1. What is it? How may it help women? PrEP

2. What is PrEP? How would it work? What do we know about it? When will we know more? What could it mean for women? Today’s agenda

3. 33 million people now live with HIV/AIDS Among newly infected people: 50% are women (higher in some areas) 95% live in developing countries 80-90% of HIV+ people in southern Africa do not know they have HIV 2.7 million new infections annually

4. <20% Sex workers with access to behaviour change programmes 11% Births getting drugs as needed to stop vertical transmission 10-12% Adults in Africa accessing HIV testing 9% MSM with access to appropriate behaviour change programmes 9% Sexually active people with access to male condoms 8% Injection drug users with access to harm reduction programmes Unmet needs for HIV prevention 0 Up to 45% recently 20406080100 Global HIV Prevention Working Group 2008; WHO/UNAIDS/UNICEF 2007

5. What is PrEP? Taking medicine to prevent rather than to treat a disease or condition For example: Taking pills to prevent malaria when you travel. Using hormonal contraceptives (injections or pills) to prevent pregnancy Taking pills to avoid pneumonia, if you are at risk.

6. Imagine a full tool box Before exposure Point of transmission After exposure Male & female condoms with lubricant Preventing vertical transmission Clean injecting equipment Vaginal & rectal microbicides Cervical barriers Post-exposure prophylaxis (PEP) Counselling & testing Male medical circumcision Pre-exposure Prophylaxis (PrEP) Preventive vaccines Treating a positive partner

7. Why test ARVs to prevent HIV? ARVs already are used to prevent vertical transmission (or PMTCT). PEP already is used to prevent infection after medical accidents or rape. Monkeys that get ARVs prior to exposure are less likely to be infected with “monkey forms” of HIV.

8. Current late-stage PrEP trials WhereWhoWhat When US (CDC)*MSMtenofovir2010 Thailand (CDC)IDUstenofovir2010 Brazil, Ecuador, Peru, US, Thailand, South Africa (iPrEX) MSMTruvada2010 Botswana (CDC)Heterosexual men and women Truvada2011 Uganda, Kenya (Partners PrEP) Serodiscordant couples (men and women) tenofovir, Truvada 2012 Kenya, Tanzania, South Africa (FEMPrEP) WomenTruvada2012 South Africa, Uganda, Zambia, Zimbabwe** (VOICE) Womentenofovir (pill & gel); Truvada 2012 *CDC: US Centers for Disease Control and Prevention **TBD: Malawi may be added

9. What makes a drug a good candidate for PrEP? Now being tested: Truvada (tenofovir+emtricitabine combined) tenofovir (Viread) Easy to use: Only one pill required per day (maybe less). Safe: Few side effects in HIV-positive people. Powerful: Stays in the bloodstream a long time. Unique resistance profiles: If resistance develops, other treatment options still exist.

10. Safety concerns? Safety is a critical issue for PrEP use Look carefully at people with pre-existing conditions: hepatitis B and C, kidney problems, bone density Pregnancy, post-menopause (osteoporosis), adolescents (bone formation) Look carefully at drug clearance in people with low body weight, including women and Asians

11. Why so many different studies? Why is PrEP being tested in drug users, men who have sex with men, discordant couples, & high-risk women?

12. Drug resistance: a concern with PrEP HIV makes thousands of copies of itself daily. Every time HIV copies itself, errors can occur, like typing errors on a page. These are mutations – changes that can make the virus weaker or stronger. If a mutation makes HIV able to resist an ARV drug, it is called drug-resistant HIV.

13. Think of weeds in a garden If you use weed killer: Some weeds die. Others thrive, grow bigger, and take over. The weed killer accidentally helps resistant weeds – it takes away all their competition. To stop the big weeds: Take away the first weed killer. Introduce other weed killers that stop all weeds – big and small. Slide concept by Jeanne Marrazzo, MD and John Mellors, MD, MTN

14. Be sure person is HIV negative when starting PrEP. User must get tested for HIV regularly. If user tests positive, PrEP use must stop right away. – OTHERWISE – Drug-resistant virus can emerge. Tenofovir and Truvada may no longer work for the person. The person must use other ARVs that may be less effective. PrEP & the risk of resistance

15. Preventing resistance in clinical trials PrEP trials test participants every month. Those who sero-convert: Stop using PrEP right away. Are checked over time for drug resistant virus. Are assured they will get ARVs that will work against their virus.

16. Preventing resistance in the real world 1. Make sure no one gets PrEP without an HIV test. 2. Make HIV testing much more common. 3. Recognise that spread of drug-resistant HIV is a risk to: – The people who become HIV-positive. – Those they transmit it to. – The effectiveness of national HIV programs.

17. In an ideal world Is it possible? Is it ethical? ARVs for treatment ARVs for prevention

18. Introductory studies and post-marketing surveillance Research & Readiness Map Animal trials Large scale implementation Bridging studies Large-scale effectiveness studies Safety studies in humans 

19. Women’s questions about PrEP If I think my husband has HIV, will I be able to get PrEP? If I take PrEP, how will I make a man use a condom? Even if the doctor gives me pills, will I be able to keep them for myself? Will it affect my contraceptive method?

20. More questions People will notice if I have to go in for testing and to get my pills. What will they say about me? Will it make me sick? Will my husband let me go to the clinic? How much will it cost? Where will I get it? Can I take PrEP when I’m pregnant? Will it hurt my baby? What about breastfeeding?

21. Next steps for science Gather more data on how PrEP works across populations. Address safety concerns through current trials and further research Learn how to monitor widespread resistance. Study intermittent use: for example, taking it only when you expect to have sex. Find out about impact on pregnancy and breast feeding. Test other ARVs to see if they might also work as PrEP.

22. Next steps for community readiness Figure out how to make HIV testing much more widespread and acceptable. Discover how to provide regular access to HIV testing and resistance monitoring. Develop strategies to minimise black marketing and sharing of PrEP drugs. Conduct large-scale community education about PrEP benefits and risks.

23. Addressing women’s concerns Women in every country using PrEP must be involved in designing and implementing: Appropriate programs for men and women on HIV testing, PrEP, stigma, and prevention challenges. HIV testing and PrEP access plans that guard privacy and help women keep pills for their own use. Support systems to help women develop and share strategies for managing their HIV risk. Local and global leaders who demand resources to support these efforts.

24. What YOU can do Join an advocacy group that is asking questions about new HIV prevention tools, including PrEP. Invite women’s groups to take on HIV prevention, and HIV/AIDS advocates to address women’s needs. Imagine equal access to HIV prevention for women and ask “Why not?”

25. Where to go for information Global Campaign for Microbicides www.global-campaign.org PrEP Watch www.prepwatch.org CHAMP’s Prevention Research Advocacy Working Group www.champnetwork.org

26. What does PrEP mean for women? The answer depends on us! “Science teaches us everything except what to think and what to do.” – Søren Kierkegaard

27. Questions you may get from the audience This section is for speaker’s reference only. It does not need to be displayed as part of the presentation. The next two slides are for the speaker’s use. They will help you answer questions you may get from the audience. The most frequently asked question is “how do you know that?” The next slide has a list of sources for the facts in this presentation. You can cite these as the sources for your information. In the notes section are some other questions, and ideas on how to answer them. These are the questions we have heard so far. If you get questions that you think should be included to help future speakers, please send them to Anna Forbes at asforbes@path.org. Thanks!

28. “How do you know that?” The notes here indicate the sources of facts in this presentation. Commonly known numbers are not cited here, only the less common statistics and facts. You can cite these as the sources for your information.