HIV & Hepatitis in the Americas 28–30 April 2016, Mexico City, Mexico

The development of potent interferon‐free regimens of direct‐acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection has moved at a remarkable pace. Highly effective, extremely well‐tolerated regimens are now available for most patient populations. Remarkably, advances have moved as quickly for those with HIV–HCV co‐infection as for those with HCV monoinfection, with recent studies showing similar results with most regimens in both populations. This has raised the question of whether HIV co‐infection continues to represent a “special” population among HCV‐infected individuals. There are, however, some data suggesting that HIV may still impair responses in particularly difficult‐to‐cure populations. For example, attempts to shorten therapy to eight weeks with sofosbuvir/NS5A combinations have been at least somewhat less successful in HIV‐co‐infected patients than in those with HCV monoinfection. It is clear that innate and possibly adaptive immune function are still necessary for viral clearance even with highly effective DAA‐based regimens, and thus, it is possible that particularly as therapy is pushed to shorter and simpler combinations, HIV may again emerge as an issue necessitating special consideration. The rationale behind DAA combinations will be reviewed with a focus on relevance for HIV‐HCV co‐infection. A general discussion of remaining issues to be addressed including drug interactions and treatment access will also be included.

The development of potent interferon-free regimens of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection has moved at a remarkable pace. Highly effective, extremely welltolerated regimens are now available for most patient populations.
Remarkably, advances have moved as quickly for those with HIVÁHCV co-infection as for those with HCV monoinfection, with recent studies showing similar results with most regimens in both populations. This has raised the question of whether HIV co-infection continues to represent a ''special'' population among HCV-infected individuals. There are, however, some data suggesting that HIV may still impair responses in particularly difficult-to-cure populations. For example, attempts to shorten therapy to eight weeks with sofosbuvir/NS5A combinations have been at least somewhat less successful in HIV-coinfected patients than in those with HCV monoinfection. It is clear that innate and possibly adaptive immune function are still necessary for viral clearance even with highly effective DAA-based regimens, and thus, it is possible that particularly as therapy is pushed to shorter and simpler combinations, HIV may again emerge as an issue necessitating special consideration. The rationale behind DAA combinations will be reviewed with a focus on relevance for HIV-HCV co-infection. A general discussion of remaining issues to be addressed including drug interactions and treatment access will also be included. Injection drug use (IDU) is an important vector in HIV and hepatitis C virus (HCV) transmission. Though the United States, Canada and western Europe have had major successes in controlling the HIV epidemic due to IDU, that is not the case in eastern Europe and Southeast Asia. Moreover, the recent increases of IDU in the United States fuelled by the epidemic of prescription opioid abuse were responsible for last year's HIV outbreak in Indiana and for the increases in HCV across the country and highlight the continued importance of IDU in fuelling these two epidemics. Injecting drug users infected with HIV or HCV can quickly lead to generalized HIV and HCV epidemics as they serve as bridges to other populations through sexual transmission. This highlights the importance of addiction treatment of IDU (particularly medication-assisted treatment or MAT) as prevention strategy for HIV and HCV infection as well as ''antiretroviral therapy treatment as prevention strategy'' to prevent HIV transmission. Addiction treatment also improves adherence to antiretroviral and clinical outcomes for HIV. The role of MAT in the prevention and outcomes for HCV has been much less studied. However, despite the effectiveness of MAT for the treatment of opioid use disorders, its use in IDU is very restricted. Strategies are required to expand its use within the healthcare system including infectious disease clinics as well as criminal justice settings. Success in its implementation will be necessary for achieving an AIDS-free generation and also for containing the growing HCV epidemic. The advent of potent combination antiretroviral therapy (ART) has led to a dramatic decrease in the incidence of AIDS and AIDS-related mortality worldwide. For most patients, full suppression of HIV type 1 (HIV-1) replication can be achieved by once-daily administration of an ART regimen available as a fixed-dose combination that is safe, convenient and well tolerated. Nevertheless, a treatment that led to durable drug-free remission or eradication (cure) of HIV-1 could reduce the burden, cost, toxicities and stigma associated with longterm ART and might lower immune activation and the associated risk of non-AIDS clinical events. The search for a cure therefore remains a high priority for clinicians, investigators and patients. To date, only a single individual (a Mr Timothy Ray Brown, known as the ''Berlin'' patient) has had apparent cure of HIV infection. In his case, the patient underwent allogeneic hematopoietic stem cell transplantation for treatment of acute myelogenous leukaemia using cells from a donor homozygous for a deletion in the CCR5 gene. Although ART was stopped at the time of transplantation, HIV did not rebound and has remained undetectable during more than seven years of follow-up. Attempts to repeat this approach in other patients have been unsuccessful to date. Current efforts at eradicating HIV infection or inducing long-term ART-free remission include activating HIV transcription in latently infected CD4' T-cells, enhancing HIV-specific immunity in order to target and destroy cells harbouring latent infectious proviruses and employing cell-based therapies using genetically modified CD4' T-cells or hematopoietic stem cells. Several exploratory pilot studies are underway with each of these approaches. Major challenges include the difficulty of quantifying the HIV reservoir, the uncertain safety of the experimental treatments under study and the need to balance the risk of these interventions against the generally well-tolerated and proven efficacy of long-term ART. Recent progress towards a cure presented at the 2016 CROI in Boston will be discussed. Over the last five years, the release of multiple direct acting antiviral (DAA) agents has created a therapeutic revolution in the world of hepatitis C (HCV) treatment. These novel, short-course (12 week) alloral regimens can routinely cure HCV infection in the vast majority of patients, regardless of genotype or liver fibrosis stage, in essence replacing completely the use of injectable peginterferon and its attendant side effects. Based on these striking developments, a clear message is emerging that virtually every patient with chronic HCV should be treated. . . Now! If such a policy is enacted, we can eradicate HCV within a decade or two, resulting in a marked reduction in disease burden and eliminating all new infections. Whether we achieve this aspirational goal depends on our collective will and creative solutions to access clinics prepared to treat HCV and solutions to access medicines, most of which are priced beyond the Late presenters represent a significant proportion of HIV-diagnosed patients. The factors that contribute to their late diagnosis might also contribute to poor adherence after initiating treatment, including lack of social support, active drug use or lack of knowledge about HIV and the benefits of highly active antiretroviral therapy. HIV diagnosed at advanced stage is associated with several adverse outcomes including clinical progression, blunted immune recovery after treatment, greater risk of drug toxicity and increased risk of immune reconstitution inflammatory syndrome. Randomized studies in patients presenting with opportunistic infections, including trials involving patients with pulmonary TB, have demonstrated the benefit of initiating treatment early, although controversy remains regarding the optimal time for initiating ART in patients with meningeal TB or meningeal cryptococcosis. A significant proportion of advanced patients will require intensive care. Maintaining or initiating ART during an intensive care unit admission presents distinct challenges related to drug distribution, drug doses, drug interactions and antiretroviral-associated toxic effects.

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Comprehensive care for elderly HIV-positive patients As the efficacy of antiretroviral treatment is maximized over time with the use of more potent, convenient and better tolerated drugs, and as a consequence of the test and treat era, there will be a growing number of virologically suppressed HIV-positive individuals over time. A number of virologically suppressed patients have been also under antiretroviral treatment for long periods, and individuals are growing older with emerging age-related comorbidities and polypharmacy. Monitoring laboratory tests for HIV antiretroviral treatment have been evaluated for this new era to come, and new questions naturally emerge. How frequently should HIV viral loads monitoring be performed for long-term suppressed patients? How to manage low-level viraemia among these individuals, and what is the real significance for low-level viraemia among those patients? Is CD4' T-cell counts monitoring necessary among virologically suppressed individuals? Are genotyping or tropism tests on peripheral blood mononuclear cells of use as tool for antiretrovirals switch or antiretroviral de-intensification? Are cell activation markers promising to design strategies in order to mitigate chronic HIVrelated inflammation? Blood tests for safety should also be carefully strategized in the future. Toxicities may emerge due to long-term use of antiretrovirals, age-related frailties and organ/tissues degeneration, and antiretroviral interactions with polypharmacy. It is also conceivable that long-term antiretroviral suppression may facilitate cancer emergency, specially lymphoma, due to the clonal expansion of lymphocytes with HIV integration in cancer genes [1,2]. While HIV-positive individuals with access to modern antiretroviral therapy (ART) have experienced a dramatic improvement in life expectancy, they remain at higher risk than the general population for morbidity and mortality, particularly from non-AIDS complications typically associated with ageing. While lifestyle factors (e.g., smoking, illicit drug use and obesity) as well as ART toxicities likely play a role, it is now well recognized that abnormal immune activation and inflammation persist in many ART-suppressed individuals, including those that restore normal CD4' T-cell counts, and that the extent of these immunologic defects strongly predicts morbidity and mortality from non-AIDS conditions. Interestingly, while some of the immunologic predictors of morbidity and mortality overlap with those of ageing, many are unique to HIV infection, suggesting distinct interventional targets. Multiple causes of the persistent inflammatory state in treated HIV infection have been proposed including HIV persistence, microbial translocation, cytomegalovirus and other prevalent co-infections. While earlier initiation of ART appears to be beneficial in reducing the inflammatory state and in reducing some morbidities, and some commonly used medications with antiinflammatory properties (e.g., statins) have shown some promise in pilot studies, there is a clear need for effective interventions to reverse persistent immune activation in this setting. These issues will become increasingly important as the HIV epidemic gets older, particularly in resource-limited settings, where the vast majority of HIV-positive individuals live. The expansion of universal access programmes worldwide has dramatically reduced morbidity and mortality, albeit in a different manner regionally. While the HIV epidemic in high-income countries has gone through a clear epidemiologic transition in which cardiovascular, non-AIDS neoplasias and chronic non-transmissible diseases have become the predominant cause of death among people living with HIV, limited data from Latin America and the Caribbean region suggest a more modest and apparently earlier phase of the transition in which most people with HIV still die of potentially preventable opportunistic infections early after diagnosis. Non-AIDS associated causes of death are increasing heterogeneously throughout the region but are not yet predominant. The information available about causes of death among people living with HIV at the national level in most countries in Latin America and the Caribbean is scarce. National and regional data for Brazil, and regional or single-centre published information for several countries in Latin America suggest that the impact of the expansion of universal access to antiretroviral therapies on mortality has been heterogeneous across the region and has decreased mortality the least among women. Evidence from Brazil shows that chronic non-communicable diseases have steadily increased as a cause of death in the last decade but tuberculosis and endemic transmissible diseases (e.g. histoplasmosis and visceral leishmaniasis) continue to kill a very high proportion of people living with HIV. Evidence from other countries appears to confirm this pattern happening at different rates regionally. The high prevalence of late diagnosis, shortcomings of health systems, maturity of expanded access programmes and ageing of the epidemic are most likely shaping this transition. Non-white individuals were at an increased risk of a faster decline of CD4 counts ( Figure 1). Older age was a risk factor for lower CD4 counts at seroconversion and to faster declines to CD4 counts to B350 cells/mm 3 . Additionally, individuals with the acute retroviral syndrome evolved with higher viral loads, which in turn were associated with a faster decline of CD4 counts. There were no differences between genders in the median time of CD4 decline to B350 cells/mm 3 .
Conclusions: Due to the current recommendations for treatment of HIV-1 infection regardless of CD4' T-cell count, it is unlikely that similar studies will be conducted in the future, which increases its importance, particularly for the discussion of the cost-effectiveness of various possible prioritization strategies for testing and initiation of antiretroviral therapy. The Cuban HIV/AIDS Prevention and Control Program was conceived based on well-known public health approaches applied in the country for disease prevention and control. Use was made of previous experiences in the control of sexually transmitted infections, and actions were implemented for the early diagnosis of cases, their epidemiological investigation, partner reporting, education of the population and availability of prevention, care and treatment services for those affected. Almost 30 years later, these strategies still exist and have been resized and adapted to each point in the evolution of the epidemic. Our Maternal and Infant Care programme constitutes the platform for the prevention of maternal and congenital syphilis and HIV transmission. Care comprises follow-up of the health status of pregnant women, including the performance of serological tests for syphilis and HIV for them and their sexual partners. Access to prenatal care that includes actions to prevent mother-to-child transmission of HIV, specialized HIV care, antiretroviral treatment and support for people living with HIV network is guaranteed. In the last four years, the annual rate of congenital syphilis has ranged between 0 and 0.04 per thousand live births and the annual rate of mother-to-child transmission of HIV under 2%. Considering these results, we officially requested validation by the Pan American Health Organization and the World Health Organization, and after completing each step established by the regional strategy, Cuba became the first country in the world to receive validation from the World Health Organization that it has eliminated mother-to-child transmission of HIV and syphilis. Introduction: Acute phase of HIV infection is a crucial moment; from 2 to 3 weeks after infection, exponential growth of the virus occurs and the person is most infectious, knowing the risks involved [1,2]. We observed a significant impact of applications among men who have sex with men (MSM) and meeting places in sexual health, and use of these applications leads to a greater likelihood of having unprotected sex and spread of disease by sexual transmission [3]. Materials and methods: Semistructured interview about using applications and meeting places in the last three months before diagnosis was applied. Introduction: Acute phase of HIV infection is a crucial moment of infection to the spread of the virus [1,2]. Weeks 2Á3 after infection exponential growth of the decrease in viral load and CD4 occurs. This reported in the literature that sexual risk behaviours as traumatic sex, receptive anal intercourse, active ulcerative disease, sex work, drug use and regular multiple sexual partners. In men, the risk factors have been associated with who are not circumcised [3].

Reference
Methods: Semistructured interview about risky sexual behaviour and substance use self-report in the three months prior to HIV diagnosis is applied. Introduction: Two international, randomized, double-blinded, phase 3 trials in distinct regions directly compared TAF versus TDF, each co-formulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At week 48, E/C/F/TAF met the primary objective of non-inferior efficacy with improved renal and bone secondary safety endpoints compared with E/C/F/TDF. We describe longer-term follow-up of efficacy, safety and tolerability endpoints through week 96. Materials and methods: Antiretroviral (ARV) naïve participants were randomized 1:1 to receive E/C/F/TAF (TAF) or E/C/F/TDF (TDF).
Week 96 viral suppression (HIV-1 RNA B50 c/mL) by FDA snapshot analysis, pre-defined bone and renal safety, and tolerability endpoints are reported. Results: A total of 1733 subjects were randomized and treated: 15% women, 43% non-white and 23% viral load (VL) !100,000 c/mL. Median baseline characteristics: age 34 years, CD4 count 405 cells/mL and VL 4.58 log10 c/mL. Virologic suppression (HIV-1 RNA B50 c/mL) was 86.6% (TAF) and 85.2% (TDF) (difference 1.5%; 95%CI [ (1.8, 4.8%], p00.36). Viral outcomes did not vary by age, sex, race, geography or baseline CD4/VL. Mean [SD]% decrease in BMD was significantly less in the TAF group for both lumbar spine ((0.96 [3.72] vs. (2.79 [3.92], p B0.001) and total hip ((0.67 [3.89] vs. (3.28 [3.97], pB0.001). As shown in Table 1, renal safety endpoints favoured TAF. There were greater increases in lipids in the TAF arm versus TDF but no difference in rate of initiation of lipid-modifying agents (TAF: 3.8% vs. TDF: 4.4%). There were no cases of renal tubulopathy in the TAF arm versus two on TDF, including one that led to discontinuation. Conclusions: Through week 96, rates of virologic suppression were high and similarly maintained in both the TAF and TDF groups. E/C/F/ TAF continued to have a statistically superior bone and renal safety profile compared with E/C/F/TDF. These longer-term data support the use of E/C/F/TAF as a safe, well-tolerated and durable regimen for initial and ongoing HIV-1 treatment. Introduction: As the HIV-infected population ages and has increasing prevalence of co-morbidities, efficacy and safety of antiretrovirals in older patients is of heightened importance. In the general population, E/C/F/TAF demonstrated similar efficacy and improved bone and renal safety compared with E/C/F/TDF. Materials and methods: Treatment-naïve HIV-positive adults were randomized 1:1 to a single-tablet regimen of E/C/F/TAF or E/C/F/TDF once daily in two phase 3 double-blind studies. Pre-specified pooled week 48 analyses of efficacy, renal safety and bone mineral density (BMD) in those ]50 years are described in this analysis. Introduction: Despite expansion of universal access to antiretroviral therapy (ART) in Mexico, AIDS mortality has remained constant. Recent data show heterogeneity in AIDS mortality by state and gender pointing to health inequities within the country. Here we describe the causes and time to death in HIV-positive subjects in Mexico City. Materials and methods: We obtained data from death certificates (2012Á2014) from Mexico City's Ministry of Health (MoH). We included certificates in which HIV infection was listed. Causes of death were ICD-coded. We obtained all-cause mortality by age groups from the National Institute for Statistics, Geography and Informatics. We evaluated socio-demographic characteristics, causes of death and time to death after HIV diagnosis by gender. We estimated the proportion of deaths from all-deaths by age group, gender and borough. We fit logistic models to determine factors related to early mortality (EM, deaths occurring the first year after diagnosis).
Results: There were 1602 registered deaths in HIV-positive subjects in Mexico City (2012Á2014). Sixty-six per cent were early deaths. Women accounted for 27% of deaths, were older at death than men (57 years vs. 41 years), were less frequently single (22% vs. 60%) and were less educated. Twenty-four per cent of women died in the first month after diagnosis in contrast to men (50%). Twenty-six per cent of women died more than five years after the HIV diagnosis, while 12% of men did. Most deaths (74%) among men were early deaths and concentrated in a few boroughs. Boroughs with the highest number of deaths showed a northÁsouth geographic pattern that did not follow the size of the population or its overall mortality. The most common causes of death were AIDS-defining opportunistic infections (OI), respiratory illnesses, liver disease and non-AIDS-related infections. Male gender, younger age (B20 years), single and lack of social insurance were independent risk factors associated with EM.
Conclusions: A large proportion of deaths in HIV-positive individuals occur within the first year of diagnosis, which might be explained by late diagnosis and poor linkage to care. We observed differences in socio-demographic, geographic and clinical profiles across age groups and gender in HIV-positive individuals that died in Mexico City in 2012Á2014. Most deaths occur early in young, uninsured, single men in two city areas. More deaths among women occurred due to chronic diseases late after diagnosis. EM accounts for most of the deaths among uninsured people. Addressing late diagnosis and lack of linkage to care could contribute to reduce AIDS-associated deaths in Mexico City even further.

P006 Co-morbidities in a sample of HIV-positive adults in Puerto Rico
Introduction: Puerto Rico (PR) is among the areas with the highest estimated rates of people with HIV in the United States. Despite the availability of epidemiologic data, there is a lack of real-world information that can help in understanding the co-morbidities of people with HIV in PR. The objective of this study was to describe common co-morbidities among HIV-positive adults who attend treatment clinics in PR.
Methods: An exploratory, retrospective, cross-sectional study was conducted at five clinics that provide services to people with HIV in PR. A random sample of medical records was reviewed from HIVpositive adult patients. Patient with HIV-related illness and pregnant women were excluded from the sample. Descriptive statistics were used to summarize patient demographics, morbidity and clinical characteristics. Multivariate analyses were conducted to explore differences by age and sex.
Results: A total of 250 (179 men and 71 women) medical records were reviewed. The mean age was 47.9 years, and in average, they have been living with HIV for nine years. Most (97.6%) had at least one comorbidity. The most common co-morbidities were dyslipidaemia (men: 60.8%; women: 69.0%) and hypertension (men: 39.6%; women: 46.5%). The most common co-morbidity treatments and supplements were multivitamins, lipid lowering therapy and antihypertensive agents. These remain as the most common treatments after stratifying by sex. Men were more likely to have been diagnosed with alcohol misuse ( Material and methods: The cohort is built by a multinational Executive Committee and National Coordinating Centers in charge of local logistics, identification and inclusion of contributing sites. From initial involvement of sites who participated in the retrospective cohort, we moved forward to include new sites specializing in HIV ensuring data quality. The prospective cohort started gathering data in September 2013 from six sites and progressed to the current 12 distributed in Argentina (nine sites), Mexico (two sites) and Peru (one site). Data presented here correspond to patients enrolled until March 2015. Inclusion criteria were recent HIV diagnosis (within one year) and at least two prior visits to the site in order to ensure commitment. Data collection was performed through a website (www.latina.cical.org) including data obtained in standard of care visit. Diagnosis for AIDS defining diseases was based on CDC criteria, and standardized criteria were developed by the Executive Committee for serious non-AIDS events. Database was periodically checked for incompleteness and consistency. All data were consolidated in an Access database and analyzed using Statistics V17.
Results: A total of 748 patients were included in this analysis of baseline visit; 578 (77%) were from Mexican sites, 158 (21%) from Argentinian and 12 (2%) from Peruvian Site. Characteristics of our cohort were provided in Table 1.
Conclusions: Data presented reflects the situation of HIV epidemics, with mostly young males, predominantly men who have sex with men and with a significant proportion of late presenters and selfreported users of alcohol and tobacco. A major limitation of this cohort is selection bias due to convenience sampling. Data quality is acceptable among all participating sites present and constitutes a quite diverse and interesting data set for both continue to follow-up and expansion of its regional representativity. This pooled analysis will assess safety and sustained virologic response at week 12 (SVR12). LDV, SOF and GS-331007 exposures in HCV/HIV-co-infected subjects were also compared across ARV regimens, race, SVR12 and to subjects with HCV monoinfection. A genome-wide association study (GWAS) was conducted to identify host genetic determinants of HCV relapse after LDV/SOF therapy in HCV/HIV-co-infected individuals on ARVs.
Results: A total of 865 patients were treated with LDV/SOF for 12 weeks in the Phase III ION programme. In ION-4, the overall SVR12 was 96% and relapse rate was 3%. In ION 1Á3, the overall SVR12 was 97% and the relapse rate was 2%. SVR12 by treatment history, cirrhosis status, race and GT1 subtype is reported in Table 1.
Most common adverse events ( !10% reported in any arm) were fatigue, headache, diarrhoea and nausea. There were no clinically relevant differences in pharmacokinetics (PK) of LDV/SOF in HCV/HIVco-infected subjects compared with HCV monoinfected subjects. GWAS did not reveal significant associations with HCV relapse. Conclusions: In this pooled analysis, the once daily, single-tablet regimen of LDV/SOF for 12 weeks provided high rates of SVR regardless of the presence of HIV infection and is a safe, well-tolerated option for patients with both HCV monoinfection and HCV/HIV co-infection.  (96) Introduction: Historically, HIV co-infection was considered a negative predictor of HCV response to treatment with interferon/ribavirin (IFN/ RBV). For sofosbuvir-based regimens, HIV/HCV patients have achieved similar sustained virologic response (SVR) rates as HCV monoinfected patients. We evaluated the safety and efficacy of the IFN-free, RBVfree, single-tablet regimen of ledipasvir/sofosbuvir (LDV/SOF) in HCV genotype 1 or 4 patients co-infected with HIV-1 in the Phase 3 ION-4 study. Co-infection is no longer considered a special population, and HIV/HCV-co-infected persons should be treated the same as persons without HIV infection. Materials and methods: HCV treatment-naïve and experienced HIV co-infected patients on stable, antiretroviral (ARV) regimens were enrolled and received LDV/SOF (90 mg/400 mg) once daily for 12 weeks. Permitted concomitant ARVs included tenofovir and emtricitabine (TDF'FTC) with raltegravir (RAL), efavirenz (EFV) or rilpivirine (RPV). Safety evaluations included adverse event (AE) and laboratory monitoring including renal parameters, CD4 count and HIV-1 RNA levels. The primary efficacy endpoint was SVR12. The pharmacokinetics (PK) of LDV, SOF, GS-331007 (SOF predominant circulating metabolite) and tenofovir (TFV) were evaluated in all subjects with measurable plasma concentrations using previously established population PK models. A genome-wide association study (GWAS) was conducted to identify common host genetic determinants of HCV relapse after LDV/SOF therapy in HIV/HCV individuals on antiretrovirals (ARVs).
Conclusions: In treatment-naïve women, E/C/F/TAF demonstrates higher rates of virologic success and significant improvements in renal and bone safety compared to E/C/F/TDF at week 48. These results support the use of E/C/F/TAF for the initial treatment of HIV-1 in women. Background: Since the commitment to eliminate the mother-to-child transmission (MTCT) [1,2] of HIV by 2018, the Mexican Health Ministry has generated evidence that contributes to the design of strategies for HIV testing promotion in pregnant women and their linkage to HIV health services. As part of these actions, the current study gives an overview of the gap between the detection and the antiretroviral treatment (ART) access to prevent the MTCT (PMTCT) of the HIV; also, it shows the need to strengthen the monitoring of cases considering the moment of transmission and the timeliness of diagnosis. Methods:We estimated the number of pregnant women with HIV in 2014 through the UNAIDS Spectrum model. The total detections were obtained from the percentage of screening coverage [3]. The number of pregnant women with HIV who received ARV for PMTCT was obtained from the reports of the HIV Sector Information Group (part of the National Council for the Prevention and Control of AIDS

P019 Incidence and time-varying predictors of HIV and sexually transmitted infections among male sex workers in Mexico City
Methods: MSWs recruited from Clínica Condesa HIV Testing Clinic and community sites in Mexico City were tested and treated for STIs (chlamydia, gonorrhoea, syphilis and HIV) and viral hepatitis (hepatitis B and C) at a baseline, 6-month follow-up and 12-month follow-up clinic visits. Participants completed surveys at all visits to document socio-demographic characteristics and health behaviours. We estimated incidence rates and calculated 95% confidence limits using a bias-corrected and accelerated bootstrap method with 1000 replicates. We used mixed effects logistic regression with individual fixed effects to examine unadjusted and multivariable adjusted timevarying predictors of incident STIs (excluding HIV in order to retain participants with prevalent HIV infection). Introduction: The early diagnosis of HIV as well as the access to the highly active antiretroviral therapy (HAART) of people living with HIV is key to avoid AIDS mortality. In our country, in spite of the fact that HAART is available for free, and active policies to promote testing have been implemented, 1400 people die from AIDS every year. It is essential to know the characteristics of people who die due to causes related to AIDS in order to define strategic interventions in the most vulnerable groups. Materials and methods: A retrospective observational study was carried out among people over 18 years old who died from a basic cause related to AIDS during 2010 in the Metropolitan Area of Buenos Aires. A collection tool was used to gather information about medical records of hospitalized people and outpatients. Absolute and relative frequency rates were obtained and tests of statistical significance in the analyzed variables were calculated whenever appropriate.

Results
Results: A total of 331 deaths were studied, out of which 64% took place in the Autonomous City of Buenos Aires. The average age of the people studied was 40 years and 64% were men; 71.3% lived in areas that belong to the province of Buenos Aires. The main mode of transmission was unprotected opposite-sex sexual intercourse, both in men and women. 31% of the deaths were of people who had a late diagnosis, and 40% of them were diagnosed while in the same hospital in which death occurred. The median period of time since the diagnosis and death was of five years, and it was shorter in men than in women (p B0.05). The main causes of deaths in confirmed diagnoses were tuberculosis, both pulmonary and disseminated, and meningeal cryptococcosis. The presence of a great number of defining diseases and the clinical and immune deterioration was a common result in all the hospitalizations that were analyzed. Introduction: The increase of 78.3% of the female prison population in Brazil in the period 2005 to 2013 has brought great challenges, especially those related to the vulnerability to sexually transmitted infections [1]. Gender inequality, stigma and discrimination increase imprisoned women's vulnerability to HIV infection [1,2]. The State of São Paulo (SSP) accounts for 30% of this Brazilian population and has sought to develop actions within the National Policy for Integral Women's Health [3]. The aim of this study was to estimate the prevalence of HIV infection in women deprived of freedom in SSP, to establish parameters for monitoring and evaluation. Conclusions: This is the first study-based action in this extension in SSP. This population-based survey reinforces the status of great vulnerability to HIV infection for women in the State penal system, both in urban and rural realities. This study brings as possibilities to be assigned: establishment of flowcharts and indicators for monitoring and evaluation of preventive and therapeutic strategies to this population, establishment of appropriate flowcharts to the State Epidemiological Surveillance System, definition of elements for interventions in the prison system addressing public health policies and scientific knowledge production from this and other nested publications to the project [3,4]. These initiatives could ultimately contribute to improving the quality of life of women with a neglected and vulnerable condition [2,3,4].
Introduction: The overall rate of new HIV infections appears to be in decline worldwide; however, among key populations, men who have sex with men (MSM) and trans-women (TGW), new HIV infections continue growing [1]. Since the introduction of highly active antiretroviral therapy (HAART), people living with HIV live longer than ever before. The HIV cascade of care is a comprehensive monitoring tool to evaluate the HIV continuum of care and to evaluate ''leakage points'' along the points of attention [2]. The objective of this study was to evaluate the HIV cascade along the services in MSM and TGW and compare this with the general HIV population in an outpatient clinic in Santo Domingo, Dominican Republic. Materials and methods: We used a retrospective database of one outpatient clinic for HIV patients to assess our population-based cascade. Paper-based data were collected from clinical files. Characterization of target populations was based on past clinical history or self-identification as exclusively MSM or TGW and compared with the HIV-positive with unknown risk ('WUR). Treatment access and administration of HIV drugs was based according with the Dominican Republic Ministry of Health criteria ( B350 cell/mL) and viral suppression below 20 copies/mL. Results: We identified 405 HIV diagnosed individuals during the study period; 60% were male. Of these, 25.18% (n 0102) were MSM and TGW. Overall, 64.44% in the 'WUR was retained in care versus 65.68% in MSM/TGW (Figure 1). HAART access in 'WUR was 56.04%, while in MSM/TGW 38.29%. Viral suppression in 'WUR was 43.70% and in MSM/TGW 24.50%. Conclusions: We found a significant difference between access to HAART and viral suppression in both groups. It is necessary to note that higher viral loads among these groups will be of significant influence for HIV persistence in social and sexual networks. Drops in the proportion to be achieved in each step may be a reflection of challenges specific to MSM/TGW access to care. It is necessary to evaluate the potential role of antiretroviral and hormone replacement therapy interactions.

Introduction:
Little is known about the mental health of female sex workers (FSW) and women living with HIV (WLWH) in the Dominican Republic (DR), which may impede the effectiveness of HIV prevention, testing and treatment programming. This is important, since studies across multiple sociocultural contexts show that the prevalence of depression in FSW ranges from 50% to 80%. Depression is also prevalent in WLWH, ranging from 25.8% to 81.0%. There is almost no scientific work about depression in FSW and WLWH in the DR. This is problematic, since the DR is home to a generalized HIV epidemic (0.8% to 1.5%) and a concentrated HIV epidemic for FSW (3.3% to 8.4%), making this a high priority area for study. Materials and methods: This study estimated the prevalence of elevated depression symptoms and identified key correlates in FSW, WLWH and a comparison group. Participants were FSW (N0349), WLWH (N0213) and a comparison group of HIV-negative women who were not sex workers (N0314) from San Felipe de Puerto Plata, DR. Participants completed questionnaires assessing demographics and depression. FSW and WLWH completed items ascertaining HIV or sex work-related internalized stigma. Descriptive statistics summarized the demographic characteristics of the sample, and chi-square (categorical variables) and t-tests (continuous variables) detected significant differences between the comparison group and FSW or WLWH. Unadjusted and adjusted logistic regressions identified significant relationships between covariates and the outcome variable, elevated depression symptoms (EDS). Interaction terms were calculated to determine the strength of association of significant relationships with (1) FSW and the comparison group and (2)  Introduction: Trends study allows us to perform future projections and anticipate results on the HIV/AIDS epidemic trends. The objectives were to describe and analyze the AIDS and the HIV-positive cases trends in the state of São Paulo, in teenagers and adults, during the period of 2004 to 2013, according to age groups and men who have sex with men (MSM). Materials and methods: Trends study was performed with AIDS and HIV-positive notification data compared by age group and exposure categories. It was considered as a dependent variable (Y), the annual number of HIV-positive patients and the number of AIDS cases, in each of the studied categories, and the independent variable (X) was the time, represented by the calendar years, concerning the study period. The goodness of fit via R 2 and p B0.05 were used to determine which models and data were most appropriate.
Results: Among the MSM, 15,810 cases of AIDS and 16,138 cases of HIV-positive patients were analyzed. The obtained modelling was of first order to all age groups. The trends of the HIV-positive patients were growing in all age groups during the period of 2004 to 2013. The trends were linearly growing in the age groups of 13 to 19 years (Y 05'16X, R 2 00.78, p00.032); 20 to 29 years (Y 013'63X, R 2 00.89, p 00.001); 30 to 39 years (Y 0177'49X, R 2 00.86, p 00.002); 40 to 49 years (Y 060'22X, R 2 00.92, p B0.001) and 50 years and more (Y 017'8X, R 2 00.82, p B0.001). However, in the AIDS cases, growing trends were observed only in the age groups of 13 to 19 years (Y 013'3X, R 2 00.52, p 00.050) and in the 20 to 29 years group (Y 063'22X, R 2 00.93, p B0.001). In the age groups of 30 to 39 years, 40 to 49 years and 50 years and more, the trend analysis of the AIDS cases revealed stability along the historical series.
Conclusions: During the period of 2004 and 2013, it was observed among the HIV-positive patients that the higher growth rate occurred among the MSM in the age group of 20 to 29 years, followed by the age group of 30 to 39 years. Among the AIDS cases, it was observed that the MSM in the age group of 20 to 29 years also presented the highest growth rate. This analysis points to the importance of this most vulnerable group that are the young MSM and the need to prioritize them, planning actions of the epidemic control programmes. Introduction: Mexico has a concentrated epidemic with an estimated 180,000 HIV-positive individuals in 2014, which translates to a prevalence of 0.3%. Among Mexico's 32 states, Mexico City has consistently had the highest cumulative HIV-AIDS incidence, being the oldest epidemic so far. Considering HIV a chronic disease, public health strategies should be implemented to optimize medical care programmes in ambulatory settings. Materials and methods: Condesa Clinic is Mexico City's ambulatory HIV unit that assists more than 10,000 active patients up to January 2016. We describe a new medical protocol to detect, evaluate and incorporate new HIV patients to the clinic. This protocol has been implemented since 2012 and is updated yearly according to results. We started an early incorporation to medical assistance and a time reduction strategy to start HAART, which potentially will reduce the number of lost patients (Figure 1). them before medical evaluation. There were 1839 medical evaluations and incorporation to medical assistance (57.3%) and 841 initiated HAART in the following week (79.7%); 478 patients were referred to other centres (25.9%). The strategy also includes 8-week viral load to detect early virological failures. With this strategy, the comparative time to undetectability in those starting HAART was reduced from 12.9 (2009) to 5.9 months (2015). Of those on treatment, 99.7% have had a viral load/CD4 determination in the last year, and those with more than 6 months of therapy (n09,056), 89.2% (8,079) and 98.6% had viral load of B50 and B200 copies/mL, respectively.

Conclusions:
The new HIV Care algorithm implemented allows to detect, evaluate and retain more patients, reducing the time to undetectability and the potential of HIV transmission. This is the first approach to early incorporation of HIV patients into medical care and early therapy starting time.  [2] and the needs of the Condesa Clinic patients, the MHP developed a process that included early detection and treatment for mental disorders. Within the first week of initial medical assessment, patients recently diagnosed with HIV had an evaluation to detect any mental disorder that could impair adherence to HAART or impact patients' quality of life. A clinical psychologist through a clinical interview based on DSM-5/ICD-10 criteria and valid psychometric instruments [3] performs this evaluation. If the patient had an adjustment disorder, he/she received a brief intervention. If the patient had a moderate or severe common mental disorder, he/she received psychopharmacological treatment by a psychiatrist; and if the patient had acute psychosis or suicidal ideation, he/she was referred to a psychiatric hospital. MHP has evaluated 2158 patients, most of whom were men (89.0%), middle aged (30.999.3), with 11.8 (93.9) years of formal education and single (76.7%). The 37.9% did not have any mental disorder at the moment of the mental assessment, but 35.3% had an adjustment disorder, 8.8% a depressive disorder, 4.3% an alcohol use disorder, 2.7% an anxiety disorder and 11.0% other disorders. They also had a mean viral load of 293,922 (9903,286) copies/mL, and a mean CD4 count of 308 (9229) cell/mL. Conclusions: Incorporation of mental healthcare services to the HIV treatment cascade at first-level facilities could be feasible and probably effective in order to help retention, to adhere to HAART and to get undetectable viral loads in patients. Further analysis to detect mental health factors related to unfavourable outcomes in HIV patients should be performed.
Introduction: High attrition during the period from HIV testing to antiretroviral therapy (ART) initiation is widely reported. Though treatment guidelines have changed to broaden ART eligibility and services have been widely expanded over the past decade, data on the temporal trends in ART initiation rates are limited. Materials and methods: We evaluated temporal trends and predictors of retention for each step from HIV testing to ART initiation over the past decade at the GHESKIO clinic in Port-au-Prince Haiti.  Figure 1 for a bar chart of retention at different time points). Predictors of ART initiation included later year of HIV testing, older age and higher educational status.

Conclusions:
The proportion of patients newly diagnosed with HIV who initiate ART has increased over the last decade in Haiti. Over the same time period, services have been delivered more rapidly. ART is now provided to most patients on the day that CD4 count results are provided, with very high rates of treatment initiation.    (Table 1).
Conclusions: HIV diagnosis in women in group occurs at advanced stages of pregnancy increasing the risk of vertical transmission. In Mexico, coverage of HIV testing during pregnancy is about 58% [2]. Better strategies must be implemented to increase the coverage of HIV testing in pregnant women.
Introduction: Life expectancy of people living with HIV has increased as it has become a chronic manageable condition. Primary care preventive services play a crucial role in older patients with HIV infection given the higher incidence of co-morbidities when compared with non-HIV population. We aim to assess the frequency of screening tests for malignant and non-communicable diseases in HIVpositive patients !50 years seen at INCMNSZ in Mexico City before and after an intervention designed to improve awareness among physicians. Methods: All HIV-positive patients aged !50 years were included. The application of internationally recommended primary care screening tests [1] was reviewed in clinical charts. We evaluated the frequency of tests prescribed in the last year and at least once since patients became 50 years old. Factors associated with better screening practices (defined as more than 80% of screening performed as recommended) were analyzed. We developed a checklist of screening tests, as a reminder for physicians in each visit during a follow-up period of 12 months. Frequencies of tests before and after this intervention were compared. Results: Of 1602, 355 (22%) patients were aged !50 years, 84.4% were men with a mean age at HIV diagnosis of 45.6 years and a median time in care of 10.9 years (SD 5.94). Only 7.5% of patients had !80% of non-communicable diseases related tests compared with 90% of complete HIV-care-related tests (syphilis, vaccination and PPD) before our intervention. After reaching 50 years during care, 87% of women had at least one mammogram and 91% cervical cancer screening; 61% of MSM had anal cancer screening; colorectal cancer screening was done in 24.5%; and cardiovascular risk was calculated in B10%. Frequency of densitometries was higher in women (55% vs. 16%; p B0.001) (Figure 1.A). In the last year of care, only vaccination, dyslipidaemia, hypertension and diabetes screening were achieved in !90% (Figure 1.B). Those with CD4 B200 c/mm 3 at HIV diagnosis were more likely to have better screening (p 00.02).
Neither smoking (p 00.2) nor family history of cancer (p00.3) was associated with better performance of screening. After the intervention, screening remained low for malignancies (52% and 24% for cervical and anal cancer, 30% for mammograms, 7.4% for colorectal cancer) and densitometries (8%). Cardiovascular risk assessment improved to 79%. Conclusions: Cancer and osteoporosis screening were underperformed. Lipids, glucose and blood pressure were done following recommendations. Only cardiovascular risk assessment improved after our intervention. Barriers to improve preventive primary care practices in older HIV-positive patients need further evaluation. Conclusions: This analysis shows high rates of RVR with DBRs at week 4, translated into high PPV, suggesting potential predictability of week 4 RVR on SVR. Further analysis of long-term data would be key to support the relationship between early and long-term response. Higher RVR with DBRs, associated with high PPV for SVR, may have implications for early monitoring frequency.

Reference
Results: Success of therapy was defined as B50 copies/mL and was observed in 407 (76.5%) women and 2,088 (81.6) men; the difference observed was statistically significant (p B0.0001). A bivariate analysis showed that men had a higher probability of achieving success than women (OR 1.36; CI95% 1.08 to 1.71; p 00.0068).
The prevalence of LLV in women and men was 7.3 and 10.1%, respectively, and 9.6% for both sexes (Figure 1). The amount of patients with LLV differed significantly between NNRTI-based firstline regimens (9.17%) and PI-based regimens (11.62%) (p B0.0001); a bivariate analysis showed that patients on NNRTI-based regimens had a higher probability of achieving B50 copies/mL (OR 1.66; CI 95% Introduction and aims: The optimal duration of therapy to achieve sustained virological response (SVR) depends on multiple factors. Patients treated with ledipasvir/sofosbuvir (LDV/SOF) with 8Á24 weeks achieved SVR12 from 94 to 100% in the ION Phase 3 studies. A decision to shorten therapy to 8 weeks is based on treatment history, cirrhosis status and baseline VL. In a post hoc analysis of the ION-3 (treatment-naïve (TN) non-cirrhotic (NC) patients) 8-week data, a viral load (VL) B6 million was shown to be the best predictor of SVR. Real work effectiveness (RWE) is often different from Phase 3 trials and there is a need to understand real-world 8-week regimens in a broader spectrum of patients.

Poster Abstracts
Methods: RWE 8-week LDV/SOF data are emerging from multiple single-centre and multicentre retrospective and prospective cohorts. In this analysis, the Phase-3 ION-3 data are compared with data from several diverse real-world populations and one post-marketing investigator sponsored HIV/HCV trial. Patient demographics, characteristics, SVR12 and discontinuation data have been collated and compared.
Results: The ION-3 post hoc analysis reported 123 patients who were TN, NC (VL B6 million) and treated with 8 weeks of LDV/SOF. Mean age was 52 y, 22% were black, 72% had GT1a and the overall SVR12 was 97% (119/123). The overall SVR12 rate from six diverse realworld and post-marketing cohorts was also 97% (638/658). There was no significant impact of HCV genotypes or subtypes (GT1a, 1b versus GT4), prior treatment history, presence or absence of cirrhosis, high viral load (HCV VL!6 million) or HIV/HCV co-infection. All response rates are detailed in Table 1.
Conclusions: LDV/SOF for 8 weeks yielded high SVR rates in ION-3. Analysis of RWE data from several diverse and heterogeneous cohorts from the United States and Europe shows SVR outcomes that were consistent with the Phase-3 ION-3 results and supports the use of 8 weeks LDV/SOF in treatment-naïve, non-cirrhotic GT1 patients with a baseline HCV VL B6 million and possibly in other populations including HIV/HCV co-infected patients. Discontinuation rates were low despite diverse patients and clinical settings. Data from the TARGET and TRIO cohorts also suggest that the 8-week regimen is under-utilized. Introduction: Chronic Hepatitis C (CHC) affects approximately 2.7 million people in Brazil [1]. Until December 2015, the majority of patients have been treated with interferon-based therapy [2]. The use of direct acting agents (DAAs) in Brazil has been recently introduced and only for patients with severe liver disease [3].
Objectives: The objectives of the present study were: 1) To describe the results of the clinical characteristics of CHC patients attended at a reference centre in Brazil; 2) To identify patients who are yet to be treated; 3) To differentiate easy-to-treat from difficult-to-treat patients. Materials and methods: We developed a retrospective and descriptive cohort study at Hospital das Clinicas, which is a public hospital and a reference centre to treat CHC in São Paulo, Brazil. The enrolled patients were selected from those registered at the Infectious Diseases Division. Medical records from all patients with CHC were reviewed in order to analyze selected variables: age, gender, HIV coinfection, HCV genotype, stage of liver fibrosis ( by using Metavir Score and/or evidence of portal hypertension) and information regarding previous hepatitis C treatment. In this study, difficult-to-treat patients were defined as follows: experienced genotype 3-infected or genotype 1-infected patients who failed first-generation protease inhibitors, cirrhotic or HIV co-infected patients.
Results: Between April 2015 and December 2015, 1,757 patients with CHC were identified and included in our data bank. Of these patients, 219 (12.4%) had HIV co-infection. 893 (50.8%) were women, and mean age was 41.95914.5 years. Genotype 1 predominated with 972 (55.3%) cases. Genotype 2, 3, 4 and 5 were 50 (2.85%), 513 (29.2%), 11 and 1 cases, respectively. Among all patients, 747 (42.5%) were F3 or F4, and 293 (16.6%) had cirrhosis. Among all patients, 1,048 (59.6%) had received previous hepatitis C treatment, with interferonbased therapy (n 0901, 86%) or telaprevir/boceprevir-based therapy (n 0147, 14%). Among 1,048 previously treated patients, only 480 (46%) obtained sustained virologic response (SVR) at a previous treatment and 250 were genotype 3 patients. Among all included patients, 1277 (73%) were yet to be treated and only 660 (37.5%) were considered difficult-to treat patients. Conclusions: In this Brazilian cohort from an urban tertiary medical centre, the majority of patients still wait for a proper HCV treatment. Less than half of those treated prior to DAAs had an SVR. However, the majority of patients in the cohort were considered easy-to-treat patients.
Introduction: Infection by hepatitis B virus (HBV) can occur through blood transfusions when routine screening of hepatitis B surface antigen (HBsAg) is negative. The aim of this study was to evaluate the seroprevalence of HBV infection and to identify occult hepatitis B infection (OBI) among donors with only antibodies against the hepatitis B core (anti-HBc). Materials and methods: A cross-sectional study was carried out in three blood banks in Bucaramanga city, Colombia, in 2013. Demographic and epidemiological information was collected from each donor, whereas HBV serological markers and DNA were investigated in serum by immunoassays and nested-PCR, respectively. A 1085 nucleotide fragment overlapping the s gene of hepatitis B virus was sequenced after cloning in a sequencing plasmid to identify the viral genotype.
Conclusions: The 7.3% of OBI among donors with anti-HBc(') antibodies in the north-east region of Colombia is the highest prevalence reported in blood banks of Latin America so far. As expected, F3 is the predominant viral subtype circulating in the country with low mutation rate inside the s gene. Molecular assays should be included in the screening for infectious diseases to reduce the risk of HBV transmission through blood donation.