Conflict of interests

Transcription

1 Sociodemographic clinical characteristics, quality of life, sexual sphere, mood stage and neurocognitive function in HIV+ young and mature women in Spain. EVhA 1 and EVhA 3 studies. The EVhA Stages Project CELIA MIRALLES 1, M JESUS PEREZ ELIAS 2, M JOSE GALINDO 3, PIEDAD ARAZO 4, M JOSE MELLADO 5, ROSA POLO 6, ANGEL BURGOS 7, CRISTINA DE ALVARO 7, ESTHER CABRERO 7, EVHA 1 AND EVHA 3 COLLABORATIVE GROUPS 1. Infectious Diseases Dpmt. Hospital Xeral Cíes Vigo, Spain; 2. Infectious Diseases Dpmt. Hospital Ramón y Cajal, Madrid. Spain; 3. Infectious Diseases Dpmt. Hospital Universitario Clínico de Valencia. Spain; 4. Infectious Diseases Dpmt. Hospital Universitario Miguel Servet, Zaragoza. Spain; 5. Pediatric Infectology Dpmt. Hospital Carlos III, Madrid. Spain; 6. National AIDS Plan, Madrid. Spain; 7. Medical and Quality Assurance Dpmt. AbbVie Farmacéutica, S.L.U. Madrid. Spain 1

2 Conflict of interests The design, study conduct, and financial support of these clinical studies (epidemiological on women HIV+ population) EVhA 1 and EVhA 3 was provided by Abbvie (former Abbott). Abbvie participated in the interpretation of data, review, and approval of the 3 abstracts related to each study and the comparison between both (EVhA1 and EVhA3 belonging to the EVhA Stages Project). Dr. Celia Miralles reports receiving consulting fees from Bristol Myers Squibb, Gilead Sciences, Janssen, Abbott Laboratories and Merck, payment for development of educational materials from Bristol Myers Squibb, compensation for advisory board membership from Gilead Sciences, Janssen lecture fees from Merck, Bristol Myers Squibb, Gilead Sciences, HIV, and compensation for travel, accommodations, or meeting expenses from, Bristol Myers Squibb and Gilead Sciences. No other potential conflict of interest relevant to this article was reported. Dr M Jesús Pérez Elías has received honoraria for lectures or for participation in advisory boards from Abbott, Bristol Myers Squibb, Boehringer Ingelheim, Gilead Sciences, ViiV and Janssen Cilag; and unrestricted grants from Abbott, ViiV, Gilead and Janssen Cilag. 2

3 Conflict of interests 2 Mª José Galindo Puerto has undergone activities related to advisory for the following laboratories, Abbott Laboratories, Boehringer Ingelheim, GlaxoSmith Kline, Gilead Sciences, Janssen, Merck, Pfizer and ViiV Healthcare; has received fellowships for clinical research from Gilead Sciences, GlaxoSmith Kline, Janssen; has got economical compensation as speaker for Janssen, Bristol Myers Squibb, Merck, Gilead Sciences, Pfizer and ViiV Healthcare; and has received payment to develop educational presentations for Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmith Kline, Gilead, ViiV, Abbott laboratories, Janssen and Merck. Dr. Piedad Arazo Garcés declares to have participated as advisor and in scientific activities sponsored by Glaxo Smith Kline, Bristol Myers Squibb, Abbott Laboratories, Jansen Cilag, Merck SharpDohme, Gilead Sciences, Roche Pharma and Boehringer Ingelheim Pharmaceuticals. Dr. María José Mellado Peña has received honoraria, for participation in advisory boards and as clinical trials investigator from Bristol and Abbott Companies. Dr. Rosa Polo has received honoraria for participating in the development of teaching materials from Gilead and Abbott. Authors Cristina de Álvaro, Esther Cabrero and Ángel Burgos are Abbvie employees and may hold stock or options. 3

4 Background Globally, half of adults living with HIV are women [1]. Figures are lower in Spain where they make up to 25% of the HIV/AIDS population on antiretroviral treatment ART (about 25,000 patients) [2]. Women are different than men and face unique challenges regarding HIV infection [3]. Over the last years there has been an increasing interest in the HIV+ women topic. Although there is still a lack of information about how women deal with the virus in real life, They are under represented in clinical trials Most of which only focus on the efficacy and the safety of ART [4 6]. Not forgetting that only few studies are performed having women as the unique research population [7, 8]. 1. UNAIDS report on the Global AIDS Epidemic (2010), 2.HIV women report in Spain, AIDS Nat Plan, 2009; 3. Squires KE. Gend Med 2007;4:294; 4. DaSilva B et al.#tupe0069 XVII AIDS Mexico 2008; 5. Andrade Villanueva J et al. Therap Pharm & Clin Toxicol 2008; 12(3):367; 6. Absalon J et al M, et al. # TUPE0062 XVII AIDS Mexico 2008 XVII AIDS Mexico 2008; 7. Bacon MC at al. Clin Diagn Lab Immunol September; 12(9): 1013; 8. Squires, K et al 5th IAS 2009 #MOPEB042 4

5 Background 2 Highly active ART has changed the life perspective of women living with HIV. With this shift in the HIV epidemic the focus of health care has evolved towards improving the Quality of Life (QoL). HYPOTHESIS of the EVhA Stages Project There might nevertheless be found differences on QoL between women with HIV infection and those with similar age and education/employment level but without HIV infection. Additionally, aging with HIV could increase the risk of comorbidities and may cause differences from HIV women in several life fields. These characteristics might affect the QoL of HIV+ women at different age stages. 5

6 Design HIV+ young women vs HIVyoung women in Spain. EVhA1 study Cross sectional Single visit studies HIV+ mature women vs HIVmature women in Spain. EVhA3 study

7 Design HIV+ young women vs HIVyoung women in Spain. EVhA1 study Main inclusion criteria HIV+: Woman,16 to 22 yrs old HIV+ infection On stable ART >3 months Cross sectional Single visit studies HIV+ mature women vs HIVmature women in Spain. EVhA3 study Main inclusion criteria HIV+: Woman, 35 to 60 yrs old HIV+ infection On stable ART >3 months 7

8 Design HIV+ young women vs HIVyoung women in Spain. EVhA1 study Main inclusion criteria HIV+: Woman,16 to 22 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,16 to 22 yrs old No HIV infection/risk behavior Similar education level and student/employment situation Cross sectional Single visit studies HIV+ mature women vs HIVmature women in Spain. EVhA3 study Main inclusion criteria HIV+: Woman, 35 to 60 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,35 to 60 yrs old No HIV infection/risk behavior Similar education level and student/employment situation * Protocol only suggested possible source of controls; relatives, friends, hospital employees, 8

9 Design and objectives HIV+ young women vs HIVyoung women in Spain. EVhA1 study Main inclusion criteria HIV+: Woman,16 to 22 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,16 to 22 yrs old No HIV infection/risk behavior Similar education level and student/employment situation Cross sectional Single visit studies Sign and date Informed Consent Socio demographics Clinical data for the HIV+ women Sexual sphere HIV+ mature women vs HIVmature women in Spain. EVhA3 study Main inclusion criteria HIV+: Woman, 35 to 60 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,35 to 60 yrs old No HIV infection/risk behavior Similar education level and student/employment situation * Protocol only suggested possible source of controls; relatives, friends, hospital employees, 9

10 Design and objectives HIV+ young women vs HIVyoung women in Spain. EVhA1 study Main inclusion criteria HIV+: Woman,16 to 22 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,16 to 22 yrs old No HIV infection/risk behavior Similar education level and student/employment situation Cross sectional Single visit studies Sign and date Informed Consent Socio demographics Clinical data for the HIV+ women Sexual sphere HIV+ mature women vs HIVmature women in Spain. EVhA3 study Main inclusion criteria HIV+: Woman, 35 to 60 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,35 to 60 yrs old No HIV infection/risk behavior Similar education level and student/employment situation * Protocol only suggested possible source of controls; relatives, friends, hospital employees, 1. QoL ** 2. Mood stages ** 3. Neurocognitive function** ** Paired women HIV+/HIV 10

11 Design and objectives HIV+ young women vs HIVyoung women in Spain. EVhA1 study Main inclusion criteria HIV+: Woman,16 to 22 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,16 to 22 yrs old No HIV infection/risk behavior Similar education level and student/employment situation Cross sectional Single visit studies Sign and date Informed Consent Socio demographics Clinical data for the HIV+ women Sexual sphere HIV+ mature women vs HIVmature women in Spain. EVhA3 study Main inclusion criteria HIV+: Woman, 35 to 60 yrs old HIV+ infection On stable ART >3 months Main inclusion criteria HIV *: Woman,35 to 60 yrs old No HIV infection/risk behavior Similar education level and student/employment situation * Protocol only suggested possible source of controls; relatives, friends, hospital employees, 1. QoL ** 2. Mood stages ** 3. Neurocognitive function** ** Paired women HIV+/HIV HIV+ young women vs HIV+ mature women in Spain. EVhA1 vs EVhA3 sub analysis 11

12 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. 12

13 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. MOS HIV [1] and MOS(SF 36) [2] 1. Wu AW et al. Qual Life Res. 1997; 2. Steward AL et al. Med Care 1988; 13

14 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. To describe and compare of both HIV+ vs. HIV young women and mature women regarding, Socio demographic characteristics and clinical history MOS HIV [1] and MOS(SF 36) [2] Structured interview and medical history records 1. Wu AW et al. Qual Life Res. 1997; 2. Steward AL et al. Med Care 1988;

15 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. To describe and compare of both HIV+ vs. HIV young women and mature women regarding, Socio demographic characteristics and clinical history 2 Sexual sphere MOS HIV [1] and MOS(SF 36) [2] Structured interview and medical history records Ad hoc designed interview [3] 1. Wu AW et al. Qual Life Res. 1997; 2. Steward AL et al. Med Care 1988; 3. Polo R et al. I Congreso GESIDA, Madrid (Spain) Oct 2009 Oral poster#po

16 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. To describe and compare of both HIV+ vs. HIV young women and mature women regarding, Socio demographic characteristics and clinical history 2 Sexual sphere Mood: anxiety and depression level (positive screening) MOS HIV [1] and MOS(SF 36) [2] Structured interview and medical history records Ad hoc designed interview [3] HADS A and HADS D [4] 1. Wu AW et al. Qual Life Res. 1997; 2. Steward AL et al. Med Care 1988; 3. Polo R et al. I Congreso GESIDA, Madrid (Spain) Oct 2009 Oral poster#po 27; 4. Savard J et al. AIDS and Behavior 1999; 16

17 Objectives and tools To compare the impact of HIV in the quality of life (QoL) of HIV+ vs. HIV in young and in mature women. MOS HIV [1] and MOS(SF 36) [2] To describe and compare of both HIV+ vs. HIV young women and mature women regarding, Socio demographic characteristics and clinical history 2 Sexual sphere Mood: anxiety and depression level (positive screening) Neurocognitive function: neurocognitive level and positive screening for neurocognitive damage Structured interview and medical history records Ad hoc designed interview [3] HADS A and HADS D [4] Brief NeuroCognitive Screen (BNCS) [5, 6] : Trailmaking A and B Wais III 1. Wu AW et al. Qual Life Res. 1997; 2. Steward AL et al. Med Care 1988; 3. Polo R et al. I Congreso GESIDA, Madrid (Spain) Oct 2009 Oral poster#po 27; 4. Savard J et al. AIDS and Behavior 1999; 5. Robertson K. AIDS 2007; 6. Wechsler D. The Psychological Corporation

18 Sociodemographicclinical characteristics, quality of life, sexual sphere, mood stage and neurocognitive function in HIV+ young women in Spain. EVhA1 Abstract O 10c Sociodemographic clinical characteristics, quality of life, sexual sphere, mood stage and neurocognitive function in HIV+ mature women in Spain. EVhA3 Abstract O 10a Quality of life, mood stage and neurocognitive function in HIV+ young vs. HIV+ mature women in Spain. EVhA1 and EVhA3 Studies (EVhA Stages Project). Abstract O 10b 18

19 HIV+ VS HIV YOUNG WOMEN

20 Young women: disposition EVhA 1 Young HIV+ Young HIV Sites # and distribution Total enrollment Evaluable (1) Pontevedra Bilbao Zaragoza Madrid 6 Barcelona 3 Valencia Well paired HIV+/HIV (2) 46 Málaga 14 sites (1) A participate could be excluded for evaluation for more than one reason. EVhA1: 3 HIV+ women did not meet age requirements. (2) HIV+/HIV pairs were discharged when the match was not well done even for at least one criteria: age, education level, current student/employment status 20

21 Young women: social demographic characteristics All (N=113) HIV+ (n=54) HIV (n=59) P value Age years [mean+sd] (1) Race n ( %) (1) Caucasian 90 (79.6) 43 (79.6) 47 (79.7) Black 14 (12.4) 9 (16.7) 5 (8.5) Hispanic 8 (7.1) 1 (1.9) 7 (11.9) Other 1 (0.9) 1 (1.9) 0 (0.0) Highest education level n (% ) (2) Primary 14 (12.4) 9 (16.7) 5 (8.5) Secondary 81 (71.7) 43 (79.6) 38 (64.4) University 18 (15.9) 2 (3.7) 16 (27.1) Employment/Student current status n ( %) (1) No student/no job 19 (16.8) 11 (20.4) 8 (13.6) Student 80 (70.8) 35 (64.8) 45 (76.3) Employed 9 (8.0) 7 (13.0) 3 (3.4) Student and employed 5 (4.4) 1 (1.9) 4 (6.8) (1) No significant statistical difference is maintained and p value increased among paired HIV+ and HIV : age, p=0.716; race, p= 0.320; employment/student status, p=0.501 (2) Reached no significant statistical difference among paired HIV+ and HIV, education level p=

22 Young women: social characteristics LIVING WHERE/WITH AND PARTNERSHIP STATUS* 5,1% 3,4% 5,1% 3,4% Lives in a town 23,7% Lives in a city** p=0.462 HIV- 59,3% Lives w s/body Stable partner Single p= HIV+ HIV (percentage) p= ,9% 11,1% 27,8% HIV+ 3,7% 35,2% Alone Parents Father/mother Legal tutor Partner Friends * P values for categories distribution in brackets comparison between HIV+ and HIV young women 20,4% ** It includes big cities, region capitals and medium cities 22

23 Young women: sexual sphere SEXUAL HISTORY AND HABITS Stable sexual partner Currently sexual active (1) S/body to talk to about (2) Contraceptives use Any sexual experience HIV+ HIV (percentage) (1) More HIV+ young women declare to have dimished the libido (5.7%) compared to the HIV young women (2.6%), although not statistically significant (p=0.475). (2) 91.4% HIV+ young women have somebody to talk about concerns regarding sex (mainly, 43.8% doctor and 59.4% parents/legal caregivers). Also a 97.4 % of HIV young women talk about this, but mainly with parents/legal caregivers (40.5%) and doctors (13.5%). 23

24 Young women: sexual sphere 2 Menstruation All (N=113) HIV+ (n=54) HIV (n=59) P value Age at 1st menstruation yrs [mean+sd] Time since last menstruation days [mean+sd] Menstruation duration days [mean+sd] Pregnancy history All (N=113) HIV+ (n=54) HIV (n=59) P value At any time n (%) (1) 11 (15.1) 9 (25.7) 2 (5.3) Women with children n Abortions n Women without children (n=28/34) Have thought to have children n (%) 55 (87.3) 25 (89.3) 30 (85.7) Have talked with doctor? n (%) 20 (31.7) 17 (60.7) 3 (8.6) <0.001 (1) When paired HIV+/HIV women were analyzed, only 6 HIV+ young women declared to have been pregnant at any time vs 2 HIV, and the difference was no longer significant (p=0.150 ) 24

25 Young HIV women: quality of life HIV MOS (SF 36): MEAN SCORE PER DIMENSION 8 (*) Global health 2,Corporal pain 3.Physical function 4.Physical rol 5.Social function 6.Vitality 7.Mental health 8.Emotional rol * Mainly all mean scores were over 70 for the 8 QoL dimensions for HIV young women (mean score for vitality is 69). We mark this in the Figure as an arbitrary cut off for comparison 25

26 Young HIV women: quality of life HIV 8 MOS (SF 36): MEAN SCORE PER DIMENSION (*) Dimensions Pct. 75 Min. Max. 8. Emotional Rol Mental Health Vitality Social Function Physical Rol Physical Function Corporal Pain Overall Health Components Pct. 75 Min. Max. Physical Mental Global health 2,Corporal pain 3.Physical function 4.Physical rol 5.Social function 6.Vitality 7.Mental health 8.Emotional rol * Mainly all mean scores were over 70 for the 8 QoL dimensions for HIV young women (mean score for vitality is 69). We mark this in the Figure as an arbitrary cut off for comparison 26

27 Young HIV+ women: quality of life HIV+ MOS HIV; MEAN SCORE PER DIMENSION (*) Dimensions Pct. 75 Min. Max. 11. Transient Health Quality of Life Cognitive Function Health Problems Mental Health Energy Social Function Rol Function Physical Function Pain Overall Health Components Pct. 75 Min. Max. Physical Overall health 2. Pain 3. Physical function 4. Rol function 5. Social function 6. Energy 7. Mental health 8. Health problems 9. Cognitive function 10. Quality of life 11. Transient health * Mainly all mean scores are nearly over 70 for the 8 QoL dimensions for HIV young women (mean score for vitality is 69). We mark this in the Figure as an arbitrary cut off for comparison Mental

28 Young women: quality of life (comparison) HIV+ MOS HIV; MEAN SCORE PER DIMENSION p=0.160 p=0.634 HIVp= (*) HIV+ (n=46) HIV (n=46) p value Comparable dimensions 2. Pain Energy (n=44/44) Mental Health (n=44/44) Standardized components Physical (n=42/42) Mental (n=42/42) MOS (SF 36): MEAN SCORE PER DIMENSION * Mainly all mean scores are over 70 for the 8 QoL dimensions for HIV young women (mean score for vitality is 69). We mark this as an arbitrary cut off for comparison (*) 28

29 Young women: mood stages and neurocognitive damagescreening HIV+ (n=46) HIV (n=46) P value Anxiety HADS A score [mean+sd] Positive screening (HADS A score>8) n(%) 2 (4.3) 2 (4.7) Depression HADS D score [mean+sd] Positive screening (HADS D score>8) n(%) 12 (26.7) 6 (14.3) Neurocognitive function (BNCS) Trailmaking A score[mean+sd] Trailmaking B score[mean+sd] Wais III score [mean+sd] Positive screening for neurocognitive damagen(%) 4 (8.7) 3 (6.5)

30 Young women: conclusions This cross sectional study showed in 16 to 22 years old HIV+ and HIVwomen: Similar socio demographic and sexual sphere characteristics with few differences some lost in well paired HIV+/HIV young women. Similar QoL scores profiles with only a trend to reduced QoL in HIV+ young women and statistically significant a lower score for Pain dimension compared with HIV young women. No statistical differences for anxiety, depression or neurocognitive function. 30

31 HIV+ VS HIV MATURE WOMEN

32 Mature women: disposition EVhA 3 Mature HIV+ Mature HIV Sites # and distribution Total enrollment Evaluable (1) Well paired HIV+/HIV (2) A Coruña Santander Pontevedra 2 León Burgos Sevilla Cádiz Madrid 7 Granada Málaga Barcelona 5 Valencia Palma de Mallorca 3 Alicante Murcia Almería 29 sites (1) A participate could be excluded for evaluation for more than one reason. EVhA3: 3 HIV+ and 2 HIV did not meet age requirements; 6 HIV+ NO stable ART for at least 3 months. (2) HIV+/HIV pairs were discharged when the match was not well done even for at least one criteria: age, education level, current student/employment status 32

33 Mature women: social demographic characteristics All (N=221) HIV+ (n=108) HIV (n=113) P value (3) Age years[mean+sd] Race n(%) Caucasian 190 (86.0) 97 (89.8) 93 (82.3) Black 4 (1.8) 2 (1.9) 2 (1.8) Hispanic 26 (11.8) 8 (7.4) 18 (15.9) Other 1 (0.5) 1 (0.9) 0 (0.0) Highest education level n(% ) No studies 3 (1.4) 2 (1.9) 1 (0.9) Primary 53 (24.0) 29 (26.9) 24 (21.2) Secondary 124 (56.1) 57 (52.8) 67 (59.3) University (1) 41 (18.6) 20 (18.5) 21 (18.5) Employment/Student current status n(%) (2) No student/no job 54 (24.4) 29 (26.9) 25 (22.1) Student 5 (2.3) 3 (2.8) 2 (1.8) Employed 125 (56.6) 60 (55.6) 65 (57.5) Student and employed 36 (16.3) 15 (13.9) 21 (18.6) (1) University includes also PhD/other degrees: 1 HIV+ and 5 HIV mature women. (2) One HIV+ woman did not answer to this question (3) The p values for the 103 paired mature women were: age (0.554), race (0.203), education (0.528) and employment/student status (0.696) 33

34 Mature women: social characteristics LIVING WHERE/WITH AND PARTNERSHIP STATUS* 13,3% 4,4% Lives in a town 46,9% Lives in a city** p=0.200 HIV- 23,9% Lives w s/body p= ,8% 9,7% Alone Widowed 27,8% 21,3% Parents Divorced Married Legal partner p=0.002 HIV+ 1,9% 16,7% 25,0% 7,4% Partner Children Friends Family Single (percentage) HIV+ HIV * P values for categories distribution in brackets comparison between HIV+ and HIV mature women ** It includes big cities, region capitals and medium cities 72.2% of HIV+ mature women have children and 77.0% of HIV mature women (p=0.255), but only 48.1% HIV+ live with their children, while 62.8% of HIV mature women do (p=0.026) 34

35 Mature women: sexual sphere SEXUAL HISTORY Diminished libido (1) p=0.010 Contraceptives use p=0.001 Stable sexual partner p=0.003 Current sexually active p< HIV+ HIV (percentage) (1) The HIV+ mature women who declare to have the libido diminished reported a median (range) time elapsed since libido reduction signals of 24 (3, 240) months superior to the time elapsed for HIV mature women of 15 (1, 72) months, p=

36 Mature women: sexual sphere 2 Menstruation All (N=218) HIV+ (n=106) HIV (n=112) P value Age at 1st menstruation yrs[mean+sd] Time since last menstruation days [median(range)] 50 (0, 9,840) 51 (0, 9,840) 45 (0, 6,184) Menstruation duration days [mean+sd]

37 Mature women: sexual sphere 2 Menstruation All (N=218) HIV+ (n=106) HIV (n=112) P value Age at 1st menstruation yrs[mean+sd] Time since last menstruation days [median(range)] 50 (0, 9,840) 51 (0, 9,840) 45 (0, 6,184) Menstruation duration days [mean+sd] Pregnancy history Women with children n (%) 200 (92) 94 (89) 106 (95) Abortions n (%) 172 (79) 87 (82) 85 (76) Women without children (n=20/12) Have thought to have children n(%) 18 (56) 11 (52) 9 (56)

38 Mature women: sexual sphere 2 Menstruation All (N=218) HIV+ (n=106) HIV (n=112) P value Age at 1st menstruation yrs[mean+sd] Time since last menstruation days [median(range)] 50 (0, 9,840) 51 (0, 9,840) 45 (0, 6,184) Menstruation duration days [mean+sd] Pregnancy history Women with children n (%) 200 (92) 94 (89) 106 (95) Abortions n (%) 172 (79) 87 (82) 85 (76) Women without children (n=20/12) Have thought to have children n(%) 18 (56) 11 (52) 9 (56) Menopause Diagnosis, n (%) 75 (33.7) 40 (37) 35 (31) Time since diagnosis months [mean+sd)]

39 Mature HIV women: quality of life HIV MOS (SF 36); MEAN SCORE PER dimension (*) Dimensions Pct. 75 Min. Max. 8. Emotional Rol Mental Health Vitality Social Function Physical Rol Physical Function Corporal Pain Overall Health Components Pct. 75 Min. Max. Physical Mental Overall health 2. Corporal pain 3. Physical function 4. Physical role 5. Social function 6. Vitality 7. M ental health 8. Emotional role * Mainly all mean scores are over 70 for the 8 QoL dimensions for HIV mature women (mean score for vitality is 68). We mark this as an arbitrary cut off for comparison 39

40 Mature HIV+ women: quality of life HIV+ MOS HIV; MEAN SCORE PER DIMENSION (*) Dimensions Pct. 75 Min. Max. 11. Transient Health Quality of Life Cognitive Function Health Problems Mental Health Energy Social Function Rol Function Physical Function Pain Overall Health Components Pct. 75 Min. Max Physical Overall health 2. Pain 3. Physical function 4. Rol function Mental Social function 6. Energy 7. Mental health 8. Health problems 9. Cognitive function 10. Quality of life 11. Transient health * Mainly all mean scores are over 70 for the 8 QoL dimensions for HIV mature women (mean score for vitality is 68). We mark this as an arbitrary cut off for comparison 40

41 Mature women: quality of life (comparison) HIV+ MOS HIV; MEAN SCORE PER DIMENSION 11 (*) 10 HIV MOS (SF 36); MEAN SCORE PER DIMENSION 9 (*) 8 8 p= p= p= * Mainly all mean scores are over 70 for the 8 QoL dimensions for HIV mature women (mean score for vitality is 68). We mark this as an arbitrary cut off for comparison HIV+ (n=103) HIV (n=103) p value Comparable dimensions 2. Pain Energy Mental Health (n=100/102) Standardized components Physical (n=92/99) Mental (n=92/99)

42 Mature women: mood stages and neurocognitive damagescreening HIV+ (n=103) HIV (n=103) P value Anxiety HADS A score [mean+sd] Positive screening (HADS A score>8) n (%) 37 (35.9) 18 (17.5) Depression HADS D score [mean+sd] <0.001 Positive screening (HADS D score>8) n(%) 18 (17.5) 3 (3.0) <0.001 Neurocognitive function (BNCS) Trailmaking A score [mean+sd] Trailmaking B score [mean+sd] Wais III score [mean+sd] Positive screening for neurocognitive damage n (%) 52 (49.5) 31 (30.1)

43 Mature women: conclusions This cross sectional study showed in 35 to 60 years old HIV+ and HIVwomen differences in most fields analyzed: Most social and sexual sphere characteristics differed significantly A trend for lower QoL scores in HIV+ than HIV mature women with statistical significant differences in Pain and Mental health items Statistically increased positive screening for anxiety, depression and neurocognitive function impairment in HIV+ mature women compared with HIV. 43

44 HIV+ YOUNG VS HIV+ MATURE WOMEN

45 Young and mature HIV+ women: clinical and disease characteristics Disease Young (N=54) Mature (N=108) P value HIV Risk Factor n (%) Vertical transmission 51 (94.4) 0 (0.0) <0.001 Heterosexual 2 (3.7) 75 (69.4) IVDU 0 (0.0) 24 (22.2) More than one 0 (0.0) 5 (4.6) Other/ Not known 1 (1.9) 4 (3.7) HIV/AIDS Duration of HIV infection yrs [mean+sd] AIDS diagnosis n (%) 12 (22.2) 32 (29.6) Time since AIDS yrs [mean+sd]

46 Young and mature HIV+ women: disease characteristics 2 Immunovirological data/other diseases Young (N=54) Mature (N=108) P value Viral load (VL) Current VL <50cop/mL n (%) 40 (75.0) 89 (82.4) Time since undetectability yrs [mean+sd] CD4 count cell/µl [mean+sd] Current CD CD4 Nadir <0.001 Other chronic diseases n(%) HCV+ 4 (7.4) 43 (39.8) <0.001 HBV+ 1 (1.9) 32 (29.6) <

47 Young and mature HIV+ women: ART characteristics Antiretroviral therapy (ART) Young (N=54) Mature (N=108) P value Previous ART Time since first ART yrs [median (range)] 13 (2, 17) 12 (0, 25) # previous ARTs [median (range)] 2 (0, 10) 3 (0, 17) Current ART Time since current ART yrs [median (range)] 2 (0, 8) 2 (0, 10) Reasons to start current ART n(%) First ART 8 (14.8) 8 (7.4) Intolerance 4 (7.4) 20 (18.5) Simplification 9 (16.7) 44 (40.7) Virological failure 19 (35.2) 12 (11.1) Intensification 3 (5.6) 0 (0.0) Simplification or intolerance + other 2 (3.8) 2 (1.8) Other 9 (16.7) 21 (19.4) 47

48 Young and mature HIV+ women: quality of life MOS HIV; MEAN SCORE PER DIMENSION Young Mature N=54 N=108 p<0.001 p=0.027 p= Transient health 10.Quality of life 9. Cognitive function 8. Health problems 7. Mental health 6. Energy 5. Social function 4. Rol function 3. Physical function 2. Pain 1. Global health 48

49 Young and mature HIV+ women: mood stages and neurocognitive damage screening Young (n=54) Mature (n=108) P value Anxiety HADS A score [mean+sd] Positive screening (HADS A score>8) n(%) 14 (26.4) 39 (36.1) Depression HADS D score [mean+sd] Positive screening (HADS D score>8) n(%) 2 (3.7) 18 (16.7) Neurocognitive function (BNCS) Trailmaking A score [mean+sd] Trailmaking B score [mean+sd] Wais III score [mean+sd] Positive screening for neurocognitive damage n (%) 6 (11.1) 54 (50.0) <

50 HIV+ women: factors analysis for quality of life Outcome variables: each of the 11 MOS HIV dimensions Variables included in the initial bivariate model: Age (> or >18 yrs o)/(<41, 41 45, 45 50, >50 yrs o) Weight (<50, 50 59, >59 kg) Height (<160, , >165 cm) BMI (<20, 20 23, >23) Ethnicity (Caucasian vs Other) Living situation (city, country) Education/employment status (none, student, employee and/or student) Employment (unemployed vs. employed) Time from HIV diagnosis (10 yrs ranges) VL (detectable/undetectable) CD4+ count (<350 c/mcrl, >350c/mcrL) CD4+ count nadir (<200 c/mcrl, >200c/mcrL) Time from AIDS diagnosis (<10, >10 yrs) Anxiety screening (HADS A score >8 vs <8) Depression screening (HADS D score >8 vs <8) Neurocognitive damage screening (BNCS) 50

51 Young HIV+ women: factors analysis for quality of life (linear regression analysis) MOS HIV items Overall health Physical function Health problems Cognitive function Transient health Associated factors Race (Caucasian /Other) p=0.013 Years on curent ART p=0.029 Anxiety p< p= p< p=0.005 Neurocognitive damage (No impairment / impairment) p=

52 Mature HIV+ women: factors analysis for quality of life (linear regression analysis) 1. Overall health 2. Pain 3. Physical function 4. Rol function 5. Social function 6. Energy 7. Mental health 8. Health problems 9. Cognitive function 10.Quality of life 11. Transient health Associated factors Age MOS HIV items p=0.021 Weight p=0.034 Years on curent ART p=0.018 Anxiety p= p= p< p= p=0.023 Depression p< p= p< p< p< p< p< p< p= p= p=

53 Young and mature HIV+ women: conclusions Young HIV+ women show less damage in their sexual sphere, better mood stage, neurocognitive function and higher QoL scores in some items than in HIV+ mature women. In younger women anxiety positive screening correlated with lower QoL scores in physical function, energy, mental health, cognitive function and transitional health components. Both, anxiety and depression positive screening was a related factor with lower QoL scores in all components for mature women. Whether other factors could explain this differences (I.E: HCV coinfection) as well as taking into account confounding factors is a matter of further analysis. 53

54 EVhAs stages project: limitations and strengths Limitations These are cross sectional, single visit, studies. The sample size in EVhA 1 (young women) is small to get definitive conclusions. There is an age range missing between the 2 studies, 23 to 34 years. Not all HIV women had a previous HIV test performed as non infectivity documentation. The tool for QoL were different for HIV+ and HIV not allowing a 100% comparison despite the MOS HIV has been adapted to this disease population from MOS (SF 36). Strengths These are together the largest ever studies performed in HIV+ and HIV women in Spain in 2 different age stages. In both studies many different sites from different regions in Spain have participated, therefore providing a good representation of HIV+ women in our country. This kind of cross sectional studies with several instruments provide a large amount of data to analyse apart from what has been shown here. 54

55 EVhAs stages project: final conclusions Young HIV+ women show less damage in their sexual sphere, better mood stage, neurocognitive function and higher QoL scores than in HIV+ mature women. How clinical demographic differences between groups influence on these results it is something that deserves further investigation A multidimensional management with special focus on mental health and mood stage of the HIV+ women might be critical to improve their wellbeing facing aging and living with HIV. These data support recent Spanish published guidelines on special overall health HIV+ women might need [1]. 1. Polo R. Executive summary. Consensus document of National AIDS Plan Secretariat/AIDS Expert Group on healthcare assistance for HIV infected women. Enferm Infecc Microbiol Clin

56 EVhAs stages project: acknowledgements To all women, those living with HIV and those living without HIV and who volunteered to provide their time and thoughts to better understand what they may have in common and in what they may differ. EVhA 1 study collaborative group National Coordinator Committee: MJ Mellado, Hospital Carlos III, Madrid; P Arazo, H. Miguel Servet; R Polo, AIDS National Plan. MoH Spain. Study Site(s): 14 active sites in Spain (detailed per region as follows, P. Investigator, Hospital City). Andalucía: E Nuñez, H. Materno Infantil Carlos Haya Málaga; Aragón: P Arazo, H. Miguel Servet Zaragoza; Cataluña: C Fortuny, H. Sant Joan de Deu Barcelona; P Soler, H. Vall d Hebrón Barcelona; E Negredo, H. Germans Trias i Pujol Badalona; Galicia: JA Couceiro, H. Provincial de Pontevedra Pontevedra; Madrid: JT Ramos, H. de Getafe Getafe; M Navarro*, MD Gurbindo, H. Gregorio Marañón Madrid; MJ Mellado, H. Carlos III Madrid; MI de José, H. La Paz Madrid; MI González Tomé, H. Doce de Octubre Madrid; J Martínez Pérez, H. Niño Jesús Madrid; Valencia: C Otero, H. La Fé Valencia P. Vasco: MI Garrote, H. de Basurto Bilbao. * Site Study Coordinator 56

57 EVhAs stages project: acknowledgements 2 EVhA 3 study collaborative group National Coordinator Committee: MJ Galindo. Hospital Universitario Clínico de Valencia; C Miralles, Hospital Xeral Cíes Vigo; MJ Pérez Elías, Hospital Ramón y Cajal Madrid Study Site(s): 29 active sites in Spain (detailed per region as follows; P. Investigator, Hospital City) Andalucía: M Márquez, H. Virgen de la Victoria Málaga; C Hidalgo, H. Virgen de las Nieves Granada; A Terrón, H. de Jerez Jerez de la Frontera; C Gálvez, H. Torrecárdenas Almería; J Rodríguez Baño, H. Virgen de la Macarena Sevilla. Baleares: C Cifuentes, H. Son Llatzer Palma de Mallorca. Cantabria: S Echevarría, H. Marqués de Valdecilla Santander. Cataluña: J Mallolas, H. Clínic Barcelona; H Knobel, H. del Mar Barcelona; E Negredo, H. Germans Trias i Pujol Badalona; A Fontanet**, A Sambeat, H. Santa Creu i Sant Pau Barcelona, N Pons**, C Cortés Lletget, H. General de Hospitalet Hospitalet de Llobregat. Castilla León: R Pérez Simón, Complejo H. de León León; H. General Yagüe Burgos; Galicia: A Mariño, H. Arquitecto Marcide El Ferrol; J Diz, H. Provincial de Pontevedra Pontevedra; A. Rodríguez Da Silva*, C Miralles, H. Xeral Cies Vigo. Madrid: S Corral**, P Miralles, H. Gregorio Marañón Madrid; ML Montes, H. La Paz Madrid; MJ Pérez Elías, H. Ramón y Cajal Madrid; E Casas, H. Universitario Príncipe de Asturias Alcalá de Henares; R Torres, H. Severo Ochoa Leganés; J Sanz, H. La Princesa Madrid; E Condes*. C Barros, H. de Móstoles Móstoles; Murcia: B de Haro, H. Virgen de Arrixaca Murcia; Valencia: J Portilla, H. General de Alicante Alicante; MJ Galindo, H. Clínico de Valencia Valencia; M Montero, H. La Fé Valencia; C Ricart, H. Doctor Peset Valencia. * Site Study Coordinator; ** Site Study Nurse To 3D Health Research for the data management and statistics, and specially to Elena Villarrubia and to Eva Baró. To the Abbott Medical Affairs and operations virology team: Concepción Cuadros, Pedro Marmiesse, Eva Gutiérrez, María Codina, Natalia García, Pilar Ezcurra, Julián Jiménez. 57