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London, United Kingdom
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Burch L.S.,University College London | Smith C.J.,University College London | Anderson J.,University of London | Sherr L.,University College London | And 13 more authors.
The Lancet Public Health | Year: 2016

Background Few studies have assessed the effect of socioeconomic status on HIV treatment outcomes in settings with universal access to health care. Here we aimed to investigate the association of socioeconomic factors with antiretroviral therapy (ART) non-adherence, virological non-suppression, and virological rebound, in HIV-positive people on ART in the UK. Methods We used data from the Antiretrovirals, Sexual Transmission Risk and Attitudes (ASTRA) questionnaire study, which recruited participants aged 18 years or older with HIV from eight HIV outpatient clinics in the UK between Feb 1, 2011, and Dec 31, 2012. Participants self-completed a confidential questionnaire on sociodemographic, health, and lifestyle issues. In participants on ART, we assessed associations of financial hardship, employment, housing, and education with: self-reported ART non-adherence at the time of the questionnaire; virological non-suppression (viral load >50 copies per mL) at the time of questionnaire in those who started ART at least 6 months ago (cross-sectional analysis); and subsequent virological rebound (viral load >200 copies per mL) in those with initial viral load of 50 copies per mL or lower (longitudinal analysis). Findings Of the 3258 people who completed the questionnaire, 2771 (85%) reported being on ART at the time of the questionnaire, and 2704 with complete data were included. 873 (32%) of 2704 participants reported non-adherence to ART and 219 (9%) of 2405 had virological non-suppression in cross-sectional analysis. Each of the four measures of lower socioeconomic status was strongly associated with non-adherence to ART, and with virological non-suppression (prevalence ratios [PR] adjusted for gender/sexual orientation, age, and ethnic origin: greatest financial hardship vs none 2·4, 95% CI 1·6–3·4; non-employment 2·0, 1·5–2·6; unstable housing vs homeowner 3·0, 1·9–4·6; non-university education 1·6, 1·2–2·2). 139 (8%) of 1740 individuals had subsequent virological rebound (rate=3·6/100 person-years). Low socioeconomic status was predictive of longitudinal rebound risk (adjusted hazard ratio [HR] for greatest financial hardship vs none 2·3, 95% CI 1·4–3·9; non-employment 3·0, 2·1–4·2; unstable housing vs homeowner 3·3, 1·8–6·1; non-university education 1·6, 1·1–2·3). Interpretation Socioeconomic disadvantage was strongly associated with poorer HIV treatment outcomes in this setting with universal health care. Adherence interventions and increased social support for those most at risk should be considered. Funding National Institute for Health Research. © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license

PubMed | University of Cologne, University Miguel Hernández, University of Zürich, HIV i Base and 23 more.
Type: Journal Article | Journal: JAMA | Year: 2016

A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy (ART) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex.To evaluate the rate of within-couple HIV transmission (heterosexual and men who have sex with men [MSM]) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/mL.The prospective, observational PARTNER (Partners of People on ART-A New Evaluation of the Risks) study was conducted at 75 clinical sites in 14 European countries and enrolled 1166 HIV serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex (September 2010 to May 2014). Eligibility criteria for inclusion of couple-years of follow-up were condomless sex and HIV-1 RNA load less than 200 copies/mL. Anonymized phylogenetic analysis compared couples HIV-1 polymerase and envelope sequences if an HIV-negative partner became infected to determine phylogenetically linked transmissions.Condomless sexual activity with an HIV-positive partner taking virally suppressive ART.Risk of within-couple HIV transmission to the HIV-negative partner.Among 1166 enrolled couples, 888 (mean age, 42 years [IQR, 35-48]; 548 heterosexual [61.7%] and 340 MSM [38.3%]) provided 1238 eligible couple-years of follow-up (median follow-up, 1.3 years [IQR, 0.8-2.0]). At baseline, couples reported condomless sex for a median of 2 years (IQR, 0.5-6.3). Condomless sex with other partners was reported by 108 HIV-negative MSM (33%) and 21 heterosexuals (4%). During follow-up, couples reported condomless sex a median of 37 times per year (IQR, 15-71), with MSM couples reporting approximately 22,000 condomless sex acts and heterosexuals approximately 36,000. Although 11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual; 8 reported condomless sex with other partners), no phylogenetically linked transmissions occurred over eligible couple-years of follow-up, giving a rate of within-couple HIV transmission of zero, with an upper 95% confidence limit of 0.30/100 couple-years of follow-up. The upper 95% confidence limit for condomless anal sex was 0.71 per 100 couple-years of follow-up.Among serodifferent heterosexual and MSM couples in which the HIV-positive partner was using suppressive ART and who reported condomless sex, during median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission (upper 95% confidence limit, 0.30/100 couple-years of follow-up). Additional longer-term follow-up is necessary to provide more precise estimates of risk.

Venter W.D.F.,University of Witwatersrand | Clayden P.,HIV I Base | Serenata C.,University of Witwatersrand
Current Opinion in HIV and AIDS | Year: 2017

Purpose of review Current WHO-recommended first-line therapy in low-income and middle-income countries has been very successful in saving millions of lives but still has toxicity concerns and a low barrier to resistance. Recent findings Two candidate antiretrovirals may substantially transform first-line therapy in low-income and middle-income countries, yielding a safer, more robust and cheaper regimen. Tenofovir alafenamide carries toxicity and cost benefits over tenofovir disoproxil fumarate. Dolutegravir could replace efavirenz, with substantial toxicity, resistance and cost benefits. However, these drugs are currently not manufactured together in developed countries, for commercial reasons. Summary We describe a large randomized controlled study testing a combination of these candidate antiretrovirals against the current first-line recommendation that commenced recruitment in early 2017. We justify the study design and discuss how we will deal with complex issues such as tuberculosis and pregnancy. © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.

Lundgren J.D.,Copenhagen University | Babiker A.G.,University College London | Gordin F.,George Washington University | Emery S.,University of New South Wales | And 15 more authors.
New England Journal of Medicine | Year: 2015

Background Data from randomized trials are lacking on the benefits and risks of initiating antiretroviral therapy in patients with asymptomatic human immunodeficiency virus (HIV) infection who have a CD4+ count of more than 350 cells per cubic millimeter. Methods We randomly assigned HIV-positive adults who had a CD4+ count of more than 500 cells per cubic millimeter to start antiretroviral therapy immediately (immediate-initiation group) or to defer it until the CD4+ count decreased to 350 cells per cubic millimeter or until the development of the acquired immunodeficiency syndrome (AIDS) or another condition that dictated the use of antiretroviral therapy (deferred-initiation group). The primary composite end point was any serious AIDS-related event, serious non-AIDS-related event, or death from any cause. Results A total of 4685 patients were followed for a mean of 3.0 years. At study entry, the median HIV viral load was 12,759 copies per milliliter, and the median CD4+ count was 651 cells per cubic millimeter. On May 15, 2015, on the basis of an interim analysis, the data and safety monitoring board determined that the study question had been answered and recommended that patients in the deferred-initiation group be offered antiretroviral therapy. The primary end point occurred in 42 patients in the immediate-initiation group (1.8%; 0.60 events per 100 personyears), as compared with 96 patients in the deferred-initiation group (4.1%; 1.38 events per 100 person-years), for a hazard ratio of 0.43 (95% confidence interval [CI], 0.30 to 0.62; P<0.001). Hazard ratios for serious AIDS-related and serious non-AIDS-related events were 0.28 (95% CI, 0.15 to 0.50; P<0.001) and 0.61 (95% CI, 0.38 to 0.97; P = 0.04), respectively. More than two thirds of the primary end points (68%) occurred in patients with a CD4+ count of more than 500 cells per cubic millimeter. The risks of a grade 4 event were similar in the two groups, as were the risks of unscheduled hospital admissions. Conclusions The initiation of antiretroviral therapy in HIV-positive adults with a CD4+ count of more than 500 cells per cubic millimeter provided net benefits over starting such therapy in patients after the CD4+ count had declined to 350 cells per cubic millimeter. Copyright © 2015 Massachusetts Medical Society.

Geffen N.,University of Cape Town | Aagaard P.,Copenhagen University | Corbelli G.,European AIDS Treatment Group | Meulbroek M.,Projecte dels NOMS Hispanosida | And 4 more authors.
HIV Medicine | Year: 2015

Determining when to start antiretroviral treatment (ART) is vitally important for people living with HIV. Yet the optimal point at which to start to maximize clinical benefit remains unknown. In the absence of randomized studies, current guidelines rely on conflicting observational data and expert opinion, and consequently diverge on this point. In the USA, ART is recommended irrespective of CD4 cell count. The World Health Organization now recommends starting ART at a CD4 cell count of 500cells/μL, while the threshold for the UK and South Africa remains at 350cells/μL. The Strategic Timing of AntiRetroviral Treatment (START) study, one of the largest clinical trials on the treatment of HIV infection, will answer this question. START compares two treatment strategies: immediate treatment at a CD4 cell count of 500cells/μL or higher versus deferring treatment until the CD4 cell count decreases to 350cells/μL or until AIDS develops. START includes seven substudies, five of which will clarify the relative contributions of HIV and ART in common comorbidities. START is fully enrolled and expected to be completed in 2016. HIV advocates support the study's design and have been involved from inception to enrolment. The trial will produce rigorous data on the benefits and risks of earlier treatment. It will inform policy and treatment advocacy globally, benefitting the health of HIV-positive people. © 2015 British HIV Association.

Sabin C.A.,University College London | Cooper D.A.,University of New South Wales | Collins S.,HIV I Base | Schechter M.,Federal University of Rio de Janeiro
AIDS | Year: 2013

Guidelines for the initiation of combination antiretroviral therapy (cART) in those living with HIV are provided by several national and international treatment guidelines committees. Following recent changes to some of these guidelines, there is now considerable variation between the guidelines in terms of the recommendations for initiation of cART among asymptomatic individuals with high (>350 cells/μl) CD4 cell counts. In this review we compare the schemes used for rating evidence by the various committees and assess the strengths and weaknesses of the available evidence for initiating cART at higher CD4 cell counts. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Daskalopoulou M.,University College London | Rodger A.,University College London | Phillips A.N.,University College London | Sherr L.,University College London | And 20 more authors.
The Lancet HIV | Year: 2014

Background: Recreational drug use in men who have sex with men (MSM) is of concern because it might be linked to the transmission of HIV and other sexually transmitted infections. Evidence about drug use in HIV-diagnosed MSM in the UK is limited by representativeness of the study populations. We describe patterns of drug use and associations with sexual behaviours in HIV-diagnosed MSM in the UK. Methods: We used data from the cross-sectional ASTRA study, which recruited participants aged 18 years or older with HIV from eight HIV outpatient clinics in the UK between Feb 1, 2011, and Dec 31, 2012. We examined data for MSM, assessing the prevalence of recreational drug use and polydrug use in the previous 3 months and associations with sociodemographic and HIV-related factors. We examined the association of polydrug use with measures of condomless sex in the previous 3 months and with other sexual behaviours. Findings: Our analysis included data for 2248 MSM: 2136 (95%) were gay, 1973 (89%) were white, 1904 (85%) were on antiretroviral treatment (ART), and 1682 (76%) had a viral load of 50 copies per mL or lower. 1138 (51%) used recreational drugs in the previous 3 months; 608 (27%) used nitrites, 477 (21%) used cannabis, 460 (21%) used erectile dysfunction drugs, 453 (20%) used cocaine, 280 (13%) used ketamine, 258 (12%) used 3,4-methylenedioxy-Nmethylamphetamine (MDMA), 221 (10%) used gamma-hydroxybutyrate or gamma-butyrolactone, 175 (8%) used methamphetamine, and 162 (7%) used mephedrone. In the 1138 individuals who used drugs, 529 (47%) used three or more drugs and 241 (21%) used fi ve or more. Prevalence of injection drug use was 3% (n=68). Drug use was independently associated with younger age (p<0·0001), not being religious (p=0·001), having an HIV-positive stable partner (p=0·0008), HIV-serostatus disclosure (p=0·009), smoking (p<0·0001), evidence of harmful alcohol drinking (p=0·0001), and ART non-adherence (p<0·0001). Increasing polydrug use was associated with increasing prevalence of condomless sex (prevalence range from no drug use to use of fi ve or more drugs was 24% to 78%), condomless sex with HIV-seroconcordant partners (17% to 69%), condomless sex with HIV-serodiscordant partners (10% to 25%), and higher-HIV-risk condomless sex after taking viral load into account (4% to 16%; p≤0·005 for all). Associations were similar after adjustment for sociodemographic and HIV-related factors. Methamphetamine was more strongly associated with higher-HIV-risk condomless sex than were other commonly used drugs. Interpretation: Polydrug use is prevalent in HIV-diagnosed MSM and is strongly associated with condomless sex. Specialist support services for MSM with HIV who use recreational drugs might be benefi cial in the reduction of harm and prevention of ongoing transmission of HIV and other sexually transmitted infections. © Daskalopoulou et al.

Foreman C.,London Specialised Commissioning Group | Gazzard B.,Chelsea and Westminster Hospital NHS Foundation Trust | Johnson M.,Ian Charleson Day Center | Sharott P.,London Specialised Commissioning Group | Collins S.,HIV i Base
Sexually Transmitted Infections | Year: 2012

Background: In the UK, meeting the £20 billion efficiency challenge in the NHS requires new approaches to protect quality and improve productivity. In London, clinicians, people living with HIV and commissioners are collaborating to reduce the cost of antiretrovirals as part of the Quality Innovation Productivity and Prevention agenda. Objectives: To describe how collaboration in antiretroviral procurement in 2011/2012 aimed to significantly reduce drug acquisition costs, ensure equity of prescribing and protect the quality and experience of care and treatment for patients. Methods: Greater clinical leadership and engagement and involvement of patient representatives enabled an approach to drug procurement focused on clinical outcomes at a patient and population level while reducing cost. Consensus guidelines for implementation were developed and agreed by all London lead clinicians while people living with HIV produced a patient information leaflet to explain the tender process and outcomes. A planned audit is underway at all services to monitor prescribing changes and outcomes for those on treatment. Results: HIV clinicians, pharmacists and patient representatives were directly involved in this novel therapeutic tendering approach to antiretroviral drug procurement. Modelling indicates that £8-£10 million savings will be released through the process over 2 years. Conclusions: Clinically led therapeutic tendering of antiretroviral drugs provides an opportunity to protect quality and improve productivity in HIV. The approach is novel in HIV in the UK, and the emergent learning has implications for quality and cost improvement in HIV spending in the UK and potentially in other countries.

PURPOSE OF REVIEW: When should people with HIV start treatment? This question is widely debated. The recent momentum to initiate treatment at a CD4 cell count above 350 cells/mm is driven by the potential population benefits of antiretroviral treatment reducing infectiousness together with operational concerns. These are important. However, we focus on the clinical benefits and risks for the person taking treatment, and how this may vary depending on the background health setting. RECENT FINDINGS: We refer to the recent guideline changes and the limited evidence on which they are based. Many studies that have informed guideline changes reference plausible benefits, but have limited follow-up and are not designed to assess the potential risks. We note historical examples to show that expert opinion in the absence of data warrants caution. SUMMARY: Results from well powered studies designed to look at the question of when to start treatment are essential for quantifying the benefits and risks of earlier treatment. Meanwhile, the decision of when to start must be taken by the HIV-positive person in consultation with their health worker based on accurate information. That choice will vary depending on a person's individual health, their reason to want to treat and the resources of the health-care facility. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Rodger A.J.,University College London | Bruun T.,Copenhagen University | Vernazza P.,Cantonal Hospital | Collins S.,HIV I Base | And 5 more authors.
Antiviral Therapy | Year: 2013

The results from the HPTN 052 trial have increased the focus on use of antiretroviral therapy (ART) for prevention of HIV transmission; however, condom use also effectively prevents HIV transmission. Studies in heterosexual serodiscordant couples with viral suppression have so far only reported follow-up data for 330 couple-years when condoms were not being used. Data are even more limited for anal sex in men who have sex with men. Additional data on the effectiveness of ART as prevention when practicing condom-less sex is urgently needed. ©2013 International Medical Press.

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