Rectal Microbicides

Rectal Microbicides

Rectal Microbicides: New Hope for HIV and STD Prevention Objectives Why we need rectal microbicides What is involved in development Where the research is What you can do to get involved

Men at risk High rates of condom use are difficult to maintain, as the rate of new HIV infections shows New data reveals reasons for concern: UK: 48.8% UAI in the past year US: 30% UAI (HIV - men in past year) STD rates confirm UAI prevalence Women at risk In large US survey, 35% of women age 25-44 report having had anal sex at some time in their life

32% of high-risk women reported anal sex in past 6 months (Gross et al, 2000) What is a microbicide? Microbicides are substances that can reduce the transmission of HIV and other STD pathogens when applied vaginally and, possibly, rectally. They are not yet available. Currently, they are formulated as lubes, gels or creams applied with an applicator like those shown

here We need a product that is Inexpensive Easily accessible (over the counter) Easy to use Safe, non-irritating Available in various forms (in lubes, suppositories, on condoms) Effective What if we had a complete HIV toolkit?

Prior to exposure Point of transmission Rights-focused behaviour change Male and female condoms and lube Voluntary counselling and testing ART to prevent

perinatal transmission STI screening and treatment Clean injecting equipment Preventative Vaccines Vaginal and rectal microbicides Pre-exposure prophylaxis

(PREP) Cervical barriers Male circumcision Post-exposure prophylaxis (PEP) Treatment Improved antiretroviral therapy Treatment for opportunistic infections Basic

care/nutrition Prevention for positives Education and behavior change Therapeutic Why vaginal microbicides? Women currently have no way to protect themselves when her partner wont use a condom Women biologically more vulnerable to HIV 2-4 times more likely than men to get HIV from vaginal sex

Women may be less able to assert their rights Current methods (abstinence, fidelity, and condom use) often require male consent, knowledge, or cooperation Vaginal Microbicide Research in 2005 10-20 products Laboratory Testing 2-6 Years 6 products

3 products 5 products Phase 1 (safety) Phase 2 (safety) Phase 3 (efficacy) 1 to 6 Months

Up to 2 Years 2 to 4 Years 25 40 people 200-400 people 3,000-10,000 people Simultaneous studies in some cases: HIV+, penile & rectal safety

10 or more years How could microbicides work? Kill/inactivate/immobilize the virus Boost bodys natural defenses Prohibit viral entry by blocking fusion Inhibit viral replication Create a physical barrier

or some combination of these approaches Physiological Differences Vagina Rectum Most of the epithelium is 40 cell layers thick Very fragile epithelium, 1 cell layer thick.

Fewer CD4 cells than rectum More inflammatory cells under surface (CD4 receptors) Acidic pH Alkaline, rather than acidic pH Enclosed pouch Open-ended tube Anatomy 101 Research questions Infection more to learn about anal intercourse and HIV infection Testing - What assays (tests) to measure impact? Distribution how would it spread? Application Methods? Dosing how much, what is acceptable? How does rectal shedding of HIV impact risk?

Laboratory research To learn more about: How HIV infection occurs in the rectum what cells are most vulnerable The impact of intercourse on rectal tissue (trauma, inflammation, speed of healing) What markers can we look at to determine impact of a product on the rectum? Laboratory research in action Dr. Ian McGowan, HPTN 056

University of California/Los Angeles Goal: To define measurements that can be made on rectal tissue biopsies that would be of use in rectal microbicide safety studies. Repeated measurements on 16 men, and studied variation based on: Time Location in the rectum Sero status Penile Acceptability Studies To learn more about How much tissue is likely to be

exposed to a microbicide Impact of a product on the penis Distribution research in action: Dr. Craig Hendrix at Johns Hopkins University in Baltimore Volunteers simulated anal intercourse MRI scans done up to five hours after its release Initial studies suggest that semen could travel up to 60 centimeters Showed where a microbicide would be needed to protect vulnerable tissues Behavioral Research To learn more about Prevalence of anal intercourse for both mean and women and how many of these acts are protected Preferences re: formulation and delivery systems Sexual practices that affect microbicide feasibility How much product is acceptable Behavioral research in action:

Alex Carballo-Diguez, Columbia Univ (NY) Ken Mayer, Fenway Community Health (Boston) How much gel is tolerable? 18 HIV uninfected men Maximum acceptable dose for insertion and anal intercourse Behavioral research in action: Alex Carballo-Diguez and Sigma Research Center both did surveys of MSM interest in using microbicide Results:

In San Francisco: 59% heard of microbicides, 25% - 35% might use (depending on stated effectiveness) In the UK: 23% had heard of microbicides, 59% might use More vital steps 1. Men and women need education about the risks of unprotected anal sex 2. Safety trials on rectal application of vaginal microbicides that are currently in large scale trials 3. Testing over the counter lubes to see how safe they are 4. Advocacy for increased research Rectal safety trials on vaginal products We wont know if the first vaginal microbicides are effective for rectal use But we must know if they are safe to put in the rectum or not Because some people will try to use them rectally If deemed harmful for the rectum, labels warning against rectal use are imperative. Testing on over the counter lubes

Drs. Sudol & Phillips at Population Council, New York Tested 5 OTC lubes in mice to see if they caused damage to rectal cells KY-Plus (no longer on market) and DeLube caused the most damage Viamore, Vagisil and Astroglide caused some damage More research is underway, with findings expected soon. Need more research to see if these products cause damage to human rectal cells Advocacy for rectal

microbicides Microbicide research is drastically underfunded Need for increased funding for both vaginal and rectal microbicides Talk to your government officials e.g., U.S. Microbicide Development Act Global Campaign for Microbicides A worldwide effort co-sponsored by groups working on HIV/AIDS reproductive health gay health womens empowerment

Working to educate, raise awareness and generate collective advocacy for increased political and public investment in microbicide development New strategy to raise awareness and demand among gay men Three components: Internet Public presence in forums & conferences Media print, electronic, guerilla!

International Rectal Microbicides Working Group Working Collaboratively: Global listserv Bi-monthly conference calls Developed an advocacy agenda To join, contact Jim Pickett, [email protected] Presence at conferences: Microbicides 2006 conference Gay Mens Health Conferences Gay and Lesbian Medical Association annual meeting What you can do Visit or to Join the International Rectal Microbicide Working Group calls and listserve Learn more about rectal microbicides Sign up for the Global Campaigns newsletter Host a talk on microbicides this and other presentations available for download Endorse the Global Campaign

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