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What is up with Nonoxynol-9?

What is up with Nonoxynol-9?. Global Campaign for Microbicides www.global-campaign.org. Background on Nonoxynol-9. Nonoxynol-9 is the active ingredient in most over the counter spermicides Film 70 mg Foams 70 - 85 mg Suppositories 100 mg Gels 52 -200 mg

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What is up with Nonoxynol-9?

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  1. What is up with Nonoxynol-9? Global Campaign for Microbicides www.global-campaign.org

  2. Background on Nonoxynol-9 • Nonoxynol-9 is the active ingredient in most over the counter spermicides • Film 70 mg • Foams 70 - 85 mg • Suppositories 100 mg • Gels 52 -200 mg • Sponge 1000 mg

  3. N-9 also added to • Some over-the-counter sexual lubricants • KY Plus (with N-9) 2% by volume • ForPlay (with N-9) 1% by volume • Some lubricated condoms • 25-60 mg (US) • 10-25 mg (outside US)

  4. History of N-9 testing • Early testing proceeded in the hope that an existing product might prove effective against HIV • Previous human studies suggested that it offered some protection against gonorrhea, chlamydia, & HIV (based on epidemiological studies not RCTs) • Early clinical trials done with different products in different populations showed contradictory results some suggested that N-9 could increase HIV risk some suggested that low dose products could decrease risk • So work on lower dose N-9 products continued

  5. UNAIDS trial reveals no protection for Advantage-S • Preliminary data out of Durban in July, 2000 • showed that sex workers using Advantage-S gel (52.5 mg of N-9) had higher rates of HIV sero-conversion than those using placebo, • possibly due to increased vaginal disruption caused by the N-9 • These data are difficult to generalize because of the variation in dose and formulation among various N-9 products • Sex workers had on average 3.7 clients per day

  6. Nonoxynol-9 and rectal sex • David Phillips et al found that even low doses of N-9 caused massive sloughing of the rectal epithelium (n=4 people). Findings duplicated in large sample • Rectal epithelium heals quickly – less than 8 hours • Damage associated with rectal use of N-9 is far more extensive than observed with vaginal use of products • Rectal exposure to N-9 increases transmission of HSV in mice and monkeys

  7. Who is at risk? • In US, more women than men have receptive anal sex • 6 - 13% of heterosexual women in the US had anal sex in the last year (Gross et al, 2000) • In one US study, 32% of high-risk women participants reported anal sex in past six months (Gross et al 2000) • In a Chinese study of 1300 people from 41 cities, nearly 70% of men and women reported engaging in anal intercourse (Burton 1990).

  8. What happened next? • Work with N-9 as a potential microbicide ceased • CDC issued guidance saying that N-9 should not be recommended for HIV prevention or included in “hierarchical” messages and N-9 lubricated condoms should no longer be recommended • WHO held an expert consultation in October 2001 to further refine public health messages around N-9 and N-9 lubricated condoms

  9. WHO Expert Group Findings • N-9 does not provide protection against HIV or bacterial STDs such as gonorrhea and chlamydia. • When used frequently in the vagina (more than once a day*), N-9 productscause epithelial disruption that may increase the risk of HIV infection. • Women who are at risk of HIV or have multiple acts of intercourse in a day should use a different form of contraception. • Spermicides containing N-9 remain a safe contraceptive option for women who are not at risk of HIV

  10. Findings (continued) • Under no circumstances, should N-9 containing products be used rectally. • There is no evidence that condoms lubricated with N-9 are more effective in preventing pregnancy or infection when used vaginally than condoms lubricated with silicone. Therefore N-9 condoms shouldno longer be promoted. • (Nonetheless, a condom with N-9 is still better than no condom at all)

  11. Public Health Challenges The ideathat N-9 offers “extra protection” from HIV is very entrenched Big confusion regarding N-9 products and messages Complicated message to impart: • N-9 does not work for STD/HIV prevention • Should NOT be used rectally – may increase risk • Safe to use vaginally for pregnancy prevention if you are not at risk of HIV and use infrequently

  12. Gay men are still seeking out N-9 • Among a diverse sample of 573 MSM in San Francisco, 67% had used N-9 in the past year • This was after CDC issued warnings and the San Francisco DOH undertook outreach activities • Among those who had used N-9 in the last year: • 41% used it without a condom because they thought the N-9 might be protective • 74% used it with a condom for “added protection”

  13. Origins of N-9 Call • Global Campaign for Microbicides responded because data on rectal use of N-9 isn’t being heard • Formed partnership with GAAN to develop strategy to reduce risks due to rectal exposure to N-9 • Simultaneous goal to build stronger partnerships with gay/lesbian and mainstream AIDS groups around need for rectal microbicide research • Created working group of scientists and representatives of key constituent groups to developstrategy

  14. Consensus message • New data reveal that when used rectally, even small doses of nonoxynol-9 can increase risk of HIV transmission •  When used consistently and correctly, lubricated condoms give excellent protection against pregnancy and HIV, even without the addition of Nonoxynol-9.; • Adding N-9 to condom lubrication may not provide any additional protection against pregnancy • Therefore, we are asking manufacturers to help eliminate this public health risk by phasing out the addition of N-9 to condoms and sexual lubricants

  15. Logic behind Call • Two pronged strategy for change: • public education to “undo” entrenched messages re: N-9 • phasing out source of risk by removing N-9 from products used rectally • N-9 in lubricant benefits no one, therefore it should be phased out • N-9 on condoms can harm those using it rectally. It has no proven benefit in terms of birth control. Therefore, it should be eliminated. • N-9 contraceptive products are the only user-controlled, non-hormonal birth control methods available in the US. Women need this option. They also need education about its benefits and risks.

  16. Global Campaign Response • Conversations with manufacturers • Call to Discontinue Use • Letter to FDA re: labeling etc. • Efforts to pressure CDC to fund major education effort (via consortium of groups like NFPRHA, ASHA, etc). • Follow up efforts re: safety testing of existing lubricants • Coalition building for microbicides

  17. What does this mean for microbicides in general? • Recent news about N-9 has led some people to think that developing a safe, effective microbicide is impossible. This isn't true! • The N-9 research data don’t suggest that a developing safe and effective microbicides is impossible -- only that N-9 probably is not one of them.

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