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Weight Gain During Pregnancy Among Women Initiating Dolutegravir in Botswana

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Weight Gain During Pregnancy Among Women Initiating Dolutegravir in Botswana UKCAB January 2020 Dr Nadine Chamay Medical Advisor ViiV UK Dr Thom Van Every Medical Director ViiV UK The content of the presentation has been created in response to a specific request from UKCAB NP-GB-HVX-PPT-200002 – Jan 2020 ➢DOLUTEGRAVIR ➢ WEIGHT GAIN ➢ TANGO ➢PIPELINE ➢ CABOTEGRAVIR- LA ➢ FOSTEMSAVIR ➢ Pipeline and Investigational pipeline ➢ Maturation Inhibitor ➢ Combinectin ➢ BNABs ➢ investigational drugs ➢ Your questions! Drivers of Weight Gain/Loss Adapted from Hill et al. EACS 2019; Basel, Switzerland. Slides ML1. Drivers of Weight Gain/Loss (cont) Adapted from Hill et al. EACS 2019; Basel, Switzerland. Slides ML1. ADVANCE: study design Inclusion criteria: treatment-naïve, HIV-1 RNA level ≥500 copies/mL, no TB or pregnancy, no baseline genotyping TAF/FTC + DTG N = 351 1053 participants TDF/FTC + DTG N = 351 TDF/FTC/EFV N = 351 96 weeks Open-label, 96 Week study in Johannesburg, South Africa. Study visits at Baseline, Week 4, 12, 24, 36, 48, 60, 72, 84, and 96. Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. ADVANCE: baseline characteristics (1/2) TAF/FTC + DTG TDF/FTC + DTG TDF/FTC/EFV Characteristic (n = 351) (n = 351) (n = 351) Age, mean (SD), years 33 ± 8 32 ± 8 32 ± 7 Female 61% 59% 57% Black 99% 100% 100% Baseline HIV-1 19% 18% 21% 100,001–500,000 copies/mL Baseline HIV-1 3% 3% 2% ≥500,000 copies/mL CD4+ cell count, 349 ± 225 323 ± 234 337 ± 222 mean (SD), cells/mm3 Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. ADVANCE: baseline characteristics (2/2) TAF/FTC + DTG TDF/FTC + DTG TDF/FTC/EFV Characteristic (n = 351) (n = 351) (n = 351) Weight, mean (kg) Male 67.9 67.1 67.3 Female 68.8 69.5 70.2 BMI, mean (kg/m2) Male 21.7 21.6 21.8 Female 25.6 26.1 26.1 Categories of BMI, n (%) Underweight (<18.5) 42 (12) 35 (10) 37 (11) Normal (18.5–25) 177 (51) 190 (54) 193 (55) Overweight (25–30) 96 (27) 78 (22) 77 (22) Obese (>30) 35 (10) 48 (14) 44 (13) Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. Changes in DXA body composition: men 3.48 kg 2.59kg 10 9 8 +5.1kg (53% fat) +5.9kg (59% fat) 7 6 +3.5kg (74% fat) 5 +2.7kg (70% fat) 4 3 +0.7kg (100% fat) +1.2kg (100% fat) 2 1 0 (n=77) (n=69) (n=74) (n=117) (n=111) (n=128) Change in weight (kg) weight in Change TDF/FTC/EFV TDF/FTC/EFV TAF/FTC+DTG TAF/FTC+DTG TDF/FTC+DTG Limb Lean TDF/FTC+DTG Trunk Lean Limb Fat Trunk Fat Week 48 Week 96 Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. Changes in DXA body composition: women 6.14kg 3.92kg 10 9 +8.3kg (74% fat) 8 7 +6.3kg (76% fat) 6 +1.6kg (100% fat) +5.3kg (74% fat) 5 4 +3.4kg (74% fat) +3.4kg (91% fat) 3 2 1 0 (n=79) (n=93) (n=91) (n=137) (n=157) (n=157) TDF/FTC/EFV TDF/FTC/EFV TAF/FTC+DTG TAF/FTC+DTG TDF/FTC+DTG TDF/FTC+DTG Limb Lean Trunk Lean Change in weight (kg) weight in Change Week 48 Week 96 Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. ADVANCE: changes in lipids to Week 48 Lipid (mmol/L) TAF/FTC + DTG TDF/FTC + DTG TDF/FTC/EFV Total cholesterol, median +0.1 -0.1 +0.3 LDL, median +0.1 0.0 +0.1 HDL, median +0.1 +0.1 +0.3 Triglycerides, median 0.0 -0.1 0.0 • Some statistically significant differences between arms: however, of small magnitude (not clinically significant) Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. Perceptions? administered before weight gain information leaflet and consent • 69 participants surveyed by 15 July 2019: 51 women, 17 men • No discontinuations for weight gain: most participant’s estimation of their weight gain was similar to the actual weight gain, with a few wild exceptions • 8 women reported unhappiness with weight gain (one actually had lost 1.3 kg); 3 had actually gained <5%, while 4 had >10% weight gain – 2 of those who gained >10% of their baseline weight expressed that they were very unhappy • 6 women participants reported uneven weight gain: 3 abdominal, 2 upper body, 1 hip area, and 1 lower body • 2 men reported unhappiness with weight loss (verified weight loss for both) • Most participants were happy with the weight gain, even though they had to get new clothes as their pre-ART clothes could not fit anymore – Some viewed the weight gain as “return to health” although they had not reported weight loss at screening Source: Dr Simiso Sokhela Adapted from: Hill A, et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. ADVANCE: Factors Associated Obesity and Weight Gain (2/2) • After multivariable analysis, associated factors were: – Treatment-emergent obesity: • TAF/FTC+DTG, baseline CD4+ count, baseline VL, and baseline BMI • When baseline BMI was excluded the following predictors were also significant: • Female sex, South African nationality, and employment – ≥10% increase in body weight: • TAF/FTC+DTG, baseline CD4+ count, baseline VL, female sex, age, and baseline weight Adapted from: Hill et al. IAS 2019; Mexico City, Mexico. Slides MOAX0102LB. Weight Gain During Pregnancy Among Women Initiating Dolutegravir in Botswana Ellen Caniglia,1,2 Roger Shapiro,2,3 Modiegi Diseko,3 Blair Wylie,4 Chloe Zera,4 Sonya Davey,5 Arielle Isaacson,3 Gloria Mayondi,3 Judith Mabuta,3 Rebecca Luckett,4 Joseph Makhema,3 Mompati Mmalane,3 Shahin Lockman,3,6 Rebecca Zash3,4 1New York University School of Medicine; 2Harvard T.H. Chan School of Public Health; 3Botswana-Harvard AIDS Institute Partnership; 4Beth Israel Deaconess Medical Center; 5University of Pennsylvania Perelman School of Medicine, 6Brigham and Women’s Hospital Study Inclusion By Exposure Group Adapted from: Caniglia et al. IAS 2019; Mexico City, Mexico. Poster LBPEB14. Baseline Characteristics By Exposure Group Characteristic (mean or %) EFV DTG HIV-negative Age 28.8 28.9 28.3 Primigravid 29.1% 26.6% 32.7% Pre-ART CD4 cell count 419 cells/μl 390 cells/μl -- Pre-pregnancy weight 62.60kg 62.80kg 63.01kg 66.51kg Weight at ART initiation 65.62kg 65.66kg (at firstANC) Caniglia et al. IAS 2019; Mexico City, Mexico. Poster LBPEB14. Weekly Weight Gain: Unadjusted Mean (kg/week) Adjusted for: age, CD4, employment, education, parity, gravidity, marital status, site, smoking, alcohol, pre-pregnancy weight, weight at ART initiation (or first ANC), gestational age at ART initiation (or first ANC). Adapted from: Caniglia et al. IAS 2019; Mexico City, Mexico. Poster LBPEB14. Weekly Weight Gain: Adjusted Mean Difference (kg/week) Adjusted for: age, CD4, employment, education, parity, gravidity, marital status, site, smoking, alcohol, pre-pregnancy weight, weight at ART initiation (or first ANC), gestational age at ART initiation (or first ANC). Adapted from: Caniglia et al. IAS 2019; Mexico City, Mexico. Poster LBPEB14. Changes in BMI associated with antiretroviral regimens in treatment-experienced, virologically suppressed individuals living with HIV Karam Mounzer, M.D. Philadelphia FIGHT, Philadelphia, PA, USA Karam Mounzer, Laurence Brunet, Ricky Hsu, Terra Fatukasi, Jennifer Fusco, Vani Vannappagari, Cassidy Henegar, Jean van Wyk, Melissa Crawford, Janet Lo, Gregory Fusco IDWeek 2019 October 4, 2019 18 OPERA Cohort • Prospectively captured, routine clinical data from electronic health records • 100,000+ PLWH, 65 cities, 19 States, 1 US Territory ~ 8% of all PLWH receiving care in the US 19 Overall study population (N=10,653) DTG 9% (n=3,478) 33% EVG/c 18% (n=3,721) RAL (n=545) 5% RPV 35% (n=1,959) 20 22 Summary of findings Lower increases in mean BMI compared to DTG EVG/c RAL RPV bDRV vs. DTG vs. DTG vs. DTG vs. DTG Overall 6 -month ↓ ↓ ≈ ↓ 12-month ≈ ≈ ≈ ↓ 24-month ≈ ≈ ≈ ↓ Normal baseline BMI 12-month ↓ ≈ ≈ ↓ Overweight at 12-month ≈ ≈ ≈ ↓ baseline 23 Extreme weight gain (>10% increase from baseline weight), unadjusted DTG EVG/c RAL RPV bDRV >10% weight increase at >10% weight increase at >10% weight increase at 6-month 12-month 24-month DTG 173/3,273 (5.3%) 239/2,757 (8.7%) 231/1,548 (14.9%) EVG/c 178/3,484 (5.1%) 280/2,774 (10.1%) 209/1,506 (13.9%) RAL 16/513 (3.1%) 28/402 (7.0%) 25/217 (11.5%) RPV 99/1,830 (5.4%) 157/1,513 (10.4%) 121/795 (15.2%) bDRV 37/880 (4.2%) 53/697 (7.6%) 43/370 (11.6%) 24 Weight change at 96 weeks in treatment-naïve patients: overview 10 DTG + 9 TAF/FTC 8 8 7 DTG + 6 TDF/FTC DTG + BIC/ BIC/ 5 TAF/FTC 5 TAF/FTC TAF/FTC 4 DTG/ DTG + 3TC 3.9 DTG + EFV/ 3.6 ABC/3TC 3.5 3 3.1 TDF/FTC TDF/FTC 2.4 2 2.1 2 1 n=314 n=315 n=320 n=325 n=716 n=717 n=351 n=351 n=351 Weight change kg from baseline, 0 Study 14891 Study 14902 GEMINI pooled3 ADVANCE4 Median Mean Adapted from: 1. Wohl DA, et al. Lancet HIV 2019;6:e355–63; 2. Stellbrink HJ, et al. Lancet HIV 2019;6;e364–72; 3. Cahn P, et al. IAS 2019. Oral WEAB0404LB; 4. Hill A, et al. IAS 2019. Oral MOAX0102LB. EFV, efavirenz. Phase 3 Trials Under-Represent the People at Highest Risk of Adverse Events Pepperrell et al.
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