those with recent drug dependence, gaps remain. Strategies which aim to reduce marginalisation and increase treatment uptake to ensure equitable HCV elimination must be advanced.
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http://dx.doi.org/10.1016/j.jhep.2020.08.038DOI Listing
February 2021

Is Parent Engagement with a Child Health Home-Based Record Associated with Parents Perceived Attitude towards Health Professionals and Satisfaction with the Record? A Cross-Sectional Survey of Parents in New South Wales, Australia.

Int J Environ Res Public Health 2020 07 30;17(15). Epub 2020 Jul 30.

Faculty of Medicine and Health Sciences, Macquarie University, Sydney 2109, Australia.

We examined parent views of health professionals and satisfaction toward use of a child health home-based record and the influence on parent engagement with the record. A cross-sectional survey of 202 parents was conducted across New South Wales (NSW), Australia. Bivariate and multivariate logistic regressions were conducted to identify predictors of parent engagement with the record book using odds ratio (OR) at 95% confidence interval (CI) and 0.05 significance level. Parents reported utilizing the record book regularly for routine health checks (63.4%), reading the record (37.2%), and writing information (40.1%). The majority of parents (91.6%) were satisfied with the record. Parents perceived nurses/midwives as most likely to use/refer to the record (59.4%) compared to pediatricians (34.1%), general practitioners (GP) (33.7%), or other professionals (7.9%). Parents were less likely to read the record book if they perceived the GP to have a lower commitment (Adjusted OR = 0.636, 95% CI 0.429-0.942). Parents who perceived nurses/midwives' willingness to use/refer to the record were more likely to take the record book for routine checks (Adjusted OR = 0.728, 95% CI 0.536-0.989). Both parent perceived professionals' attitude and satisfaction significantly influenced information input in the home-based record. The results indicate that improvements in parent engagement with a child health home-based record is strongly associated with health professionals' commitment to use/refer to the record during consultations/checks.
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http://dx.doi.org/10.3390/ijerph17155520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432040PMC
July 2020

Is Parent Engagement with a Child Health Home-Based Record Associated with Parents Perceived Attitude towards Health Professionals and Satisfaction with the Record? A Cross-Sectional Survey of Parents in New South Wales, Australia.

Int J Environ Res Public Health 2020 07 30;17(15). Epub 2020 Jul 30.

Faculty of Medicine and Health Sciences, Macquarie University, Sydney 2109, Australia.

We examined parent views of health professionals and satisfaction toward use of a child health home-based record and the influence on parent engagement with the record. A cross-sectional survey of 202 parents was conducted across New South Wales (NSW), Australia. Bivariate and multivariate logistic regressions were conducted to identify predictors of parent engagement with the record book using odds ratio (OR) at 95% confidence interval (CI) and 0.05 significance level. Parents reported utilizing the record book regularly for routine health checks (63.4%), reading the record (37.2%), and writing information (40.1%). The majority of parents (91.6%) were satisfied with the record. Parents perceived nurses/midwives as most likely to use/refer to the record (59.4%) compared to pediatricians (34.1%), general practitioners (GP) (33.7%), or other professionals (7.9%). Parents were less likely to read the record book if they perceived the GP to have a lower commitment (Adjusted OR = 0.636, 95% CI 0.429-0.942). Parents who perceived nurses/midwives' willingness to use/refer to the record were more likely to take the record book for routine checks (Adjusted OR = 0.728, 95% CI 0.536-0.989). Both parent perceived professionals' attitude and satisfaction significantly influenced information input in the home-based record. The results indicate that improvements in parent engagement with a child health home-based record is strongly associated with health professionals' commitment to use/refer to the record during consultations/checks.
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http://dx.doi.org/10.3390/ijerph17155520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432040PMC
July 2020

Progress towards elimination of hepatitis C infection among people who inject drugs in Australia: The ETHOS Engage Study.

Clin Infect Dis 2020 May 18. Epub 2020 May 18.

The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.

Background & Aims: Evaluating progress towards HCV elimination is critical. This study estimated prevalence of current HCV infection and HCV treatment uptake among people who inject drugs (PWID) in Australia.

Methods: ETHOS Engage is an observational study of PWID attending drug treatment clinics and needle and syringe programs (NSP). Participants completed a questionnaire including self-reported treatment history and underwent point-of-care HCV RNA testing (Xpert® HCV Viral Load Fingerstick).

Results: Between May 2018-September 2019, 1,443 participants were enrolled (64% injected drugs in the last month, 74% receiving opioid agonist therapy [OAT]). HCV infection status was uninfected (28%), spontaneous clearance (16%), treatment-induced clearance (32%), and current infection (24%). Current HCV was more likely among people who were homeless (adjusted odds ratio: 1.47; 95%CI: 1.00, 2.16), incarcerated in previous year (2.04; 1.38, 3.02), and those injecting drugs ≥daily (2.26; 1.43, 2.42). Among those with previous chronic or current HCV, 66% (n=520/788) reported HCV treatment. In adjusted analysis, HCV treatment was lower among females (0.68; 0.48, 0.95), participants who were homeless (0.59; 0.38, 0.96), and those injecting ≥daily (0.51; 0.31, 0.89). People aged ≥45 (1.46; 1.06, 2.01) and people receiving OAT (2.62; 1.52, 4.51) were more likely to report HCV treatment.

Conclusions: Unrestricted DAA access in Australia has yielded high treatment uptake among PWID attending drug treatment and NSPs, with a marked decline in HCV prevalence. To achieve elimination, PWID with greater marginalisation may require additional support and tailored strategies to enhance treatment.
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http://dx.doi.org/10.1093/cid/ciaa571DOI Listing
May 2020

Monitoring Health and Well-Being in Emerging Adults: Protocol for a Pilot Longitudinal Cohort Study.

JMIR Res Protoc 2020 Apr 23;9(4):e16108. Epub 2020 Apr 23.

Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.

Background: Emerging adulthood is a unique segment of an individual's life course. The defining features of this transitional period include identity exploration, instability, future possibilities, self-focus, and feeling in-between adolescence and adulthood, all of which are thought to affect quality of life, health, and well-being. A longitudinal cohort study with a comprehensive set of measures would be a unique and valuable resource for improving the understanding of the multi-faceted elements and unique challenges that contribute to the health and well-being of emerging adults.

Objective: The main aim of this pilot study is to evaluate the feasibility and acceptability of recruiting university graduates to establish a longitudinal cohort study to inform our understanding of emerging adulthood.

Methods: This is a pilot longitudinal cohort study of Australian university graduates. It will involve collecting information via online surveys (baseline and 12-month follow-up) and data linkage with health records. Recruitment, response, and retention rates will be calculated. Descriptive analysis of the representativeness of recruited participants and completeness of survey responses will be conducted.

Results: Participant recruitment was completed in October 2018, and data collection for the baseline and follow-up surveys was completed in November 2019. As of April 2020, the process of acquiring health records from administrative data collections has commenced.

Conclusions: The findings from this pilot study will identify areas for improvement and inform the development of a future longitudinal cohort study of emerging adults.

Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001364268; https://tinyurl.com/teec8wh.

International Registered Report Identifier (irrid): DERR1-10.2196/16108.
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http://dx.doi.org/10.2196/16108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206521PMC
April 2020

Reinfection Following Successful Direct-acting Antiviral Therapy for Hepatitis C Virus Infection Among People Who Inject Drugs.

Clin Infect Dis 2021 04;72(8):1392-1400

The Kirby Institute, University of New South Wales Sydney, Sydney, Australia.

Background: The aim of this analysis was to calculate the incidence of hepatitis C virus (HCV) reinfection and associated factors among 2 clinical trials of HCV direct-acting antiviral treatment in people with recent injecting drug use or currently receiving opioid agonist therapy (OAT).

Methods: Participants who achieved an end-of-treatment response in 2 clinical trials of people with recent injecting drug use or currently receiving OAT (SIMPLIFY and D3FEAT) enrolled between March 2016 and February 2017 in 8 countries were assessed for HCV reinfection, confirmed by viral sequencing. Incidence was calculated using person-time of observation and associated factors were assessed using Cox proportional hazard models.

Results: Seventy-three percent of the population at risk of reinfection (n = 177; median age, 48 years; 73% male) reported ongoing injecting drug use. Total follow-up time at risk was 254 person-years (median, 1.8 years; range, 0.2-2.8 years). Eight cases of reinfection were confirmed for an incidence of 3.1/100 person-years (95% confidence interval [CI], 1.6-6.3) overall and 17.9/100 person-years (95% CI, 5.8-55.6) among those who reported sharing needles/syringes. Younger age and needle/syringe sharing were associated with HCV reinfection.

Conclusions: These data demonstrate the need for ongoing monitoring and improved strategies to prevent HCV reinfection following successful treatment among people with ongoing injecting drug use to achieve HCV elimination.

Clinical Trials Registration: NCT02336139 and NCT02498015.
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http://dx.doi.org/10.1093/cid/ciaa253DOI Listing
April 2021

Is parent engagement with a child health home-based record influenced by early child development and first-born status? hypotheses from a high-income countries' perspective.

Med Hypotheses 2020 Apr 25;137:109605. Epub 2020 Jan 25.

Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW 2109, Australia.

Home-based records for child health are widely used for documenting primary healthcare services including vaccinations and health screening. It serves as an educational tool for parents and promote continuity of care as well as communication between health professionals and parents. In our previous systematic review, we identified that parents in low- and middle-income countries and high-income countries value such a record and consider it important for childcare, yet questions were raised about its wide distribution and utilisation in high-income countries. We therefore aim to examine predictors that could be related to the use/usefulness of the record book in a high-income country, Australia. We hypothesize that parent engagement with the child health home-based record may be influenced by early child development (in-terms of age and hitting milestones) as measured by parent evaluation of developmental status (PEDS) tool and first-born status of the child (as compared to later-born). To test these hypotheses, we will be conducting a community-based survey and review of the record books across New South Wales state of Australia. This paper includes a summary of the findings of our previous review study that prompted the development of these hypotheses and the study protocol we will follow to test these hypotheses.
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http://dx.doi.org/10.1016/j.mehy.2020.109605DOI Listing
April 2020

Adherence to Once-daily and Twice-daily Direct-acting Antiviral Therapy for Hepatitis C Infection Among People With Recent Injection Drug Use or Current Opioid Agonist Therapy.

Clin Infect Dis 2020 10;71(7):e115-e124

The Kirby Institute, University of New South Wales, Sydney, Australia.

Background: This study investigated adherence and associated factors among people with recent injection drug use (IDU) or current opioid agonist therapy (OAT) and compared once-daily to twice-daily hepatitis C virus (HCV) direct-acting antiviral (DAA) therapy.

Methods: SIMPLIFY and D3FEAT are international, multicenter studies that recruited participants with recent IDU (previous 6 months; SIMPLIFY, D3FEAT) or current OAT (D3FEAT) between March 2016 and February 2017 in 8 countries. Participants received sofosbuvir/velpatasvir (once daily; SIMPLIFY) or paritaprevir/ritonavir/ombitasvir, dasabuvir (twice daily) ± ribavirin (D3FEAT) for 12 weeks administered in electronic blister packs. We evaluated overall adherence (proportion of prescribed doses taken) and nonadherence (<90% adherent) between dosing patterns.

Results: Of 190 participants, 184 (97%) completed treatment. Median adherence was 92%, with higher adherence among those receiving once-daily vs twice-daily therapy (94% vs 87%, P = .005). Overall, 40% of participants (n = 76) were nonadherent (<90% adherent). Recent stimulant injecting (odds ratio [OR], 2.48 [95% confidence interval {CI}, 1.28-4.82]), unstable housing (OR, 2.18 [95% CI, 1.01-4.70]), and twice-daily dosing (OR, 2.81 [95% CI, 1.47-5.36]) were associated with nonadherence. Adherence decreased during therapy. Sustained virologic response was high in nonadherent (89%) and adherent populations (95%, P = .174), with no difference in SVR between those who did and did not miss 7 consecutive doses (92% vs 93%, P = .897).

Conclusions: This study demonstrated high adherence to once- and twice-daily DAA therapy among people with recent IDU or currently receiving OAT. Nonadherence described did not impact treatment outcomes, suggesting forgiveness to nonadherence.
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http://dx.doi.org/10.1093/cid/ciz1089DOI Listing
October 2020

Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study.

Clin Infect Dis 2020 05;70(11):2369-2376

Kirby Institute, University of New South Wales, Australia.

Background: In many settings, recent or prior injection drug use remains a barrier to accessing direct-acting antiviral treatment (DAA) for hepatitis C virus (HCV) infection. We examined patterns of drug and alcohol use and injection equipment sharing among people with recent injecting drug use or receiving opioid agonist treatment (OAT) during and following DAA-based treatment.

Methods: SIMPLIFY and D3FEAT are phase 4 trials evaluating the efficacy of DAA among people with past 6-month injecting drug use or receiving OAT through a network of 25 international sites. Enrolled in 2016-2017, participants received sofosbuvir/velpatasvir (SIMPLIFY) or paritaprevir/ritonavir/dasabuvir/ombitasvir ± ribavirin (D3FEAT) for 12 weeks and completed behavioral questionnaires before, during, and up to 2 years posttreatment. The impact of time in HCV treatment and follow-up on longitudinally measured longitudinally measured behaviors was estimated using generalized estimating equations.

Results: At screening, of 190 participants (mean age, 47 years; 74% male), 62% reported any past-month injecting 16% past-month injection equipment sharing, and 61% current OAT. Median alcohol use was 2 (Alcohol Use Disorders Identification Test-Consumption; range, 1-12). During follow-up, opioid injecting (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.92-0.99) and sharing (OR, 0.87; 95% CI, 0.80-0.94) decreased, whereas no significant changes were observed for stimulant injecting (OR, 0.98; 95% CI, 0.94-1.02) or alcohol use (OR, 0.99; 95% CI, 0.95-1.04).

Conclusions: Injecting drug use and risk behaviors remained stable or decreased following DAA-based HCV treatment. Findings further support expanding HCV treatment to all, irrespective of injection drug use.

Clinical Trials Registration: SIMPLIFY, NCT02336139; D3FEAT, NCT02498015.
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http://dx.doi.org/10.1093/cid/ciz633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245153PMC
May 2020

Declining hepatitis C virus-related liver disease burden in the direct-acting antiviral therapy era in New South Wales, Australia.

J Hepatol 2019 08 10;71(2):281-288. Epub 2019 May 10.

The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.

Background & Aims: Population-level evidence for the impact of direct-acting antiviral (DAA) therapy on hepatitis C virus (HCV)-related disease burden is lacking. We aimed to evaluate trends in HCV-related decompensated cirrhosis and hepatocellular carcinoma (HCC) hospitalisation, and liver-related and all-cause mortality in the pre-DAA (2001-2014) and DAA therapy (2015-2017) eras in New South Wales, Australia.

Methods: HCV notifications (1993-2016) were linked to hospital admissions (2001-2017) and mortality (1995-2017). Segmented Poisson regressions and Poisson regression were used to assess the impact of DAA era and factors associated with liver-related mortality, respectively.

Results: Among 99,910 people with an HCV notification, 3.8% had a decompensated cirrhosis diagnosis and 1.8% had an HCC diagnosis, while 3.3% and 10.5% died of liver-related and all-cause mortality, respectively. In the pre-DAA era, the number of decompensated cirrhosis and HCC diagnoses, and liver-related and all-cause mortality consistently increased (incidence rate ratios 1.04 [95% CI 1.04-1.05], 1.08 [95% CI 1.07-1.08], 1.07 [95% CI 1.06-1.07], and 1.05 [95% CI 1.04-1.05], respectively) over each 6-monthly band. In the DAA era, decompensated cirrhosis diagnosis and liver-related mortality numbers declined (incidence rate ratios 0.97 [95% CI 0.95-0.99] and 0.96 [95% CI 0.94-0.98], respectively), and HCC diagnosis and all-cause mortality numbers plateaued (incidence rate ratio 1.00 [95% CI 0.97-1.03] and 1.01 [95% CI 1.00-1.02], respectively) over each 6-monthly band. In the DAA era, alcohol-use disorder (AUD) was common in patients diagnosed with decompensated cirrhosis and HCC (65% and 46% had a history of AUD, respectively). AUD was independently associated with liver-related mortality (incidence rate ratio 3.35; 95% CI 3.14-3.58).

Conclusions: In the DAA era, there has been a sharp decline in liver disease morbidity and mortality in New South Wales, Australia. AUD remains a major contributor to HCV-related liver disease burden, highlighting the need to address comorbidities.

Lay Summary: Rising hepatitis C-related morbidity and mortality is a major public health issue. However, development of highly effective medicines against hepatitis C (called direct-acting antivirals or DAAs) means hepatitis C could be eliminated as a public health threat by 2030. This study shows a sharp decline in liver disease morbidity and mortality since the introduction of DAAs in New South Wales, Australia. Despite this, heavy alcohol use remains an important risk factor for liver disease among people with hepatitis C. To ensure that the benefits of new antiviral treatments are not compromised, management of major comorbidities, including heavy alcohol use must improve among people with hepatitis C.
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http://dx.doi.org/10.1016/j.jhep.2019.04.014DOI Listing
August 2019

Incidence and time trends of anal cancer among people living with HIV in Australia.

AIDS 2019 07;33(8):1361-1368

The Kirby Institute.

Background: Anal cancer incidence increased markedly in people living with HIV (PLWHIV) after the introduction of HAART, but in a few setting settings, recent declines have been reported. We report the incidence and time trends of anal cancer in PLWHIV in Australia.

Study Design: A data linkage study between the National HIV Registries and the Australian Cancer Database.

Methods: Cases of anal squamous cell carcinoma (ASCC) in Australians aged 16 years and above diagnosed with HIV between 1982 and 2012 were identified. Standardized incidence ratios (SIRs) were calculated to compare incidence with that of the general population. Poisson regression models were developed to describe the time trends of ASCC over time and to compare ASCC risk within subgroups of PLWHIV.

Results: Among 28 696 individuals, a total of 129 cases of ASCC were identified. The crude incidence was 36.3 per 100 000 person-years and it increased sharply from 14.8 to 62.1 per 100 000 person-years between 1982-1995 and 2009-2012 (P trend <0.001). The SIR was 35.3 (95% confidence interval 29.5-42.0), and there was an inverse association between SIR and increasing age (P trend <0.001). In multivariate analyses, ASCC incidence was significantly higher in recent years (P trend <0.001), in those who acquired HIV through male homosexual contact (P = 0.002), and in those who had a history of AIDS (P < 0.001).

Conclusion: PLWHIV in Australia are at markedly higher risk of anal cancer. Unlike in some industrialized countries with a mature HIV epidemic, the incidence of anal cancer is still increasing in this population in Australia.
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http://dx.doi.org/10.1097/QAD.0000000000002218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141812PMC
July 2019

Are Parent-Held Child Health Records a Valuable Health Intervention? A Systematic Review and Meta-Analysis.

Int J Environ Res Public Health 2019 01 14;16(2). Epub 2019 Jan 14.

Faculty of Medicine and Health Sciences, Macquarie University, NSW 2109, Australia.

Parent-held child health record (PHCHR), a public health intervention for promoting access to preventive health services, have been in use in many developed and developing countries. This review aimed to evaluate the use of the records toward promoting child health/development. We searched PubMed, PsycINFO, CINAHL, Cochrane Library and Google Scholar to identify relevant articles, of which 32 studies met the inclusion criteria. Due to considerable heterogeneity, findings were narratively synthesised. Outcomes with sufficient data were meta-analysed using a random-effects model. Odds Ratio (OR) was used to compute the pooled effect sizes at 95% confidence interval (CI). The pooled effect of the PHCHR on the utilisation of child/maternal healthcare was not statistically significant (OR = 1.31, 95% CI 0.92⁻1.88). However, parents who use the record in low- and middle-income countries (LMIC) were approximately twice as likely to adhere to child vaccinations (OR = 1.93, 95% CI 1.01⁻3.70), utilise antenatal care (OR = 1.60, 95% CI 1.23⁻2.08), and better breastfeeding practice (OR = 2.82, 95%CI 1.02⁻7.82). Many parents (average-72%) perceived the PHCHR as useful/important and majority (average-84%) took it to child clinics. Health visitors and nurses/midwives were more likely to use the record than hospital doctors. It is concluded that parents generally valued the PHCHR, but its effect on child health-related outcomes have only been demonstrated in LMIC.
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http://dx.doi.org/10.3390/ijerph16020220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352207PMC
January 2019

Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study.

Int J Drug Policy 2018 12 22;62:14-23. Epub 2018 Oct 22.

The Kirby Institute, UNSW Sydney, Sydney, Australia.

Background: This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection.

Methods: SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1-6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics.

Results: Among 103 participants, 97% (n = 100) completed treatment. Median adherence to therapy was 94%. Overall, 32% (n = 33) were considered non-adherent (<90% adherence). Adherence significantly decreased over the course of therapy. Recent stimulant injecting (cocaine and/or amphetamines) at treatment initiation and during treatment was independently associated with non-adherence. Inconsistent dose timing (standard deviation of daily dose timing of ≥240 min) was also independently associated with non-adherence to therapy. Factors associated with inconsistent dose timing included lower levels of education and recent stimulant injecting. SVR was similar among adherent and non-adherent populations (94% vs. 94%, P = 0.944).

Conclusion: This study demonstrated high adherence to once-daily sofosbuvir/velpatasvir therapy among a population of people with recent injecting drug use. Recent stimulant injecting prior to and during DAA therapy and inconsistent dose-timing during treatment was associated with non-adherence. However, there was no impact of non-adherence on response to therapy, suggesting that adherence is not a significant barrier to successful DAA therapy in people with recent injecting drug use.
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http://dx.doi.org/10.1016/j.drugpo.2018.08.013DOI Listing
December 2018

Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study.

Lancet HIV 2018 11 17;5(11):e629-e637. Epub 2018 Oct 17.

Liverpool Sexual Health Clinic, Liverpool, NSW, Australia.

Background: HIV pre-exposure prophylaxis (PrEP) is highly effective in men who have sex with men (MSM) at the individual level, but data on population-level impact are lacking. We examined whether rapid, targeted, and high-coverage roll-out of PrEP in an MSM epidemic would reduce HIV incidence in the cohort prescribed PrEP and state-wide in Australia's most populous state, New South Wales.

Methods: The Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) study is an implementation cohort study of daily co-formulated tenofovir disoproxil fumarate and emtricitabine as HIV PrEP. We recruited high-risk gay men in a New South Wales-wide network of 21 clinics. We report protocol-specified co-primary outcomes at 12 months after recruitment of the first 3700 participants: within-cohort HIV incidence; and change in population HIV diagnoses in New South Wales between the 12-month periods before and after PrEP roll-out. The study is registered with ClinicalTrials.gov, number NCT02870790.

Findings: We recruited 3700 participants in the 8 months between March 1, 2016, and Oct 31, 2016. 3676 (99%) were men, 3534 (96%) identified as gay, and 149 (4%) as bisexual. Median age was 36 years (IQR 30-45 years). Overall, 3069 (83%) participants attended a visit at 12 months or later. Over 4100 person-years, two men became infected with HIV (incidence 0·048 per 100 person-years, 95% CI 0·012-0·195). Both had been non-adherent to PrEP. HIV diagnoses in MSM in New South Wales declined from 295 in the 12 months before PrEP roll-out to 221 in the 12 months after (relative risk reduction [RRR] 25·1%, 95% CI 10·5-37·4). There was a decline both in recent HIV infections (from 149 to 102, RRR 31·5%, 95% CI 11·3 to 47·3) and in other HIV diagnoses (from 146 to 119, RRR 18·5%, 95% CI -4·5 to 36·6).

Interpretation: PrEP implementation was associated with a rapid decline in HIV diagnoses in the state of New South Wales, which was greatest for recent infections. As part of a combination prevention approach, rapid, targeted, high-coverage PrEP implementation is effective to reduce new HIV infections at the population level.

Funding: New South Wales Ministry of Health, Gilead Sciences.
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http://dx.doi.org/10.1016/S2352-3018(18)30215-7DOI Listing
November 2018

Evaluation of a Hepatitis C Virus Core Antigen Assay in Plasma and Dried Blood Spot Samples.

J Mol Diagn 2018 09 26;20(5):621-627. Epub 2018 Jun 26.

Kirby Institute, University of New South Wales, Sydney, Australia. Electronic address:

Simplified, affordable tools to diagnose active hepatitis C virus (HCV) infection are needed to scale up treatment. This study evaluated the analytical performance of HCV core antigen (HCVcAg) detection in samples of plasma and dried venous blood spots (DBSs). Paired plasma and DBS samples were prepared from remnant diagnostic samples, and plasma HCV RNA and HCVcAg were quantified. Sensitivity and specificity for HCVcAg (>3 fmol/L) at two HCV RNA thresholds (≥15 and ≥3000 IU/mL) were calculated. Of 120 paired samples tested, 25 had nonquantifiable HCV RNA and 95 had quantifiable HCV RNA. The median HCV RNA level in plasma was 5.6 log IU/mL (interquartile range: 5.2 to 6.2). The median HCVcAg levels in plasma and DBS samples were 2.3 log fmol/L (interquartile range: 0.1 to 3.1) and 1.1 log fmol/L (interquartile range: 0.0 to 1.9), respectively. For diagnosing HCV RNA ≥3000 IU/mL, the sensitivity and specificity of HCVcAg in plasma were 97.7% (95% CI, 91%-100%) and 100% (95% CI, 87%-100%), respectively. The sensitivity and specificity of HCVcAg in DBS were 88.6% (95% CI, 80%-94%) and 97% (95% CI, 82%-100%), respectively. The data from this study demonstrate good sensitivity and specificity of HCVcAg in plasma at an HCV RNA threshold of ≥3000 IU/mL. The level of HCVcAg quantified in plasma was higher than that in DBS.
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http://dx.doi.org/10.1016/j.jmoldx.2018.05.010DOI Listing
September 2018

Mortality trends among people with hepatitis B and C: a population-based linkage study, 1993-2012.

BMC Infect Dis 2018 05 9;18(1):215. Epub 2018 May 9.

Biostatistics and Databases Program, The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW, Sydney, NSW, 2052, Australia.

Background: This study evaluated cause-specific mortality trends including liver-related mortality among people with a hepatitis B virus (HBV) and hepatitis C virus (HCV) notification in New South Wales, Australia.

Methods: Notifications 1993-2012 were linked to cause-specific mortality records 1993-2013.

Results: Among 57,929 and 92,474 people with a HBV and HCV notification, 4.8% and 10.0% died since 1997. In early 2010s, 28% and 33% of HBV and HCV deaths were liver-related, 28% and 17% were cancer-related (excluding liver cancer), and 5% and 15% were drug-related, respectively. During 2002-2012, annual HBV-related liver death numbers were relatively stable (53 to 68), while HCV-related liver death numbers increased considerably (111 to 284). Age-standardised HBV-related liver mortality rates declined from 0.2 to 0.1 per 100 person-years (PY) (P < 0.001); however, HCV-related rates remained stable (0.2 to 0.3 per 100 PY, P = 0.619). In adjusted analyses, older age was the strongest predictor of liver-related mortality [birth earlier than 1945, HBV adjusted hazard ratio (aHR) 28.1, 95% CI 21.0, 37.5 and; HCV aHR 31.9, 95% CI 26.8, 37.9], followed by history of alcohol-use disorder (HBV aHR 7.0, 95% CI 5.5, 8.8 and; HCV aHR 8.3, 95% CI 7.6, 9.1).

Conclusions: Declining HBV-related liver mortality rates and stable burden suggest an impact of improved antiviral therapy efficacy and uptake. In contrast, the impact of interferon-containing HCV treatment programs on liver-related mortality individual-level risk and population-level burden has been limited. These findings also highlight the importance of HBV/HCV public health interventions that incorporate increased antiviral therapy uptake, and action on health risk behaviors.
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http://dx.doi.org/10.1186/s12879-018-3110-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944091PMC
May 2018

Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay.

J Infect Dis 2018 05;217(12):1889-1896

The Kirby Institute, UNSW Sydney, Sydney, Australia.

Point-of-care hepatitis C virus (HCV) RNA testing is advantageous, enabling diagnosis of active infection in a single visit. This study evaluated the sensitivity and specificity of the Xpert HCV Viral Load Finger-Stick assay (Xpert HCV VL FS) for HCV RNA detection (finger-stick) and the Xpert HCV Viral Load assay (plasma) compared with the Abbott RealTime HCV Viral Load assay by venepuncture. Plasma and finger-stick capillary whole-blood samples were collected from participants in an observational cohort in Australia. Of 223 participants enrolled, HCV RNA was detected in 40% of participants (85 of 210) with available Xpert HCV Viral Load testing. Participants receiving HCV therapy were excluded from subsequent analyses (n = 16). Sensitivity of the Xpert HCV Viral Load assay for HCV RNA quantification in plasma collected by venepuncture was 100.0% (95% confidence interval [CI] 96.9%-100.0%) and specificity was 100.0% (95% CI, 94.4%-100.0%). Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% CI, 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.
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http://dx.doi.org/10.1093/infdis/jiy114DOI Listing
May 2018

Correction: expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in new South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

BMC Public Health 2018 02 28;18(1):297. Epub 2018 Feb 28.

The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.

After publication of the article [1], it has been brought to our attention that one of the members of the EPIC-NSW study group has had their name spelt incorrectly in the acknowledgements. The article mentions "Muhammad Hammoud" when in fact the correct spelling is "Mohamed Hammoud".
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http://dx.doi.org/10.1186/s12889-018-5173-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831707PMC
February 2018

Survival following hospitalization with hepatocellular carcinoma among people notified with hepatitis B or C virus in Australia (2000-2014).

Hepatol Commun 2017 10 16;1(8):736-747. Epub 2017 Aug 16.

The Kirby Institute UNSW Sydney Sydney Australia.

We assessed trends in HCC survival in patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection in New South Wales, Australia. Data on HBV (n = 54,399) and HCV (n = 96,908) notifications (1993-2012) were linked to a hospitalization database (July 2000-June 2014), the New South Wales Cancer Registry, and the New South Wales Death Registry. A total of 725 (1.3%) first HBV-hepatocellular carcinoma (HCC) and 1,309 (1.4%) first HCV-HCC hospitalizations were included. Death occurred in 60.4% of HBV-HCC and 69.6% of HCV-HCC patients. Median survival following first HBV-HCC hospitalization improved from 0.6 years (95% confidence interval [CI] 0.39-1.28) in 2000-2004 to 2.8 years (1.54-5.54) in 2010-2014. Median survival following first HCV-HCC hospitalization was 0.8 years (0.45-1.33) in 2000-2004 and 0.9 (0.67-1.18) in 2010-2014. One-year HBV-HCC survival in 2010-2014 compared to 2000-2004 improved for those with (94% versus 81%) and without (42% versus 33%) potentially curative procedures (liver resection, liver transplantation, and radiofrequency ablation). Factors associated with improved survival following HBV-HCC were later study period (hazard ratio [HR] = 0.74; 95% CI, 0.57-0.97) and potentially curative procedures (liver resection, liver transplantation, and radiofrequency ablation) (HR = 0.23; 95% CI, 0.17-0.29), while male gender (HR = 1.37; 95% CI, 1.03-1.82), human immunodeficiency virus coinfection (HR = 3.06; 95% CI, 1.36-6.88), and Charlson Comorbidity Index ≥3 (HR = 1.81; 95% CI, 1.35-2.40) were associated with reduced survival. Factors associated with improved survival following HCC-HCV were Asia-Pacific country of birth (HR = 0.68; 95% CI, 0.55-0.84) and potentially curative procedures (HR = 0.21; 95% CI, 0.17-0.25), while age (HR = 1.01; 95% CI, 1.01-1.02), rural place of residence (HR = 1.46; 95% CI, 1.22-1.74), and human immunodeficiency virus coinfection (HR = 2.71; 95% CI, 1.19-6.15) were associated with reduced survival. : All-cause survival following HBV-HCC has improved considerably, suggesting an impact of more effective antiviral therapy and earlier HCC diagnosis; in contrast, all-cause survival for HCV-HCC is unchanged. ( 2017;1:736-747).
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http://dx.doi.org/10.1002/hep4.1073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5678911PMC
October 2017

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

BMC Public Health 2018 02 2;18(1):210. Epub 2018 Feb 2.

The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.

Background: The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals.

Methods: EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW.

Discussion: EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic.

Trial Registration: https://clinicaltrials.gov/ (identifying number NCT02870790 ; registration date 14 August 2016), pre-results stage.
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http://dx.doi.org/10.1186/s12889-017-5018-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797394PMC
February 2018

Longitudinal injecting risk behaviours among people with a history of injecting drug use in an Australian prison setting: The HITS-p study.

Int J Drug Policy 2018 04 24;54:18-25. Epub 2018 Jan 24.

The Kirby Institute, UNSW Sydney, Sydney, Australia.

Background: HCV transmission remains high in prisons globally. Understanding injecting risk behaviours in prisons is crucial to effectively develop and implement HCV prevention programs in this setting including treatment as prevention.

Methods: HITS-p is a cohort study which enrolled people with a history of injecting drug use in prisons in NSW, Australia from 2005 to 2013. Participants completed an interview at enrolment and follow-up visits to determine injecting behaviours. Generalized estimating equation (GEE) and logistic regression methods were used to assess injecting risk behaviours prior to and following prison entry and to investigate injecting risk behaviours in prison.

Results: Overall, 499 participants with a history of injecting drug use were included (median age, 26 years; 65% male). Participants were significantly less likely to inject drugs following incarceration. Among injectors, participants were less likely to inject ≥weekly but more likely to share a needle/syringe. At enrolment, the proportion reporting any injecting, ≥weekly injecting, and needle/syringe sharing in prison was highest among younger individuals. Younger age was associated with both re-initiation and continuation of injecting drug use following prison entry. Among those continuously imprisoned, younger age was associated with increased odds of any injecting, ≥weekly injecting, and sharing a needle/syringe.

Conclusions: Upon entry to prison, injecting drug use decreased but syringe sharing increased among injectors. Younger individuals are most likely to exhibit high-risk injecting behaviours in prison. These data highlight the need for improved HCV prevention strategies (including improved needle/syringe access and scale up of HCV therapy) for those at increased risk of HCV transmission in prison, including younger individuals.
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http://dx.doi.org/10.1016/j.drugpo.2017.12.013DOI Listing
April 2018

Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.

Lancet Gastroenterol Hepatol 2018 03 6;3(3):153-161. Epub 2018 Jan 6.

Auckland City Hospital, Auckland, New Zealand.

Background: Despite revised guidelines that no longer exclude people who inject drugs (PWID) from treatment for hepatitis C virus (HCV) infection, many clinicians are reluctant to treat recent PWID. This study aimed to evaluate the efficacy of sofosbuvir and velpatasvir therapy in people with chronic HCV infection and recent injection drug use.

Methods: In this open-label, single-arm phase 4 trial (SIMPLIFY), we recruited participants with recent injection drug use (past 6 months) and chronic HCV genotype 1-6 infection from seven countries (19 sites). Participants received oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks. Therapy was given in 1-week electronic blister packs to record the time and date of each dose. The primary endpoint was the proportion of patients with sustained virological response 12 weeks after completion of treatment (SVR12; defined as HCV RNA <12 IU/mL), analysed in all patients who received at least one dose. This study is registered with ClinicalTrials.gov, number NCT02336139, and follow-up is ongoing to evaluate the secondary endpoint of HCV reinfection.

Findings: Between March 29, and Oct 31, 2016, we enrolled 103 participants; 29 (28%) of whom were female, nine (9%) had cirrhosis, 36 (35%) had HCV genotype 1, five (5%) had genotype 2, 60 (58%) had genotype 3, and two (2%) had genotype 4. 61 (59%) participants were receiving opioid substitution therapy during the study, 76 (74%) injected in the past month, and 27 (26%) injected at least daily in the past month. 100 (97%) of 103 participants completed treatment; two people were lost to follow-up and one person died from an overdose. There were no virological failures. 97 (94%, 95% CI 88-98) of 103 people achieved SVR12. Three participants with an end-of-treatment response did not have a SVR; two were lost to follow-up and one had reinfection. Drug use before and during treatment did not affect SVR12. Treatment-related adverse events were seen in 48 (47%) patients (one grade 3, no grade 4). Seven (7%) patients had at least one serious adverse event; only one such event (rhabdomyolysis, resolved) was possibly related to the therapy. One case of HCV reinfection was observed.

Interpretation: HCV treatment should be offered to PWID, irrespective of ongoing drug use. Recent injection drug use should not be used as a reason to withhold reimbursement of HCV therapy.

Funding: Gilead Sciences.
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http://dx.doi.org/10.1016/S2468-1253(17)30404-1DOI Listing
March 2018

Relationship between untimed plasma lopinavir concentrations and virological outcome on second-line antiretroviral therapy.

AIDS 2018 01;32(3):357-361

The Kirby Institute, University of New South Wales, Sydney, Australia.

Background: Resource constraints in low and middle-income countries necessitate practical approaches to optimizing antiretroviral therapy outcomes. We hypothesised that an untimed plasma lopinavir concentration (UPLC) at week 12 would predict loss of virological response in those taking lopinavir as part of a second-line antiretroviral regimen.

Methods: We measured plasma lopinavir concentration at week 12 on stored samples from the SECOND-LINE study. We characterized UPLC as: detectable and optimal (≥1000 μg/l); detectable but suboptimal (≥25 to < 1000 μg/l); and undetectable (<25 μg/l). We used Cox regression to explore the relationship between UPLC and loss of virological response over 48 weeks and backwards stepwise logistic regression to explore the relationship between UPLC and other predictors of virological failure at week 48.

Results: At week 48, we observed virological failure in 15/32 (47%) and 53/485 (11%) of patients with undetectable and detectable UPLC, respectively, P < 0.001. Both suboptimal [adjusted hazard ratio (HR) 2.94; 95% confidence interval (CI) 1.54-5.62; P = 0.001], and undetectable (adjusted HR 3.55; 95% CI 1.89-6.64; P < 0.001) UPLC were associated with higher rates of loss of virological response over 48 weeks. In multivariate analysis, an independent association with virological failure at week 48 and undetectable UPLC was observed after adjustment (odds ratio 5.48; 95% CI 2.23-13.42; P < 0.01).

Conclusion: In low and middle-income countries implementing a public health approach to antiretroviral therapy treatment, an untimed plasma drug concentration may provide a practical method for early identification of patients with inadequate medication adherence and facilitate timely corrective interventions to prevent virological failure.
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http://dx.doi.org/10.1097/QAD.0000000000001688DOI Listing
January 2018