Early Safety of Tenofovir Alafenamide in Patients With a History of Tubulopathy on Tenofovir Disoproxil Fumarate

A Randomized Controlled Clinical Trial

L Hamzah; D Williams; AC Bailey; R Jones; F Ibrahim; CG Musso; K Burling; B Barbini; L Campbell; FA Post

Disclosures

HIV Medicine. 2020;21(3):198-203. 

In This Article

Results

Study Population

Between February 2017 and May 2018, 36 individuals were screened. Four patients were excluded having not met the eligibility criteria at screening (glycosuria, n = 1; proteinuria, n = 1; HIV viral load > 200 copies/mL, n = 2), and one by investigator decision, leaving 31 subjects randomized to the immediate arm (n = 16) or deferred arm (n = 15); all 31 completed their week 12 visit on the allocated strategy and were included in the analyses (Figure S1).

Figure S1.

Consort diagram

Figure S2.

Median [IQR] Urine retinol binding protein:creatinine ratio by allocated study arm

Baseline demographic and clinical characteristics were similar in the two treatment arms (Table 1 and Table S2). The majority of study participants were white and male, with a median age of 52.4 years and prolonged known HIV infection (median 20.1 years) and exposure to ART (median 12.6 years). The median time since PRT resulting in TDF discontinuation was 6.8 (IQR 5.0, 10.1; range 0.8, 13.2) years. The diagnosis of PRT was based on biochemical criteria in 28 and on kidney biopsy in three participants. Incomplete assessment or documentation precluded an evaluation of all tubulopathy criteria in each participant.

Primary Outcome

RBPCR levels at baseline were numerically higher in participants randomized to the immediate arm, while at week 12 they were similar in the two arms. The mean adjusted change in RBPCR from baseline to week 12 in the deferred arm versus the immediate arm was + 19.6 (95% CI −35.5, 74.5) μg/mmol (P = 0.471; Table 2 and Figure S1), with no increase in outliers (Table S1).

Secondary Outcomes

We observed no significant changes in serum or urine biomarkers of renal function, and no significant difference in PTH and bone turnover markers between the two study arms. No serious adverse events or cases of PRT were reported.

processing....