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Antiretroviral Therapy: An HIV Prevention Strategy?

Antiretroviral Therapy: An HIV Prevention Strategy?. Wafaa El-Sadr, MD, MPH Columbia University Harlem Hospital New York. Persons Living with HIV/AIDS 2008 33.2 million (30.6-36.1 million) worldwide. E. Europe/Central Asia 1.6 million. Western & Central Europe 760,000. North America

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Antiretroviral Therapy: An HIV Prevention Strategy?

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  1. Antiretroviral Therapy:An HIV Prevention Strategy? Wafaa El-Sadr, MD, MPH Columbia University Harlem Hospital New York

  2. Persons Living with HIV/AIDS 200833.2 million (30.6-36.1 million) worldwide E. Europe/Central Asia 1.6 million Western & Central Europe 760,000 North America 1.3 million E. Asia/Pacific 800,000 N. Africa/Mid-East 380,000 Caribbean 230,000 South/S.E. Asia 4.0 million Sub-Saharan Africa 22.5 million Latin America 1.6 million Oceana 75,000 Source: UNAIDS, AIDS Epidemic Update, December 2009

  3. Use of ART for PMTCT

  4. <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 HIV RNA Levels Associated with HIV Transmission Risk 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 Quinn TC, et al.NEJM 2000; Fideli U, et al. AIDS Res Hum Retrovir 2001

  5. Impact of Antiretroviral Therapy (ART)on HIV Transmission • Prospective cohort study of home-based ART in a rural community in Uganda (n=926) • After starting ART • Median HIV RNA levels decreased from 122,500 to <50 copies/mL • Estimated HIV transmission rate reduced by 98% • From 46 to 1 per 1000 PY • Risky sex decreased by 70% (P=0.002) Bunnell R, et al. AIDS. 2006;20(1):85

  6. Impact of ART on HIV Transmission • HIV discordant couples (Rwanda and Zambia) (n= 2,993 discordant couples) • HIV+ persons with CD4 <200 cells/mm3on ART • HIV incidence by partner ART status: • Not on ART: 3.4 / 100 PY • On ART: 0.7 / 100 PY • OR, 0.2; 95% CI, 0.08-0.6 Sullivan P, et al. CROI Montreal. 2009

  7. HIV sexual transmissibility meta-analysis:No transmission on ART below 400 copies/ml Attia S, et al.AIDS 2009 Jul 17;23(11):1397-404.

  8. Antiretroviral Treatment as Prevention • Anema A, et al. The use of HAART to reduce HIV incidence at the population level. CMAJ 2008; 179:13-4. • Bateman C. Treat all HIV-positive people--and bury the pandemic in 14 years. S Afr Med J 2009; 99:80-2. • Montaner JS, et al. The case for expanding access to HAART to curb the growth of the HIV epidemic. Lancet 2006;368:531-6. • DeGruttola V, et al. Controlling the HIV epidemic, without a vaccine! AIDS 2008; 22:2554-5. • Dieffenbach CW, Fauci AS. Universal VCT and ART for prevention of HIV transmission. JAMA 2009; 301:2380-2

  9. Modeling of Test and Treat Lancet 2009; 373:48-57

  10. Model Assumptions • High uptake of annual testing by all >15 year old individuals • All HIV+ individuals start ART immediately, irrespective of stage of HIV disease • 99% decrease in infectiousness • High adherence with ART • Low failure with first line ART

  11. Estimated number of new HIV infections by transmission category, 1977-2006 *50 States and District of Columbia MSM IDU HET Courtesy of Kevin Fenton, CDC

  12. HIV Prevalence for Selected Countries in Sub Saharan Africa and Subpopulations in the United States

  13. Test and Treat + Decrease in HIV Transmission Test Adoption of safer behaviors by HIV+ persons Treat with ART Maintain viral suppression

  14. HPTN TNT-Plus Study Concept Initiationof ART Increase in Testing Support of adherence Linkage to care sites Positive Prevention Decrease in HIV Transmission Test HIV Positive Adopt safer behaviors Enroll in Care Treat with ART Maintain viral suppression

  15. Testing

  16. Coverage of ART among eligible people living with HIVKenya (2007 KAIS) 39% know status, on ART 57% Unaware of status, not on ART 39% 57% 4% know status, not on ART HIV test Among those who knew status and were eligible 92% were on ART Mohammed, CROI 2009

  17. Percentage HIV Tested

  18. New AIDS Cases and “Late Testers” Persons newly diagnosed with AIDS, and proportion first diagnosed with HIV within 12 months, 2001-2006 (N=4,640) 992 842 780 668 692 54.0% 666 30.3% 646 32.3% 37.1% 43.3% 37.8% 33.9% 69.7% 67.7% 46.0% 62.9% 62.2% 56.7% 66.1% 2009 PREVIEW 20

  19. Late Diagnosis of HIV • NYC: 27% of persons newly diagnosed with HIV had concurrent diagnosis of AIDS in 2005 • First CD4+ count performed within 12 months after HIV test • CD4+<200: 31.7% • CD4+ 200-350: 8.2% • CD4+ 351-500: 6.9% • CD4+ >500: 8.8% • Missing: 44% • Concurrent HIV/AIDS diagnosis (1 month) • More than twice risk of death within 4 months HR: 2.27 (95% CI 1.94-2.65) NYC DOHMH surveillance 2007 Hanna et al 2008

  20. Positive Prevention

  21. Positive Prevention Interventions

  22. Linkage to Care

  23. Time from HIV Diagnosis to Care Entry* 1,340 1,827 1,635 1,502 1,342 1,510 50% 25 2009 PREVIEW

  24. Factors Associated with Delayed Initiation of Care • Of 1,928 patients, • 1,228 (63.7%) initiated care within 3 months of HIV diagnosis • 369 (19.1%) initiated care >3 months • 331 (17.2%) never initiated care • Predictors of delayed initiation of care: • Diagnosis at community testing site (HR: 1.9, 95%CI 1.5-2.3) • Diagnosis in corrections, STI or TB clinic (HR:1.3, 95% CI; 1.1-1.6) • Non-white race/ethnicity (HR: 1.8; 95% CI 1.5-2.0) • Injection drug use (HR: 1.3; 95% CI1.1-1.5) • Foreign born (HR: 1.1; 95% CI 1.0-1.2) Torian et al 2008

  25. Treatment with ART

  26. When to Start Antiretroviral Therapy Earlier Later

  27. Early versus Later ART

  28. INSIGHT START Study HIV-infected individuals who are ART-naïve with CD4+ count > 500 cells/mm3 Early ART Group Initiate ART immediately following randomization N=2,000 for definitive trial Deferred ART Group Defer ART until the CD4+ count declines to < 350 cells/mm3 or AIDS develops N=2,000 for definitive trial Serious AIDS, Non-AIDS Events or Death

  29. HPTN 052 HIV-infected subjects with CD4 350 to 550cells/µL with discordant partner Randomization Immediate ART 350-550cells/uL Deferred ART CD4 <250>200 AZT+3TC+EFV Endpoints: i) HIV Transmission to partners ii) OIs and clinical Events iii) ART toxicity Thailand, South Africa, Botswana, Kenya, Malawi, Brazil, India

  30. Other Modelling --- All treated Relative infectivity 0.01 Dropout: 1.5% /year 14% prevalence in population --- ART: 65% symptomatic 20% asympotmatic Relative infectivity 0.03 Dropout: 5% symptomatic 20% asymptomatic Elimination theoretically possible --- ART: 65% symptomatic no ART asymptomatic Treated individuals noninfectious Dropout: 5%/yr HIV remains endemic at 34% prevalence and 2%/yr incidence Wagner and Blower, Nature Proceedings, 2009

  31. Adherence

  32. Adherence to Antiretroviral Treatment Percent reporting 100% adherence *p<0.01 for difference between months 1 & 4 and months 1 & 8 Mannheimer et al, FIRST Study CPCRA, 2000.

  33. HPTN 065 TLC-Plus Study “Testing Linkage to Care Plus Treatment” • PURPOSE • To evaluate the feasibility of an enhanced community-level HIV test, link-to-care plus treat strategy in the U.S.

  34. Study Components I. Testing II. Linkage to care III. Viral suppression IV. Positive prevention V. Patient and provider survey

  35. Study Communities Intervention communities Washington DC Bronx, NY Comparison communities Houston Philadelphia Chicago Miami

  36. HIV Testing in NYC: The Bronx Knows • Bronx with excess AIDS-related deaths (32% vs. 17% NYC pop.) • 1 in 4 diagnosed with HIV & AIDS concurrently in the Bronx

  37. “The Bronx Knows” Initiative • Test all Bronx residents ages 18-64 yrs who have never been tested before to identify undiagnosed HIV+ persons • Link all HIV+ persons to high quality care and supportive services

  38. Washington, D.C.: 7 of 8 wards with 1.7-2.8% prevalence City-wide by race/ethnicity and sex ----------------- WF 0.2% HF 0.7% BF 2.6% WM 2.6% HM 3.0% BM 6.5% Population Prevalence 0.0 - 0.6 0.7 - 1.2 1.3 - 1.8 1.9 - 2.4 2.5 - 3.0 REF: Shannon Hader. CROI 2009. Abst.57

  39. HIV Rapid Testing Expansion in DC N=43,271 N=72,864 68.4% increase in number of tests done in 1 yr 94% of new HIV positives were identified in clinical settings 97% of new HIV positives were identified in clinical settings 2009 PREVIEW 41

  40. Study ComponentsI. Expanded HIV Testing This includes 1- social mobilization, with targeted messaging to promote testing

  41. 2- universal offer of HIV testing in emergency departments (EDs) and hospital inpatient admissions 43

  42. Study ComponentsII. Linkage to Care This component involves: test site randomization (20 per community) determine feasibility and effectiveness of financial incentives vs. standard of care (SOC) Outcome: Proportion of newly identified HIV+ patients from HIV test sites who complete two clinical visits at HIV care sites

  43. Study Components III. Viral Suppression This component involves: care site randomization (20 per community) determine feasibility and effectiveness of financial incentives vs. standard of care (SOC) Outcome: Proportion of patients at HIV care site achieving and maintaining viral suppression

  44. Financial Incentives • 2-arm RCT: • Information about programs • Incentives worth up to $750 for program completion, short-term cessation, long-term cessation • Eligibility for incentives tied to quitting within first 6 months of enrollment p-value for difference < 0.0001 Volpp, Troxel, Pauly et al, New England Journal of Medicine. 2009; 360(7): 699-709.

  45. Study ComponentsIV. Prevention for Positives This involves: individual randomization of patients (6 care sites per community) determine effectiveness in decreasing risk behaviors computer-delivered intervention vs. standard of care (SOC)

  46. Study ComponentsPrevention for Positives The computer-delivered intervention is: A modification of the Computer Assessment and Risk Reduction Education for HIV-positives (CARE+) platform, integrated with an audio-narrated self-interview (ACASI)

  47. Study ComponentsV. Patient and Provider Surveys These surveys aim to determine: knowledge, attitudes and practices regarding early initiation of ART knowledge and attitudes regarding financial incentives for linkage to care and viral suppression

  48. Study Objectives and Outcomes • Assesses feasibility and effectiveness outcomes, dependent on study component • Assesses the feasibility of using surveillance data for outcomes • All aim at determining feasibility of overall strategy • TLC-Plus is not designed to measure a change in HIV incidence

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