CROI 2017 Abstract e-Book

Abstract eBook

Oral Abstracts

pregnancy outcomes, including stillbirths, preterm delivery, and low birth weight infants. Until recently there has been little data to compare individual ART exposures, but concerns have now emerged for increased risk with specific antiretroviral agents and combinations. This talk will review the current data for adverse pregnancy outcomes associated with specific ART regimens used in pregnancy. Mechanisms to explain these findings are lacking, and remain an urgent field of study. Ongoing surveillance for adverse pregnancy outcomes is warranted for women exposed to ART in pregnancy, particularly as new ART regimens become available. 101 THE ART AND SCIENCE OF INFANT DIAGNOSIS Martina Penazzato, WHO, Geneva, Switzerland Early identification of HIV infection in infants born to HIV-infected mothers is a critical intervention to accelerate treatment initiation and reduce early mortality. Despite important investments in early infant diagnosis (EID), as of December 2015, only 51% of HIV-exposed infants received a virological test by their second month of life. Rates of retention and linkage to treatment and care among those tested is low, with loss to follow-up of 30-80%. While further expansion and strengthening of existing EID programmes remains of paramount importance, promising innovative approaches have been identified and included in recommendations issued by the World Health Organization (WHO) in 2016. These include: addition of a virological test at birth to the EID algorithm, assays to be used at or close to point-of-care (POC). Birth testing enables earlier identification of infants infected in utero and allows identification of those infants who may not return for the standard 6 weeks virological test. Use of POC assays may further improve retention in the testing- to-treatment cascade by shortening results turnaround time and providing opportunities for decentralisation of EID. South Africa, which introduced birth testing in 2014, offers a model for other countries in Sub-Saharan Africa. Provision of virological testing at maternities appears to be feasible and well accepted. However, a number of challenges are being uncovered by the national scale up: increasing human resources need, importance of ensuring positive test results are confirmed, need for active tracking to ensure follow up testing and effective linkage to care when required as well as availability of the appropriate antiretrovirals in adequate formulations to treat neonates. The first point-of-care EID technologies were validated and prequalified in 2016. Field evaluations of the first commercially available POC assays have investigated their accuracy compared to laboratory EID assays and further studies are exploring their impact on the testing-to-treatment cascade. This presentation will summarize the rationale for recent global guidance on infant diagnosis, provide an overview of the emerging evidence to inform introduction of key innovations and discuss how implementation science remains critical to fully inform future policies and ensure that tailored approaches that maximize resources and outcomes are implemented. 102 THE HIV-EXPOSED AND UNINFECTED CHILD: WHAT’S TO WORRY? Claire Thorne, Univ College London, London, United Kingdom There has been a substantial increase in the proportion of pregnant and breastfeeding women receiving antiretroviral drugs worldwide, from an estimated 50% in 2010 to 77% in 2015. This reflects improved coverage of services for prevention of mother-to-child transmission and has contributed to the 51% decline in the number of new HIV infections in children aged 0-14 years since 2010. It also means that there are now over 1 million infants born every year who are exposed to both maternal HIV infection and antiretroviral drugs in utero and early life, the large majority of whom are HIV-uninfected. There is a large and growing literature focussed on the question of whether and how these exposures may impact on the health of HIV-exposed uninfected (HEU) children, with an increasing number of studies in low and middle income countries, providing important data in settings where most HEU children are born. Outcomes assessed to date have been diverse and include metabolism and mitochondrial function, neurodevelopment, immune function and infections, growth and malignancies. Although studies have provided data pointing to poorer health outcomes in HEU children, there are some conflicting results and methodological weaknesses. In this presentation, the latest literature on the health of HEU children will be synthesized, focussing on those exposed to both HIV and antiretrovirals. The challenges in assessing outcomes in HEU children and in interpreting study results will be discussed. These include the difficulties of disentangling potential effects of maternal HIV infection from antiretroviral exposure and of comparing findings from studies (often small) conducted in diverse populations with different methodologies/tools, as well as the need for studies to have appropriate HIV-unexposed controls and long-term follow-up to assess persistence of abnormalities and/or to identify potential late sequelae. In the context of Option B+, increasing numbers of infants will be exposed to antiretroviral exposure for their entire gestation, as well as during breastfeeding. This highlights the need to improve our understanding of the potential short- and long-term health outcomes associated with the changing in utero and early life exposure to antiretrovirals, in order to optimize the health of HEU children. 103 THE TREATMENT OF NEWBORNS AND INFANTS LIVING WITH HIV Elizabeth Maleche Obimbo, Univ of Nairobi, Nairobi, Kenya As HIV diagnostics improve and point of care diagnosis becomes available in wider settings it is hoped that infants with HIV-1 infection will be identified earlier and initiated on anti-retroviral therapy at a younger age. As this takes place there is need to understand which ARV drugs are available for infants, fromwhich age, and what the persisting challenges around early ART initiation are, including paediatric drug formulation and palatability, dosing and safety. Specifically, for the newborn where evidence and ARV options have been minimal what evidence is emerging to inform therapy during the first days of life? What are our experiences on early treatment outcomes in varying settings, and how do these compare to outcomes of infants who access ART later? Given that children require lifelong treatment, there is need to better understand which ARV combinations are most durable, and what factors are impacting regimen efficacy. In the current environment where mothers living with HIV are now increasingly on combination ART during pregnancy and breastfeeding, for those infants that do become infected is there good evidence to guide the design of optimal regimens for them? The speaker shall explore and expound on emerging evidence and experiences on ART in HIV infected newborns and infants around the world. 104 ACTING OR NOT ACTING ON VIRAL LOAD Steven J. Reynolds, NIAID, NIH, Washington, DC, USA Access to routine viral load (VL) monitoring for patients on antiretroviral therapy (ART) has been limited in many resource-constrained settings until recently. Alternative monitoring approaches correlate poorly with virologic failure and can substantially delay switch to second-line therapy. The recent change in WHO monitoring guidelines to move towards routine VL monitoring as standard of care has empowered countries to scale up access to this important monitoring tool. Despite this change, the majority of individuals receiving antiretroviral therapy remain on first line treatment. Several implementation challenges have been faced by countries scaling up VL monitoring including low compliance with monitoring guidelines and frequent delays in switching patients with evidence of virologic failure to second line regimens. Delayed switching to second line therapy of patients with virologic failure could result in increased morbidity and mortality, accumulated drug resistance and increased risk of HIV transmission to partners, ultimately compromising the 90-90-90 goals set by UNAIDS. Innovative strategies will be needed in order to make viral load monitoring routine, ensure timely switching of regimens in the setting of virologic failure and ultimately maximize the benefits offered by the current scale up of this important monitoring tool. 105 MEASURING VIRAL LOAD: INNOVATIONS AND TAKING TO SCALE RosannaW. Peeling, London Schl of Hygiene and Tropical Med, London, United Kingdom Recent technological advances have given countries a variety of options for measuring HIV Viral Load. While laboratory based nucleic acid amplification tests for quantifying viral load in plasma samples are highly accurate, these tests are costly and not widely accessible to patients outside of tertiary care settings. The use of Dried Blood Spots (DBS) has enabled country programs to increase access to VL monitoring but issues remain, such as backlogs in sample processing and the interpretation of viral load levels in patients who are plasma undetectable but DBS detectable. Innovations in VL tests that can be performed at the point-of-care (POC) have opened up possibilities of taking VL monitoring to scale within health care systems in both developed and developing countries. Continued innovations such as protocols to elute free virus fromwhole blood have resolved difficulties in the interpretation of plasma VL versus those measured in whole blood samples. Apart from technological innovations, there are also opportunities to introduce innovations in the

Oral Abstracts

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CROI 2017