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HIV Prevention - at a Crossroads?

HIV Prevention - at a Crossroads?. Quarraisha Abdool Karim, PhD Director: CU-SA Fogarty AITRP Co-Chair HIV Prevention Trials Network Associate Scientific Director: CAPRISA Columbia University and University of KwaZulu-Natal Celebrating 20 years of the HIV Center, March 27, 2008, New York.

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HIV Prevention - at a Crossroads?

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  1. HIV Prevention - at a Crossroads? Quarraisha Abdool Karim, PhD Director: CU-SA Fogarty AITRP Co-Chair HIV Prevention Trials Network Associate Scientific Director: CAPRISA Columbia University and University of KwaZulu-Natal Celebrating 20 years of the HIV Center, March 27, 2008, New York

  2. Overview • What have we achieved in HIV Prevention to date • Importance of knowledge of HIV Epidemic for Effective Prevention • HIV Prevention in 2008 - Challenges and Opportunities

  3. Ten most important causes of loss of healthy life globally Source: C Dye. WHO. http://www.who.int/tb/surveillanceworkshop/

  4. Unsafe sex is the second most important risk factor to global health… Each and every year, there are: • 340 million new curable STIs • 80 million unwanted pregnancies • 68,000 deaths from unsafe abortion • 536,000 maternal deaths from childbirth • 500,000 new cases of cancer of the cervix • 3 million girls undergo Female Genital Mutilation • 2.8 million deaths from HIV/AIDS Lancet, 2002

  5. 50 45 40 35 30 25 20 15 10 5 0 Celebrating 27 years of achievements in responding to HIV/AIDS.......... First cases of unusual immune deficiency are identified among gay men in the USA Global Fund to fight AIDS, Tuberculosis and Malaria In 1991-1993, HIV prevalence in Uganda and in Thailand begins to decrease The Human Immunodeficiency Virus (HIV) identified as cause of AIDS The UN General Assembly Special Session on HIV/AIDS Millions UN Political Declaration on HIV/AIDS Highly Active Antiretroviral Treatment launched Global Network of People living with HIV/AIDS (GNP+) WHO and UNAIDS launch the "3 x 5" initiative The World Health Organization launches the Global Programme on AIDS Brazil becomes the first developing country to provide antiretroviral therapy Evidence that male circumcision reduces HIV transmission. The first HIV antibody test becomes available First regimen to reduce mother-to-child transmission of HIV President Bush announces PEPFAR Acquired Immune Deficiency Syndrome (AIDS) defined International AIDS Conference in Durban 2.3 million people on ART in the developing world The first therapy for AIDS — zidovudine, or AZT — is approved for use in the USA UNAIDS created Drug Access Initiative is launched in Africa A heterosexual AIDS epidemic is revealed in Africa 1980 ‘81 ‘82 ‘83 ‘84 ‘85 ‘86 ‘87 ‘88 ‘89 ‘90 ‘91 ‘92 ‘93 ‘94 ‘95 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 ‘07 2008 People living with HIV Children orphaned by AIDS in sub-Saharan Africa

  6. Success of ART in the USA Persons living with AIDS Persons living with AIDS 90 90 450 450 80 80 400 400 AIDS Cases AIDS Cases 70 70 350 350 60 60 300 300 50 50 250 250 (AIDS cases and deaths in thousands) (AIDS cases and deaths in thousands) (Persons living with AIDS in thousands) (Persons living with AIDS in thousands) 40 40 200 200 30 30 150 150 Deaths 20 20 100 100 10 10 50 50 0 0 0 0 1985 1985 1987 1987 1989 1989 1991 1991 1993 1993 1995 1995 1997 1997 1999 1999 2001 2001 2003 2003 Years Years Source: US Centers for Disease Control and Prevention, AIDS Surveillance - Trends 1985-2004 available from: http://www.cdc.gov/hiv/topics/surveillance/resources/slides/trends/ index.htm,

  7. Slow scaling up of ART in sub-Saharan Africa Total 351,500 ±10% 3,283,000 *number of people aged 0-49 in need of ART in 2005less the estimated number treatment by June 2005 Source:The WHO reproductive health library. Reproductive Health Library informing best practice in reproductive health. 2005

  8. Shortage of health care personnel • Health care services in Africa are struggling to cope with the additional burden of AIDS care • shortage of skilled health care personnel, • overworked and stressed staff, • concerns about accidental HIV exposure (low morale) • doctors & nurses taken away from other care eg. EPI • Africa has been struggling for years to retain their skilled health professionals • The “brain drain” phenomenon: • Over the last 35 years, 44% of WITS Medical School graduates (Johannesburg) have emigrated

  9. Global Access to existing HIV prevention methods, 2003 0.2% Adults with access to HIV testing 4% Harm reduction got injection drug users 8% Prevention of mother-to-child transmission 11% Behaviour change programs for men who have sex with men 16% Behaviour change programs for commercial sex workers 21% Condom access 0 20 40 60 80 100 Prevention works! BUT we have failed to scale-up prevention Source: UNAIDS et al, 2004

  10. Prevention Success - Declining epidemics in several countries HIV prevalence rates in pregnant women in Uganda from 1985 to 2001 Source: Stoneburner RL, Low-Beer D. Population –level HIV declines and behaviour risk avoidance in Uganda. Science 2004; 304: 714-718

  11. The Ugandan Success Story • HIV incidence declined by two-thirds in just one decade • Most attribute Uganda’s success to the targeted behavior change program of ABC: Abstinence, Be Faithful, and Condomize

  12. Uganda: Increasing HIV prevalence

  13. No room for complacency: Increasing HIV risk in Uganda

  14. Deeper Understanding of Multiple Layers of Risk • Tissue / cellular level • e.g. HLA, cervical ectopy, 32 deleted CCR5 • Individual level • e.g. condom use, circumcision • Community level • e.g. access to health service, poverty • Country level • e.g. punitive sex work legislation • Global level • e.g. TRIPS agreement

  15. Know your epidemic and target populations • Latin America, Caribbean, North America • MSM • North America, Caribbean • Women-at-risk • Black MSM • Asia • IDUs • Sub-Saharan Africa • Adolescents/young adults

  16. Status of the HIV pandemic - 2007 UNAIDS 2007

  17. The evolving HIV epidemic in Africa Source: UNAIDS. 2006 Report on the global AIDS epidemic. UNAIDS, Geneva

  18. HIV prevalence by age and sex Kenya Malawi Lesotho Cameroon

  19. The explosive HIV epidemic in South Africa 35 30 25 20 HIV Prevalence (%) 15 10 5 0 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 HIV prevalence in pregnant women attending public antenatal clinics in South Africa 1989-2006 Source: Data from South African Department of Health Antenatal Surveys. www.doh.gov.za/

  20. 10 Male JUN/JUL 1992 Female 8 6 Prevalence (%) 4 2 0 <9 10-14 15-19 20-24 25-29 30-39 40-49 >49 Age and gender distribution of HIV infection in South Africa Source: Abdool Karim Q, Abdool Karim SS, Singh B, Short R, Ngxongo S. AIDS 1992; 6: 1535-9

  21. Age trends in HIV infection in rural South Africa Temporal trends in the age-specific HIV prevalence (%) in ANC attendees in rural South Africa Sources: Wilkinson et al, JAIDS Gouws E et al, HIV in South Africa

  22. Age and gender distribution of HIV infection among 15–24 year olds in South Africa 2003: Source: Pettifor AE, Reesa HV, Kleinschmidt I, Steffensond AE, MacPhail C, Hlongwa-Madikizelaa L, Vermaake K, Padian NS. AIDS 2005, 19:1525–1534

  23. HIV incidence and HIV prevalence by age and sex, South Africa 2005 30 Prevalence (females) Prevalence (males) 25 Incidence (females) Incidence (males) 20 HIV prevalence and incidence (%) 15 10 5 0 <20 20-29 30-39 40-49 50+ Age group (years) Source: Rehle T, Shisana O, Pillay V, Zuma K, Puren A, Parker W. National HIV incidence measures: new insights into the South African epidemic. South African Medical Journal 2007

  24. 70 65 60 Botswana 55 South Africa Life expectancy at birth (years) 50 45 Swaziland 40 35 Zambia 30 Zimbabwe 25 20 1970–1975 1980–1985 1990–1995 2000–2005 1975–1980 1985–1990 1995–2000 2005–2010 Source: United Nations Population Division (2004). World Population Prospects: The 2004 Revision, database. 4.1 Impact of AIDS on life expectancy in five African countries, 1970–2010

  25. Adult Mortality rates in South Africa: Age and Sex - 1997-2004 STATS SA. Adult mortality 1997-2004

  26. Anticipated Prevention Trial Results - 2006 Microbicide Behaviour Treatment pMTCT Vaccine Barrier HVTN 503 trial HPTN 035: Pro 2000 & Buffergltrial Population Council Carraguard Trial Truvada PrEP trial: Hetero-sexual HPTN 052: Index Rx HPTN 039-1 trial: HSV-2 Infectiousness HVTN 204 trial PAVE 100 trial Project accept: Community based VCT trial MDP 301 Pro 2000 Trial HPTN 039 HSV-2 Susceptibility CAPRISA 004: Tenofovir gel trial UCSF MIRA Diaphragm trial HPTN 046 trial 2011 2007 2008 2010 2009 Estimated trial completion date

  27. Actual Prevention trial results - 2008 Microbicide Behaviour Treatment pMTCT Vaccine Barrier HVTN 503 trial HPTN 035: Pro 2000 & Buffergltrial Population Council Carraguard trial CDC Truvada PrEP trial: Hetero-sexual HPTN 052: Index Rx HVTN 204 trial ( PAVE 100 trial  NIMH Project Accept trial: Community based VCT MDP 301 Pro 2000 2% and 5% Trial HPTN 039 HSV-2 Susceptibility CAPRISA 004: Tenofovir gel trial UCSF MIRA Diaphragm trial HPTN 046 trial 2011 2007 2008 2010 2009 Estimated trial completion date

  28. Cellulose Sulphate MIRA HPTN 039 HVTN 502/503 Carraguard Male Circumcision SWEN IMAGE OPTIONS – positive prevention Country level success – Kenya & Zimbabwe Summary of Prevention Successes and Failures in 2007/8

  29. What have we learnt from trial failures? • Vaccines & microbicides – medium- to long-term goal • Need to optimize combinations of what we have available today • No single solution – know your epidemic and target population • Public Health Imperative to respond in the face of scientific uncertainty and absence of surrogate markers of protection

  30. Customising and Optimising HIV Prevention Interventions • Establish prevention combinations for epidemic, target groups and/or mode of transmission • Behavior change including “ABC” • Targeted Structural interventions • Male circumcision, STD control • VCT • Integration prevention & care • Social mobilisation • Needle exchange • Positive prevention • Add new evidence-based insights in future • Opiate substitution therapy, PrEP, Microbicides, ,Vaccines,

  31. Integrating prevention and care • Provision of AIDS care creates opportunities for improving prevention efforts • Few successful, sustained efforts to integrate prevention into care programs. • Prevention interventions have traditionally concentrated on protecting those at risk of infection • New models which refocus prevention interventions to target those already infected, are emerging

  32. Why isn’t there more prevention in treatment programs? 11 of 12 rigorous RCTs of Interventions that target people living with HIV/AIDS demonstrate risk reduction Crepaz et al., AIDS, 2006

  33. 5.0 4.0 Number of new HIV infections (millions) 3.0 2.0 1.0 0.0 2003 2005 2010 2015 2020 Year Baseline Treatment-centered Prevention-centered Comprehensive response Source: Salomon JA et al. (2005). Integrating HIV prevention and treatment: from slogans to impact 6.1 Impact of three scenarios on HIV infection in sub-Saharan Africa, 2003–2020

  34. 3.0 2.5 Number of AIDS- related deaths (millions) 2.0 1.5 1.0 0.5 0.0 2003 2005 2010 2015 2020 Year Baseline Treatment-centered Prevention-centered Comprehensive response Source: Salomon JA et al. (2005). Integrating HIV prevention and treatment: from slogans to impact 6.2 Impact of AIDS-related deaths in sub-Saharan Africa, 2003–2020

  35. Uganda Kenya Lesotho South Africa Family VCT Provider-initiated Universal Community-based Promoting knowledge of HIV status - Lessons from experiences in: NB of VCT

  36. Male Circumcision: Evidence from 3 RCTs insufficient for Action! Orange Farm, Johannesburg, South Africa (N=3128) 60% protective effect (95% CI: 32%–76%). Kisumu, Kenya (N=2784) 53% protective effect (95% CI: 22%–72%). Rakai, Uganda (N=4996) 51% protective effect (95% CI: 16–72; p=0·006) Source: Auvert B, et al (2005). PLoS Med, 2, e298; Bailey RC, et al (2007). Lancet, 369, 643-56; Gray RH, et al (2007). Lancet, 369, 657-66

  37. Male Circumcision: an Opportunity? • To impact HIV trajectories in low circumcision and high HIV prevalence settings • To involve consenting adult men in response • To integrate safe male circumcision services with other sexual and reproductive health services for men • For promoting greater male responsibility • Reduce HIV incidence in adult men by 50-60% • BUT, despite unprecedented rapid recommendations on scaling up from WHO/UNAIDS……….. • Lack of consensus in scientific community • Ambivalence to make policy decision at a country level

  38. Modern Contraceptive Prevalence, Married Women 15-49 2005 Adult HIV Prevalence2005 20.0-34.0% Over 20% 10% - 20.0% 10% - 19.9% 5% - 10.0% 5% - 9.9% 1% - 5.0% 1% - 4.9% 0% - 0.9% Contraceptive Use &HIV Prevalence

  39. Pregnancies are Often Unintended or Unwanted 100% 90% 80% 70% 60% 50% 40% 40% 30% 20% 13% 10% 0% Haiti Kenya Nigeria Zambia Namibia Vietnam Ethiopia Uganda Rwanda Tanzania Botswana Côte d'Ivoire South Africa Mozambique % births unintended % births unwanted Source: DHS and other surveys

  40. Women with HIV Also Have Unintended Pregnancies • 84% unintended pregnancies among PMTCT clients in South Africa • 51% unintended pregnancies among women with HIV in Cote d’Ivoire • 99% unintended pregnancies among women in an ART program in Uganda Sources: Rochat et al., JAMA2006:295:1376-8; Desgrées-du-Loû et al., Int J STD AIDS 2002;13:462-468; Smart, T. Aidsmap. July 14, 2006.

  41. Preventing Unintended Pregnancies Will Help Achieve HIV Goals • UNGASS goals cannot be met without preventing unintended pregnancy • Moderate decreases in pregnancies to HIV+ women will reduce same number of HIV+ births as current PMTCT programs • Contraception is the “best-kept secret” in HIV prevention Cates W, 2007

  42. Female condoms in prevention programs increase overall condom use 80 72,0 69,6% 67,7 65,8 70 Male condom use at the beginning of the study 60 50 Male and female condom use at the end of the study % 35,7 40 33,5% 31,6 29,7 30 20 10 0 Total Community Health care setting Combined Proportion of safe sex acts in the last sexual intercourse at start and end of female condom promotion in various health care settings in Brazil Source: Barbosa R et al, XIIIth Int AIDS Conference, 2000

  43. <400 <400 <400 >50 000 >50 000 >50 000 400-3499 400-3499 400-3499 3500-9999 3500-9999 3500-9999 10 000-49 999 10 000-49 999 10 000-49 999 ARV Prophylaxis: Rationale for ART to reduce heterosexual HIV transmission 30 Female-to-Male Transmission Male-to-Female Transmission All subjects 25 20 15 Transmission rate per 100 Person-Years 10 5 0 Viral load (HIV-1 RNA copies/ml) and HIV transmission Source: Quinn N, et al,N Eng J Med 2000

  44. Tenofovir Effective in preventing SIV infection in non-human primate challenge studiesTenofovir, a thymidine analogue (nRTI), protects against SIV in 15 monkey challenge studies; FTC effective in preventing HIV infection

  45. Humans: Excellent Safety Profile in Treatment (HD), Minimal Toxicity in Tissues, High tissue levels, Effective in Cervical Explant models C959 BaL Tenofovir placebo Source: Kashuba & MTN - Dezutti

  46. ARVS for Preventing HIV infection: The Future Face of Microbicides? Pill Implant Physical Barrier IUD Vaginal ring Pills Gel LLong-Acting Injectible Film

  47. Summary • Not a single epidemic but a mosaic of multiple differing & diverse epidemics • Responses have to be shaped by knowledge of epidemic & target populations • Combating the HIV pandemic requires scaling up known prevention options & the development of new prevention technologies • Need to define optimal combinations of known interventions appropriate for target population and epidemic • More than a health issue - social mobilization is effective • Treatment scale up creating new opportunities for prevention • Need to deal with drivers of epidemic

  48. 50 45 40 35 30 25 20 15 10 5 0 ....we need to change this course of events First cases of unusual immune deficiency are identified among gay men in the USA Global Fund to fight AIDS, Tuberculosis and Malaria In 1991-1993, HIV prevalence in Uganda and in Thailand begins to decrease The Human Immunodeficiency Virus (HIV) identified as cause of AIDS The UN General Assembly Special Session on HIV/AIDS Millions UN Political Declaration on HIV/AIDS Highly Active Antiretroviral Treatment launched Global Network of People living with HIV/AIDS (GNP+) WHO and UNAIDS launch the "3 x 5" initiative The World Health Organization launches the Global Programme on AIDS Brazil becomes the first developing country to provide antiretroviral therapy Evidence that male circumcision reduces HIV transmission. The first HIV antibody test becomes available First regimen to reduce mother-to-child transmission of HIV President Bush announces PEPFAR Acquired Immune Deficiency Syndrome (AIDS) defined International AIDS Conference in Durban 2.3 million people on ART in the developing world The first therapy for AIDS — zidovudine, or AZT — is approved for use in the USA UNAIDS created Drug Access Initiative is launched in Africa A heterosexual AIDS epidemic is revealed in Africa 1980 ‘81 ‘82 ‘83 ‘84 ‘85 ‘86 ‘87 ‘88 ‘89 ‘90 ‘91 ‘92 ‘93 ‘94 ‘95 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 ‘07 2008 People living with HIV Children orphaned by AIDS in sub-Saharan Africa

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