New Findings on the Future of Sex

The Latest in HIV Prevention Technology Latino HIV/STD Network April 13, 2011 Jim Pickett Director Prevention Advocacy and Gay Men’s Health AIDS Foundation of Chicago 1

Today

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Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them

AFC secretariat

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rectalmicrobicides.org

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Condoms work.

So why do we need new strategies to halt the sexual transmission of HIV?

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Here are some reasons for new strategies Source: Roger Tatoud PhD, Senior Programme Manager, International HIV Clinical Trials Research Mgmt Office,

Imperial College London & IRMA Steering Committee Member

What if we had a complete prevention tool kit?

Prior to exposure •Rights-focused behaviour change •Voluntary counselling and testing •STI screening and treatment •Male medical circumcision •Preventive Vaccines •Pre-exposure

prophylaxis (PrEP)

Point of transmission Treatment •Male and female condoms and lube •ARV treatment to prevent vertical transmission (PMTCT) •Clean injecting equipment •Post-exposure prophylaxis (PEP) •Vaginal and rectal

microbicides

• Improved ARV therapy • Treatment for opportunistic infections • Basic care/nutrition • Prevention for positives • Education & rights-focused behaviour change • Therapeutic vaccines ARV = antiretroviral 9

The prevention landscape has forever changed 10

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What is a microbicide

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• • • • A product applied topically in the vagina or the rectum that can offer protection against HIV and, ideally, other STI pathogens Ideally would have a contraceptive version, and another to allow for pregnancy Formulated as a lubricant, gel, film, or vaginal ring A rectal suppository, douche, or an enema – in addition to a lube microbicide (RM) might be delivered via

Microbicides are still in development they are not available yet!

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How would a microbicide work

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Non-ARV-based

• Prevents HIV from entering healthy cells by creating a barrier between the cell and HIV

ARV-based

• Blocks specific proteins of HIV so that it cannot bind with a healthy cell • In the case of a vaginal microbicide, could enhance the vagina’s natural defense system • Kills the virus by attacking it • Blocks receptors on healthy cells so that HIV cannot bind with them • Deactivates key components of the HIV to inhibit replication 13

Film Gel, lubricant Vaginal ring Suppository

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Rectal Applicator Enema

CAPRISA 004

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South Africa 2 sites in KwaZulu-Natal Phase IIB - 889 HIV- women, 18 – 40 Enrolled May 2007 – Jan. 2009 Vaginally formulated tenofovir gel Results July 20, 2010 – AIDS 2010

VOICE/MTN 003 Vaginal and Oral Interventions to Control the Epidemic Phase IIB safety, effectiveness Tenofovir 1% gel, tenofovir tablet, and Truvada tablet -prev HIV infection in women Trial sponsors collaborators: CONRAD, Gilead, MTN, NIH 17

VOICE/MTN 003 18

Other follow-up studies 19

Pre-exposure prophylaxis (PrEP)

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Following slides courtesy Bob Grant 21

* n= 225 *

iPrEx – U.S. youth Mean age Boston and San Francisco >30. Boston closer to 40

Race # % Black/African-American White Mixed/Other Asian Total (out of 225) 5 5 5 13 28 17.86

46.43

17.86

17.86

100.0

*Only about half the men took their pills

Acceptability of rectal microbicides • • • • • • iPrEx – Only 50% of men took their pills regularly, if at all An ARV-based prevention option based on a lubricant or an enema could be more acceptable to these men Two Phase I studies completed MTN 007 Phase I underway Phase II down the road Buffet approach!

PrEP – our kind of town

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Following slides courtesy Sybil Hosek 37

Exploring the Acceptability and Feasibility of PrEP Young MSM Chicago

What did they want to find out?

• • • Acceptability and feasibility – Are young gay men willing to join and stay in this kind of PrEP study? What makes them stay?

– Is it possible to do this with a large group of young men? What are the possible barriers: • • adherence acting riskier because they feel they are protected They were not testing to see if the drug worked (efficacy) Results forthcoming

What was involved?

• 9 clinic visits over approximately 8 months, 2-day weekend intervention (Many Men Many Voices – 3MV) • Participants randomly assigned to one of three study arms: – 1) Once-daily Truvada – 2) Placebo (sugar pill) – 3) No pill

Who did they enroll?

• • • 68 participants enrolled – 10 discontinued prior to randomization Average age 20 (range 18-22) 48% Black, 42% Latino, 10% White

Where did participants come from?

Rectal microbicides

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RM research activities • Baseline studies – What normally happens during AI?

• Formulation studies – How will different chemicals and substances be put together to make a safe, effective RM?

• Distribution studies – Where do RMs need to go?

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RM research activities • • • Acceptability & behavioural studies – What kinds of products would people use? – Who is having AI?

Pre-clinical/basic science – developing and testing products in labs and in animal studies Clinical trials – safety and efficacy – Are these RMs safe? Do they work?

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RM research activities 46 Source: From Promise to Product: Advancing Rectal Microbicide Research and Advocacy

The RM pipeline is flowing • •

RMP 01 – UC-781 MTN 006 – tenofovir

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36 U.S.

18 U.S.

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MTN 007 – modified tenofovir , underway Project Gel underway

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60 U.S., 3 sites 120/42 U.S., Puerto Rico

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MTN 017

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150 – 200 Peru, RSA, Thailand, U.S.

Boston, Pittsburgh, Birmingham Almost complete

Project Gel [Microbicide Safety and Acceptability in Young Men] Pittsburgh, Boston, Puerto Rico

Stage 1A

Screening 240 MSM Consensual RAI in last month URAI in last year

Stage 1B

3 month Acceptability & Adherence study with placebo gel 120 MSM RAI in last 3 months STI negative

Stage 2

Phase 1 tenofovir rectal safety study 42 MSM 80% adherence in Stage 1B McGowan & Carballo-Dieguez 49

Populations for RM studies

Phase 2B studies

• 3% seroincidence MSM populations • North America

They work… NOW WHAT?

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iPrEx - U.S. youth

Race # Black/African-American White Mixed/Other Asian Total 5 13 5 5 28 Roll-over ATN 082 into OLE 17.86

46.43

17.86

17.86

100.0

%

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Intimacy Connection Pleasure Emotion

PrEP studies underway

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PrEP studies underway

CDC 4940

1,200 HIV-neg heterosexual men, women – vaginal sex Results 2011 once-daily Truvada Botswana

PrEP studies underway

CDC 44370

Once-daily tenofovir 2,400 HIV negative injecting drug users (IDUs) Thailand (Bangkok) Results 2012

PrEP studies underway

Partners PrEP

Once-daily Truvada and once daily tenofovir 4,700 HIV serodiscordant couples Gates Foundation, Gilead, Univ Washington Kenya, Uganda Results 2013

PrEP studies underway

Fem PrEP

Once-daily Truvada 3,900 women vaginal sex Kenya, Malawi, South Africa, Tanzania, Zambia Gates, FHI, Gilead, USAID

Public health response CDC

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CDC steps

MMWR [Morbidity & Mortality Weekly Report]

• Review trial data, interim guidance for physicians*

U.S. Public Health Service guidelines Identifying the most effective mix of interventions Avoiding increases in risk behaviors Cost, access Continuation of PrEP research

CDC interim guidance

Close consultation with doctor Wait for full guidelines Daily dosing critical Initial and regular testing Only obtained from doctor Truvada only – nothing else proven Only if confirmed HIV-negative

Public health response CDPH

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Advantages • Minimal side effects • Convenience • Effectiveness Disadvantages • Resistance • Behavioral Cost • PrEP estimated $14,400/yr (varies by source and attendant services) • Annual cost of ARV for POZ = $24,000 +/-

CDPH

• Intervention not forever

One last thing

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Lube safety o

Safety of lubricants for rectal use: A fact sheet for HIV educators and advocates

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Safety of lubricants for rectal use: Questions & Answers for HIV educators and advocates rectalmicrobicides.org

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Lube safety 72

Questions?

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Thank you

Jim Pickett [email protected]

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