EACS2023: 574 The two sides of doravirine-based regimens: a descriptive study focusing on kidney function and lipidic profile M. Menozzi , M. Mazzitelli , M. Albertini , B. Fontana , M.D. Di Trapani , A.M. Cattelan , C. Mussini University of Modena, Infectious diseases, Modena, Italy, University of Padova, Infectious Diseases, Padova, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Doravirine (DOR) is a recently approved NNRTI, often combined with Tenofovir backbones (Disoproxil -TDF or Alafenamide -TAF). We investigated serum lipids and creatinine changes in a cohort of people living with HIV (PLWH) switched to DOR-based regimens containing TDF or TAF. Method: A retrospective study was conducted including PLWH from Modena and Padova clinics switched to DOR-based regimens: DOR+TAF/FTC (TAF-group) or DOR/TDF/3TC (TDF-group). Data on serum lipids and creatinine were collected at switch (baseline), then at 6 and 12 months. Cut-off for baseline altered laboratory values were Total Cholesterol>200mg/dl (H-COL), LDL>120mg/dl (H-LDL), Triglycerides>150mg/dl (H-TG) and creatinine>1.2mg/dl (KI). The reasons for DOR switch, side effects and previous antiretroviral regimens were recorded. After a descriptive statistical analysis according to DOR-groups, a p-per-trend test was used to investigate laboratory values variations. Results: 80 PLWH included, Table 1 describes cohort characteristics and antiretroviral regimens. We recorded 13(16.3%) DOR interruptions, mainly due to gastroenteric and neurologic side effects; one person in TDF-group experienced acute kidney failure.As shown in Table 2, PLWH in TDF-group presented higher TC decline (-37 Vs -16 mg/dl, p0.056 for PLWH with H-COL, -15 Vs -2 mg/dl, p0.017 for PLWH without H-COL). No triglycerides change was observed. TAF-based regimens were more common (20, 55.6%) before the switch in people with H-COL and they were predominantly switching from NNRTI-based triple therapy.A significant improvement in creatinine levels was detected in KI people in TAF-group (-0.29 Vs -0.13 ml/min, p0.036). TAF was the most common backbone in KI people and main previous antiretroviral strategies in these PLWH included NNRTI-based triple therapy 4(66%) in TDF-group and INSTI-based triple regimen 1(50%) in TAF-group. Table 1 TOTAL 80 pts DOR/3TC/TDF 54 (67.5%) DOR/TAF/FTC 26 (32.5%) P value Male sex 57 (71.3 %) 38 (70.3 %) 19 (73.1 %) 0,802 Age 57 (50-60) 56.5 (49-59) 58 (54-61) 0.292 Age at DOR start 55 (49-58) 55 (48-58) 56 (52-60) 0.402 Age >50 yrs 60 (75) 40 (74) 20 (77) 0.783 HIV duration (yrs) 36 (28-43) 36.9 (27.2-43.6) 35.6 (32.4-43.3) 0.704 DOR duration (months) 20.7 (16.9-23.9) 20.3 (14-23) 21.4 (19-25.1) 0.025 DOR stop 13 (16.3 %) 11 (20.4 %) 2 (7.7 %) 0.150 DOR stop reason Intolerance Failure Genotype resist Viremic blip Optimization Others 4 (36.3 %) 1 (9 %) 1 (9 %) 1 (9 %) 3 (27.7 %) 1 (9 %) 2 (22 %) 1 (11 %) 1 (11 %) 1 (11 %) 3 (33 %) 1 (11 %) 2 (100%) 0.370 DOR start reason Side effects Drug Drug interact Metabolic switch Simplification Failure 6 (7.4 %) 5 (6.2 %) 23 (28.4 %) 43 (53.1 %) 4 (4.9 %) 3 (5. %8) 3 (5.8 %) 16 (30.8 %) 28 (53.9 %) 2 (3.9 %) 3 (10.3 %) 2 (6.9 %) 7 (24.1 %) 15 (51.7 %) 2 (6.9 %) 0.446 DOR side effects Gastro-enteric Insomnia Skin reaction Neuro Blood exams alt 3 (27.3 %) 1 (9 %) 2 (18.2 %) 3 (27.3 %) 2 (18.2 %) 2 (33.3 %) 0 (0 %) 2 (33.3 %) 1 (16.7 %) 1 (16.7 %) 1 (20 %) 1 (20 %) 0 (0 %) 2 (40 %) 1 (20 %) 0.441 Table 2 TOTAL 80 pts DOR/3TC/TDF 54 (67.5%) DOR/TAF/FTC 26 (32.5%) P value Previous ARV reg Triple NRTI Triple PI Triple INSTI Dual PI Dual INSTI Others 30 (38.5 %) 17 (21.8 %) 17 (21.8 %) 5 (6.4 %) 5 (6.4 %) 4 (5.1 %) 24 (45.3 %) 11 (20.8 %) 8 (15.1 %) 4 (7.5 %) 4 (7.5 %) 2 (3.8 %) 6 (24 %) 6 (24 %) 9 (36 %) 1 (4 %) 1 (4 %) 2 (8 %) 0.240 Previous Tenofovir TDF TAF 14 (18 %) 39 (50%) 13 (24.5) 21 (39.6) 1 (4) 18 (72) 0.027 Previous PI DRV ATV 21 (27%) 12 (57.1%) 9 (42.9%) 14 (26.4) 7 (50) 7 (50) 7 (28) 5 (71.5) 2 (28.5) 0.883 Previous INSTI DTG BIC RAL 21 (27 %) 12 (57.1 %) 6 (28.6 %) 3 (14.3 %) 12 (22.6) 7 (58.3) 3 (25) 2 (16.7) 9 (36) 5 (55.6) 3 (33.3) 1 (11.1) 0.215 Post ARV reg Triple NRTI Triple PI Triple INSTI Dual PI Dual INSTI Others 1 (10 %) 0 (0 %) 4 (40 %) 0 (0 %) 4 (40 %) 1 (10 %) 0 0 4 (50) 0 3 (37.5) 1 (12.5) 1 (50) 0 0 0 1 (50) 0 0.150 Post Tenofovir TDF TAF 0 4 (40) 0 4 (50) 0 0 0.197 Post PI DRV ATV 0 0 0 0 0 0 Post INSTI DTG BIC RAL CAB 8 (80) 1 (12.5) 4 (50) 1 (12.5) 2 (25) 0 4 (57.1) 1 (14.3) 2 (28.6) 1 (100) 0 0 0 0.236 Table3 DOR/3TC/TDF DOR/TAF/FTC P per trend Baseline At 1 year Delta Baseline At 1 year Delta Cholesterol Hyperchol at switch No Hyperchol at switch 229 (211; 250) 165 (132; 181) 197 (174; 212) 137 (120; 160) -37 (-59; - 24) -15 (-44; +7) 234 (213; 265) 172 (144; 184) 219 (211; 239) 169 (155; 182) -16 (-45; - 12) -2 (-13; +29) 0.056 0.017 1 2 1 1 1 2 1 1 2
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