1040. Real-World Implementation of Dolutegravir-Lamivudine to Achieve and Maintain HIV-1 Viral Suppression at an Academic Medical Center

Abstract

Background Two-drug antiretroviral (ARV) regimens to achieve and maintain HIV viral suppression may lead to decreases in associated drug interactions, adverse events, and pill burden. Dolutegravir-lamivudine (DTG-3TC) has been established as safe and effective in treatment naïve and experienced adults. Further research is warranted to assess insertion into real-world practice. Methods This descriptive retrospective cohort consisted of all patients at an academic medical center HIV practice with a confirmed order of DTG-3TC between April 2019 and March 2020. Patients who were not linked to care by the site’s practices were excluded. The primary endpoint was number of patients initiated on DTG-3TC to determine uptake. Secondary endpoints included demographics and viral outcomes. Descriptive measures of central tendencies and variability were used for analysis. Results DTG-3TC was initiated in 49 patients. Sixty-nine percent were male (34/49), 90% carried publicly funded insurance (44/49), median age at DTG-3TC initiation was 55 years (IQR 46-60), and mean years since HIV diagnosis was 14 (SD ±8). The largest racial/ethnic category represented was Black (45%, 22/49). Forty-seven patients with a mean CD4 of 753 cells/mm3 (±413) and viral load of 88.2 copies/mL (±525) were switched from alternative regimens, mostly containing an integrase inhibitor (41/47, 87%), and with the primary rationale of medication modernization (27/47, 58%) followed by avoidance of adverse drug reactions (15/47, 32%). From 42 assessed patients, 62% had previous ARV exposure length of over 10 years. No patients were found to have significant resistance mutations to the involved agents. After initiation, 6% (3/49) of patients reported side effects. Among switch patients with follow up lab values, median CD4 (n=20) and viral load (n=21) deltas were -10 cells/mm3 (-59-67) and 0 copies/mL (0-0) respectively. Overall median length of therapy through April 1, 2020 was 110 days (71-156). Conclusion Initial implementation of DTG-3TC was successful in a northeast academic HIV practice primarily among virally suppressed treatment switch patients with long exposures to ARV and time since diagnosis. No clinically relevant change in CD4 or Viral Loads were immediately seen. Disclosures David E. Koren, PharmD, BCPS, AAHIVP, Gilead Sciences (Advisor or Review Panel member)Janssen Pharmaceuticals (Advisor or Review Panel member)Thera Technologies (Advisor or Review Panel member)

HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review

“…This analysis included 5017 PWH who were reported to be using dolutegravir plus lamivudine. In 20 studies that reported data for sex, the majority of PWH treated with dolutegravir plus lamivudine were male (range, 60-97%) [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47].…”

“…In 20 studies that reported data for sex, the majority of PWH treated with dolutegravir plus lamivudine were male (range, 60-97%) [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47]. In the other two studies, one population was 29% White, 45% Black, and 27% Hispanic [42] and the other population was 52% White, 35% Black, and 13% Asian [43].…”

“…In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47]. In the other two studies, one population was 29% White, 45% Black, and 27% Hispanic [42] and the other population was 52% White, 35% Black, and 13% Asian [43]. Median ages ranged from 34.0 to 60.5 years among the 17 studies that reported median age [29-37, 39, 41, 42, 44, 45, 47, 48].…”

“…Baseline substitutions associated with ART resistance were reported in 286/1668 (17%) PWH with available baseline genotype data [30,31,34,35,40,45,48,[54][55][56]. Among studies that reported information on prior regimens (n = 1958), many PWH switched to dolutegravir plus lamivudine from 3DRs (n = 1718; 88%) [29,35,42,43,48,49,54,57]. Primary reasons for switching to dolutegravir plus lamivudine included toxicity of the previous regimen [48,52], avoidance of drug interactions [36,48,52,53], treatment regimen simplification [34,48,52,58], and comorbidities (including cardiovascular, renal, and bone disease) [34,53,58].…”

“…Six studies (all in virologically suppressed PWH) switching to dolutegravir plus lamivudine assessed serum creatinine levels and estimated glomerular filtration rate (eGFR) measured by creatinine clearance (Table 3) [34,36,42,52,69,70]. Although increases in serum creatinine [52,69] and decreases in eGFR [36,70] were reported, changes were minimal and generally not considered to be clinically significant.…”