Descovy® (FTC/TAF)

Renal Safety of FTC/TAF-Containing Regimens in HIV-1 Treatment

This document is in response to your request for information from key clinical trials and real‑world studies that assessed the renal safety of Descovy® (emtricitabine/tenofovir alafenamide [FTC/TAF])-based regimens, including Biktarvy® (bictegravir/emtricitabine/ tenofovir alafenamide [BIC/FTC/TAF]), Genvoya® (elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide [E/C/F/TAF]), and Odefsey® (rilpivirine/emtricitabine/tenofovir alafenamide [RPV/FTC/TAF]) in people with HIV (PWH).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.

Summary

Product Labeling1

FTC/TAF and FTC/TAF-based regimens are not recommended in individuals with severe renal impairment (estimated CrCl of 15 to <30 mL/min), or ESRD (estimated CrCl <15 mL/min) who are not receiving chronic HD.1-4 BIC/FTC/TAF is also not recommended in individuals with no ARV treatment history and ESRD who are receiving chronic HD.2

Postmarketing cases of renal impairment, including acute renal failure, PRT, and Fanconi syndrome have been reported with TAF-containing products; while most of these cases were characterized by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related AEs.1-4

Clinical Trials: Renal Safety of FTC/TAF-Containing Regimens in PWH

An integrated analysis of 26 TAF clinical trials (N=9322) yielded the following:5

• No cases of PRT/Fanconi syndrome were reported in participants who received TAF, compared with 10 reported cases in participants who received TDF.
• Significantly fewer DCs due to renal AEs occurred after exposure to TAF than after exposure to TDF. Renal AEs were significantly less frequent in treatment-naive participants on TAF than in those on TDF (P=0.042), and all renal biomarker results significantly favored TAF over TDF.

A summary of renal safety results from Gilead clinical trials is presented below.6-13

In FANTA (N=28), a phase 4 trial that evaluated the renal safety of TAF treatment in participants with a prior history of PRT/Fanconi syndrome on a TDF-containing regimen, no participants experienced recurrent PRT over the course of 5 years of TAF exposure.14

Real-World Data: Renal Safety of FTC/TAF-Containing Regimens in PWH

• In PWH who switched from TDF-based to TAF‑based ARV regimens, significant improvements in eGFR were observed after switching, particularly in patients with pre‑switch eGFRs <90 mL/min/1.73 m2.15
• In a study among TE PWH and a history of CKD in BICSTaR, median eGFR levels were stable through 24 months of BIC/FTC/TAF treatment.16
• In ARV-naive PWH who initiated FTC/TAF-based regimens in the TAFNES cohort study, there was a significant decrease in eGFR (P<0.001) from baseline to Month 3 and a significant increase in the median SCr level (P<0.0001) from baseline to Month 24; among TE participants who switched from TDF to TAF and had a baseline eGFR (MDRD) <60 mL/min/1.73 m2, there was a significant increase in eGFR of +5.7 mL/min/1.73 m2 (P=0.003).17
• Case reports of renal events in individuals taking TAF have rarely been reported since the approval of TAF-containing products. Most of these cases are characterized by the presence of known risk factors for renal dysfunction (eg, history of prior TDF use, preexisting renal disease, diabetes or hypertension, HIV/HCV co-infection, coadministration with nephrotoxic drugs).18-25

Product Labeling1

Dosage and Administration

Not recommended in patients with severe renal impairment

FTC/TAF is not recommended in individuals with severe renal impairment (estimated CrCl of 15 to <30 mL/min), or ESRD (estimated CrCl <15 mL/min) who are not receiving chronic HD.1-4 BIC/FTC/TAF is also not recommended in individuals with no antiretroviral treatment history and ESRD who are receiving chronic HD.2

Warnings and Precautions

New onset or worsening renal impairment

Postmarketing cases of renal impairment, including acute renal failure, acute tubular necrosis, PRT, and Fanconi syndrome have been reported with TAF-containing products; while most of these cases were characterized by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related AEs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Individuals taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including nonsteroidal anti-inflammatories are at increased risk of developing renal-related adverse reactions.1-4

Clinical Pharmacology

Pharmacodynamics: effects on SCr

BIC2

BIC has been shown to increase SCr due to inhibition of tubular secretion of Cr without affecting renal glomerular function. Mean change from baseline in SCr in healthy subjects who received BIC 75 mg (1.5 times the approved recommended dosage) once daily with food for 14 days was 0.1 mg/dL on Days 7 and 14 compared to placebo. BIC did not have a significant effect on the estimated CrCl or on the actual GFR (determined by the clearance of probe drug, iohexol).

COBI3

COBI, a component of E/C/F/TAF, produces elevations of SCr due to inhibition of tubular secretion of Cr without affecting GFR. The elevation of SCr is typically seen within 2 weeks of starting therapy and is reversible after DC. Patients who experience a confirmed increase in SCr of >0.4 mg/dL from baseline should be closely monitored for renal safety.

The actual GFR, as determined by the clearance of probe drug iohexol, was not altered from baseline following treatment of COBI among subjects with an estimated CrCl of ≥50 mL/min, indicating COBI inhibits tubular secretion of Cr, reflected as a reduction in estimated CrCl without affecting the actual GFR. 

Clinical Trials: Renal Safety of FTC/TAF-Containing Regimens in PWH

Background

The renal safety profile of TAF-containing regimens has been well established, with >41,000 PY experience in clinical trials and >3.7 million PY experience with post‑approval use worldwide.5,26 Results from clinical trials involving TAF-containing regimens have demonstrated a renal safety profile comparable to regimens without tenofovir, such as regimens with ABC or DTG/3TC in PWH.6,8,27

In clinical trials of TAF-containing regimens for HIV treatment, PrEP, and HBV treatment, there have been no cases of PRT.5,26 Significantly fewer cases of renal AEs and fewer DCs due to renal AEs were observed in PWH taking TAF than in those taking TDF in clinical trials.5,11 Additionally, more favorable renal tubular biomarkers, such as RBP:Cr and β2M:Cr (increased levels of which signify evidence of potential tubular injury in PWH), were recorded in clinical trials with TAF use than with TDF use in the HIV treatment (Table 3), PrEP, and HBV treatment populations.5,11,28-30

Pooled Analysis of 26 TAF Clinical Trials

Study design5

An integrated analysis of participants from 26 TAF clinical trials (N=9322) was conducted to evaluate whether the improved renal biomarker profiles in the individual clinical trials were associated with improvements in clinical renal safety. Study details, primary outcomes, and secondary outcomes regarding the 26 clinical trials included in the analysis are listed in Table 1. Baseline demographics and characteristics of all participants are listed in Table 2.

Table 1. Pooled Analysis: Studies Included in the Integrated Analysis5,6,31

Table 2. Pooled Analysis: Baseline Demographics and Characteristics5

Results

There were no cases of PRT or Fanconi syndrome after 12,519 PY of exposure to TAF, compared with 10 cases after 5947 PY of exposure to TDF (P<0.001). A significantly greater number of participants discontinued treatment due to renal AEs after exposure to TDF than after exposure to TAF (14 vs 3; P<0.001).

Renal AEs were significantly less frequent in the TAF group than in the TDF group in studies of treatment-naive participants (47/866 [5.4%] vs 74/867 [8.5%]; P=0.042). However, there was no difference in the rate of renal AEs between the TAF and TDF groups in studies of virologically suppressed participants (114/2291 [5%] vs 89/1801 [5%]; P=1).

All pooled renal biomarker analyses (SCr, CrCl, dipstick proteinuria, UACR, RBP:Cr, β2M:Cr) in both treatment‑naive and virologically suppressed participants significantly favored TAF over TDF (Table 3).

Table 3. Renal Biomarker Analyses for TDF and TAF at Week 965

Note: Differences in the change or percentage change from baseline between the two treatment groups were compared using a linear regression analysis and rank analysis of covariance (baseline values were adjusted), respectively. Differences in incidence rates between treatment groups were compared using a logistic regression model.

Select Gilead Clinical Trial Data

Long-term data from clinical trials showed that the beneficial effects on markers of renal safety were maintained through Week 144 when TDF was compared with TAF in Studies 0104 and 0111.11 When comparing regimens containing TAF vs ABC (Studies 1489 and 1717), changes in markers of renal safety were comparable between the study arms.6,9 Additionally, in a pooled analysis of Studies 1489 and 1490 (BIC/FTC/TAF vs DTG + FTC/TAF), changes in eGFR were not statistically different between BIC/FTC/TAF and DTG-containing regimens in the comparator arms at Week 144 (DTG/ABC/3TC, P=0.13; DTG + FTC/TAF, P=0.28).12

FANTA Trial

Study design and demographics

FANTA was a phase 4, open-label, single-arm, multicenter trial in the UK that assessed the renal safety of a TAF-based regimen in participants who had previously developed PRT/Fanconi syndrome while receiving TDF (N=28).14,32 Participants without diabetes, with HIV RNA <200 c/mL, eGFR >30 mL/min/1.73 m2, and UPCR <100 mg/mmol who were naive to TAF were followed for 5 years on a TAF-based ARV regimen. Participants had a median age of 55 years, and 89% were White; the median time since HIV diagnosis was 21.3 years, and the median time since TDF discontinuation was 6.8 years.14

Results14

At Year 5, 26/28 participants (93%) remained on TAF. Two participants discontinued TAF (treatment simplification, n=1; switch in critical care unit for COVID-19 treatment, n=1). No participants experienced recurrent PRT during 134 PY of follow-up. No significant changes in eGFR, albuminuria, proteinuria, fractional excretion of phosphate, or ALP were observed.

Real-World Data: Renal Safety of FTC/TAF‑Containing Regimens in PWH

Renal Outcomes With TDF to TAF Conversions15

Study design and demographics

A retrospective study assessed changes in eGFR in PWH (N=1037) who switched from TDF- to TAF-based regimens. The included patients had received each regimen for ≥6 months, had ≥2 eGFR measurements (≥6 months apart) for each regimen and a baseline eGFR measurement within 6 months prior to the switch, and were not taking other HIV medications other than the switch regimens of interest. Estimated GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.

The cumulative mean duration of prior exposure to TDF was approximately 4.8 years. Details of baseline demographics are summarized in Table 4.

Table 4. Baseline Demographics, Clinical Characteristics, and Drug Exposure
(Rathbun et al)15

aBaseline eGFR was measured during treatment with TDF, within 6 months before switching to TAF.

Results

In general, mean adjusted eGFR improved after patients switched to a TAF-based regimen, with greater improvements observed in patients with eGFR <90 mL/min/1.73 m2 at baseline.

Table 5. Adjusted Changes in Mean eGFR15a

aMean eGFR changes were adjusted for individual and clinical characteristics, comorbidities, and concomitant medications and were stratified by baseline eGFR (≥90 mL/min/1.73 m2 and <90 mL/min/1.73 m2).

bP<0.001.

Adjusted, annualized eGFR slope calculations found that in patients with eGFR <90 mL/min/1.73 m2 during TDF treatment (baseline), eGFR increased significantly after switching to TAF. Among patients with baseline eGFR <90 mL/min/1.73 m2, patients with baseline eGFR ≥90 mL/min/1.73 m2, and the entire cohort, annualized eGFR slopes calculated from the mean baseline eGFR to the first eGFR measurement during TAF treatment were +6.51 (P<0.001), +0.54 (P=0.82), and +3.57 (P<0.01), respectively, over a mean time period of approximately 270 days. Annualized slopes to the last eGFR measurement during TAF treatment were +3.23 (P<0.001), -0.77 (P=0.52), and +1.51 (P=0.025), respectively, over a mean period of approximately 520 days.

BICSTaR Study16

Study design and demographics

BICSTaR is an ongoing, multinational, prospective cohort study investigating the effectiveness and safety of BIC/FTC/TAF in ARV-naive and TE PWH. The primary endpoint is virologic suppression (HIV-1 RNA <50 c/mL) at 12 months. A study was conducted to assess the renal safety profile and effectiveness of BIC/FTC/TAF in TE participants with a history of CKD. Participants who had baseline and Month 24 data or had discontinued BIC/FTC/TAF and/or the study prior to the analysis cutoff date (February 2022) and had baseline eGFR data were included (N=843). Baseline demographics are presented in
Table 6.

Table 6. BICSTaR: Baseline Demographics and Characteristics by Baseline eGFR16

aAt time of BIC/FTC/TAF initiation.

bAccording to a M=E analysis.

cAccording to the IA7 definition.

Results

A total of 90/843 participants (11%) with baseline eGFR data had CKD (eGFR <60 mL/min/1.73 m2); median eGFR values were stable through 24 months (Table 7).

Table 7. BICSTaR: MDRD eGFR Changes Through Month 2416

At 24 months, all participants with baseline CKD were virologically suppressed (HIV-1 RNA <50 c/mL). One participant with baseline CKD <50 mL/min/1.73 m2 had a drug-related AE of proteinuria that did not result in a discontinuation of BIC/FTC/TAF.

TAFNES Study17

Study design and demographics

TAFNES was a prospective, multicenter, non-interventional study conducted in Germany between 2016 and 2019 in ARV-naive (n=301) and TE (n=466) PWH who initiated or switched to an FTC/TAF-based treatment regimen (ie, E/C/F/TAF, RPV/FTC/TAF, or FTC/TAF + third agent). Outcomes included changes from baseline in SCr and eGFR MDRD and CG equations. Overall baseline demographics and disease characteristics are presented in Table 8.

Table 8. TAFNES: Baseline Demographics and Characteristics17

aBaseline scores were available for 253 ARV-naïve participants and 365 TE participants; 2% and 7%, respectively, were excluded from calculations due to an eGFR <60 mL/min/1.73m2.

Results

Among ARV-naive participants, the median (IQR) eGFR (MDRD) decreased from baseline to Month 3 by ‑11.3 (-21.2 to -1.6) mL/min/1.73 m2 (n=177; P<0.001) and was maintained thereafter; the median (IQR) change in eGFRCG was -3.2 (‑17.4 to 6.5) mL/min/1.73 m2 (n=119). From baseline to Month 24, the median level of SCr increased by +0.1 mg/dL (n=178; P<0.0001). In TE participants overall, eGFR (MDRD) was stable, and there were no significant changes in SCr regardless of treatment regimen or age at Month 24. Among those who switched from TDF to TAF and had a baseline eGFR (MDRD) <60 mL/min/1.73 m2, there was a significant increase in eGFR of +5.7 mL/min/1.73 m2 (P=0.003), with similar results seen when calculated with eGFRCG.

At Month 24, the median (IQR) change in the full 5-year CKD risk score among ARV-naive participants was 0% (0–0.6%); median 5-year risks for CKD were low, medium, and high in 0.2%, 2.1%, and 7.1%, respectively. The median (IQR) change among TE participants was 0% (0–0.8; n=178; P<0.001), and median 5-year risks for CKD were low in 0.4%, medium in 2.1%, and high in 8%. In participants who switched from TDF to TAF, the median change in 5-year CKD risk was estimated as 0% (0–‍0.6; n=127), compared with 0% (0–1.7; n=51) in all other participants.

Virologic suppression (HIV RNA <50 c/mL) at Month 24 was 96% (M=E). Overall, 133/767 participants (17%) discontinued; there was no significant difference in persistence between ARV-naive (80%) and TE participants (82%) at Month 24. Discontinuations due to ADRs were reported in 30/767 participants (4%). One ARV‑naive participant discontinued study drug due to an ADR of nephropathy toxic.

Case Reports of TAF and Suspected Renal Injury or Fanconi Syndrome

Renal events in individuals taking TAF have been reported rarely since the approval of TAF‑containing products.26 Rare is generally defined as a frequency of 0.01% to 0.1%.33 Events identified post marketing in the Gilead safety database informing 2021 product label updates included acute renal failure (58/88 [66%] cases), acute tubular necrosis (5/88 [6%] cases), proximal renal tubulopathy (16/88 [18%] cases), and Fanconi syndrome (12/88 [14%] cases), primarily in PWH. Most of these cases are characterized by the presence of known risk factors for renal dysfunction (eg, history of prior TDF use, pre-existing renal disease, diabetes or hypertension, HIV/HCV co-infection, coadministration with nephrotoxic drugs).19-23,26 Table 9 describes published case reports of AKI or suspected Fanconi syndrome development in patients who were switched to or initiated on TAF either empirically or because of TDF-associated tubulopathy. Please note this table only includes case reports where the primary focus is AKI or Fanconi syndrome. This list is not exhaustive of all cases found in the literature. Case reports not included can be found by conducting a literature search via PubMed or other databases.

There are limitations in the interpretation of case reports. Case reports cannot be generalized. Unlike controlled clinical trials, causality cannot be inferred based on the uncontrolled observational nature of a spontaneous case report. Additionally, incidence or prevalence cannot be estimated due to the lack of a representative population sample. Other limitations of spontaneous case reports include the retrospective nature of the information provided and publication bias.34

Table 9. Summary of Published Case Reports With TAF and Suspected Renal Injury or Fanconi Syndrome18-25

References

1. Enclosed. Gilead Sciences Inc, DESCOVY® (emtricitabine and tenofovir alafenamide) tablets, for oral use. U. S. Prescribing Information. Foster City, CA.

2. Enclosed, Gilead Sciences Inc. BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use. US Prescribing Information. Foster City, CA.

3. Enclosed. Gilead Sciences Inc, GENVOYA® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use. US Prescribing Information. Foster City, CA.

4. Enclosed. Gilead Sciences Inc, ODEFSEY® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use. US Prescribing Information. Foster City, CA.

5. Gupta SK, Post FA, Arribas JR, et al. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019;33(9):1455-1465.

6. Winston A, Post FA, DeJesus E, et al. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018;5(4):e162-171. http://dx.doi.org/10.1016/S2352-3018(18)30010-9

7. Workowski K, Orkin C, Sax P, et al. Four-year outcomes of B/F/TAF in treatment-naïve adults [Poster 2268]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI) Virtual; 6-10 March, 2021.

8. Orkin C, DeJesus E, Sax PE, et al. Three-Year Outcomes of the Fixed-Dose Combination Bictegravir, Emtricitabine, and Tenofovir Alafenamide vs Dolutegravir-Containing Regimens for Initial Treatment of HIV-1 Infection: Week 144 Results from Two Randomised, Double-Blind, Multicentre, Phase 3, Non-Inferiority Trials. The Lancet HIV. 2020;7:e389–400.

9. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials [Supplementary Appendix]. The Lancet HIV. 2020;7(6):e389-e400. https://www.ncbi.nlm.nih.gov/pubmed/32504574

10. Winston A, Post FA, DeJesus E, et al. Randomized Double-blind Trial Comparing Switching to TAF/FTC- versus Continuing ABC/3TC-based Regimens in Virologically Suppressed Adults (Study 1717): 48 Week Results [Presentation]. Paper presented at: 16th European AIDS Conference; 25-27 October, 2017; Milan, Italy.

11. Arribas JR, Thompson M, Sax PE, et al. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017;75(2):211-218. http://www.ncbi.nlm.nih.gov/pubmed/28282300

12. Orkin C, Sax PE, Arribas J, et al. Long-term Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve Adults [Poster PE3/14]. Paper presented at: 17th European AIDS Conference; 06-09 November, 2019; Basel, Switzerland.

13. Wohl DA, Pozniak A, Workowski K, et al. B/F/TAF Five-Year Outcomes in Treatment-Naïve Adults [Poster 494]. Paper presented at: Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 12-16 February, 2022.

14. Campbell L, Barbini B, Cromarty B, et al. Safety of Tenofovir Alafenamide in individuals with a history of Proximal Renal Tubulopathy on TDF [Poster 828]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver, CO.

15. Rathbun R, Skol L, Kandilian R, et al. Real-World HIV Renal Outcomes With TDF to TAF Switch. Paper presented at: AIDS 2022; 29 July-2 August, 2022; Montreal, Quebec, Canada.

16. Rieke A, De Wet J, Esposito V, et al. Real-World Effectiveness and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in Treatment-Experienced (TE) People With HIV With a History of CKD [Poster TH-PO1072]. Paper presented at: ASN Kidney Week; November 2-5, 2023; Philadelphia, PA.

17. Stephan C, Spinner CD, Rieke A, et al. Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study. HIV Med. 2025;26(2):239-251.

18. Davis S, Mendez PR, Sampson R, Silverman R, Kaul V. Obstructive Nephropathy versus Tenofovir-induced Fanconi Syndrome in a 17 y/o Gravida with Congenital HIV: A case Report. [Abstract #83]. Journal of Pediatric and Adolescent Gynecology. 2025;38(2):270.

19. Bahr NC, Yarlagadda SG. Fanconi Syndrome and Tenofovir Alafenamide: A Case Report. Annals of Internal Medicine. 2019;170(11):814-815. https://www.ncbi.nlm.nih.gov/pubmed/30690644

20. Serota DP, Franch HA, Cartwright EJ. Acute Kidney Injury in a Patient on Tenofovir Alafenamide Fumarate After Initiation of Treatment for Hepatitis C Virus Infection. Open Forum Infect Dis. 2018;5(8):ofy189. https://www.ncbi.nlm.nih.gov/pubmed/30151414

21. Novick TK, Choi MJ, Rosenberg AZ, McMahon BA, Fine D, Atta MG. Tenofovir alafenamide nephrotoxicity in HIV-positive patient. Medicine (Baltimore). 2017;96(36).

22. Ibrahim BB, Lamarche J, Velez AP, et al. Tenofovir Alafenamide and proximal tubule mitochondrial toxicity. American Journal of Kidney Diseases. 2018;7(4).

23. Abbasi AA, Patti R, Ghatak A, Seneviratne C, Kupfer Y, Kamholz S. Tenofovir Alafenamide-Induced Renal Tubular Acidosis. Am J Ther. 2019;26(5):e627-e628. https://www.ncbi.nlm.nih.gov/pubmed/31498779

24. Lamarche J, Ibrahim BB, Radoianu N, et al. Tenofovir alafenamide and proximal tubule mitochondrial toxicity [Poster]. 2018.

25. Ueaphongsukkit T, Gatechompol S, Avihingsanon A, et al. Tenofovir alafenamide nephrotoxicity: a case report and literature review. AIDS Res Ther. 2021;18(1):53.

26. Gilead Sciences Inc. Data on File.

27. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC Fixed-Dose Combination (FDC) is Non-Inferior to Continuing a TAF-Based Regimen (TBR) in Maintaining Virologic Suppression Through 96 Weeks (TANGO Study) [Presentation]. Paper presented at: HIV Drug Therapy Glasgow 2020 Virtual; 05-08 October, 2020.

28. Mayer KH, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020;396(10246):239-254.

29. Chan HLY, Lim YS, Seto WKW, et al. 3-Year Efficacy and Safety of Tenofovir Alafenamide Compared With Tenofovir Disoproxil Fumarate in HBeAg-Negative and -Positive Patients With Chronic Hepatitis B [Poster 381]. Paper presented at: AASLD: The Liver Meeting® 2018; 09-13 November, 2018; San Francisco, CA.

30. Fiseha T, Gebreweld A. Urinary Markers of Tubular Injury in HIV-Infected Patients. Biochem Res Int. 2016;2016:1501785.

31. Gallant JE, Daar ES, Raffi F, et al. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016;3(4):e158-165. https://www.ncbi.nlm.nih.gov/pubmed/27036991

32. Campbell L, Barbini B, Burling K, et al. Safety of Tenofovir Alafenamide in People With HIV Who Experienced Proximal Renal Tubulopathy on Tenofovir Disoproxil Fumarate. J Acquir Immune Defic Syndr. 2021;88(2):214-219.

33. European Medicines Agency. New product information wording – Extracts from PRAC recommendations on signals. EMA/PRAC/1320/2016.  January 2016.

34. Nissen T, Wynn R. The Clinical Case Report: A Review of Its Merits and Limitations. BMC Res Notes. 2014;7:264. https://www.ncbi.nlm.nih.gov/pubmed/24758689

Abbreviations

3TC=lamivudine
ABC=abacavir
ADR=adverse drug reaction
AE=adverse event
AKI=acute kidney injury
ALP=alkaline phosphatase
ARV=antiretroviral
β2M=β-2 microglobulin
BIC=bictegravir
CG=Cockcroft-Gault
CKD=chronic kidney disease
COBI=cobicistat
CVD=cardiovascular disease
DC=discontinuation
DRV=darunavir
DRV/c=darunavir/cobicistat
DRV/r=darunavir/
ritonavir
DTG=dolutegravir
E/C/F/TAF=elvitegravir/
cobicistat/emtricitabine/
tenofovir alafenamide
E/C/F/TDF=elvitegravir/
cobicistat/emtricitabine/
tenofovir disoproxil fumarate
ESRD=end-stage renal disease
FTC=emtricitabine
HD=hemodialysis
HTN=hypertension
ICU=intensive care unit
LDV/SOF=ledipasvir/
sofosbuvir
M=E=missing=excluded
MDRD=Modification of Diet in Renal Disease
PWH=people with HIV
PrEP=pre-exposure prophylaxis
PRT=proximal renal tubulopathy
PY=patient years
RAL=raltegravir
RBP=retinol-binding protein
RPV=rilpivirine
T2DM=type 2 diabetes mellitus
TAF=tenofovir alafenamide
TDF=tenofovir disoproxil fumarate
TE=treatment-experienced
UACR=urine albumin:creatinine ratio
UPCR=urine protein:creatinine ratio
 

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Descovy, Biktarvy, Genvoya, and Odefsey US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.

Follow-Up

For any additional questions, please contact Gilead Medical Information at:

☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

Data Privacy

The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.

It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact privacy@gilead.com.

DESCOVY, BIKTARVY, GENVOYA, ODEFSEY, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
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