WOMEN S INTERAGENCY HIV STUDY. Semiannual Executive Committee Meeting June 20-22, 2017 North Bethesda, Maryland

Transcription

1 Report WOMEN S INTERAGENCY HIV STUDY Semiannual Executive Committee Meeting June 20-22, 2017 North Bethesda, Maryland Prepared by: WIHS Data Management and Analysis Center (WDMAC) JHSPH.wdmac@jhu.edu web:

2 # of Publications WIHS Publications ! * Number of publications as of June Includes published and in press for Year

3 WIHS Timeline WIHS I WIHS III WIHS V WIHS II WIHS IV Cumulative Enrollment HIV HIV st Visit 10/3/94 Bronx, NY Brooklyn, NY Chicago, IL Los Angeles, CA San Francisco, CA Washington, DC 22.7 years (8,296 days) WDMAC Baltimore, MD Atlanta, GA Birmingham, AL/ Jackson, MS Chapel Hill, NC Miami, FL 46 th Visit 6/20/17

4 Cohort Status

5 WIHS Cohort: Enrollment Through 9/30/16 * 4982 Seroprevalent: 3677 (74%) Seronegative: 1305 (26%) AIDS baseline 789 (21%) AIDS-free baseline 2888 (79%) Seroconverter 26 (+1) (2%) Seronegative 1279 (98%) AIDS 907 (+11) (31%) AIDS-free 1981 (-11) (69%) AIDS 11 (42%) AIDS-free 15 (+1) (58%) Dead 471 (+1) (60%) Dead Dead 409 (+15) (45%) 270 (+10) (14%) Dead Dead 6 (55%) 4 (+1) (27%) Dead 108 (+9) (8%) * HIV & AIDS status as of the end of visit 44 (9/30/16). Deaths via NDI (through 12/31/14 for sites 1-6) and through 9/30/16 via other reports Two seroconverters found at death

6 WIHS Cohort by Enrollment Wave WIHS I N=2623 (53%) WIHS II N=1143 (23%) WIHS IV N=371 (7%) WIHS V N=845 (17%) HIV Serostatus at Baseline Seronegative Seropositive Therapy-naïve Therapy-exp d 569 (22) 2054 (78) (36) 255 (22) 482 (42) 95 (26) 78 (21) 198 (53) 234 (28) 92 (11) 519 (61) Current Cohort a (N=2416) 721 (30%) 575 (24%) 290 (12%) 796 (33%) a Current cohort = All participants seen at Visit 43 or 44

7 Race/Ethnicity among HIV+ Women: U.S. & WIHS Diagnoses of HIV Infection, U.S.* WIHS Active HIV+ Participants 15% 5% 15% 4% 19% 61% 11% 71% Black/African American White Hispanic/Latina Multiple Races/Other * Data from the Centers for Disease Control and Prevention; includes diagnoses of HIV infection among adult and adolescent females (n=7,402), by race/ethnicity in 2015.

8 Percent of Cohort Age Distribution of Active* Participants 25 HIV SN HIV SP SN SP Median Age (IQR) (40, 55) (43, 55) 20 Age > 60 12% 12% < * Active = All participants seen at Visit 43 or 44

9 Retained (%) Retention Rates among WIHS Recruits (WIHS I) (WIHS II) (WIHS IV) (WIHS V) 96% 94% 92% 90% 80 79% 78% HIV+ HIV- 70% 61% WIHS Visit Number

10 WIHS Database (as of 9/30/16) Total number of PARTICIPANTS enrolled 3,701 HIV+ 1,281 HIV- Total number of PERSON-YEARS 34,384 HIV+ 12,753 HIV- Median (Mean) FOLLOW-UP TIME in years (12.14) WIHS I (10.80) WIHS II 4.46 (3.98) WIHS IV 1.87 (1.75) WIHS V Total number of PERSON-VISITS 64,931 HIV+ 23,871 HIV- Total number of CD4 MEASUREMENTS 60,717 HIV+ 10,554 HIV- Total number of VIRAL LOAD MEASUREMENTS 60,531 Total number of REPOSITORY ALIQUOTS* 2,775,412 * Available as of 05/23/2017

11 ART Exposure and Pathogenesis

12 Antiretroviral Therapy Use Among WIHS HIV-infected Participants 100% Mono/Dual Therapy PI-based Regimens Integrase Inhibitorbased Regimens NNRTI-based/3+ NRTI Regimens Jan 95 Jan 97 Jan 99 Jan 01 Jan 03 Jan 05 Jan 07 Jan 09 Jan 11 Jan 13 Jan 15 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% % Receiving Therapy Calendar Time

13 % Reporting 95% Adherence ARV Adherence and HIV RNA Among All Women on Therapy NucliSens TaqMan All women Women w/adherence > 95% 100 % with HIV RNA <80 copies/ml

14 Viral Load Among HIV+ Participants VL > 10,000 VL > VL 10,000 > 10,000 10,000 < < VL VL VL < 10,000 VL < 1,000 VL < 80 VL < Jan 95 Jan 97 Jan 99 Jan 01 Jan 03 Jan 05 Jan 07 Jan 09 Jan 11 Jan 13 Jan % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Study Visit

15 CD4 Cell Counts Among HIV+ Participants 100% CD4 > 500 CD4 < 500 CD4 < 350 CD4 < 200 CD4 < 200 CD4 < Jan 95 Jan 97 Jan 99 Jan 01 Jan 03 Jan 05 Jan 07 Jan 09 Jan 11 Jan 13 Jan 15 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Study Visit

16 AIDS Outcomes And Deaths

17 Therapy Use Among HIV + (%) WIHS Mortality, Self-Reported AIDS Incidence, and Use of Therapy 80% 60% 40% 20% 0% Death AIDS Therapy Incidence (per 100 person years) Year NDI data available through 12/31/14

18 Change in Age-Adjusted 6-Month Mortality Rates HIV+ All-cause HIV+ AIDS HIV+ Pneu/Inf HIV+ Non-AIDS HIV- All-cause Year (as of 12/31/14)

19 Change in Age-Adjusted 6-Month Mortality Rates HIV+ All-cause 6-month mortality HIV- All-cause mortality (overall average) Calendar Time (as of 12/31/14)

20 Causes of Death Deaths among HIV+ Participants 1160 (+33) SR AIDS at BL 471 a (+7) SR AIDS during F/U 378 b (+14) No SR AIDS 311 c (+12) AIDS death 228 (48%) 148 (39%) 99 (32%) Pneumonia or Infection death 64 (14%) 61 (16%) 34 (11%) Non-AIDS death 147 (31%) 130 (34%) 154 (50%) Indeterminate/Missing 32 (7%) 39 (10%) 24 (8%) Data based on NDI match through 12/31/14 for original sites and through 9/30/16 for all sites via other reports a Includes 6 deaths among 01/02 recruits, 2 11/12 recruits, and 2 Southern recruits b Includes 56 deaths among 01/02 recruits, 3 11/12 recruit, and 6 HIV seroconverters (HIV SC) c Includes 54 deaths among 01/02 recruits, 8 11/12 recruits, 6 Southern recruits and 4 HIV SC (2 found at death)

21 Non-AIDS Outcomes And Deaths

22 Non-AIDS Causes of Death Non-AIDS Deaths d 527 (+35) HIV+ 431 (+29) HIV- 96 (+6) Trauma or OD a 99 (+4) (23%) 22 (+1) (23%) Malignancy 101 (+11) (23%) 19 (+2) (20%) Liver disease b 66 (+2) (15%) 7 (7%) CVD 63 (+5) (15%) 12 (+2) (13%) All other non-aids causes c 102 (+7) (24%) 36 (+1) (38%) Data based on NDI match through 12/31/14 for original sites and through 9/30/16 for all sites via other reports a Includes 2 deaths among HIV seroconverters b Includes 1 death among HIV seroconverters; 54 HIV+ and 6 HIV- were HCV Ab+ at baseline c Includes 1 death among HIV seroconverters d Does not include 12 deaths (including 6 new) among HIV- with missing causes

23 Confirmed Incident Cancers through Visit 44 Total Cancers: HIV-positive 267 (+3); HIV-negative 49 Includes accrued follow-up of 47,150 person-years through 9/30/16 HIV-negative: 12,757 person-years (27%) HIV-positive: 34,394 person-years (73%) Newly identified cancers since v43 (n=3) Tongue (n=1), anus (n=1), cervix (n=1) Changes/deletions (n=0) Confirmation based on one or more of the following sources: Cancer registry match (CNCR form) Medical record abstraction (CORE form) WIHS biopsy (L15 form)

24 Confirmed Incident Cancers by HIV Status Cancer HIV+ HIV- Cancer HIV+ HIV- All Cancers 267 (84%) 49 (16%) Genital system 24 3 Oral cav./pharynx Cervix 6 0 Digestive system Uterus 8 3 Colon 9 3 Vulva 6 0 Rectum 7 0 Other genital Anus 10 0 Urinary system Liver 10 4 Brain/CNS 3 3 Pancreas 8 0 Endocrine Other digestive Hodgkins lymphoma 4 1 Respiratory system NHL 46 1 Larynx 7 1 Myeloma 4 0 Lung/bronchus 39 9 Leukemia 3 2 Soft tissues 3 0 Mesothelioma 1 0 Melanoma 4 0 KS 10 0 Breast Metastatic/other Categories defined per SEER SITERECODE algorithm ( Footnotes defined on next page

25 Confirmed Incident Cancers by HIV Status Footnotes 1 Oral cavity HIV+ throat (5), tongue (3), floor mouth (1), salivary gland (1) HIV- n/a 2 Other digestive HIV+ gallbladder (1), stomach (2), small intestine (1), cholangiocarcinoma (1), ill-defined GI site (1) HIV- gallbladder (1), duodenum (1), esophagus (2) 3 Other genital HIV+ vagina (3), ovary (1) HIV- n/a 4 Urinary system HIV+ bladder (1), kidney (3) HIV- n/a 5 Endocrine system HIV+ pituitary (1), thyroid (3) HIV- pituitary (1), thyroid (1) 6 Metastatic/other HIV+ metastatic/unk primary (8), polycythemia vera (1), histiocytic sarcoma (1) HIV- metastatic/unk primary (1), idiopathic thrombocythemia (1)

26 CVOUTCOME Summary File Wave 4 Wave Wave 3 21 Baseline scan only (Wave 1) 855 CV01 IMT 1 LESION 2 DIST/ELAS 3 PLAQUE 4 GREY SCALE 4 W W W Min & max diameter W1-W3; right bifurcation W4 2 Right external carotid artery measured at W4 only 3 Need BP & min/max diameter 4 Not measured for all scans W CV01 IMT LESION DIST/ELAS PLAQUE GREY SCALE ALERT, CVUSSYS, CVUSDIAS, HRTRATE IMT, MINCAD, MAXCAD, BIFIMT CCANW, CCAFW, BIFNW, BIFFW, ICANW, ICAFW, ECANW, ECAFW, ANYLESION1, NLESIONS1, ANYLESION2, NLESIONS2 DIST1, DIST2, ELAS1, ELAS2 MCPT, PLAQUE_STEP1, PLAQUE_STEP2, PLAQUE_TEXT, PLAQUE_SURF AVEGSM1, AVEGSM2

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28 Chronic Disease Indicators Current Cohort (v43 or v44) BMI Median (IQR) % BMI >30 [>40] Hypertension (SBP>140, DBP>90, meds) Diabetes (HbA1C>6.5%, FG>126, meds) Dyslipidemia (LDL>130, HDL<40) Chronic Kidney Disease (CKD-Epi egfr <60 [<30]) Baseline Hepatitis C Ab+ (Baseline HCV RNA+) HIV+ N= (25, 36) 50% [16%] HIV- N= (27, 37) 60% [18%] 50% 48% 20% 23% 30% 29% 12% [2%] 6% [1%] 20% (10%) 15% (7%) Baseline Chronic Hepatitis B 3% 1% Depressive Symptoms 30% 32%

29 HCV Summary through Visit 44 HCV Status at Last Follow-up Visit HCV- HCV Status at Baseline HCV+ (Ab+ and/or RNA+) HCV unknown Overall Uninfected 3508 (99%) 0 2 (10%) 3510 (71%) Cleared 11 (<1%) 399 (28%) (8%) Chronic 39 (1%) 861 (61%) 1 (5%) 901 (18%) Incomplete/Unknown (10%) 17 (85%) 161 (3%)

30 Substance Use Current Cohort (v43 or v44) Smoking: Current Former HIV+ N= % 28% HIV- N= % 28% Injection Drug Use: Non-Injection Drug Use: Recreational Rx Drug Use: Current Ever Current Ever 1% 18% 22% 73% 1% 17% 32% 82% Current 1% 3% Alcohol Use: >12 drinks/week 7-12 drinks/week 7% 3% 13% 7%

31 Reproductive Health & Behavior Current Cohort (v43 or v44) HIV+ N= 1672 HIV- N= 710 Hormonal contraceptive use (current) 5% 6% Pregnancy Any time during WIHS In past year Number male sex partners Median (IQR) Baseline Current Condom use No male partners At least one male partner, always At least one male partner, sometimes At least one male partner, never Self-reported STD* Any STD Multiple STDs 17% 1% 10 (5, 30) 1 (0, 1) 44% 32% 10% 13% 4% <1% 29% 3% 12 (6, 40) 1 (0, 1) 38% 14% 15% 34% 3% <1% * Gonorrhea, syphilis, chlamydia, pelvic inflammatory disease, genital herpes, genital warts, or trichomonas

32 Pregnancies in WIHS Retrospective Data # Pregnant women Number of pregnancies 554 HIV+ HIV- N= 1908 a N= 777 a 1024 Live births 471 (46%) 355 (43%) Miscarriages 216 (21%) 166 (19%) Abortions 279 (27%) 300 (35%) Other adverse outcomes b 55 (5%) 27 (3%) Other outcomes 3 (<1%) 4 (<1%) Age at reported pregnancy Median (IQR) 32 (28, 37) 31 (26, 35) CD4+ Cell Count Median (IQR) c 454 (292, 656) NA HIV RNA Median (IQR) c 820 (80, 12000) NA % on Therapy c,d 69% NA a Susceptible to pregnancy while on study (sexually active, <46 years, no hyst/tl/ooph). Among active cohort, 139 HIV SN and 211 HIV SP are eligible for pregnancy; b Stillbirth or Ectopic Pregnancy; c At reported pregnancy, among HIV+ women only; d Any therapy at reported pregnancy

33 Geocoding Consent Status of Active Participants in the WIHS Cohort at V44, by Site 100% % % 40% % 90 0% Bronx Brooklyn D.C. SF Chicago UNC Emory Miami UAB MS n=329 n=314 n=280 n=288 n=259 n=188 n=256 n=130 n=106 n=107 Consented Not consented or refused

34 WIHS Participants States of Residence < 5 < 5 < 5 < RI: < 5 6 NJ: < 5 < 5 MD: < 5 < 5 < 5 < < 5 < < 5 DE: < 5 DC: < 5 95 PR: < 5

35 Percent of Census Tract Selected Characteristics of Census Tracts where WIHS Participants Reside at V44, by Site BNX BKLYN DC SF CHI UNC ATL MIA UAB MISS Under Federal Poverty Level Uninsured [ ]

36 WIHS Repository Updates

37 Summary of WSAC Reviews 6,310 (7%) of 88,802 visits are restricted 183 specimen requests reviewed 80 all specimens approved 93 selected specimens approved 9 no specimens approved 8,082 total VIP specimens requested 7,214 specimens (89%) approved for release (As of 5/23/2017)

38 WIHS Central Repository DAIDS National Repository Precision BioServices Frederick, Maryland

39 Committed Specimens As of 5/23/2017 Total ever 3,121,328 ( 1%) Not Available 345,916 Shipped 340,475 ( 2,495) To be Shipped a 1 Unusable b 5,440 ( 50) Incoming Temp Storage 0 11% utilization Currently Available 2,775,412 a Less than four weeks since submitted for withdrawal b Discrepant, destroyed, broken, empty, lost, or missing

40 100% % of Expected Person-Visits with Committed Vials of Serum 90% 80% 70% V42 V43 V44 60% 95%

41 100% % of Expected Person-Visits with Committed Vials of Plasma 90% 80% 70% V42 V43 V44 60% 95%

42 100% % of Expected Person-Visits with Committed Vials of Cells 90% 80% 70% V42 V43 V44 60% 95%

43 100% % of Expected Person-Visits with Committed Vials of Cell Pellets 90% 80% 70% V42 V43 V44 60% 95%

44 100% % of Expected Person-Visits with Committed Vials of CVL 90% 80% 70% V42 V43 V44 60% 95%

45 Number of Vials Shipped Vials Shipped from Precision Bioservices, ,329 25,15925,355 26,189 22,654 25,067 17,13617,144 19,403 19,252 13,527 14,445 10,563 5,192 1, * * 2017 includes shipments through 5/23/2017 Mean number of vials shipped per year for is 20,315