HIV Prevention in US Women

Transcription

1 HIV Prevention in US Women Sally L. Hodder M.D. Sally L. Hodder MD Professor of Medicine December 1, , 2010

2 Overview Epidemiology of HIV in US women HIV testing Antiretroviral i treatment as HIV prevention Vaginal microbides and HIV prevention

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4 HIV Prevalence in US % HIV seropositive (95%CI) Add Health Adolescents NHANES Age NHANES Age Whites (0.00,0.64) 0.26 (0.05,0.38) 0.36 (0.14,0.92) Blacks 0.49 (0.18,0.87) 1.42 (0.71,2.84) 3.58 (1,88,6.71) White men 0.52 (0.11,2.45) 0 (0,0.92) Black men 1.93 (0.77,4.72) 4.54 (2.24,8.97) White women 0 (0,0.31) 0 0 (0,0.92) 0 Black women 1.01 (0.36,2.84) 2.78 (1.00,7.45) Morris et al, AJPH, 2006 McQuillan et al, JAIDS 2006

5 HIV Prevalence in Select Countries Country Prevalence (%) Senegal 0.9 India 0.9 Cambodia 1.6 Burkina Faso 2.0 Ghana 2.3 Rwanda 3.1 Haiti 3.8 Cameroon 5.4 Uganda UNAIDS, 2007

6 HIV Prevalence in Select Countries Country Prevalence (%) Senegal 0.9 India 0.9 Cambodia 1.6 Burkina Faso 2.0 Ghana Rwanda 3.1 Haiti Cameroon 5.4 Uganda 6.7 UNAIDS, 2007

7 Reported AIDS Cases By Metropolitan Area El Sadr W et al. N Engl J Med 2010;

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16 HIV Disease Is a Leading Cause of Death for Black Females Aged Years Death Rate From HIV Disease (%) Females Aged Years Anderson RN, Smith BL. Hyattsville, Maryland: National Center for Health Statistics; 2005;53(17): Accessed March 8, 2008.

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18 Young Black Individuals with Low Risk Behavior Have More HIV Than Young White Individuals Behavior Pattern Adjusted* Odds Ratio Blacks to Whites Low Risk Behavior 24.9 *Adjusted for gender, marital status, school dropout, poverty Hallfors et al. Am J Pub Health 97:125, 2007

19 Why Patients Decline HIV Testing Gray et al. Obstet Gynecol. 2007;110(5):

20 Why Are Women of Color At Especially High Risk? HIV risk is far higher than individual risk characteristics predict Underestimation of partner risk Concurrency Incarceration Gender inequality (social and economic) Impaired access to HIV care and prevention

21 HIV Testing Track D Sally L. Hodder UMDNJ; Newark, New Jersey

22 Time course of HIV 1 infection symptoms HIV proviral DNA symptoms window period HIV antibodies HIV viral load HIV-1 p24 antigen / infection weeks years Time following infection

23 A. Fauci, 2006

24 HIV Transmission as relates to Serostatus Knowledge People Living With HIV/AIDS* ~25% unaware of infection (n=250,000) New Sexual Infections ~75% aware of infection (n= ,000) 000) ~54% of new infections ~46% of new infections Marks G et al. AIDS. 2006;20(10):

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28 Percent of Persons Ever Tested and Tested in the Preceding 12 Months NHIS Ever tested Preceding 12 months Per rcent MMWR August 8,

29 Barriers to Testing Social chaos Patient acceptance Stigma and discrimination paramount Health literacy Logistics of clinic implementation Rapidtesting vs. traditional Cost

30 Why Increase HIV Testing Foster earlier detection of HIV Within 1 year of HIV identification, 40% of persons in US are diagnosed with AIDS 1 Individual s knowledge of HIV+ status reduces prevalence of high risk sexual behavior (~68%) 2 Identify and link to care/prevention services Further reduce perinatal transmission in US Routine HIV testing is cost effective 3 1.0% HIV prevalence: $15,078 per QALY >0.05% prevalence: <$50,000 per QALY 1. MMWR Marks G et al. JAIDS Sanders G. NEJM 2005

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32 Revised CDC Recommendations for HIV Testing in Adults and Adolescents Routine, voluntary, HIV screening for all persons aged years, not based on risk If known risk, repeat annually Opt out HIV screening Opportunity to ask questions Option to decline Consent for HIV test is part of general consent for care Separate consent not recommended Preventioncounseling not requiredinin conjunction with HIV screening Low prevalence setting If yield ildfrom screening <0.1%, 01% continued routine screening not warranted Branson BM et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.

33 Experience With Implementing Opt Out Testing HIV Test Rates San Francisco Department of Public Health its Tests Per 1000 Vis Requirement for written consent for HIV testing eliminated (Policy Δ) ) Jan May Sep Jan May Sep Jan May Sep Trend Pre/Post Δ in Policy *P<.001 observed vs expected trend. Zelota NM. JAMA. 2007;297(10): Expected Trend if No Δ in Policy Number of positives increased 50% 95% CI for Trend Pre/Post Δ in Policy*

34 Early Indications of Progress: National Health Interview Survey Ever Tested Last 12 months ,036,336 (39.9%) 18,042,610 (10.44%) ,468,420 (40.4%) 17,775,006 (10.39%) ,848,002 (41.3%) 18,791, (10.67%) ,172,602 (44.6%) 19,055,402 (10.74%) Change since 2006: 8.7 million 1.3 million Source: National Health Interview Survey

35 Impact of Expanded HIV Testing in Washington, DC 37f 3.7 fold ldincrease in number of publicly l Mdi Median CD4+ cell count at time of HIV funded HIV tests performed in diagnosis significantly increased from Washington, DC, from : 19, : 72,866 17% increase in number of new HIV/AIDS name based case reports from Significant reduction in time to progression to AIDS following HIV diagnosis from (P <.0001) Time interval between diagnosis to entry into care significantly improved from Median CD4 4+ Cell Cou unt (cells/mm m 3 ) Castel A, et al. CROI Abstract 34. Reproduced with permission. P <.05 for trend Yr of Diagnosis

36 Recent Studies Suggest Gaps Remain in HIV Testing Telephone survey of 284,688 US adults % ever tested for HIV Less than 44 years of age, women more likely to be tested Testing less likely in rural areas and states with optin testing requirements Outpatient US veterans testing rate of 92% 9.2% 2 1. Du P et al. 48 th IDSA Abstract Welch et al. 48 th IDSA Abstract 4257.

37 Antiretroviral Treatment as HIV Prevention Track D Sally L. Hodder UMDNJ; Newark, New Jersey

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39 ART Suppresses HIV in Semen: Biological Plausability Controls (drug naive) n=55 th semen ts (%) wit e HIV in s Patient detectable p< Potent ART n=114 0 Vernazza, Cohen et al., AIDS, 2000

40 Correlation between Viral Load and HIV Transmission All subjects Male-to-Female Transmission Female-to-Male Transmission Transmission rate per 100 Person-Years < > < > < > Viral load (HIV-1 RNA copies/ml) Quinn T et al, N Engl J Med 2000; also see Fideli U et al, ARHR 2001

41 HIV Transmission Risk in Heterosexual Serodiscordant d Couples Initiating ARV 92% lower HIV transmission risk in African serodiscordant d couples with HIV infected partner receiving ARV therapy vs couples with infected partner not receiving ARVs 102 of 103 cases of confirmed HIV transmission occurred in couples with HIV infected partner not receiving ARV therapy Unadjusted relative risk: 0.17 (95% CI: ; P =.037) Adjusted relative risk: 0.08 (95% CI: ; P =.004) Adjusted for visit and CD4+ cell count at initiation Donnell D, Lancet 2010; 375:

42 Test and Treat Hypothesis Test Treat with ART + Adoption of safer Mi Maintain i viral behaviors by HIV+ suppression persons Decrease in HIV Transmission

43 Test and Treat to Eliminate HIV Lancet 2009; 373:48-57

44 Test and Treat Test and Treat enough HIV+ people Decrease in HIV Transmission Granich et al, 2009

45 Model Assumptions High uptake of annual testing by all >15 years All HIV+ individuals start ART immediately, irrespective of stage of HIV disease 50% uptake by 2012 and 90% by % decreasein infectiousness High adherence with ART Low failure with first line ART (8% first year then 1.5% per year)

46 Vaginal Microbicides for HIV Prevention Track D Sally L. Hodder UMDNJ; Newark, New Jersey

47 INFECTION ROUTE Routes of Exposure and H.I.V. RISK OF INFECTION Sexual Transmission a. Female to male transmission 1 in 700 to 1 in 3,000 b. Male to female transmission 1 in 200 to 1 in 2,000 c. Male to male transmission 1 in 10 to 1 in 1,600 d. Fellatio??.0 (CDC) or 6% (SF) Parenteral transmission i a. Transfusion of infected blood 95 in 100 b. Needle sharing 1 in 150 c. Needle stick 1 in 200 d. Needle stick /AZT PEP 1 in 10,000 Transmission from mother to infant a. Without AZT treatment 1 in 4 b. With AZT treatment Less than 1 in 10 Royce, Sena, Cates and Cohen, NEJM 336: , 1997

48 CAPRISA 004: 1% Tenofovir Gel for HIV Prevention in Women Randomized, d placebo controlled, ll double blind, bli d proof of concept f study conducted dat 2 sites in South Africa HIV-uninfected women, at high risk of HIV, 2 vaginal sex acts within 30 days of screening 1% Tenofovir Gel (n = 445) Study continued until 92 HIV infections (N = 889)* Placebo Gel observed (n = 444) *N = 889 enrolled from screened population of 2160 subjects. Common causes of exclusion included HIV infection (n = 536), failure to return (n = 142), no sexual activity (n = 132), coenrollment in a separate study (n = 135), pregnancy (n = 51). Gel applied using BAT 24 regimen: 1 gel dose < 12 hrs before sex; 1 gel dose within 12 hrs after sex; maximum of 2 in 24-hr period. Abdool Karim Q, et al. Science DOI: /science Abdool Karim Q, et al. AIDS Abstract TUSS0202.

49 CAPRISA: Reduced HIV Incidence With Tenofovir vs Placebo Gel Tenofovir gel associated itdwith decrease in HIV incidence [1] 50% decrease at 12 mos 39% decrease at 30 mos Tenofovir Placebo Tenofovir Efficacy vs Levels of Adherence Adherence Level, % n No. of Infections Efficacy, % > < Incidence e Rate (Infections/ /100 PY) P =.007 P =.017 cervicovaginal fluid tenofovir 10.5 concentrations associated with HIV seroconversion [2] Mo 12 Mo 30 No HIV resistance to tenofovir in patients infected while using gel Use of tenofovir gel also associated with 51% %decrease ease in HSV 2 infection [3] 1. Abdool Karim Q, et al. Science DOI: /science Kashuba A, et al. AIDS Abstract TUSS Abdool Karim S, et al. AIDS Abstract TUSS0204.

50 Conclusions Women of color are disproportionately impacted by HIV, however, responsible factors require further study Expanded HIV testing still with gaps in US Expanded treatment and vaginal microbicides offer promise as future HIV prevention tools Enormous stigma, limited access to care and prevention, and gender inequality must be impacted to improve HIV prevention and treatment t tin US women