CROI 2019 Abstract eBook

Abstract eBook

Oral Abstracts

60 ART OPTIONS AND TREATMENT DECISIONS FOR WOMEN OF REPRODUCTIVE POTENTIAL

potential. This presentation will highlight the importance of and ethics around conducting such research, and attend to four (of several) pressing challenges facing researchers designing research with women of childbearing potential, including: 1) assessing and managing risks and benefits to a fetus that does not yet and may never exist; 2) deciding when it is appropriate to require and/or offer access to contraception; 3) managing unexpected (or incident) pregnancies, including decisions about data collection and continuation of study drug; and 4) appropriate communication of study results, including development of guidance that is responsive to the interests and priorities of those most affected. Finally, current or evolving international consensus recommendations regarding these specific challenges will be described. Ricky N. Bluthenthal , University of Southern California, Los Angeles, CA, USA The opioid crisis is the first truly national drug epidemic in US history. Unlike prior drug use epidemics, the opioid crisis has reached all groups regardless of demographic characteristics, economic status, or geography. HIV-related consequences of the opioid crisis include increased injection drug use (still a key risk factor for HIV transmission), increased mixing of drug using subgroups (e.g., opioid and methamphetamine use), and HIV outbreaks in remote and poorly served locales (e.g., Scott County, Indiana). In addition, increases in acute HCV are also likely to lead to elevated susceptibility to HIV transmission among people who inject drugs. Research aimed at identifying “hot spot” for HIV outbreaks and consideration of policy responses for addressing the multiple consequences of the opioid crisis on HIV epidemiology, prevention, and care will be presented. Chemsex refers to the use of psychoactive substances in sexual settings by gay, bisexual, and other men who have sex with men (GBMSM). Chemsex is a socially constructed phenomenon and as such there is no specific case definition for it and substances used and social contexts vary between countries. Chemsex is often facilitated by smartphone geospatial networking applications and the substances linked to chemsex include methamphetamine, GHB/GBL (Gamma hydroxybutyrate/Gamma butyrolactone), mephedrone, other cathinones, cocaine, ketamine, and other amphetamines. The presentation will review published data on chemsex across the globe. In particular it will explore its relationships with STIs, shigellosis, hepatitis C and HIV. Additionally it will explore implications for PrEP use in this population. Potential drug-drug interactions between the psychoactive substances and antiretrovirals will be explored and data on antiretroviral adherence in HIV-positive men disclosing chemsex will also be presented. Finally there will be practical suggestions for clinicians on effective clinical communication around chemsex and how to address harmminimization. Implications for health policy and research gaps will also be highlighted. Leickness C. Simbayi , Human Sciences Research Council, Pretoria, South Africa Alcohol is widely used for pleasure by many cultures throughout the world except in Muslim-majority countries. Although it has also been credited with having some protective effect for some health outcomes, its abuse is highly problematic as it causes a large social and economic burden, both to individuals who consume it and other people close to them such as family members, friends, co-workers and strangers. Most importantly, causal relationships have now been established between harmful alcohol drinking and the risk of HIV acquisition. Alcohol abuse also has some impact on the engagement in care and adherence with antiretroviral therapy among people living with HIV. This presentation will present an update on the global epidemic of alcohol especially harmful drinking, followed by the global epidemic of HIV, and then a brief discussion of how the two epidemics converge with each other especially in sub-Saharan Africa. It will then posit about the mechanisms that explain the link between alcohol and HIV/AIDS as well as provide some relevant research evidence in support thereof. Finally, the implications of convergence of the two epidemics for both policies and intervention programmes will be presented.

Monica Gandhi , University of California San Francisco, San Francisco, CA, USA In light of recent data on the safety of antiretrovirals in pregnancy, a review of what is known and what is not known about ART options and treatment decisions for women of reproductive potential will be undertaken. This talk will summarize guidelines for the use of ART for women of childbearing potential desiring pregnancy and during pregnancy and the data (or lack of data) behind these recommendations. Pharmacokinetic, safety, tolerability, and efficacy considerations for various ART regimens during pregnancy will be covered. The importance of involving women in decision-making around treatment options pre-conception and during pregnancy will be emphasized. Moreover, the talk will touch upon ART considerations for women of reproductive potential not desiring pregnancy and on contraception. The talk will conclude with recommendations to researchers and policy-makers on how to increase the participation of women of child-bearing potential and pregnant women in clinical trials and observational cohorts. Women represent 51% of persons living with HIV globally. In sub-Saharan Africa, women account for close to 60% of HIV-infected persons, a large proportion of whom are in their reproductive years. Women living with HIV have changing fertility desires and reproductive health needs and frequently become pregnant particularly with increasing access to antiretroviral therapy (ART). Making programmatic, public health, and clinical management decisions for HIV infected women requires consideration of factors that influence women, maternal and fetal health safety. HIV care and treatment programs are uniquely placed to address child bearing desires of women, provide an opportunity to prevent unwanted pregnancies by availing effective contraception, make choices for use of antiretroviral agents that minimize risk of maternal transmission of HIV, and provide optimal maternal outcomes and have minimal or no potential fetal teratogenic effects. This presentation will provide insight into public health and programmatic considerations that middle and lower income countries that manage large HIV treatment programs have to make while developing policy guidance for ART use among women of reproductive potential. These considerations include safety and efficacy of ARV agents, availability of and access to comprehensive reproductive and family planning services, the need for understanding of women’s fertility desires and reproductive health choices and the balance between individualized care versus a public health approach to program implementation. Recent safety concerns on use of dolutegravir (DTG) suggesting possible increased risk of neural tube defects in infants born to women who were taking DTG at the time of conception have brought into sharp focus and reinvigorated the discussion on the need for safety data among women of reproductive potential. In addition, many large public health programs are now faced with the realities of individualized care and choice versus public policy directives, which can present significant implementation challenges based on how sophisticated health systems are. The talk will include case studies frommiddle and lower income countries’ adaptation of DTG following the release of the WHO interim guidance recommending use of DTG based regimes as preferred first-line with caution on DTG use at periconception period . The presentation will also explore the involvement and role of women in policy decision making and lessons learnt. Anne D. Lyerly , University of North Carolina at Chapel Hill, Chapel Hill, NC, USA The HIV research agenda has historically been characterized as having a “vessels and vectors” orientation toward woman – in other words, when included in research, women have been studied primarily in terms of their capacity to infect partners and fetuses. While progress has been made, significant evidence gaps remain due to under-representation of women, including women who become pregnant while on ARVs (and their interests) in the HIV research agenda. These evidence gaps lead to uncertainty about safety and dosing of drugs in women of reproductive potential, suboptimal or adverse outcomes for women and offspring, as well as issues of access to effective treatments and preventives. Advancing the evidence base will require addressing a range of ethical, legal and cultural challenges around research with women of childbearing

63 CHASING THE DRAGON: OPIATES AND HIV

Oral Abstracts

61 POLICY AND PROGRAM DECISIONS FOR ART IN WOMEN OF REPRODUCTIVE POTENTIAL Irene Mukui , Ministry of Health, Nairobi, Kenya

64 CHEMSEX AND IMPLICATIONS FOR HIV TRANSMISSION AND MANAGEMENT Mark R. Pakianathan , St. George’s University of London, London, UK

65 HIDDEN IN PLAIN SIGHT: THE ALCOHOL EPIDEMIC

62 CHALLENGES IN ANTIRETROVIRAL RESEARCH IN WOMEN OF REPRODUCTIVE POTENTIAL

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CROI 2019