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Prina Donga,1 Bruno Emond,2 Carmine Rossi,2 Brahim K Bookhart,1 Johnnie Lee,1 Gabrielle Caron-Lapointe,2 Fangzhou Wei,3 Marie-Hélène Lafeuille2 1Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Analysis Group, Inc, Montréal, QC, Canada; 3Analysis Group, Inc, Menlo Park, CA, USACorrespondence: Carmine Rossi, Analysis Group, Inc, 1190 Avenue des Canadiens-de-Montréal, Tour Deloitte, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1 514-871-4233, Email carmine.rossi@analysisgroup.comIntroduction: Integrase strand transfer inhibitor-based regimens (eg, containing dolutegravir [DTG]) are associated with weight/body mass index (BMI) increases among people living with HIV-1 (PLWH). Assessing antiretroviral therapy (ART)-related weight/BMI changes is challenging, as PLWH may experience return-to-health weight gain as a result of viral suppression. This retrospective, longitudinal real-world study compared weight/BMI outcomes among overweight/obese (BMI ≥ 25 kg/m2; thus excluding return-to-health weight/BMI changes), treatment-naïve PLWH who initiated darunavir (DRV)/cobicistat (c)/emtricitabine (FTC)/tenofovir alafenamide (TAF) or DTG + FTC/TAF.Methods: Treatment-naïve PLWH with BMI ≥ 25 kg/m2 who initiated DRV/c/FTC/TAF or DTG + FTC/TAF (index date) had ≥ 12 months of baseline observation and ≥ 1 weight/BMI measurement in baseline and post-index periods in the Symphony Health IDV® database (07/17/2017– 12/31/2021) were included. Inverse probability of treatment weighting (IPTW) was used to balance differences in baseline characteristics between cohorts. On-treatment time-to-weight/BMI increases ≥ 5% were compared between cohorts using weighted adjusted Cox models.Results: Post-IPTW, 76 overweight/obese DRV/c/FTC/TAF-treated (mean age = 51.2 years, 30.7% female, 35.6% Black, mean baseline BMI = 33.2 kg/m2) and 88 overweight/obese DTG + FTC/TAF-treated PLWH (mean age = 51.5 years, 31.4% female, 31.4% Black, mean baseline BMI = 32.7 kg/m2) were included. The median [interquartile range] time from ART initiation to weight/BMI increase ≥ 5% was shorter for the DTG + FTC/TAF cohort (21.8 [9.9, 32.3] months) than the DRV/c/FTC/TAF cohort (median and interquartile times not reached; Kaplan–Meier rate at 21.8 months = 20.8%). Over the entire follow-up, overweight/obese PLWH initiating DTG + FTC/TAF had a more than twofold greater risk of experiencing weight/BMI increase ≥ 5% compared to those initiating DRV/c/FTC/TAF (hazard ratio [95% confidence interval]=2.43 [1.02; 7.04]; p = 0.036).Conclusion: Overweight/obese PLWH who initiated DTG + FTC/TAF had significantly greater risk of weight/BMI increase ≥ 5% compared to similar PLWH who initiated DRV/c/FTC/TAF and had shorter time-to-weight/BMI increase ≥ 5%, suggesting a need for additional monitoring to assess the risk of weight gain-related cardiometabolic disease.Keywords: human immunodeficiency virus, weight gain, BMI, darunavir, dolutegravir, observational study

Kehinde Osinowo,1 Fintirimam Sambo-Donga,1 Oluwaseun Ojomo,1 Segun Emmanuel Ibitoye,1 Philip Oluwayemi,1 Morounfola Okunfulure,1 Oladapo Alabi Ladipo,1 Michael Ekholuenetale1,2 1Association for Reproductive and Family Health, Trade and Convention Center, Abuja, Nigeria; 2Department of Epidemiology and Medical Statistics, Faculty of Public Health, College of Medicine, University of Ibadan, Ibadan, NigeriaCorrespondence: Kehinde Osinowo Email osinowo.k@arfh-ng.orgBackground: Injectable contraceptives are fast becoming the method of choice among women in sub-Saharan Africa (SSA). Specifically, the subcutaneously administered depot–medroxyprogesterone acetate (DMPA-SC) is gaining traction as a convenient, private and effective method to address unmet need for family planning (FP). The objective of this study was to determine the trend in DMPA-SC use in Nigeria.Methods: Data was extracted from the National Health Management Information System (NHMIS) FP register on DMPA-SC uptake in public health facilities and through community-oriented resource providers (CORPS) in 10 Nigerian states. The linear trend model was adopted in data analysis based on lowest measure of dispersion and/or highest adjusted coefficient of determination (R2). The statistical significance was determined at 5%.Results: There was an upward trend in the use of DMPA-SC among clients who received the service through health providers, CORPS and self-injection in the 10 project states over a period of 12 months (August 2019–July 2020). In addition, the linear trend model showed that for every unit increase in months, the average number of women expected to use DMPA-SC through health providers, CORPS and self-injection will increase by 1308.3 (Yt = 3799.7 +1308.3*t), 756.73 (Yt = − 1030.8 +756.73*t) and 77.864 (Yt = − 159.7 +77.864*t) respectively. In all models, the adjusted coefficient of determination was 99.9% which showed good model fitness. The results also showed that the number of DMPA-SC clients varied across the project states with Niger (32,988) and Oyo (31,511) states reporting the highest number of clients over the period of 12 months.Conclusion: There was an increasing use of DMPA-SC and self–injection among clients over time. Health facility and community-based FP programs should be strengthened to ensure improved access to FP services.Keywords: family planning, contraceptive, Nigeria, DMPA-SC, self-injection, birth control

Wing Chow,1 Prina Donga,1 Aurélie Côté-Sergent,2 Carmine Rossi,2 Patrick Lefebvre,2 Marie-Hélène Lafeuille,2 Hélène Hardy,2 Bruno Emond3 1Real World Value & Evidence, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Analysis Group, Inc., Montréal, QC, Canada; 3Early Compound Development, Janssen Research & Development, LLC, Titusville, NJ, USACorrespondence: Bruno Emond Tel +1 514-394-4455Email Bruno.Emond@analysisgroup.comPurpose: Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide can be used as a single-tablet regimen (STR, DRV/c/FTC/TAF) or multiple-tablet regimen (MTR, DRV/c+FTC/TAF) to treat patients with human immunodeficiency virus (HIV). This study described treatment patterns and predictors of adherence among patients with HIV initiated on DRV/c/FTC/TAF or DRV/c+FTC/TAF.Patients and Methods: A retrospective longitudinal study was conducted using linked claims and electronic medical records from Decision Resources Group’s Real World Data Repository (7/17/2017– 6/1/2019). Treatment-naïve and treatment-experienced virologically suppressed adults with HIV-1 prescribed DRV/c/FTC/TAF or DRV/c+FTC/TAF (index date) were included. Six-month persistence (no treatment gaps > 60 and > 90 days) and adherence (proportion of days covered [PDC]) to the index regimen were evaluated among patients with ≥ 6 months of observation post-index. Predictors of low adherence (PDC< 80%) were evaluated using a logistic regression model.Results: Among 2633 eligible patients (49.5 years old, 29% female, 37% African American/Black), 12% were treatment-naïve pre-index and 88% switched from a previous antiretroviral therapy; 84% initiated DRV/c/FTC/TAF and 16% initiated DRV/c+FTC/TAF. Among 822 DRV/c/FTC/TAF patients with ≥ 6 months of observation post-index, 80% and 86% had no > 60- and > 90-day gaps in DRV/c/FTC/TAF coverage, respectively, while among 204 DRV/c+FTC/TAF patients with ≥ 6 months of observation post-index, 69% and 75% had no > 60- and > 90-day gaps in DRV/c+FTC/TAF coverage, respectively. Mean (median) PDC for the index regimen was 81% (93%) for patients treated with DRV/c/FTC/TAF and 73% (83%) for patients treated with DRV/c+FTC/TAF. Predictors of low adherence included younger age (odds ratio [OR]=2.36, p=0.017), higher Quan-Charlson comorbidity index (OR=1.32, p=0.012), use of MTR regimen at index (OR=1.69, p=0.022), and prior low adherence (OR=2.56, p< 0.001).Conclusion: Among patients initiating a DRV/c-based regimen, those initiating STR had higher 6-month adherence/persistence than those initiating MTR, highlighting the potential benefits of the STR formulation, particularly among younger patients with multiple comorbidities and prior low adherence.Keywords: HIV, protease inhibitors, treatment adherence and compliance, patient compliance, administrative claims, healthcare, electronic health records