Introduction to HIV New Prevention Technologies (NPTs)

Core Competencies for Public Health Public Health Sciences Assessment and Analysis Policy and Program Planning, Implementation and Evaluation Partnerships, Collaboration and Advocacy Diversity and Inclusiveness Communication Leadership

Learning Objectives Describe the current state of HIV in Canada Introduction Describe the current state of HIV in Canada Describe existing HIV prevention options Describe emerging HIV prevention options and how they work Explain why there is a need for additional HIV prevention options in Canada Describe how NPTs fit into comprehensive prevention and complement the existing spectrum of HIV interventions Identify means of staying informed and getting involved in NPT-related work 3

Section 1: HIV in Canada

HIV in Canada Estimated number of people living with HIV Estimated 2,200 – 4,200 new infections in 2005 Estimated 2,300 – 4,300 new infections in 2008 44% gay, bisexual and men who have sex with men 20% heterosexual/non-endemic 16% heterosexual/endemic 17% people who inject drugs 3% gay, bisexual and men who have sex with men/people who inject drugs 26% of HIV-positive Canadians (approx. 16,900) are unaware of their status

HIV Prevention Treatment-as-Prevention PrEP Male and female condoms PEP Vaccines Microbicides PMTCT HIV Prevention Behaviour change Male circumcision Clean injecting equipment Voluntary counselling and testing

Section 2: Why are new HIV prevention options needed?

Why are new HIV prevention options needed? Many people want to be able to conceive—which is not possible with male and female condoms. Receptive partners—whether male or female—are at highest risk in sexual encounters, and often require prevention options that they can better control. Many people are unable or unwilling to use condoms. We need HIV prevention tools that: allow conception are more within the control of receptive partners enhance pleasure do not form a physical barrier Experience of contraception: More options = more protected sex acts

Can’t we just promote condoms?

Can’t we just promote condoms?

Efficacy vs. effectiveness Efficacy = how well a product works under ideal conditions Effectiveness = how well a product works in practice For example, condom efficacy is 80-95% when used consistently and correctly. Their effectiveness is 69% because some people don’t always use them correctly or consistently.

Condoms and NPTs

Condoms and NPTs

Condoms and NPTs

Section 3: NPTs as part of a comprehensive approach

NPTs as part of comprehensive approach to HIV Prevention

Imagine a full spectrum of interventions Male & female condoms and lubricant Treatment to prevent vertical transmission (PMTCT) Clean injecting equipment Post-exposure prophylaxis (PEP) Vaginal & rectal microbicides Addressing social determinants of health Rights-focused behaviour change Voluntary counselling & testing Sexually transmitted infection screening and treatment Male medical circumcision Pre-exposure prophylaxis (PrEP) Preventative vaccines Antiretroviral treatment Treatment for opportunistic infections Basic care/nutrition Prevention for positives Education and rights- focused behaviour change Therapeutic vaccines Functional cure

Section 4: New HIV Prevention Technologies

HIV Prevention Treatment-as-Prevention PrEP Male and female condoms PEP Vaccines PMTCT HIV Prevention Male circumcision Clean injecting equipment Voluntary counselling and testing

What are “new” HIV prevention technologies? Preventive vaccines Vaginal and rectal microbicides Pre-exposure prophylaxis Treatment-as-prevention Medical male circumcision Non-occupational PEP Female condoms Diaphragm/cervical barriers HSV-2 treatment Still in trials Proof-of-concept, but need to confirm efficacy Recently proven effective but not yet (widely) available

Antiretroviral (ARV)-based Prevention Methods Prior to exposure Point of exposure After exposure Preventing vertical transmission (PMTCT) PrEP Vaginal and rectal microbicides Treatment-as-prevention PEP

HIV prevention Not ARV-based ARV-based Male & female condoms Circumcision Clean injecting equipment Vaccines Voluntary counselling and testing Behaviour change Vaginal and rectal microbicides Preventing vertical transmission PEP PrEP Treatment-as- prevention

Treatment-as-prevention The prevention benefits that come from HIV+ people using ARVs Treatment = less virus = less transmission Alternative names and concepts: Test and Treat (or TNT) Seek and Treat TLC+

What we know about treatment-as-prevention Works at the individual level One trial among mostly heterosexual serodiscordant couples showed a reduced risk of transmission if HIV+ partner is on treatment. Can it work at the population level? Increased testing = more knowledge of status = less risk-taking Increased testing = more HIV+ people on treatment = less virus Less risk-taking + less virus = less transmission?

Questions about “treatment-as- prevention” ARVs for prevention Access to treatment Knowledge of status

Pre-exposure prophylaxis (PrEP) The ongoing use of one or two antiretrovirals by HIV- negative individuals starting before an exposure and continuing afterwards Infection does not occur instantly after an exposure to HIV. The virus needs to spread throughout the body— this may take up to 3 days after the exposure. The “window of opportunity” for PrEP: after an exposure HIV has not yet spread throughout the body. During this time, PrEP may be able to stop HIV from causing an infection.

What we know about PrEP Using either the ARV tenofovir (Viread) or tenofovir+emthricitabine (Truvada) in combination with a comprehensive package of prevention services: One trial showed that PrEP (using Truvada) reduces the risk of infection when used by gay men and other MSM, and trans women. Two trials showed that PrEP (using either Viread or Truvada) reduces the risk of infection when used by heterosexual men and women. Two trials could NOT show that PrEP (using either Viread or Truvada) reduces the risk of infection when used by heterosexual women. Effectiveness is linked to adherence. The risk of side effects, toxicity, and drug resistance are low.

Questions about PrEP Safety/effectiveness of… a pill taken on a non-daily schedule other antiretrovirals Safety/effectiveness of Viread and Truvada… among women in populations not included in trials over a longer period of time in the “real world” PrEP has not yet been approved by Health Canada, but may already be in use off-label.

Vaginal and rectal microbicides A lube used before and during sex A douche or enema used before and/or after sex A vaginal ring that stays in place for up to a month A suppository or a gel applied with an applicator before sex

What we know about vaginal microbicides Using a gel with the ARV tenofovir, in combination with a comprehensive package of prevention services: One trial showed that vaginal use of tenofovir gel before and after sex reduced the risk of infection when used by heterosexual women. One trial was unable to show that daily vaginal use of tenofovir gel reduced the risk of infection when used by heterosexual women. Efficacy is linked to adherence. The risk of side effects, toxicity, and drug resistance are low. We need microbicides that: are both contraceptive and not contraceptive are inexpensive and easily available can be used without a partner’s active cooperation

Questions about vaginal and rectal microbicides Will we have microbicides that: help reduce the risk of getting other sexually transmitted infections? can be used vaginally or rectally? can be used by HIV+ people (products not based on ARVs)? Will we have rectal microbicides? Related question: Are currently available (non-microbicide) lubricants safe?

Vaccines A substance (i.e. part of the virus) that teaches the body to recognize and defend itself against bacteria and viruses Causes a response from the immune system—preparing it to fight if exposed to a specific infection Not a cure Prevents infection or slows disease progression

What we know about vaccines Encouraging signs include: broadly neutralizing antibodies found. precedent for other diseases: success against other viral infections. precedent from animal studies: long-term control of infection in vaccinated monkeys. immune control of HIV-1: infected individuals control infection.

Questions about vaccines Challenges remain Need a different approach for HIV vaccines. Animal models: have not yet accurately predicted how they will work in humans. Correlates of protection: what immune responses will protect an individual from infection is mostly unknown. HIV mutations HIV subtypes: there are many different subtypes of HIV may require matching vaccines.

Section 5: NPT Implementation Issues

NPT implementation issues Guidelines for front-line delivery should include tools and protocols regarding: how to assess risk. how to match NPTs with individuals and community needs. how to support adherence and manage risk compensation. how often to conduct HIV testing, STI screening and test for drug resistance. how to manage side effects for clinicians and consumers. how to communicate about partial efficacy and effectiveness.

NPTs: Measuring impact Mechanisms required to measure: safety and toxicity adherence risk compensation impact on HIV incidence

Next Steps: Actions that can be taken If you determine that your clients are at high risk of HIV… Urge them to get tested for HIV and STIs regularly. Encourage risk reduction behaviours (safer sex, harm reduction). Remind them to seek PEP as soon as possible after a potential HIV exposure. Suggest they talk to their doctor about HIV prevention options, including PrEP. If you want to engage actively in shaping the field… Urge public health officials to issue guidance on the use of NPTs. Join a local committee or group addressing some of the social determinants putting your clientele at risk of HIV. Become involved in street outreach, support needle exchange and harm reduction programs. Join social justice groups fighting stigma and discrimination, homophobia, racism, and gender violence.

Conclusion Introduction Additional Resources: Fact Sheets, Resources & Reports: http://www.catie.ca/preventing-hiv/prevention-technologies http://www.avac.org/ Webinars & Courses: http://www.catie.ca/en/treating-hiv/new-hiv-prevention-technologies-and-their-implications-hiv-prevention-canada-webinar-se http://www.catie.ca/en/treating-hiv/topics-e-learning www.hivpreventionresearch.org Listservs email: MAG-Net@cdnaids.ca rectalmicro@gmail.com