Dossier 2019 Prepared by MWCCS Data Analysis and Coordination Center email mwccsjhuedu web wwwmwccsorg 1984 2019 1989 1994 2004 2009 2014 MACS 1 1999 MACS 2 MACS 3 MACS 6 ID: 1038766
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1. MACS/WIHS Combined Cohort Study (MWCCS)Dossier, 2019Prepared by:MWCCS Data Analysis and Coordination Centeremail: mwccs@jhu.edu web: www.mwccs.org
2. 1984201919891994200420092014MACS 11999MACS 2MACS 3MACS 6MACS 4MACS 7MACS 5WIHS VWIHS IVWIHS IIIWIHS IIWIHS I35 years25 years72nd Visit51st Visit1984-851987-902010+(Focus: early stage HIV)2001-3(Add subsites; Focus: minority)1995 admin censoring of some HIV-neg11994-952011-13 (Replenishment/ Closing of LA site)2001-2 2013-15(Southern Sites)1997WDMAC1 In April 1995, 2255 HIV-negative men were administratively censored from further follow-up, per an NIH decision.Enrollment WavesEnrollment WavesGrantCyclesGrantCyclesMulticenter AIDS Cohort Study (MACS, 1983-2019) Women’s Interagency HIV Study (WIHS, 1993-2019)Study Timeline
3. MACS/WIHS Combined Cohort Study SitesUS Map from AIDSVu with shading reflecting 2016 HIV Prevalence per 100KMiami, FLSan Francisco, CALos Angeles, CAChicago, ILBirmingham, AL/Jackson, MSAtlanta, GABaltimore, MDWashington, DCChapel Hill, NCBronx, NYBrooklyn, NYPittsburgh, PAColumbus, OHJohns Hopkins serves as the MWCCS Data Analysis and Coordination Center (DACC)57-Member Executive Committee>30 Scientific & Operational Working Groups
4. Types of Data CollectedDemographicsHIV medication and adherenceFrailty, agingNeuropsychologyAttitude and beliefsHealthcare utilizationQuality of life, depressionBehaviors (substance use and sexual behavior)Medical conditions and medication use4Lab results Blood Chemistries, Complete Blood Count, Hepatitis, T-Cell flow cytometry, HIV Viral Load, Lipid PanelPhysical ExaminationOutcome verification and adjudicationBiorepository of samplesRegistry matching: National Death Index, Cancer Registry, Renal Disease Registry
5. Committed* Specimens in Central RepositoryFormer MACS MenFormer WIHS WomenPlasma (CPT)NA829,523Plasma (Heparin)719,074NAPlasma (EDTA)198,945**12,453**Serum953,522562,441Cells345,823365,955Cell Pellets50,580478,472Urine (clean void)89,87696,903Urine (supernatant)NA95,833Cervical Vaginal Lavage (CVL)NA559,792Stimulated SalivaNA5,372Stool7,144NASemen58,782NA* Committed includes all specimens ever sent to Central Repository** Former MACS/WIHS began repositing EDTA plasma at visit 45/48
6. MWCCS Visit Timeline: 2020-2026
7. Characteristics of Active* ParticipantsN=4,106* MACS and WIHS Participants Who Contributed Data in the Year Prior to MWCCS
8. Characteristics of MACS and WIHS(4,106 Active Participants)
9. Age Distribution of Active* Participants* Active = All participants who contributed data at Visit 48 or 49 for WIHS; 69 or 70 for MACSPercent of Cohort WIHS MACS HIV- PLWH HIV- PLWH Median Age 50 52 63 58 (IQR) (43, 57) (46, 58) (57, 70) (50, 64)Age > 60 18% 20% 64% 42%
10. DemographicsFormer MACS MenFormer WIHS WomenPLWHN=1,024HIV-N=915PLWHN=1,516HIV-N=651Median Age (IQR)58 (50, 64)63 (57, 70)52 (46, 58)50 (43, 57)Race/Ethnicity (%): Black/African American27%17%73%72% Hispanic/Latino, any race16%7%15%14% White53%73%7%11% Multiple Races/Other4%3%5%3%Median (mean) Follow-up Time, years16.7 (21.5)34.0 (27.9)16.3 (13.3)16.5 (13.7)
11. Chronic Disease IndicatorsFormer MACS MenFormer WIHS WomenPLWHN=1,024HIV-N=915PLWHN=1,516HIV-N=651Smoking (%) Current Former22%47%14%53%34%32%43%30%BMI Median (IQR) % BMI >30 [>40]26 (24, 30)23% [2%]27 (24, 30)26% [3%]31 (26, 37)54% [18%]32 (27, 38)58% [18%]Hypertension (SBP>140, DBP>90, meds)50%55%53%53%Diabetes (HbA1C>6.5%, FG>126, meds)16%13%25%25%Dyslipidemia (LDL>130, HDL<40)34%28%36%32%Chronic Kidney DiseaseCKD-Epi eGFR <60 [<30]14% [ 1%]8% [0.1%]15% [2%]7% [2%]% with Confirmed Cancers (%ADE)11% (4%)8%6% (1%)4%ECHO Completed (%)64%60%72%71%PFT Completed (%)64%57%73%69%
12. Antiretroviral Medication Exposure*Former MACS MenFormer WIHS WomenPLWHN=1024PLWHN=1,516% currently on any Therapy94%94%% with previous exposure to d4T, ddI, ddC48%29%% with previous exposure to Monotherapy29%21%% Ever with Low CD4: <500 cells/mm388%90% <200 cells/mm332%44%* At most recent visit
13. Antiretroviral Therapy Use Among MACS and WIHS PLWH (active participants only)Calendar Time% Receiving TherapyJan 97Jan 99Jan 01Jan 03Jan 05Jan 07Jan 09Jan 11Jan 13Jan 95Jan 15Jan 17Mono/Dual TherapyNNRTI-based/3+ NRTI RegimensPI-based RegimensIntegrase Inhibitor-based RegimensJan 19
14. Viral Load Among PLWH (active participants only)Year10,000 < VL10,000 < VLVL > 10,000 VL > 10,000 VL > 10,000 VL < 10,000VL < 1,000 VL < 80 VL < 20Jan 97Jan 99Jan 01Jan 03Jan 05Jan 07Jan 09Jan 11Jan 13Jan 95Jan 15Jan 17Jan 19TaqMan v2.0 HIV-1, sensitive to 20 copies HIV RNA/mL, implemented in 2009
15. Year10,000 < VL10,000 < VLJan 97Jan 99Jan 01Jan 03Jan 05Jan 07Jan 09Jan 11Jan 13Jan 95VL > 10,000 VL > 10,000Jan 15 VL > 10,000CD4 Cell Counts Among PLWH (active participants only)Jan 17Jan 19CD4 > 500CD4 < 500CD4 < 350CD4 < 200
16. Select Outcomes
17. Confirmed Incident Cancers in MACS and WIHS through 3/31/2019Sources of cancer confirmation in both cohortsMedical record abstraction, cancer registry match, autopsy, biopsy, death certificate matchExcluded cancer recordsCancers documented solely by self-report/next of kinBenign tumorsMost in situ tumors (except breast and melanoma)Basal cell and squamous cell skin cancers (not recorded in cancer registries)Prevalent cancers diagnosed before/at/shortly following enrollmentCancer ClassificationData from completed forms were reviewed to determine (if possible) the topology and morphology for each diagnosed cancer which was then classified according to Surveillance, Epidemiology, and End Results (SEER) Program “site-recode” definition for ICD‐O‐3/WHO 2008. (https://seer.cancer.gov/siterecode/icdo3_dwhoheme/index.html)
18. CancerSEER Code(s)Former MACSFormer WIHSPLWHHIV-PLWHHIV-All1041210 318 62 Oral Cavity20020-2009011 10 110Colon21041-210498894 Rectum21051-210528970Anus 2106036 514 0Liver2107113513 5 Pancreas211005 69 1 Other Digestive Systems21010-21030,21072,21080-21110,211306610 4Lung and Bronchus 2203025 15 52 16 Other Respiratory22010-2202025 71Bones/ Joints230001100Soft Tissues24000034 0Melanoma2501020 25 40Other non-epithelial skin ca250201100Breast 260000048 16Confirmed Incident Cancers by Cohort and HIV Status(Continued on next slide)
19. CancerFormer MACSFormer WIHSSEER Code(s)PLWHHIV-PLWHHIV-Cervix27010--9 0Uterus27020-27030--10 3Ovary27040--2 0Vagina27050--30Vulva27060--60Prostate 2801043 56 --Testis2802082--Penis2803010--Bladder/Ureter29010,29030510 10Kidney and renal pelvis290206 341 Brain/CNS31010, 31040224 3Thyroid/Pituitary32010, 320206 342Hodgkin’s Disease33011-330121445 1NHL 33041-33042231 1452 1Multiple Myeloma340006450Leukemia35010-35043444 2Mesothelioma360100010Kaposi’s Sarcoma 36020565 2100Miscellaneous/Unknown 37000147 10 2Confirmed Incident Cancers (continued)
20. Hepatitis Status at Baseline and Last TestFormer MACS MenFormer WIHS WomenPLWHHIV-PLWHHIV-Baseline:N=3,270N=4,088N=3,677N=1,305 Anti-HCV+11%5%30%19% HCV RNA+8%3%24%14% HBsAg+8%4%3%<1%Last Test Result (may be baseline result):N=3,873N=3,485N=3,702N=1,280 Anti-HCV+13%6%32%20% HCV RNA+9%4%20%12% HbsAg+7%3%No follow-upNo follow-up
21. NHLBI Substudy Timeline 2016-2019NHLBI SupplementVisit 65/44 (Apr 1, 2016-Sept 30, 2016)Visit 66/45(Oct 1, 2016-Mar 31, 2017)Visit 67/46(Apr 1, 2017-Sept 30, 2017)Visit 68/47(Oct 1, 2017-Mar 31, 2018)Visit 69/48(Apr 1, 2018-Sept 30, 2018)Visit 70/49(Oct 1, 2018-Mar 31, 2019)Visit 71/50(April 1, 2019-Sept 30, 2019)Data Cleaned and Available as of 10/1/19Resting and Ambulatory (ZIO Patch) ECGPlanningMACS Data Collection WIHS Data Collection (resting ECG only)MACS & WIHSPulmonary Function Testing PlanningMACS Data CollectionWIHS Data Collection through 12/19MACS(WIHS ready 3/20)ECHO PlanningMACS Data CollectionMACS (WIHS ready 3/20) WIHS Data Collection through 12/19Sleep Study PlanningMACS Data CollectionIn progress (MACS ready 1/20)
22. Enrollment In NHLBI SubstudiesMACSWIHSTotalECG Resting ECG Ambulatory (ZIO Patch) ECG1633 (82%)1281 (64%)2011 (90%)NA36441281Pulmonary Function Testing Pre-bronchodilation Post-bronchodilation Completed DLCO1214 (60%)1178 (58%) 1134 (56%)1536 (70%)1432 (66%) 632 (74%)*275026101766ECHO1195 (60%)1476 (77%)2671Sleep Study – Nox data851 (44%)NA851* Denominator limited to WIHS sites offering DLCOData collected in these substudies in large number of participants, now available in >2000 participants for several measures!