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Risk of Sexual Transmission under HAART Background information on Swiss statement

Risk of Sexual Transmission under HAART Background information on Swiss statement. Pietro Vernazza President EKAF- Swiss Federal Commission on AIDS. Agenda. Why a statement Formal content of the statement Impact on Swiss physicians and patients Influence on other clinical guidance (EU, US).

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Risk of Sexual Transmission under HAART Background information on Swiss statement

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  1. Risk of Sexual Transmission under HAARTBackground information on Swiss statement Pietro Vernazza President EKAF- Swiss Federal Commission on AIDS

  2. Agenda • Why a statement • Formal content of the statement • Impact on Swiss physicians and patients • Influence on other clinical guidance (EU, US)

  3. The development of the EKAF statementWhy a statement • Criminal prosecution (CH > 30 cases!) • Couples willing to conceive a child • Discrepancy public/ private information • Problems of inconsistency of information • Risk of uncontrolled diffusion

  4. PHI STDs HIV-Transmission risk over time Infectiousness (arbritrary scale) Months / Years Weeks Vernazza, AIDS 1999;13:155–166 (adapted)

  5. The development of the EKAF statementEvaluation by Expert Group (FKT) • High Risk • Relevant for Public Health • IntermediateRisk:  Relevant for the individual • NegligibleRisk:  Similar to risks of daily life Oral Sex w/o Ejac Condom, no Tx

  6. Other “negligible” risk situations • Condom-protected vaginal Sex:  0.9 / 100 py for always users Davis, 1999, Fam Plan Perspectives • Receptive oral Sex (MSM): 0.0004 / act Vittinghoff, 1999, Am J. Epid • 1:2‘500

  7. Transmission risk under ARTRisk estimation • Published partner studies • N<600, no Trsm 95%-CI: < 1:200 • Absence of observed cases • What is the denominator? • SHCS*: 20% practice unsafe sex • Europe: >300’000 ART  30 x sex/year • Detection rate 1%  1:100‘000 *Panozzo et al, 2003, SMW

  8. Activity of ART for Prevention ART is comparable to condom use Sex w/o Condom Partner under HAART Mono- / Bi- Therapy Triple- therapy None Always with condom >1/Mt. <1/Mt. Infection rate partners (%) Castilla, et al. JAIDS 2005; 40:96-101

  9. Ranges of HIV transmission risks Oral sex3 Ejac Sex under ART STD Vaginal sex1 Condom Use2 Anal sex1 10-6 10-5 10-4 10-3 0.01 0.1 Risk per act 1Royce et al, NEJM, 1997 2Davis 1999 3Vittinghoff, 1999

  10. Consider biology... • STDs: epidemiologic synergy • STDs increase genital viral load • STDs increase susceptibility to HIV • Genital viral load may take some more time to get below <40 cp/ml  Any Communication about safety under HAART should include statement on duration and STD

  11. The EKAF statementWhat the statement described • It‘s ok. to talk about risk estimates • Under optimal conditions, risk is in the range of daily life („negligible“) • Long term maximal suppression • Perfect adherence, regular checks • Absence of STDs • Only the informed partner can decide on condom use  negligible: same range as for condoms * *

  12. (based on math. Model by Wilson et al.) Swiss statement challenged confirmed In serodiscordant male couple after 100 anal contacts Garnett &Gazzard, The Lancet, 27.7.2008, editorialcomment

  13. The EKAF statementWhat the statement did not say • No advice against using condoms • No change in prevention messages

  14. Impact on physicians & patients Marianne, teacher, 35 years: „Thank you, for the first time in my 20 years of HIV infection I felt secure. I have been assured that I am not a danger for other people in my life. Even when I worked with children, I feared of infecting one of them“

  15. Court accepts Swiss statement

  16. Physicians in Switzerland ? • In general more disclosure regarding risk behavior • Discussions with partners encouraged • No massive change in risk behavior noted • STDs became important issue

  17. Reactions in EuropeGerman Statement (AIDS Hilfe)

  18. Reactions in EuropeFrench Statement (CNS)

  19. Reactions in EuropeFrench Statement (CNS) • On a public healthlevel • Increase efforts for HIV testing • Promoteresearch in the field of prventionthroughmedicaltreatment • General Communication • Promote benefits of HIV testing and treatment • Inform about risk reduction through treatment • Residual risk remains • For healthprofessionals • Consider treatment as a preventive measure in cases resistant to conventional prevention methods

  20. Swiss Position: Open information is mandatory for well educated risk management

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