Publications by authors named "Hamish McManus"

35 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

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

A new method for estimating the incidence of infectious diseases: Response to De Monte and Hudgens.

Am J Epidemiol 2021 Apr 20. Epub 2021 Apr 20.

Disease Elimination Program, The Burnet Institute, Melbourne, VIC, Australia.

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http://dx.doi.org/10.1093/aje/kwab117DOI Listing
April 2021

A New Method for Estimating the Incidence of Infectious Diseases.

Am J Epidemiol 2021 Feb 4. Epub 2021 Feb 4.

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

Ambitious World Health Organization targets for disease elimination require monitoring of epidemics using routine health data in settings of decreasing and low incidence. We evaluated two methods commonly applied to routine testing results to estimate incidence rates that assume uniform probability of infection between consecutive negative and positive tests based on: 1. the midpoint of this interval; and 2. a randomly selected point on this interval. We compared these with an approximation to the Poisson-binomial distribution which assigns partial incidence to time-periods based on the uniform probability of occurrence in these intervals. We assessed bias, variance and convergence of estimates using simulations of Weibull distributed failure times with systematically varied baseline incidence, and varying trend. We considered results for quarterly, half-yearly and yearly incidence estimation frequencies. We applied methods to assess human immunodeficiency virus (HIV) incidence in HIV-negative patients from the Treatment with Antiretrovirals and their Impact on Positive And Negative men study between 2012 and 2018. The Poisson-binomial method had reduced bias and variance at low levels of incidence and for increased estimation frequency, with increased consistency of estimation. Application of methods to real-world assessment of HIV incidence found decreased variance in Poisson-binomial model estimates, with observed incidence declining to levels where simulation results had indicated bias in midpoint and random-point methods.
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http://dx.doi.org/10.1093/aje/kwab014DOI 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

Privacy-Preserving Record Linkage of Deidentified Records Within a Public Health Surveillance System: Evaluation Study.

J Med Internet Res 2020 06 24;22(6):e16757. Epub 2020 Jun 24.

Burnet Institute, Melbourne, Australia.

Background: The Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) was established to monitor national testing and test outcomes for blood-borne viruses (BBVs) and sexually transmissible infections (STIs) in key populations. ACCESS extracts deidentified data from sentinel health services that include general practice, sexual health, and infectious disease clinics, as well as public and private laboratories that conduct a large volume of BBV/STI testing. An important attribute of ACCESS is the ability to accurately link individual-level records within and between the participating sites, as this enables the system to produce reliable epidemiological measures.

Objective: The aim of this study was to evaluate the use of GRHANITE software in ACCESS to extract and link deidentified data from participating clinics and laboratories. GRHANITE generates irreversible hashed linkage keys based on patient-identifying data captured in the patient electronic medical records (EMRs) at the site. The algorithms to produce the data linkage keys use probabilistic linkage principles to account for variability and completeness of the underlying patient identifiers, producing up to four linkage key types per EMR. Errors in the linkage process can arise from imperfect or missing identifiers, impacting the system's integrity. Therefore, it is important to evaluate the quality of the linkages created and evaluate the outcome of the linkage for ongoing public health surveillance.

Methods: Although ACCESS data are deidentified, we created two gold-standard datasets where the true match status could be confirmed in order to compare against record linkage results arising from different approaches of the GRHANITE Linkage Tool. We reported sensitivity, specificity, and positive and negative predictive values where possible and estimated specificity by comparing a history of HIV and hepatitis C antibody results for linked EMRs.

Results: Sensitivity ranged from 96% to 100%, and specificity was 100% when applying the GRHANITE Linkage Tool to a small gold-standard dataset of 3700 clinical medical records. Medical records in this dataset contained a very high level of data completeness by having the name, date of birth, post code, and Medicare number available for use in record linkage. In a larger gold-standard dataset containing 86,538 medical records across clinics and pathology services, with a lower level of data completeness, sensitivity ranged from 94% to 95% and estimated specificity ranged from 91% to 99% in 4 of the 6 different record linkage approaches.

Conclusions: This study's findings suggest that the GRHANITE Linkage Tool can be used to link deidentified patient records accurately and can be confidently used for public health surveillance in systems such as ACCESS.
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http://dx.doi.org/10.2196/16757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381059PMC
June 2020

The Association between the Australian Alcopops Tax and National Chlamydia Rates among Young People-an Interrupted Time Series Analysis.

Int J Environ Res Public Health 2020 02 19;17(4). Epub 2020 Feb 19.

Kirby Institute, University of New South Wales, Level 6, Wallace Wurth Building, High Street, Kensington NSW 2052, Australia.

A national tax increase, which became known as the "alcopops tax", was introduced in Australia on the 27th April 2008 on ready-to-drink alcoholic beverages, which are consumed predominantly by young people. The affordability of alcohol has been identified as the strongest environmental driver of alcohol consumption, and alcohol consumption is a well-known risk factor in the spread of sexually transmitted infections via its association with sexual risk-taking. We conducted a study to investigate whether there was any association between the introduction of the tax and changes in national chlamydia rates: (i) notification rates (diagnoses per 100,000 population; primary outcome and standard approach in alcohol taxation studies), and (ii) test positivity rates (diagnoses per 100 tests; secondary outcome) among 15-24 and 25-34-year-olds, using interrupted time series analysis. Gender- and age-specific chlamydia trends among those 35 and older were applied as internal control series and gender- and age-specific consumer price index-adjusted per capita income trends were controlled for as independent variables. We hypothesised that the expected negative association between the tax and chlamydia notification rates might be masked due to increasing chlamydia test counts over the observation period (2000 to 2016). We hypothesised that the association between the tax and chlamydia test positivity rates would occur as an immediate level decrease, as a result of a decrease in alcohol consumption, which, in turn, would lead to a decrease in risky sexual behaviour and, hence, chlamydia transmission. None of the gender and age-specific population-based rates indicated a significant immediate or lagged association with the tax. However, we found an immediate decrease in test positivity rates for 25-34-year-old males (27% reduction-equivalent to 11,891 cases prevented post-tax) that remained detectable up to a lag of six months and a decrease at a lag of six months for 15-24-year-old males (31% reduction-equivalent to 16,615 cases prevented) following the tax. For no other gender or age combination did the change in test positivity rates reach significance. This study adds to the evidence base supporting the use of alcohol taxation to reduce health-related harms experienced by young people and offers a novel method for calculating sexually transmitted infection rates for policy evaluation.
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http://dx.doi.org/10.3390/ijerph17041343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7068511PMC
February 2020

Adherence to Antiretroviral Regimens in Australia: A Nationwide Cohort Study.

AIDS Patient Care STDS 2020 02;34(2):81-91

Faculty of Medicine, Centre for Big Data Research in Health, UNSW Sydney, Sydney, Australia.

The lifetime use of combination antiretroviral therapy (cART) highlights the need to understand patterns of and factors associated with adherence to cART. In this cohort study using a 10% random sample of dispensing claims data for eligible Australians, we identified 2042 people dispensed cART between January 2016 and December 2017 (mean age 48.0 ± 12.0 years old, 88.6% male, and 85.9% treatment experienced). We considered people to be adherent if the proportion of treatment coverage days was ≥80% in the 360 days after their first observed cART dispensing. We also used group-based trajectory modeling (GBTM) to examine different patterns of adherence for 360 days from first observed cART dispensing. Most commonly, people receiving cART were treated with two nucleoside/nucleotide reverse transcriptase inhibitors with an integrase strand transfer inhibitors (INSTI-46.6%). Overall, 1708 people [83.6% (95% confidential interval 82.0-85.3%)] remained adherent over 360 days. GBTM identified three distinct adherence patterns: nearly always adherent [67.8% (63.7-71.9%) of the cohort], moderate adherence [26.6% (23.0-30.1%)], and low adherence [5.6% (4.1-7.2%)]. People were more likely to belong to the "nearly always adherent" trajectory if they were older (per additional year of age), treated with an INSTI regimen, and on treatment for more than 6 months. Our study demonstrates that the 360-day adherence to cART is generally high, but approximately one-third maintain a moderate or low adherence pattern. The use of INSTI regimens and additional support of treatment adherence, especially among younger people and those initiating therapy, may further improve adherence.
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http://dx.doi.org/10.1089/apc.2019.0278DOI Listing
February 2020

Two Distinct Gonorrhea Trends and Risk Factors Among Women in Australia.

Sex Transm Dis 2020 01;47(1):34-40

From the The Kirby Institute, UNSW Sydney, Sydney, Australia.

Background: In recent years, gonorrhea notifications have increased in women in Australia and other countries. We measured trends over time and risk factors among Australian Aboriginal and Torres Strait Islander ("Aboriginal") and non-Aboriginal women.

Methods: We conducted a cross-sectional analysis of data from 41 sexual health clinics. Gonorrhea positivity at each patient's first visit (first-test positivity) during the period 2009 to 2016 was calculated. Univariate and multivariate analyses assessed risk factors for first-test positivity in Aboriginal and non-Aboriginal women.

Results: Gonorrhea positivity decreased among Aboriginal women (7.1% in 2009 to 5.2% in 2016, P < 0.001) and increased among non-Aboriginal women (0.6%-2.9%, P < 0.001). Among Aboriginal women, first-test positivity was independently associated with living in a regional or remote area (adjusted odds ratio [aOR], 4.29; 95% confidence interval [CI], 2.52-7.31; P < 0.01) and chlamydia infection (aOR, 4.20; 95% CI,3.22-5.47; P < 0.01). Among non-Aboriginal women, first-test positivity was independently associated with greater socioeconomic disadvantage (second quartile: aOR, 1.68 [95% CI, 1.31-2.16; P < 0.01]; third quartile: aOR, 1.54 [95% CI, 1.25-1.89; P < 0.01]) compared with least disadvantaged quartile: recent sex work (aOR, 1.69; 95% CI, 1.37-2.08; P < 0.01), recent injecting drug use (aOR, 1.85; 95% CI, 1.34-2.57; P < 0.01), and chlamydia infection (aOR, 2.35; 95% CI, 1.90-2.91; P < 0.01). For non-Aboriginal women, being aged 16 to 19 years (aOR, 0.62; 95% CI, 0.49-0.80; P < 0.01) compared with those ≥30 years was a protective factor.

Conclusions: These findings highlight 2 different epidemics and risk factors for Aboriginal and non-Aboriginal women, which can inform appropriate health promotion and clinical strategies.
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http://dx.doi.org/10.1097/OLQ.0000000000001086DOI Listing
January 2020

Comorbidity Medications Are Dispensed to More People Receiving Antiretroviral Therapy for HIV Compared with the General Population in Australia.

AIDS Res Hum Retroviruses 2020 04 16;36(4):291-296. Epub 2020 Jan 16.

Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.

Medical comorbidities occur in more persons with HIV than without HIV. We used a nationally representative 10% sample of 2016 Pharmaceutical Benefits Scheme (PBS) dispensing data to compare the proportions of antiretroviral therapy (ART)-purchasing and non-ART-purchasing patients who also purchased prescriptions for medical comorbidities. Each patient who purchased ART was compared with two gender- and age group-matched patients who did not purchase ART in the same year. We calculated the proportions of patients who also purchased coprescriptions used for hypertension, dyslipidemia, diabetes, cancer, low bone mineral density, and mental health, defined using PBS medication coding categories, and the resulting odds ratios. A total of 1,973 ART-purchasing patients in our sample were matched to 3,946 non-ART-purchasing patients. Compared with non-ART-purchasing patients, a greater proportion of ART-purchasing patients also purchased medications for dyslipidemia (19.8% vs. 16.6%; -value = .003), low bone mineral density (1.5% vs. 0.8%; -value = .02), and mental health (29.1% vs. 15.3%; -value < .0001); a lower proportion purchased diabetes medications (4.8% vs. 6.5%; -value = .009). These differences remained when our analysis was restricted to persons >55 years of age. Rates of multimorbidity (dispensed ≥2 medications for chronic conditions) were also higher among ART-purchasing patients (19.0% vs. 15.9%; -value = .003). Using a nationally representative sample of prescription dispensing data, we found that higher proportions of ART-purchasing patients purchased coprescriptions for common comorbidities compared with non-ART-purchasing patients. Our finding that ART-purchasing patients purchased fewer diabetes medications is surprising, but may reflect differences in population characteristics between our two groups.
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http://dx.doi.org/10.1089/AID.2019.0117DOI Listing
April 2020

Strategies to improve control of sexually transmissible infections in remote Australian Aboriginal communities: a stepped-wedge, cluster-randomised trial.

Lancet Glob Health 2019 11;7(11):e1553-e1563

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

Background: Remote Australian Aboriginal communities have among the highest diagnosed rates of sexually transmissible infections (STIs) in the world. We did a trial to assess whether continuous improvement strategies related to sexual health could reduce infection rates.

Methods: In this stepped-wedge, cluster-randomised trial (STIs in remote communities: improved and enhanced primary health care [STRIVE]), we recruited primary health-care centres serving Aboriginal communities in remote areas of Australia. Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population. The health-care centres were grouped into clusters on the basis of geographical proximity to each other, population size, and Aboriginal cultural ties including language connections. Clusters were randomly assigned into three blocks (year 1, year 2, and year 3 clusters) using a computer-generated randomisation algorithm, with minimisation to balance geographical region, population size, and baseline STI testing level. Each year for 3 years, one block of clusters was transitioned into the intervention phase, while those not transitioned continued usual care (control clusters). The intervention phase comprised cycles of reviewing clinical data and modifying systems to support improved STI clinical practice. All investigators and participants were unmasked to the intervention. Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. We used Poisson regression analyses on the final dataset and compared STI prevalences and testing coverage between control and intervention clusters. All analyses were by intention to treat and models were adjusted for time as an independent covariate in overall analyses. This study was registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12610000358044.

Findings: Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11 286), year 2 clusters (n=10 288), or year 3 clusters (n=13 304). One primary health-care centre withdrew from the study due to restricted capacity to participate. We detected no difference in the relative prevalence of STIs between intervention and control clusters (adjusted relative risk [RR] 0·97, 95% CI 0·84-1·12; p=0·66). However, testing coverage was substantially higher in intervention clusters (22%) than in control clusters (16%; RR 1·38; 95% CI 1·15-1·65; p=0·0006).

Interpretation: Our intervention increased STI testing coverage but did not have an effect on prevalence. Additional interventions that will provide increased access to both testing and treatment are required to reduce persistently high prevalences of STIs in remote communities.

Funding: Australian National Health and Medical Research Council.
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http://dx.doi.org/10.1016/S2214-109X(19)30411-5DOI Listing
November 2019

Population-level diagnosis and care cascade for chlamydia in Australia.

Sex Transm Infect 2020 03 5;96(2):131-136. Epub 2019 Jun 5.

The Kirby Institute, Faculty of Medicine, UNSW Sydney, Kensington, New South Wales, Australia.

Objectives: Key strategies to control chlamydia include testing, treatment, partner management and re-testing. We developed a diagnosis and care cascade for chlamydia to highlight gaps in control strategies nationally and to inform efforts to optimise control programmes.

Methods: The Australian Chlamydia Cascade was organised into four steps: (1) annual number of new chlamydia infections (including re-infections); (2) annual number of chlamydia diagnoses; (3) annual number of diagnoses treated; (4) annual number of diagnoses followed by a re-test for chlamydia within 42-180 days of diagnosis. For 2016, we estimated the number of infections among young men and women aged 15-29 years in each of these steps using a combination of mathematical modelling, national notification data, sentinel surveillance data and previous research studies.

Results: Among young people in Australia, there were an estimated 248 580 (range, 240 690-256 470) new chlamydia infections in 2016 (96 470 in women; 152 100 in men) of which 70 164 were diagnosed (28.2% overall: women 43.4%, men 18.6%). Of the chlamydia infections diagnosed, 65 490 (range, 59 640-70 160) were treated (93.3% across all populations), but only 11 330 (range, 7660-16 285) diagnoses were followed by a re-test within 42-180 days (17.3% overall: women 20.6%, men 12.5%) of diagnosis.

Conclusions: The greatest gaps in the Australian Chlamydia Cascade for young people were in the diagnosis and re-testing steps, with 72% of infections undiagnosed and 83% of those diagnosed not re-tested: both were especially low among men. Treatment rates were also lower than recommended by guidelines. Our cascade highlights the need for enhanced strategies to improve treatment and re-testing coverage such as short message service reminders, point-of-care and postal test kits.
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http://dx.doi.org/10.1136/sextrans-2018-053801DOI Listing
March 2020

Early initiation of antiretroviral therapy for people newly diagnosed with HIV infection in Australia: trends and predictors, 2004-2015.

Med J Aust 2019 04 18;210(6):269-275. Epub 2019 Feb 18.

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

Objectives: To determine trends in and predictors of early treatment for people newly diagnosed with human immunodeficiency virus (HIV) infection in Australia.

Design, Setting: Retrospective cohort analysis of routinely collected longitudinal data from 44 sexual health clinics participating in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) program.

Participants: Patients diagnosed with HIV infections, January 2004 - June 2015.

Main Outcome Measures: Commencement of antiretroviral therapy within 6 months of HIV diagnosis (early treatment); demographic, clinical, and risk group characteristics of patients associated with early treatment; trends in early treatment, by CD4 cell count at diagnosis.

Results: 917 people were diagnosed with HIV infections, their median age was 34 years (interquartile range [IQR]: 27-43 years), and 841 (92%) were men; the median CD4 cell count at diagnosis was 510 cells/μL (IQR, 350-674 cells/μL). The proportion of patients who received early treatment increased from 17% (15 patients) in 2004-06 to 20% (34 patients) in 2007-09, 34% (95 patients) in 2010-12, and 53% (197 patients) in 2013-15 (trend, P < 0.001). The probability of early treatment, which increased with time, was higher for patients with lower CD4 cell counts and higher viral loads at diagnosis.

Conclusions: The proportion of people newly diagnosed with HIV in sexual health clinics in Australia who received treatment within 6 months of diagnosis increased from 17% to 53% during 2004-2015, reflecting changes in the CD4 cell count threshold in treatment guidelines. Nevertheless, further strategies are needed to maximise the benefits of treatment to prevent viral transmission and morbidity.
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http://dx.doi.org/10.5694/mja2.50006DOI Listing
April 2019

HIV diagnoses in migrant populations in Australia-A changing epidemiology.

PLoS One 2019 14;14(2):e0212268. Epub 2019 Feb 14.

Kirby Institute for Infection and Immunity, UNSW Sydney, Sydney, Australia.

Introduction: We conducted a detailed analysis of trends in new HIV diagnoses in Australia by country of birth, to understand any changes in epidemiology, relationship to migration patterns and implications for public health programs.

Methods: Poisson regression analyses were performed, comparing the age-standardised HIV diagnosis rates per 100,000 estimated resident population between 2006-2010 and 2011-2015 by region of birth, with stratification by exposure (male-to-male sex, heterosexual sex-males and females). Correlation between the number of permanent and long-term arrivals was also explored using linear regression models.

Results: Between 2006 and 2015, there were 6,741 new HIV diagnoses attributed to male-to-male sex and 2,093 attributed to heterosexual sex, with the proportion of diagnoses attributed to male-to-male sex who were Australian-born decreasing from 72.5% to 66.5%. Compared with 2006-2010, the average annual HIV diagnosis rate per 100,000 in 2011-15 attributed to male-to-male sex was significantly higher in men born in South-East Asia (summary rate ratio (SRR) = 1.37, p = 0.001), North-East Asia (SRR = 2.18, p<0.001) and the Americas (SRR = 1.37, p = 0.025), but significantly lower as a result of heterosexual sex in men born in South-East Asia (SRR = 0.49, p = 0.002), Southern and Central Asia (SRR = 0.50, p = 0.014) and Sub-Saharan Africa (SRR = 0.39, p<0.001) and women born in South-East Asia (SRR = 0.61, p = 0.002) and Sub-Saharan Africa (SRR = 0.61, p<0.001). Positive associations were observed between the number of permanent and long-term arrivals and HIV diagnoses particularly in relation to diagnoses associated with male-to-male sex in men from North Africa and the Middle East, North Asia, Southern and Central Asia and the Americas.

Conclusion: The epidemiology of HIV in Australia is changing, with an increase in HIV diagnosis rates attributed to male-to-male sex amongst men born in Asia and the Americas. Tailored strategies must be developed to increase access to, and uptake of, prevention, testing and treatment in this group.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212268PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6375626PMC
November 2019

HIV treatment regimens and adherence to national guidelines in Australia: an analysis of dispensing data from the Australian pharmaceutical benefits scheme.

BMC Public Health 2019 Jan 3;19(1):13. Epub 2019 Jan 3.

Kirby Institute, UNSW Sydney, Wallace Wurth Building, Sydney, NSW, 2052, Australia.

Background: Treatment guidelines for antiretroviral therapy (ART) have evolved to emphasize newer regimens that address ageing-related comorbidities. Using national Australian dispensing data we compare ART regimens with Australian HIV treatment guidelines in the context of treated comorbidities.

Methods: The study population included all individuals in a 10% sample of national data from the Australian Pharmaceutical Benefits Scheme (PBS) who purchased a prescription of ART during 2016. We defined each patient's most recently dispensed ART regimen and characterized them to evaluate regimen complexity and adherence to national HIV treatment guidelines. We then analyzed ART regimens in the context of other co-prescriptions purchased for defined comorbidities.

Results: The 1995 patients in our sample purchased 212 different ART regimens during 2016; 1524 (76.4%) purchased one of the top ten most common regimens of which 62.3% were integrase strand transfer inhibitor-based. Among the 1786 (90%) patients that purchased the most common regimens, 83.7% purchased a regimen recommended by the guidelines for initial antiretroviral therapy and 11.4% purchased antiretrovirals that are not recommended for initial therapy; < 1% of the entire cohort purchased medications not recommended for use. While most patients purchased optimal ART regimens with low potential for significant drug interactions, regimen choices in the setting of risk factors for heart disease, renal disease and low bone mineral density appeared suboptimal.

Conclusions: Australian HIV providers are prescribing ART regimens in accordance with updated treatment guidelines, but could further optimize regimens in the setting of important medical comorbidities.
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http://dx.doi.org/10.1186/s12889-018-6325-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318998PMC
January 2019

Gonorrhoea gone wild: rising incidence of gonorrhoea and associated risk factors among gay and bisexual men attending Australian sexual health clinics.

Sex Health 2019 09;16(5):457-463

The Kirby Institute, UNSW Sydney, Sydney, NSW 2052, Australia.

Background Gonorrhoea notifications continue to rise among gay and bisexual men in Australia and around the world. More information is needed on infection trends, accounting for testing and complimented by demographics and risk practices.

Methods: A retrospective cohort analysis was undertaken using repeat gonorrhoea testing data among gay and bisexual men from 2010 to 2017, which was extracted from a network of 47 sexual health clinics across Australia. Poisson and Cox regression analyses were used to determine temporal trends in gonorrhoea incidence rates, as well as associated demographic and behavioural factors.

Results: The present analysis included 46904 gay and bisexual men. Gonorrhoea incidence at any anatomical site increased from 14.1/100 person years (PY) in 2010 to 24.6/100 PY in 2017 (P<0.001), with the greatest increase in infections of the pharynx (5.6-15.9/100 PY, P<0.001) and rectum (6.6-14.8/100 PY, P<0.001). After adjusting for symptomatic and contact-driven presentations, the strongest predictors of infection were having more than 20 sexual partners in a year (hazard ratio (HR)=1.9, 95% confidence interval (CI): 1.7-2.2), using injecting drugs (HR=1.7, 95%CI: 1.4-2.0), being HIV positive (HR=1.4, 95%CI: 1.2-1.6) and being aged less than 30 years old (HR=1.4, 95%CI: 1.2-1.6).

Conclusions: Gonorrhoea has increased dramatically among gay and bisexual men in Australia. Enhanced prevention efforts, as well as more detailed, network-driven research are required to combat gonorrhoea among young men, those with HIV and those who use injecting drugs.
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http://dx.doi.org/10.1071/SH18097DOI Listing
September 2019

HIV incidence in Indigenous and non-Indigenous populations in Australia: a population-level observational study.

Lancet HIV 2018 09 7;5(9):e506-e514. Epub 2018 Aug 7.

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

Background: Australia has set a national target of ending HIV by 2020, achieving this will require the inclusion of priority populations (eg, Indigenous Australians) in strategies to reach elimination. To assist in evaluating the target of elimination, we analysed HIV notification data for Indigenous and non-Indigenous Australians.

Methods: Using the National HIV Registry at The Kirby Institute at UNSW, Sydney, NSW, Australia, we collated and analysed annual HIV notification data for 1996-2015. Patients who were not born in Australia were excluded. We calculated the rates of HIV diagnoses with annual trends in notification rates for Indigenous versus non-Indigenous Australians by demographic characteristics, exposure categories, and stage of HIV at diagnosis. For missing data, assumptions were made and verified through sensitivity analyses. Annual rate ratio (RR) and 4 year summary rate ratio (SRR) trends were calculated to determine patterns of HIV diagnosis in the two populations.

Findings: Between Jan 1, 1996, and Dec 31, 2015, 11 492 people born in Australia were reported with a diagnosis of HIV, of whom 461 (4%) were recorded as Indigenous Australians and we classified the remaining 11 031 (96%) as non-Indigenous Australians. For exposure to HIV, among Indigenous Australians a higher proportion of diagnoses occurred among women, and through injecting drug use and heterosexual sex than among non-Indigenous Australians (p<0·0001). Among Indigenous Australians, we found a significantly higher SRR of HIV diagnoses among men in the period 2012-15 than in previous periods (SRR 1·53, 95% CI 1·28-1·83; p<0·0001), and significantly higher diagnosis among Indigenous women (4·92, 4·02-6·02; p<0·0001) for the entire study period than among non-Indigenous women. Concurrently, a decrease in HIV diagnoses of 1% per annum (RR 0·99, 95% CI 0·98-0·99; p<0·0001) across the study period was seen among non-Indigenous people. Indigenous Australians were more likely to be diagnosed at an advanced stage of HIV infection than non-Indigenous Australians (20·8% vs 15·1%; p=0·0088).

Interpretation: Greater efforts should be made to include Indigenous people in prevention strategies, particularly newer biomedical interventions, such as scale up of pre-exposure prophylaxis and treatment as prevention initiatives in Australia. More involvement of Indigenous Australians in these approaches is also required to prevent widening of the gap in HIV diagnosis rates between non-Indigenous and Indigenous Australians.

Funding: None.
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http://dx.doi.org/10.1016/S2352-3018(18)30135-8DOI Listing
September 2018

National characteristics and trends in antiretroviral treatment in Australia can be accurately estimated using a large clinical cohort.

J Clin Epidemiol 2018 08 25;100:82-91. Epub 2018 Apr 25.

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

Objectives: Cohort studies are often used as a national surveillance tool to monitor trends in HIV treatment and morbidity outcomes. However, there are limited studies validating the accuracy of using cohorts as a representation of the overall HIV-positive population. We compared data from a large Australian HIV-positive cohort study (Australian HIV Observational Database [AHOD]) and a 10% longitudinal sample from Australia's subsidized prescription medication scheme (Pharmaceutical Benefits Scheme [PBS]) to assess the use of cohorts for providing representative data for surveillance and monitoring purposes.

Study Design And Setting: Basic demographics and treatment information from July 1, 2013, to March 31, 2016, were divided into half-yearly periods to compare HIV trends between AHOD (n = 2,488) and PBS (n = 18,409) patients.

Results: In both data sets, most patients were men, aged above 50 years, and primarily resided in New South Wales. Both data sets revealed a significant shift toward the increased use of integrase strand transfer inhibitors and a gradual decline in the use of protease inhibitors and nonnucleoside reverse-transcriptase inhibitors among the treated population in Australia. Similarly, a substantial increase in the use of once daily, single-tablet, fixed-dose combination regimens was also observed.

Conclusion: Our results show that observational cohort studies can serve as useful surrogate surveillance tools for monitoring patient characteristics and HIV treatment trends.
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http://dx.doi.org/10.1016/j.jclinepi.2018.04.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6289592PMC
August 2018

Treatment patterns among patients with rheumatic disease (rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and undifferentiated arthritis (UnA)) treated with subcutaneous TNF inhibitors.

Clin Rheumatol 2018 Jun 18;37(6):1617-1623. Epub 2018 Apr 18.

RPA Institute of Rheumatology and Orthopaedics, Camperdown, NSW, Australia.

The aim was to describe the real-world treatment persistence of subcutaneous TNF inhibitors (TNFi) for patients with inflammatory rheumatic disease newly initiating treatment with biologic disease-modifying antirheumatic drugs (bDMARD). This was a retrospective cohort study that extracted data for new users of TNFi between 1 August 2010 and 31 August 2016 from the Australian Optimising Patient outcome in Australian RheumatoLogy (OPAL) registry. Patients were 1:1 propensity-score matched with golimumab based on their age, sex, year of index, C-reactive protein level, baseline treatment combination and disease. Treatment persistence was calculated. Data from 3749 patients were extracted (adalimumab n = 1518; certolizumab n = 298; etanercept n = 1068; golimumab n = 865). The mean (SD) ages of patients were 51.7 (14.2) years for adalimumab, 53.7 (14.0) years for certolizumab, 52.8 (14.3) years for etanercept and 52.3 (14.6) years for golimumab, with disease durations 7.7 (10.5), 8.8 (9.2), 8.1 (10.4) and 7.3 (9.7) years, respectively. Two thirds of the patients were women. There was no significant difference in treatment persistence by treatment in the overall population (adalimumab 33.6 [95% CI 28.6-40.7], certolizumab 24.8 [95% CI 21.3-42.1], etanercept 27.6 [95% CI 23.4-36.5], golimumab 30.3 [95% CI 23.26-36.5]; months, p = 0.545), or in the propensity score-matched population. No safety signals were detected. In this real-world biologic-naïve Australian inflammatory rheumatic disease cohort treated with subcutaneous TNF inhibitors during the period 2010-2016, there was no difference in treatment persistence between agents.
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http://dx.doi.org/10.1007/s10067-018-4105-3DOI Listing
June 2018

Rising Chlamydia and Gonorrhoea Incidence and Associated Risk Factors Among Female Sex Workers in Australia: A Retrospective Cohort Study.

Sex Transm Dis 2018 03;45(3):199-206

Background: Female sex workers in Australia have achieved some of the lowest documented prevalences of human immunodeficiency virus (HIV) and other sexually transmissible infections globally but rates overall are increasing in Australia and warrant closer investigation.

Methods: We constructed a retrospective cohort using repeat testing data extracted from a network of 42 sexual health clinics. Poisson and Cox regression were used to determined trends in incidence and risk factors for HIV, chlamydia, gonorrhoea, and infectious syphilis among female sex workers.

Results: From 2009 to 2015, 18,475 women reporting sex work attended a participating service. The overall incidence of urogenital chlamydia was 7.7/100 person years (PY), declining by 38% from 2009 to 2013 before increasing by 43% to 2015 (P < 0.001); anorectal chlamydia incidence was 0.6/100 PY, and pharyngeal was 1.9/100 PY, which increased significantly during the study period (P < 0.001, both). For gonorrhoea, the urogenital incidence was 1.4/100 PY, anorectal incidence was 0.3/100 PY, P < 0.001), and 3.6/100 PY for pharyngeal; urogenital incidence doubled during the study period, anorectal increased fivefold, and pharyngeal more than tripled (P < 0.001, all). Incidence of infectious syphilis was 0.4/100 PY, which remained stable from 2009 to 2015 (P = 0.09). There were seven incident infections of HIV among female sex workers (0.1/100 PY). Inconsistent condom use with private partners, higher number of private partner numbers, recent injecting drug use, younger age, and country of birth variously predicted sexually transmissible infections among female sex workers.

Conclusions: Although infectious syphilis and HIV remain uncommon in female sex workers attending Australian sexual health clinics, the increasing incidence of gonorrhoea across anatomical sites and increasing chlamydia after a period of decline demands enhanced health promotion initiatives.
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http://dx.doi.org/10.1097/OLQ.0000000000000714DOI Listing
March 2018

Understanding the Targeting and Uptake of HIV Testing Among Gay and Bisexual Men Attending Sexual Health Clinics.

AIDS Behav 2018 02;22(2):513-521

The Kirby Institute, UNSW Sydney, Sydney, Australia.

We assessed trends in HIV testing outcomes during a period of clinic-based initiatives introduced to increase HIV testing among gay and bisexual men (GBM) attending sexual health clinics (SHCs) in New South Wales (NSW). A cohort of 25,487 HIV-negative GBM attending 32 SHCs in NSW (2009-2015) was classified into six sub-groups each year based on client-type (new/existing), risk-status (low/high-risk), and any recent HIV testing. Poisson regression methods were used to assess HIV testing outcomes in sub-groups of GBM. HIV testing outcomes and the sub-groups with greatest statistically significant annual increases were: individuals attending (26% in high-risk existing clients with recent testing); testing uptake (4% in low-risk existing clients with no recent testing); testing frequency (6% in low-risk existing clients with no recent testing and 5% in high-risk existing clients with recent testing); and total tests (31% in high-risk existing clients with recent testing). High-risk existing clients with recent testing had a 13% annual increase in the proportional contribution to total tests. Our findings show improved targeting of testing to high-risk GBM at NSW SHCs. The clinic-based initiatives should be considered for translation to other similar settings.
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http://dx.doi.org/10.1007/s10461-017-2012-2DOI Listing
February 2018

Human papillomavirus vaccination and genital warts in young Indigenous Australians: national sentinel surveillance data.

Med J Aust 2017 Mar;206(5):204-209

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

Objectives: To examine the impact of the national human papillomavirus (HPV) vaccination program (available to girls and women [12-26 years] since 2007 and to boys [12-15 years] since 2013) on the number of diagnoses of genital warts in Australian Aboriginal and Torres Strait Islander (Indigenous) people.

Design, Setting, Participants: Analysis of routinely collected data from patients attending 39 sexual health clinics (SHCs) in the Genital Warts Surveillance Network for the first time.Major outcome: The average annual proportion of Indigenous and non-Indigenous SHC patients diagnosed with genital warts during the pre-vaccination (2004-2007) and vaccination periods (2008-2014), stratified by age group and sex.

Results: 7.3% of the 215 599 Australian-born patients with known Indigenous status and seen for the first time at participating SHCs during 2004-2014 were Indigenous Australians. The average proportion of female Indigenous patients diagnosed with warts was lower during the vaccination period than during the pre-vaccination period (in those under 21, summary rate ratio [SRR], 0.12; 95% CI, 0.07-0.21; P < 0.001); in 21-30-year olds: SRR, 0.41; 95% CI, 0.27-0.61; P < 0.001); there was no significant difference for women over 30 (SRR, 0.84; 95% CI, 0.51-1.36; P = 0.47). The proportion of male Indigenous heterosexual SHC patients under 21 diagnosed with warts was also lower during the vaccination period (SRR, 0.25; 95% CI, 0.12-0.49; P < 0.001), with no significant changes among older Indigenous men over 30.

Conclusions: There were marked declines in the proportions of diagnoses of genital warts in young Indigenous women and men attending SHCs after the introduction of the HPV vaccination program. If high levels of HPV vaccine coverage are sustained, HPV-related cancer rates should also decline.
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http://dx.doi.org/10.5694/mja16.00597DOI Listing
March 2017

Chronic hepatitis C burden and care cascade in Australia in the era of interferon-based treatment.

J Gastroenterol Hepatol 2017 Jan;32(1):229-236

The Kirby Institute, UNSW Australia, Sydney, New South Wales, Australia.

Background And Aim: Interferon-free direct-acting antiviral regimens for hepatitis C virus (HCV) infection have been recently available in Australia, beginning a new era in clinical and public health management of HCV infection. This study provided updated estimates of the HCV infection care cascade and burden in Australia as a reliable platform for assessing the future impact of interferon-free therapies.

Methods: A modeling approach was applied to estimate the number of individuals living with chronic HCV infection and with various liver disease stages. Data from national registries of HCV notification and liver transplantation, literature review, and expert consensus informed the model parameters. HCV notification and Pharmaceutical Benefits Scheme data were used to estimate the number of HCV diagnosed individuals and treatment uptake.

Results: In 2014, an estimated 230 470 individuals (range: 180 490-243 990) were living with HCV, among whom 75% were diagnosed (n = 172 720; range: 156 720-188 770), 20% had ever received treatment (n = 45 000; range: 39 280-50 720), and 11% had been cured (n = 24 750; range: 21 520-27 990). Among individuals with HCV infection, the proportion with hepatic fibrosis stage ≥F3 doubled during the last decade, increasing from 9% (n = 18 580) in 2004 to 19% (n = 44,730) in 2014. Individuals initiating HCV treatment increased from 1100 in 1997 to 3840 in 2007, plateaued until 2010 and decreased to 2790 in 2014.

Conclusions: The burden of HCV-related liver disease has increased markedly. Although the proportion diagnosed was high, treatment uptake remained low, with no increase over the last 7 years. Reducing the HCV burden in Australia requires scale-up of interferon-free HCV therapies.
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http://dx.doi.org/10.1111/jgh.13453DOI Listing
January 2017

Antiretroviral treatment use, co-morbidities and clinical outcomes among Aboriginal participants in the Australian HIV Observational Database (AHOD).

BMC Infect Dis 2015 Aug 12;15:326. Epub 2015 Aug 12.

The Kirby Institute, UNSW Australia, Sydney, NSW, 2052, Australia.

Background: There are few data regarding clinical care and outcomes of Indigenous Australians living with HIV and it is unknown if these differ from non-Indigenous HIV-positive Australians.

Methods: AHOD commenced enrolment in 1999 and is a prospective cohort of HIV-positive participants attending HIV outpatient services throughout Australia, of which 20 (74 %) sites report Indigenous status. Data were collected up until March 2013 and compared between Indigenous and non-Indigenous participants. Person-year methods were used to compare death rates, rates of loss to follow-up and rates of laboratory testing during follow-up between Indigenous and non-Indigenous participants. Factors associated with time to first combination antiretroviral therapy (cART) regimen change were assessed using Kaplan Meier and Cox Proportional hazards methods.

Results: Forty-two of 2197 (1.9 %) participants were Indigenous. Follow-up amongst Indigenous and non-Indigenous participants was 332 & 16270 person-years, respectively. HIV virological suppression was achieved in similar proportions of Indigenous and non-Indigenous participants 2 years after initiation of cART (81.0 % vs 76.5 %, p = 0.635). Indigenous status was not independently associated with shorter time to change from first- to second-line cART (aHR 0.95, 95 % CI 0.51-1.76, p = 0.957). Compared with non-Indigenous participants, Indigenous participants had significantly less frequent laboratory monitoring of CD4 count (rate:2.76 tests/year vs 2.97 tests/year, p = 0.025) and HIV viral load (rate:2.53 tests/year vs 2.93 tests/year, p < 0.001), while testing rates for lipids and blood glucose were almost half that of non-indigenous participants (rate:0.43/year vs 0.71 tests/year, p < 0.001). Loss to follow-up (23.8 % vs 29.8 %, p = 0.496) and death (2.4 % vs 7.1 %, p = 0.361) occurred in similar proportions of indigenous and non-Indigenous participants, respectively, although causes of death in both groups were mostly non-HIV-related.

Conclusions: As far as we are aware, these are the first data comparing clinical outcomes between Indigenous and non-Indigenous HIV-positive Australians. The forty-two Indigenous participants represent over 10 % of all Indigenous Australians ever diagnosed with HIV. Although outcomes were not significantly different, Indigenous patients had lower rates of laboratory testing for HIV and lipid/glucose parameters. Given the elevated risk of cardiovascular disease in the general Indigenous community, the additional risk factor of HIV infection warrants further focus on modifiable risk factors to maximise life expectancy in this population.
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http://dx.doi.org/10.1186/s12879-015-1051-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4533935PMC
August 2015

Subsidized optimal ART for HIV-positive temporary residents of Australia improves virological outcomes: results from the Australian HIV Observational Database Temporary Residents Access Study.

J Int AIDS Soc 2015 12;18:19392. Epub 2015 Feb 12.

The Kirby Institute, UNSW Australia, Sydney, Australia.

Introduction: HIV-positive (HIV+) temporary residents living in Australia legally are unable to access government subsidized antiretroviral treatment (ART) which is provided via Medicare to Australian citizens and permanent residents. Currently, there is no information systematically being collected on non-Medicare eligible HIV+ patients in Australia. The objectives of this study are to describe the population recruited to the Australian HIV Observational Database (AHOD) Temporary Residents Access Study (ATRAS) and to determine the short- and long-term outcomes of receiving (subsidized) optimal ART and the impact on onwards HIV transmission.

Methods: ATRAS was established in 2011. Eligible patients were recruited via the AHOD network. Key HIV-related characteristics were recorded at baseline and prospectively. Additional visa-related information was also recorded at baseline, and updated annually. Descriptive statistics were used to describe the ATRAS cohort in terms of visa status by key demographic characteristics, including sex, region of birth, and HIV disease status. CD4 cell count (mean and SD) and the proportion with undetectable (<50 copies/ml) HIV viral load are reported at baseline, 6 and 12 months of follow-up. We also estimate the proportion reduction of onward HIV transmission based on the reduction in proportion of people with detectable HIV viral load.

Results: A total of 180 patients were recruited to ATRAS by June 2012, and by July 2013 39 patients no longer required ART via ATRAS, 35 of whom became eligible for Medicare-funded medication. At enrolment, 63% of ATRAS patients were receiving ART from alternative sources, 47% had an undetectable HIV viral load (<50 copies/ml) and the median CD4 cell count was 343 cells/µl (IQR: 222-479). At 12 months of follow-up, 85% had an undetectable viral load. We estimated a 75% reduction in the risk of onward HIV transmission with the improved rate of undetectable viral load.

Conclusions: The immunological and virological improvements highlight the importance of supplying optimal ART to this vulnerable population. The increase in proportion with undetectable HIV viral load shows the potentially significant impact on HIV transmission in addition to the personal health benefit for each individual.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4327894PMC
http://dx.doi.org/10.7448/IAS.18.1.19392DOI Listing
May 2016

Loss to follow-up in the Australian HIV Observational Database.

Antivir Ther 2015 7;20(7):731-41. Epub 2014 Nov 7.

The Kirby Institute, UNSW Australia, Sydney, Australia.

Background: Loss to follow-up (LTFU) in HIV-positive cohorts is an important surrogate for interrupted clinical care, which can potentially influence the assessment of HIV disease status and outcomes. After preliminary evaluation of LTFU rates and patient characteristics, we evaluated the risk of mortality by LTFU status in a high-resource setting.

Methods: Rates of LTFU were measured in the Australian HIV Observational Database for a range of patient characteristics. Multivariate repeated measures regression methods were used to identify determinants of LTFU. Mortality by LTFU status was ascertained using linkage to the National Death Index. Survival following combination antiretroviral therapy initiation was investigated using the Kaplan-Meier (KM) method and Cox proportional hazards models.

Results: Of 3,413 patients included in this analysis, 1,632 (47.8%) had at least one episode of LTFU after enrolment. Multivariate predictors of LTFU included viral load (VL)>10,000 copies/ml (rate ratio [RR] 1.63; 95% CI 1.45, 1.84; ref ≤400), time under follow-up (per year; RR 1.03; 95% CI 1.02, 1.04) and prior LTFU (per episode; RR 1.15; 95% CI 1.06, 1.24). KM curves for survival were similar by LTFU status (P=0.484). LTFU was not associated with mortality in Cox proportional hazards models (univariate hazard ratio [HR] 0.93; 95% CI 0.69, 1.26) and multivariate HR 1.04 (95% CI 0.77, 1.43).

Conclusions: Increased risk of LTFU was identified amongst patients with potentially higher infectiousness. We did not find significant mortality risk associated with LTFU. This is consistent with timely re-engagement with treatment, possibly via high levels of unreported linkage to other health-care providers.
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http://dx.doi.org/10.3851/IMP2916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424189PMC
November 2016

Recent trends in early stage response to combination antiretroviral therapy in Australia.

Antivir Ther 2015 4;20(2):131-9. Epub 2014 Apr 4.

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

Background: There have been improvements in combination antiretroviral therapy (cART) over the past 15 years. The aim of this analysis was to assess whether improvements in ART have resulted in improvements in surrogates of HIV outcome.

Methods: Patients in the Australian HIV Observational Database who initiated treatment using mono/duo therapy prior to 1996, or using cART from 1996 onwards, were included in the analysis. Patients were stratified by era of ART initiation. Median changes in CD4(+) T-cell count and the proportion of patients with detectable HIV viral load (>400 copies/ml) were calculated over the first 4 years of treatment. Probabilities of treatment switch were estimated using the Kaplan-Meier method.

Results: A total of 2,753 patients were included in the analysis: 28% initiated treatment <1996 using mono/duo therapy and 72% initiated treatment ≥1996 using cART (30% 1996-1999, 12% 2000-2003, 11% 2004-2007 and 19% ≥2008). Overall CD4(+) T-cell count response improved by later era of initiation (P<0.001), although 2000-2003 CD4(+) T-cell count response was less than that for 1996-1999 (P=0.007). The average proportion with detectable viral load from 2 to 4 years post-treatment commencement by era was: <1996 mono/duo 0.69 (0.67-0.71), 1996-1999 cART 0.29 (0.28-0.30), 2000-2003 cART 0.22 (0.20-0.24), 2004-2007 cART 0.09 (0.07-0.10) and ≥2008 cART 0.04 (0.03-0.05). Probability of treatment switch at 4 years after initiation decreased from 53% in 1996-1999 to 29% after 2008 (P<0.001).

Conclusions: Across the five time-periods examined, there have been incremental improvements for patients initiated on cART, as measured by overall response (viral load and CD4(+) T-cell count) and also increased durability of first-line ART regimens.
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http://dx.doi.org/10.3851/IMP2774DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4185258PMC
January 2016

Recent trends in early stage response to combination antiretroviral therapy in Australia.

Antivir Ther 2015 4;20(2):131-9. Epub 2014 Apr 4.

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

Background: There have been improvements in combination antiretroviral therapy (cART) over the past 15 years. The aim of this analysis was to assess whether improvements in ART have resulted in improvements in surrogates of HIV outcome.

Methods: Patients in the Australian HIV Observational Database who initiated treatment using mono/duo therapy prior to 1996, or using cART from 1996 onwards, were included in the analysis. Patients were stratified by era of ART initiation. Median changes in CD4(+) T-cell count and the proportion of patients with detectable HIV viral load (>400 copies/ml) were calculated over the first 4 years of treatment. Probabilities of treatment switch were estimated using the Kaplan-Meier method.

Results: A total of 2,753 patients were included in the analysis: 28% initiated treatment <1996 using mono/duo therapy and 72% initiated treatment ≥1996 using cART (30% 1996-1999, 12% 2000-2003, 11% 2004-2007 and 19% ≥2008). Overall CD4(+) T-cell count response improved by later era of initiation (P<0.001), although 2000-2003 CD4(+) T-cell count response was less than that for 1996-1999 (P=0.007). The average proportion with detectable viral load from 2 to 4 years post-treatment commencement by era was: <1996 mono/duo 0.69 (0.67-0.71), 1996-1999 cART 0.29 (0.28-0.30), 2000-2003 cART 0.22 (0.20-0.24), 2004-2007 cART 0.09 (0.07-0.10) and ≥2008 cART 0.04 (0.03-0.05). Probability of treatment switch at 4 years after initiation decreased from 53% in 1996-1999 to 29% after 2008 (P<0.001).

Conclusions: Across the five time-periods examined, there have been incremental improvements for patients initiated on cART, as measured by overall response (viral load and CD4(+) T-cell count) and also increased durability of first-line ART regimens.
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http://dx.doi.org/10.3851/IMP2774DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4185258PMC
January 2016

The significance of HIV 'blips' in resource-limited settings: is it the same? analysis of the treat Asia HIV Observational Database (TAHOD) and the Australian HIV Observational Database (AHOD).

PLoS One 2014 7;9(2):e86122. Epub 2014 Feb 7.

Monash Medical Centre, Clayton, Victoria, Australia ; Alfred Hospital, Prahran, Victoria, Australia ; Departments of Medicine and Infectious Diseases, Monash University, Clayton, Victoria, Australia.

Introduction: Magnitude and frequency of HIV viral load blips in resource-limited settings, has not previously been assessed. This study was undertaken in a cohort from a high income country (Australia) known as AHOD (Australian HIV Observational Database) and another cohort from a mixture of Asian countries of varying national income per capita, TAHOD (TREAT Asia HIV Observational Database).

Methods: Blips were defined as detectable VL (≥ 50 copies/mL) preceded and followed by undetectable VL (<50 copies/mL). Virological failure (VF) was defined as two consecutive VL ≥50 copies/ml. Cox proportional hazard models of time to first VF after entry, were developed.

Results: 5040 patients (AHOD n = 2597 and TAHOD n = 2521) were included; 910 (18%) of patients experienced blips. 744 (21%) and 166 (11%) of high- and middle/low-income participants, respectively, experienced blips ever. 711 (14%) experienced blips prior to virological failure. 559 (16%) and 152 (10%) of high- and middle/low-income participants, respectively, experienced blips prior to virological failure. VL testing occurred at a median frequency of 175 and 91 days in middle/low- and high-income sites, respectively. Longer time to VF occurred in middle/low income sites, compared with high-income sites (adjusted hazards ratio (AHR) 0.41; p<0.001), adjusted for year of first cART, Hepatitis C co-infection, cART regimen, and prior blips. Prior blips were not a significant predictor of VF in univariate analysis (AHR 0.97, p = 0.82). Differing magnitudes of blips were not significant in univariate analyses as predictors of virological failure (p = 0.360 for blip 50-≤1000, p = 0.309 for blip 50-≤400 and p = 0.300 for blip 50-≤200). 209 of 866 (24%) patients were switched to an alternate regimen in the setting of a blip.

Conclusion: Despite a lower proportion of blips occurring in low/middle-income settings, no significant difference was found between settings. Nonetheless, a substantial number of participants were switched to alternative regimens in the setting of blips.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086122PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3917848PMC
May 2015