HIV Prevention : Why we need more options for women Wanjiku Kamau Consultant: International AIDS Vaccine Initiative Consultant: International Partnership for Microbicides July 6th

HIV Prevention – a neglected area Global HIV Prevention Working Group estimated that only 1 in 5 people at risk of HIV infection in developing countries had access to prevention services and commodities Global HIV Prevention Working Group estimated that only 1 in 5 people at risk of HIV infection in developing countries had access to prevention services and commodities Urgent need to scale up existing HIV treatment and prevention to reduce transmission rates and save lives. Urgent need to scale up existing HIV treatment and prevention to reduce transmission rates and save lives. However, even when scaled up, current treatments can prolong life, but they are not a cure. Present prevention options can reduce rates of HIV incidence but will not end the epidemic. However, even when scaled up, current treatments can prolong life, but they are not a cure. Present prevention options can reduce rates of HIV incidence but will not end the epidemic. With existing technologies and approaches, the global HIV/AIDS epidemic may be slowed but will continue to grow With existing technologies and approaches, the global HIV/AIDS epidemic may be slowed but will continue to grow

Women’s greater risk and urgent need for improved HIV prevention Biological: male-to-female transmission is easier than female-to-male Biological: male-to-female transmission is easier than female-to-male Economic: financial dependence on male partners Economic: financial dependence on male partners Cultural: early marriage, intergenerational sex and marital infidelity Cultural: early marriage, intergenerational sex and marital infidelity Sexual exploitation and violence Sexual exploitation and violence

Current prevention is failing us all but particularly women – why? Current prevention is failing us all but particularly women – why? Current approaches rely on individuals recognising and understanding their risk and on personal agency or ability to control or limit risk Current approaches rely on individuals recognising and understanding their risk and on personal agency or ability to control or limit risk Relies on individuals being empowered to employ various prevention strategies Relies on individuals being empowered to employ various prevention strategies Is increasingly based on morality as a guiding principle Is increasingly based on morality as a guiding principle

The world’s main HIV prevention technology is over 3000 years old

The Case for New Preventive Technologies One size does not fit all! One size does not fit all! Combination prevention is the future Combination prevention is the future If you increase the number of options available, the overall protection increases (lessons from family planning) If you increase the number of options available, the overall protection increases (lessons from family planning) We are not meeting people’s sexual and reproductive health needs. Ever rising number of infections confirm that we need to do things differently – including providing a wider range of tools. We are not meeting people’s sexual and reproductive health needs. Ever rising number of infections confirm that we need to do things differently – including providing a wider range of tools.

Female Barrier Methods Female condoms Female condoms –Contraception and STI prevention –High initial acceptability –Large programs in Brazil, Ghana, Namibia, South Africa, Zambia –Slow uptake Diaphragms Diaphragms –Contraceptive; STI prevention under study –Use currently low—0.3% of reproductive-age women in the US

What are cervical barriers (CBs)?

Diaphragms

Cervical Caps

Why cover the cervix? The cervix is fragile The cervix is fragile –Entrance lined with delicate columnar epithelial cells –This layer is only 1 cell thick Preferential site of infection for many STIs Preferential site of infection for many STIs –Bacterial pathogens (gonorrhea, chlamydia) –Human papilloma virus Concentration of HIV receptor sites Concentration of HIV receptor sites Protection of the upper genital tract Protection of the upper genital tract

Cervical barriers - summary Cervical barriers are long-standing, safe, effective female-controlled contraceptives. Cervical barriers are long-standing, safe, effective female-controlled contraceptives. Cervical barriers are currently being studied as potential STI/HIV prevention methods. Cervical barriers are currently being studied as potential STI/HIV prevention methods. New cervical barriers are under development. New cervical barriers are under development. May be a useful preventive method for women who do not wish to conceive. May be a useful preventive method for women who do not wish to conceive.

Microbicides Vaginal product to prevent or reduce HIV transmission Vaginal product to prevent or reduce HIV transmission Could potentially be delivered in many forms Could potentially be delivered in many forms A woman could initiate use independently to protect her health A woman could initiate use independently to protect her health Ideally safe, effective, low-cost and user- friendly Ideally safe, effective, low-cost and user- friendly

Why do we need a microbicide? Women are increasingly at risk of HIV globally and yet currently have no option that can be used without male consent or knowledge Women are increasingly at risk of HIV globally and yet currently have no option that can be used without male consent or knowledge Behavioural approaches are gender-blind Behavioural approaches are gender-blind Women have practical HIV prevention needs which must be met while gender equality is striven for Women have practical HIV prevention needs which must be met while gender equality is striven for Even a partially effective microbicide could have a huge impact on number of lives saved Even a partially effective microbicide could have a huge impact on number of lives saved

Early generation microbicides Non-specifically block HIV from interacting with target cells Non-specifically block HIV from interacting with target cells In most advanced stage of clinical trials (Carraguard, PRO2000, BufferGel) In most advanced stage of clinical trials (Carraguard, PRO2000, BufferGel) Partial, low or no effectiveness Partial, low or no effectiveness Short-acting (used near time of sex) Short-acting (used near time of sex)

Next generation microbicides Based on antiretroviral drugs (ARVs) with known efficacy in humans Based on antiretroviral drugs (ARVs) with known efficacy in humans Long half-life or can be formulated for sustained release Long half-life or can be formulated for sustained release Products may contain a combination of drugs that act at different stages of HIV replication Products may contain a combination of drugs that act at different stages of HIV replication

Delivery – offering choice Semisolids/Solids Semisolids/Solids –Gels –Vaginal Tablets –Films –Emulsions Devices Devices –Vaginal Ring –Sponge –Diaphragm

Why we need a vaccine Vaccines are essential in the prevention of epidemics Vaccines are essential in the prevention of epidemics Vaccines are the only intervention historically to have eradicated communicable disease Vaccines are the only intervention historically to have eradicated communicable disease Increased personal control over vulnerability to infection Increased personal control over vulnerability to infection An HIV vaccine should be seen as an important woman-initiated HIV prevention tool An HIV vaccine should be seen as an important woman-initiated HIV prevention tool Even a partially effective vaccine could play an important role in a comprehensive framework Even a partially effective vaccine could play an important role in a comprehensive framework

New Prevention Technologies Microbicides and vaccines will give people additional choices that better meet their needs in preventing HIV transmission. Microbicides and vaccines will give people additional choices that better meet their needs in preventing HIV transmission. In both cases, women can initiate use, and may be able to do so discretely, providing an essential benefit over existing prevention options. In both cases, women can initiate use, and may be able to do so discretely, providing an essential benefit over existing prevention options. Microbicide designs aim to address issues of intimacy and to provide choice over contraceptive function, which currently hinder greater condom uptake. Microbicide designs aim to address issues of intimacy and to provide choice over contraceptive function, which currently hinder greater condom uptake.

New Preventive Technologies A vaccine would not interfere with sex itself at all. A vaccine would not interfere with sex itself at all. Microbicides may offer the potential for efficacy against a range of other STIs Microbicides may offer the potential for efficacy against a range of other STIs HIV vaccines hold out the promise of an HIV prevention option not dependant on repeat use for every sexual or injecting drug use act. HIV vaccines hold out the promise of an HIV prevention option not dependant on repeat use for every sexual or injecting drug use act. A future vaccine could protect individuals from HIV infection before they become sexually active or begin other potentially high risk activities including intravenous drug use A future vaccine could protect individuals from HIV infection before they become sexually active or begin other potentially high risk activities including intravenous drug use

Prior to exposure Point of transmission After infection Male and female condoms Anti-retroviral therapy (mother-to- child) Post exposure prophylaxis (PEP) Anti-retroviral therapy Care Education & Behavioral change Education & Behavior change Preventive Vaccines Pre-exposure prophylaxis (PREP) Male circumcision HSV2 suppression Microbicides Diaphragm & other cervical barrier Therapeutic vaccines We need a comprehensive and integrated HIV/AIDS toolkit 4