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Missed opportunities for HIV testing in people diagnosed with HIV, Estonia, 2014 to 2015
More LessBackgroundStudies of missed opportunities for earlier diagnosis of HIV have shown that patients with undiagnosed HIV often present to healthcare settings numerous times before eventually receiving their diagnosis.
AimThe aim of the study was to assess missed opportunities for HIV testing among people newly diagnosed with HIV.
MethodsIn this observational retrospective study, we collected data from the Estonian Health Board on new HIV cases in people aged 16–49 years diagnosed in 2014–15 and from the Estonian Health Insurance Fund database for treatment invoices on their contacts with healthcare services in the 2 years preceding diagnosis. Diagnoses on treatment invoices were categorised as HIV indicator conditions using ICD-10 codes.
ResultsOf 538 newly diagnosed HIV cases (62.5%; 336 men), 82% had visited healthcare services at least once during the 2 years before HIV diagnosis; the mean number of visits was 9.1. Of these, 16% had been tested for HIV and 31% had at least one ICD-10 code for an HIV indicator condition on at least one of their treatment invoices. In 390 cases of HIV indicator conditions, only 5% were tested for HIV. Of all new HIV cases aged 20–49 years from high-incidence regions (defined as priority groups in national testing guidance), 18% had been tested.
ConclusionsThe HIV testing rate in the 2 years before an HIV diagnosis was very low, even in the presence of an HIV indicator condition. This emphasises the importance of implementing the Estonian HIV testing guidelines.
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Challenges in modelling the proportion of undiagnosed HIV infections in Sweden
BackgroundSweden has a low HIV prevalence. However, among new HIV diagnoses in 2016, the proportion of late presenters and migrants was high (59% and 81%, respectively). This poses challenges in estimating the proportion of undiagnosed persons living with HIV (PLHIV).
AimTo estimate the proportion of undiagnosed PLHIV in Sweden comparing two models with different demands on data availability and modelling expertise.
MethodsAn individual-based stochastic simulation model of HIV positive populations (SSOPHIE) and the incidence method of the European Centre for Disease Prevention and Control (ECDC) HIV Modelling Tool were applied to clinical, surveillance and migration data from Sweden 1980–2016.
ResultsSSOPHIE estimated that the proportion of undiagnosed PLHIV in 2013 was 26% (n = 2,100; 90% plausibility range (PR): 900–5,000) for all PLHIV, 17% (n = 600; 90% PR: 100–2,000) for men who have sex with men (MSM), 35% in male (n = 300; 90% PR: 200–700) and 34% in female (n = 400; 90% PR: 200–800) migrants from sub-Saharan Africa (SSA). The estimates for the ECDC model in 2013 were 21% (n = 2,013; 95% confidence interval (CI): 1,831–2,189) for all PLHIV, 15% (n = 369; 95% CI: 299–434) for MSM and 21% (n = 530; 95% CI: 436–632) for migrants from SSA.
ConclusionsThe proportion of undiagnosed PLHIV in Sweden is uncertain. SSOPHIE estimates had wide PR. The ECDC model estimates were unreliable because migration was not accounted for. Better migration data and estimation methods are required to obtain reliable estimates of proportions of undiagnosed PLHIV in similar settings.
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Cost-effectiveness and budget effect of pre-exposure prophylaxis for HIV-1 prevention in Germany from 2018 to 2058
BackgroundPre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy for men-who-have-sex-with-men (MSM). The high cost of PrEP has until recently been a primary barrier to its use. In 2017, generic PrEP became available, reducing the costs by 90%.
AimOur objective was to assess cost-effectiveness and costs of introducing PrEP in Germany.
MethodsWe calibrated a deterministic mathematical model to the human immunodeficiency virus (HIV) epidemic among MSM in Germany. PrEP was targeted to 30% of high-risk MSM. It was assumed that PrEP reduces the risk of HIV infection by 85%. Costs were calculated from a healthcare payer perspective using a 40-year time horizon starting in 2018.
ResultsPrEP can avert 21,000 infections (interquartile range (IQR): 16,000–27,000) in the short run (after 2 years scale-up and 10 years full implementation). HIV care is predicted to cost EUR 36.2 billion (IQR: 32.4–40.4 billion) over the coming 40 years. PrEP can increase costs by at most EUR 150 million within the first decade after introduction. Ten years after introduction, PrEP can become cost-saving, accumulating to savings of HIV-related costs of EUR 5.1 billion (IQR: 3.5–6.9 billion) after 40 years. In a sensitivity analysis, PrEP remained cost-saving even at a 70% price reduction of antiretroviral drug treatment and a lower effectiveness of PrEP.
ConclusionIntroduction of PrEP in Germany is predicted to result in substantial health benefits because of reductions in HIV infections. Short-term financial investments in providing PrEP will result in substantial cost-savings in the long term.
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Defining linkage to care following human immunodeficiency virus (HIV) diagnosis for public health monitoring in Europe
Prompt linkage to human immunodeficiency virus (HIV) care after diagnosis is crucial to ensure optimal patient outcomes. However, few countries monitor this important public health marker and different definitions have been applied, making country and study comparisons difficult. This article presents an expert-agreed, standard definition of linkage to care for a pragmatic approach to public health monitoring, appropriate to the European context. Here, linkage to care is defined as patient entry into specialist HIV care after diagnosis, measured as the time between the HIV diagnosis date and one of the following markers: either the first clinic attendance date, first CD4+ cell count or viral load date, or HIV treatment start date, depending on data availability; Linkage is considered prompt if within 3 months of diagnosis. Application of this definition by researchers and public health professionals when reporting surveillance or research data relating to linkage to care after HIV diagnosis will enable reliable comparisons across countries, better assessment of the success of health services programmes aimed at improving peoples access to HIV treatment and care and the identification of barriers limiting access to HIV care across Europe.
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HIV in Europe and Central Asia: progress in 2018 towards meeting the UNAIDS 90-90-90 targets
In 2018, 52 of 55 European and Central Asian countries reported data against the UNAIDS 90–90–90 targets. Overall, 80% of people living with HIV (PLHIV) were diagnosed, of whom 64% received treatment and 86% treated were virally suppressed. Subregional outcomes varied: West (87%–91%–93%), Centre (83%–73%–75%) and East (76%–46%–78%). Overall, 43% of all PLHIV were virally suppressed; intensive efforts are needed to meet the 2020 target of 73%.
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Characterisation of HIV-1 transmission clusters and drug-resistant mutations in Denmark, 2004 to 2016
More LessThis study describes the prevalence of human immunodeficiency virus (HIV) drug resistance mutations among 1,815 patients in Denmark from 2004 to 2016 and characterises transmission clusters. POL sequences were analysed for subtype, drug resistance mutations and phylogenetic relationship. The prevalence of surveillance drug resistance mutations (SDRM) was 6.7%, while the prevalence of drug resistance mutations (DRM) with a clinical impact was 12.3%. We identified 197 transmission clusters with 706 patients. Patients 40 years or older were less likely to be members of a transmission cluster and patients in transmission clusters were less likely to be infected abroad. The proportion of late presenters (LP) was lower in active compared with inactive clusters. Large active clusters consisted of more men who have sex with men (MSM), had members more frequently infected in Denmark and contained a significantly lower proportion of LP and significantly fewer patients with DRM than small active clusters. Subtyping demonstrated that the Danish HIV epidemic is gradually becoming more composed of non-B subtypes/circulating recombinant forms. This study shows that active HIV-1 transmission has become increasingly MSM-dominated and that the recent increase in SDRM and DRM prevalence is not associated with more sustained transmission within identified transmission networks or clusters.
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Potential adjustment methodology for missing data and reporting delay in the HIV Surveillance System, European Union/European Economic Area, 2015
Accurate case-based surveillance data remain the key data source for estimating HIV burden and monitoring prevention efforts in Europe. We carried out a literature review and exploratory analysis of surveillance data regarding two crucial issues affecting European surveillance for HIV: missing data and reporting delay. Initial screening showed substantial variability of these data issues, both in time and across countries. In terms of missing data, the CD4+ cell count is the most problematic variable because of the high proportion of missing values. In 20 of 31 countries of the European Union/European Economic Area (EU/EEA), CD4+ counts are systematically missing for all or some years. One of the key challenges related to reporting delays is that countries undertake specific one-off actions in effort to capture previously unreported cases, and that these cases are subsequently reported with excessive delays. Slightly different underlying assumptions and effectively different models may be required for individual countries to adjust for missing data and reporting delays. However, using a similar methodology is recommended to foster harmonisation and to improve the accuracy and usability of HIV surveillance data at national and EU/EEA levels.
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Persistent disparities in antiretroviral treatment (ART) coverage and virological suppression across Europe, 2004 to 2015
Kamilla Laut, Leah Shepherd, Roxana Radoi, Igor Karpov, Milosz Parczewski, Cristina Mussini, Fernando Maltez, Marcelo Losso, Nikoloz Chkhartishvili, Hila Elinav, Helen Kovari, Anders Blaxhult, Robert Zangerle, Tatiana Trofimova, Malgorzata Inglot, Kai Zilmer, Elena Kuzovatova, Thérèse Staub, Dorthe Raben, Jens Lundgren, Amanda Mocroft, Ole Kirk and on behalf of the EuroSIDA Study GroupBackground: Direct comparisons between countries in core HIV care parameters are often hampered by differences in data collection. Aim: Within the EuroSIDA study, we compared levels of antiretroviral treatment (ART) coverage and virological suppression (HIV RNA < 500 copies/mL) across Europe and explored temporal trends. Methods: In three cross-sectional analyses in 2004–05, 2009–10 and 2014–15, we assessed country-specific percentages of ART coverage and virological suppression among those on ART. Temporal changes were analysed using logistic regression. Results: Overall, the percentage of people on ART increased from 2004–05 (67.8%) to 2014–15 (78.2%), as did the percentage among those on ART who were virologically suppressed (75.2% in 2004–05, 87.7% in 2014–15). However, the rate of improvement over time varied significantly between regions (p < 0.01). In 2014–15, six of 34 countries had both ART coverage and virological suppression of above 90% among those on ART. The pattern varied substantially across clinics within countries, with ART coverage ranging from 61.9% to 97.0% and virological suppression from 32.2% to 100%. Compared with Western Europe (as defined in this study), patients in other regions were less likely to be virologically suppressed in 2014–15, with the lowest odds of suppression (adjusted odds ratio = 0.16; 95% confidence interval (CI): 0.13–0.21) in Eastern Europe. Conclusions: Despite overall improvements over a decade, we found persistent disparities in country-specific estimates of ART coverage and virological suppression. Underlying reasons for this variation warrant further analysis to identify a best practice and benchmark HIV care across EuroSIDA.
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Assessment of HIV molecular surveillance capacity in the European Union, 2016
IntroductionExpanding access to HIV antiretroviral treatment is expected to decrease HIV incidence and acquired immunodeficiency syndrome (AIDS) mortality. However, this may also result in increased HIV drug resistance (DR). Better monitoring and surveillance of HIV DR is required to inform treatment regimens and maintain the long term effectiveness of antiretroviral drugs. As there is currently no formal European Union (EU)-wide collection of HIV DR data, this study aimed to assess the current HIV molecular surveillance capacity in EU/European Economic Area (EEA) countries in order to inform the planning of HIV DR monitoring at EU level. Methods: Thirty EU/EEA countries were invited to participate in a survey on HIV molecular surveillance capacity, which also included laboratory aspects. Results: Among 21 responding countries, 13 reported using HIV sequence data (subtype and/or DR) for surveillance purposes at national level. Of those, nine stated that clinical, epidemiological and sequence data were routinely linked for analysis. Discussion/conclusion: We identified similarities between existing HIV molecular surveillance systems, but also found important challenges including human resources, data ownership and legal issues that would need to be addressed.Information on capacities should allow better planning of the phased introduction of HIV DR surveillance at EU/EEA level.
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HIV epidemic among men who have sex with men in the Czech Republic, 2016: high time for targeted action
More LessReported incidence of human immunodeficiency virus (HIV) infection in the Czech Republic increased steeply over the past decade from 90 new cases in 2005 to 266 in 2015. This increase is almost exclusively attributed to sexual transmissions between men who have sex with men (MSM). In 2015, there were 79% (n=210) newly diagnosed cases among MSM, 17% (n=45) were attributed to heterosexual transmission and 1% (n=3) to people who inject drugs. Interventions targeted at MSM have not yet been prioritised in the broadly focused national HIV prevention strategy which this is envisaged to change in the programme set out for 2018 to 2022. The national budget for HIV prevention has been reduced, however, and this remains. Availability of voluntary counselling and testing has decreased substantially in the past decade. Post- and pre-exposure prophylaxis for sexual intercourse among MSM are not part of the HIV prevention policy and the concept of treatment as prevention is not fully recognised. Provision of a combined prevention strategy with a focus on MSM, reflecting the above factors including stigmatisation, should contribute to reverse the development of a concentrated HIV epidemic among MSM in the Czech Republic.
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HIV testing in Europe: Evaluating the impact, added value, relevance and usability of the European Centre for Disease Prevention and Control (ECDC)’s 2010 HIV testing guidance
Background: An evaluation of the 2010 ECDC guidance on HIV testing, conducted in October 2015–January 2016, assessed its impact, added value, relevance and usability and the need for updated guidance. Methods: Data sources were two surveys: one for the primary target audience (health policymakers and decision makers, national programme managers and ECDC official contact points in the European Union/European Economic Area (EU/EEA) countries and one for a broader target audience (clinicians, civil society organisations and international public health agencies); two moderated focus group discussions (17 participants each); webpage access data; a literature citation review; and an expert consultation (18 participants) to discuss the evaluation findings. Results: Twenty-three of 28 primary target audience and 31 of 51 broader target audience respondents indicated the guidance was the most relevant when compared with other international guidance. Primary target audience respondents in 11 of 23 countries reported that they had used the guidance in development, monitoring and/or evaluation of their national HIV testing policy, guidelines, programme and/or strategy, and 29 of 51 of the broader target audience respondents reported having used the guidance in their work. Both the primary and broader target audience considered it important or very important to have an EU/EEA-level HIV testing guidance (23/28 and 46/51, respectively). Conclusion: The guidance has been widely used to develop policies, guidelines, programmes and strategies in the EU/EEA and should be regularly updated due to continuous developments in the field in order to continue to serve as an important reference guidance in the region.
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Hepatitis A outbreak in HIV-infected MSM and in PrEP-using MSM despite a high level of immunity, Lyon, France, January to June 2017
Since 2016, an increase in the number of hepatitis A cases affecting mainly men who have sex with men (MSM) has been reported in low endemic countries in Europe. We calculated the attack rate in Lyon, France, in populations considered at high-risk: HIV-infected MSM and HIV-negative MSM receiving HIV pre-exposure prophylaxis (PrEP). In these populations, high level of immunity did not prevent the outbreak, indicating that vaccination should be reinforced, particularly in younger individuals.
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Reduction in undiagnosed HIV infection in the European Union/European Economic Area, 2012 to 2016
It is well-documented that early HIV diagnosis and linkage to care reduces morbidity and mortality as well as HIV transmission. We estimated the median time from HIV infection to diagnosis in the European Union/European Economic Area (EU/EEA) at 2.9 years in 2016, with regional variation. Despite evidence of a decline in the number of people living with undiagnosed HIV in the EU/EEA, many remain undiagnosed, including 33% with more advanced HIV infection (CD4 < 350 cells/mm3).
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Using data from a behavioural survey of men who have sex with men (MSM) to estimate the number likely to present for HIV pre-exposure prophylaxis (PrEP) in Ireland, 2017
More LessIn Ireland, men who have sex with men (MSM) have increased HIV risk. Pre-exposure prophylaxis (PrEP), combined with safe sex practices, can reduce HIV acquisition. We estimated MSM numbers likely to present for PrEP by applying French PrEP criteria to Irish MSM behavioural survey data. We adjusted for survey bias, calculated proportions accessing testing services and those likely to take PrEP. We estimated 1–3% of MSM in Ireland were likely to present for PrEP.
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Economic evaluation of HIV pre-exposure prophylaxis among men-who-have-sex-with-men in England in 2016
Clinical effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV acquisition in men who have sex with men (MSM) at high HIV risk is established. A static decision analytical model was constructed to inform policy prioritisation in England around cost-effectiveness and budgetary impact of a PrEP programme covering 5,000 MSM during an initial high-risk period. National genitourinary medicine clinic surveillance data informed key HIV risk assumptions. Pragmatic large-scale implementation scenarios were explored. At 86% effectiveness, PrEP given to 5,000 MSM at 3.3 per 100 person-years annual HIV incidence, assuming risk compensation (20% HIV incidence increase), averted 118 HIV infections over remaining lifetimes and was cost saving. Lower effectiveness (64%) gave an incremental cost-effectiveness ratio of + GBP 23,500 (EUR 32,000) per quality-adjusted life year (QALY) gained. Investment of GBP 26.9 million (EUR 36.6 million) in year-1 breaks even anywhere from year-23 (86% effectiveness) to year-33 (64% effectiveness). PrEP cost-effectiveness was highly sensitive to year-1 HIV incidence, PrEP adherence/effectiveness, and antiretroviral drug costs. There is much uncertainty around HIV incidence in those given PrEP and adherence/effectiveness, especially under programme scale-up. Substantially reduced PrEP drug costs are needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size.
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Fall in new HIV diagnoses among men who have sex with men (MSM) at selected London sexual health clinics since early 2015: testing or treatment or pre-exposure prophylaxis (PrEP)?
Since October 2015 up to September 2016, HIV diagnoses fell by 32% compared with October 2014–September 2015 among men who have sex with men (MSM) attending selected London sexual health clinics. This coincided with high HIV testing volumes and rapid initiation of treatment on diagnosis. The fall was most apparent in new HIV testers. Intensified testing of high-risk populations, combined with immediately received anti-retroviral therapy and a pre-exposure prophylaxis (PrEP) programme, may make elimination of HIV achievable.
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Development and validation of the HCV-MOSAIC risk score to assist testing for acute hepatitis C virus (HCV) infection in HIV-infected men who have sex with men (MSM)
Current guidelines recommend hepatitis C virus (HCV) testing for HIV-infected men who have sex with men (MSM) with ongoing risk behaviour, without specifying the type of risk behaviour. We developed and validated the HCV-MOSAIC risk score to assist HCV testing in HIV-infected MSM. The risk score consisted of six self-reported risk factors identified using multivariable logistic regression using data from the Dutch MOSAIC study (n = 213, 2009–2013). Area under the ROC curve (AUC), sensitivity, specificity, post-test-probability-of-disease and diagnostic gain were calculated. The risk score was validated in case–control studies from Belgium (n = 142, 2010–2013) and the United Kingdom (n = 190, 2003–2005) and in cross-sectional surveys at a Dutch sexually transmitted infections clinic (n = 284, 2007–2009). The AUC was 0.82; sensitivity 78.0% and specificity 78.6%. In the validation studies sensitivity ranged from 73.1% to 100% and specificity from 56.2% to 65.6%. The post-test-probability-of-disease ranged from 5.9% to 20.0% given acute HCV prevalence of 1.7% to 6.4%, yielding a diagnostic gain of 4.2% to 13.6%. The HCV-MOSAIC risk score can successfully identify HIV-infected MSM at risk for acute HCV infection. It could be a promising tool to improve HCV testing strategies in various settings.
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Estimating HIV incidence and number of undiagnosed individuals living with HIV in the European Union/European Economic Area, 2015
Since 2011, human immunodeficiency virus (HIV) incidence appears unchanged in the European Union/European Economic Area with between 29,000 and 33,000 new cases reported annually up to 2015. Despite evidence that HIV diagnosis is occurring earlier post-infection, the estimated number of people living with HIV (PLHIV) who were unaware of being infected in 2015 was 122,000, or 15% of all PLHIV (n=810,000). This is concerning as such individuals cannot benefit from highly effective treatment and may unknowingly sustain transmission.
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Meeting report: Pre-exposure Human Immunodeficiency Virus Prophylaxis in the EU/EEA: Challenges and Opportunities, Stockholm April 2016
More LessThe ECDC held an expert meeting in Stockholm on 27-28 April 2016 to discuss practical considerations for pre-exposure prophylaxis (PrEP) implementation in Europe. The meeting focused on four key areas: (i) eligibility criteria for PrEP in Europe; (ii) appropriate models of service delivery; (iii) cost-effectiveness of PrEP, and (iv) routine monitoring of people on PrEP. .
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Children and young people with perinatal HIV in Europe: epidemiological situation in 2014 and implications for the future
More LessAccurate ascertainment of the number of children living with human immunodeficiency virus (HIV) is important to plan paediatric and adolescent health services. In Europe, the first generation of perinatally HIV-infected survivors are transferring to adult care and their health needs are unknown. We undertook an online survey of HIV cohort studies participating in the EuroCoord Network of Excellence to ascertain the number of perinatally HIV-infected (pHIV) patients included, to compare it with those published by the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO) and to assess the ability of countries to follow up pHIV patients after transfer to adult care. At the end of 2013, 16 countries in EuroCoord reported 8,229 pHIV patients in follow-up in cohorts, compared with 5,160 cumulative diagnoses reported by the ECDC in the same area. Follow-up of pHIV patients after transfer to adult care varied. It is likely that the number of diagnoses of perinatal HIV reported to ECDC is an underestimate, although this varies by country. Further work is needed to refine estimates and encourage follow-up in adult HIV cohorts to investigate long-term outcomes and improve the care of the next generation of children with HIV.
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Trends in HIV surveillance data in the EU/EEA, 2005 to 2014: new HIV diagnoses still increasing in men who have sex with men
Human immunodeficiency virus (HIV) transmission remains significant in Europe. Rates of acquired immunodeficiency syndrome (AIDS) have declined, but not in all countries. New HIV diagnoses have increased among native and foreign-born men who have sex with men. Median CD4+ T-cell count at diagnosis has increased, but not in all groups, and late diagnosis remains common. HIV infection and AIDS can be eliminated in Europe with resolute prevention measures, early diagnosis and access to effective treatment.
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A systematic review of evidence to inform HIV prevention interventions among men who have sex with men in Europe
More LessAn estimated 42% of all newly diagnosed HIV cases in Europe in 2013 were transmitted during sex between men. This review was performed to identify and describe studies evaluating the efficacy and effectiveness of HIV prevention interventions among men who have sex with men (MSM), in relation to implementation data from European settings. A systematic search was performed individually for 24 interventions. Data were extracted from studies including efficacy or implementation data from European settings, appraised for efficacy, implementation and plausibility, and assigned a grade (1-4) according to the Highest Attainable Standard of Evidence (HASTE) framework. Four interventions (condom use, peer outreach, peer-led groups, and using universal coverage of antiretroviral treatment and treatment as prevention) were assigned the highest HASTE grade, 1. Another four interventions were assigned 2a for probable recommendation, including voluntary counselling and testing for HIV, using condom-compatible lubricant, using post-exposure prophylaxis, and individual counselling for MSM living with HIV. In addition, seven interventions were assigned a grade of 2b, for possible recommendation. Encouragingly, 15 interventions were graded to be strongly, probably or possibly recommended. In the relatively resource-rich European setting, there is an opportunity to provide global leadership with regard to the regional scale-up of comprehensive HIV prevention interventions for MSM.
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Effects of region of birth, educational level and age on late presentation among men who have sex with men newly diagnosed with HIV in a network of STI/HIV counselling and testing clinics in Spain
This paper analyses late presentation (LP) of HIV infection, and its determinants, among men who have sex with men (MSM) in Spain, newly diagnosed with HIV (2003-2011) in 15 sexually transmitted infection/HIV counselling and testing clinics. LP was defined as?<350 CD4 cells/µL or AIDS. In total, 3,081 MSM were included (2,499 having CD4/AIDS); overall LP was 25.3%. LP was higher in men older than 34 years, those not previously HIV-tested (adjusted odds ratio (aOR):3.1; 95% confidence intervals (CI):2.3-4.2) , and those tested?>?12 months before diagnosis (12-24 months (aOR:1.4; 95% CI:1.0-2.0);?>?24 months (aOR:2.2; 95% CI:1.7-3.0)). LP was less likely in MSM reporting a known HIV-infected partner as infection source or symptoms compatible with acute retroviral syndrome. 'Region of birth' interacted with 'educational level' and 'steady partner as infection source': only African and Latin-American MSM with low educational level were more likely to present late; Latin-American men attributing their infection to steady partner, but no other MSM, had LP more frequently. In Spain, HIV testing among MSM should be promoted, especially those > 34 years old and migrants with low educational level. The current recommendation that MSM be tested at least once a year is appropriate. .
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Antiretroviral therapy for prevention of HIV transmission: implications for Europe
The aim of this review is to summarise the evidence on the population-level effect of antiretroviral therapy (ART) in preventing HIV infections, and to discuss potential implications in the European context of recommending starting ART when the CD4 count is above 350 cells/mm3. The ability of ART to reduce the risk of HIV transmission has been reported in observational studies and in a randomised controlled trial (HPTN 052), in which ART initiation reduced HIV transmission by 96% within serodiscordant couples. As yet, there is no direct evidence for such an effect among men having sex with men or people who inject drugs. HPTN 052 led international organisations to develop recommendations with a higher CD4 threshold for ART initiation. However, there remains a lack of strong evidence of clinical benefit for HIV-positive individuals starting ART with CD4 count above 350 cells/mm3. The main goal of ART provision should be to increase ART coverage for all those in need, based on the current guidelines, and the offer of ART to those who wish to reduce infectivity; increased HIV testing is therefore a key requirement. Other proven prevention means such as condom use and harm reduction for people who inject drugs remain critical.
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