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

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

3. FB Infektiologie / Spitalhygiene The development of the EKAF statement Why 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. FB Infektiologie / Spitalhygiene The risk of Transmission of HIV What do HIV d/c couples think? What is your estimate of transmission risk after one single sexual act  during fully suppressive HAART 100% - 10% - 1% - 1:10 3 - 1:10 4 - 1:10 5 - 1:10 6 womenmen

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

6. FB Infektiologie / Spitalhygiene The development of the EKAF statement Evaluation 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 Oral Sex w/o Ejac Condom, no Tx

7. FB Infektiologie / Spitalhygiene 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

8. FB Infektiologie / Spitalhygiene Transmission risk under ART Risk 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

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

10. FB Infektiologie / Spitalhygiene Ranges of HIV transmission risks 10 -6 0.0110 -4 10 -5 10 -3 0.1 Anal sex 1 Vaginal sex 1 Sex under ART 1 Royce et al, NEJM, 1997 Ejac STD Risk per act Oral sex 3 3 Vittinghoff, 1999 Condom Use 2 2 Davis 1999

11. FB Infektiologie / Spitalhygiene 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

12. FB Infektiologie / Spitalhygiene The EKAF statement What 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 * *

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

14. FB Infektiologie / Spitalhygiene The EKAF statement What the statement did not say No advice against using condoms No change in prevention messages

15. FB Infektiologie / Spitalhygiene 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“

16. FB Infektiologie / Spitalhygiene Court accepts Swiss statement

17. FB Infektiologie / Spitalhygiene 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

18. FB Infektiologie / Spitalhygiene Reactions in Europe German Statement (AIDS Hilfe)

19. FB Infektiologie / Spitalhygiene Reactions in Europe French Statement (CNS)

20. FB Infektiologie / Spitalhygiene Reactions in Europe French 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

21. FB Infektiologie / Spitalhygiene Swiss Position: Open information is mandatory for well educated risk management