Introduction: Non-AIDS comorbidities, metabolic, renal and bone toxicities associated to combined antiretroviral therapy (cART), namely NRTIs, led to dual therapy (NUC sparing regimens). Tenofovir Alafenamide Fumarate (TAF) demonstrated improved renal and bone safety profile over TDF even with mild to moderate renal impairment.
Objectives: Evaluate if patients in NUCs sparing regimens due to previous TDF-induced renal impairment could switch to TAF/FTC/BIC, maintaining the safety renal profile.
Methods: Evaluate TAF/FTC/BIC renal parameters (estimated Glomerular Filtration Rate (eGFR) by CKD-EPI formula or Creatinine Clearence (CrCl) > 60 ml/min in 24h urine) at switch and week 4, 12, 24 and 48 and virologic suppression and lymphocytes T CD4+ count. Discontinuation by any causes reported as failure.
Results: Fourteen patients, from 36-83 years old (average 61 y.o.), where 8 were females. The time of HIV infection range between 7-20 years (mean 14). And the major risk for HIV acquisition, was heterosexual in 9, drug addiction in 4 and “accidental” in 1 patient. At baseline, HIV RNA viral load was negative in 12, but in one 28 and another 103 cps/mL and the average lymphocytes T CD4+ (CD4+) count was 725 cells/uL (194-1516). According to CDC stage, 10 patients were in stage A and 4 at C at the switch.
Prior switch to TAF/FTC/BIC, 12 patients were on Raltegravir (RAL) + Etravirine (ETR) and Dolutegravir (DTG)/Rilpivirine (RPV) and Abacavir/Lamivudine/Dolutegravir (ABC/3tc/DTG) presented 1 patient each. All participants presented normal CrCl before switching to TAF/FTC/BIC.
At 48 weeks, 12 patients maintained normal renal pattern, however 4 had negative variation due to decompensation of their chronic diseases. Currently, HIV RNA viral load was negative in 10 patients, and 1presented 43 and another 69 cps/mL; the average CD4+ was 693 cells/uL (237-1476). None discontinued was observed due to the patients maintain values of eGFR/CrCl>30 ml/min.
Conclusion: TAF/FTC/BIC is a valid treatment option for patients in NUCs sparing regimens due to TDF-induced renal toxicity after renal function normalization, demonstrating being safe and effective. However, further studies are need.
However, and regarding patients with comorbidities, renal function recovered after the TDF-induced change is so fragile that these patients require special attention and monitoring.
Tenofovir Alafenamide, Emtricitabine, Bictegravir, TAF/FTC/BIC, Tenofovir Disoproxil Fumarate, HIV-1