Browsing by Author "Kumar, Princy N."

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    1581. Weight and Metabolic Changes with Long-Acting Lenacapavir in a Combination Regimen in Treatment-Naïve People with HIV-1 at Week 80
    (Oxford University Press, 2023-11-27) Kumar, Princy N.; Goldstein, Deborah A.; Hengel, Richard L.; Gaur, Aditya H.; Wurapa, Anson K.; Khalsa, Ann M.; Newman, Cheryl L.; Saunders, Gary; Liu, Shan-Yu; Dvory-Sobol, Hadas; Rhee, Martin; Gupta, Samir K.; Medicine, School of Medicine
    Background: Lenacapavir (LEN) is a highly potent, long-acting, first-in-class inhibitor of HIV-1 capsid protein approved for the treatment of HIV-1 infection in adults with multidrug resistance in combination with other antiretrovirals. CALIBRATE is an ongoing phase 2 study in people with HIV-1 (PWH) who are newly initiating treatment. At Week 80 (W80), subcutaneous (SC) and oral LEN, in combination with other antiretrovirals, maintained high rates of virologic suppression. In PWH initiating treatment, weight increases associated with a return to health effect have been observed. This analysis examined weight and metabolic changes to the W80 timepoint. Methods: Participants were randomized (2:2:2:1) to 1 of 4 treatment groups (TG). TG1 and TG2 both received SC LEN (927 mg) every 6 months + oral once daily (QD) emtricitabine/tenofovir alafenamide (F/TAF) for 28 weeks, after which virologically suppressed participants continued a 2-drug maintenance regimen: SC LEN (927 mg) with oral QD TAF (TG1) or oral QD bictegravir (BIC) (TG2). TG3 received oral QD LEN + F/TAF, and TG4 received oral QD BIC/F/TAF throughout. The metabolic profile of LEN was assessed from baseline to W28 and after initiating the 2-drug maintenance regimen to W80. Due to the small sample size, no statistical testing was performed. Results: 182 participants (7% female, 52% Black) were randomized and dosed (n=52, 53, 52, 25 in TG1 to TG4, respectively). Baseline median age was 29 years; 15% had baseline viral load >100,000 c/mL. Baseline median weight and body mass index (BMI) were 78.2 kg and 25.8 kg/m2, respectively. Weight, BMI, and fasting lipid profiles for each treatment group through W80 are presented. Conclusion: In this phase 2 study of treatment-naïve PWH, treatment regimens that included SC or oral LEN in combination with other antiretroviral agents led to expected weight gain and increase in BMI, consistent with the return to health phenomenon, and were not associated with clinically relevant increases in lipids.
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    P-547. Efficacy and Safety of B/F/TAF in Treatment-Naïve People With HIV Aged ≥ 50 Years: 5-Year Follow-Up From Two Phase 3 Studies
    (Oxford University Press, 2025-01-29) Kityo, Cissy; Gupta, Samir K.; Kumar, Princy N.; Weinberg, Amy; Gandhi-Patel, Bhumi; Liu, Hui; Hindman, Jason; Rockstroh, Jürgen; Medicine, School of Medicine
    Background: An increasing proportion of people with HIV (PWH) are aged ≥ 50 years, with a greater burden of age-related comorbidities; however, long-term analyses of this population are limited. We present key treatment outcomes through 5 years of first-line therapy with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in PWH ≥ 50 vs < 50 years. Methods: Studies 1489 (NCT02607930; B/F/TAF vs dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) and 1490 (NCT02607956; B/F/TAF vs DTG+F/TAF) were randomized, double-blind, multicenter Phase 3 studies in adult PWH. This pooled analysis reports outcomes for participants ≥ 50 vs < 50 years who received B/F/TAF in the 144-week (W) randomization phase and the 96W open-label extension. Baseline demographics and clinical characteristics; proportion of participants with HIV-1 RNA < 50 copies/mL (missing=excluded); adherence; changes in CD4 cell count and metabolic, renal, and bone parameters; and treatment-emergent adverse events (TEAEs) are presented. Results: Overall, 634 participants received B/F/TAF up to W240; 96 (15.1%) were ≥ 50 years and 538 (84.9%) were < 50 years. Baseline demographics, clinical characteristics, and outcomes are shown in the Table. Higher rates of baseline comorbidities were observed in those aged ≥ 50 vs < 50 years. Both groups had high rates of HIV suppression at W240. A greater proportion of participants aged ≥ 50 vs < 50 years had ≥ 95% adherence (82.8% vs 66.3%; P=0.0015). Changes in CD4 count, weight, eGFR, fasting total cholesterol to high-density lipoprotein ratio, and hip and spine bone mineral density were similar between groups. Proportions of participants with study drug-related TEAEs were similar between groups, with few participants experiencing a TEAE leading to study drug discontinuation. Proportions of TE hypertension and diabetes were modestly higher in the ≥ 50 group vs the < 50 group. Conclusion: Over 5 years, participants ≥ 50 years were more likely to have high adherence to B/F/TAF treatment vs those < 50 years, with low rates of discontinuations due to AEs in both groups. B/F/TAF maintained high rates of virologic suppression, was well tolerated, and resulted in similar changes in metabolic, renal, and bone parameters in both groups, supporting its use for long-term management of HIV in older PWH.