
Methods: HIV-infected adults suppressed on regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF), were randomized 1:1 to continue their current bPI regimen or switch to open-label coformulated B/F/TAF (50/200/25 mg) once daily. Primary endpoint was proportion with HIV-1 RNA ≥50 copies/mL (c/mL) at W48 (FDA snapshot). Noninferiority was assessed through 95.002% confidence intervals (CI) using a margin of 4%. Secondary endpoints included proportion with HIV-1 RNA <50 c/mL and safety measures at W48.
Results: 577 participants were randomized and treated with B/F/TAF (n=290) or current bPI regimens (n=287): 17% women, 26% Black, median age 48 yrs. Most were receiving a bPI with FTC/TDF (85%) at screening. At W48, switching to B/F/TAF was noninferior to continuing bPI with 1.7% in each group having HIV-1 RNA ≥50 c/mL (difference -0.0%; 95.002%CI -2.5% to 2.5%, p=1.00); the proportion with HIV-1 RNA <50 c/mL was 92.1% in B/F/TAF vs 88.9% in bPI. No participant on B/F/TAF developed resistance to study drugs. One participant on DRV/ritonavir + ABC/3TC developed a treatment-emergent L74V mutation. Incidence of grade 3 or 4 AEs was similar (B/F/TAF 4%, bPI regimens 6%). No renal discontinuations or tubulopathy cases occurred with B/F/TAF.
Conclusion: Adults switching to B/F/TAF from a boosted PI maintained high rates of virologic suppression without resistance. B/F/TAF was safe and well tolerated.

E. Daar,
Bristol-Myers Squibb:
Consultant
,
Consulting fee
Gilead Sciences, Inc.:
Consultant
,
Grant Investigator
and
Scientific Advisor
,
Consulting fee
and
Research support
Janssen:
Consultant
,
Grant Investigator
and
Scientific Advisor
,
Consulting fee
and
Research support
Merck:
Consultant
,
Grant Investigator
and
Scientific Advisor
,
Consulting fee
and
Research support
Teva Pharmaceuticals:
Consultant
and
Scientific Advisor
,
Consulting fee
ViiV:
Consultant
,
Grant Investigator
and
Scientific Advisor
,
Consulting fee
and
Research support
Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and Vertex: Scientific Advisor , Consulting fee
P. Ruane, Gilead: Investigator , Scientific Advisor and Shareholder , Consulting fee and Research support
Merck: Speaker's Bureau , Speaker honorarium
Boehringer: Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
Janssen: Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
Abbott: Investigator , Scientific Advisor and Speaker's Bureau , Research support and Speaker honorarium
Idenix: Investigator , Research support
ViiV: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
BMS: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
G. Crofoot, Gilead: Investigator and Scientific Advisor , Advisory honorarium and Research grant
ViiV: Investigator and Scientific Advisor , Advisory honorarium , Research grant and Research support
G. Oguchi, None
C. Creticos, Thera Technologies and ViiV Healthcare: Scientific Advisor , Consulting fee
Gilead sciences, Merck, and ViiV Healthcare: Investigator , Research support
Pfizer: Speaker's Bureau , Speaker honorarium
J. K. Rockstroh, Abbvie: Consultant and Investigator , Consulting fee and Speaker honorarium
Gilead: Consultant , Investigator and Scientific Advisor , Consulting fee and Speaker honorarium
ViiV: Scientific Advisor , Consulting fee
Janssen: Investigator and Speaker at educational event , Speaker honorarium
J. M. Molina, Gilead, ViiV, Merck, Janssen, BMS and TEVA: Scientific Advisor , Speaker honorarium
E. Koenig, None
Y. P. Liu, Gilead: Employee and Shareholder , Salary and Shareholder
K. Andreatta, Gilead: Employee and Shareholder , Salary and Shareholder
H. Graham, Gilead Sciences: Employee and Shareholder , Salary
A. Cheng, Gilead: Employee and Shareholder , Salary
H. Martin, Gilead Sciences: Employee , Salary
E. Quirk, Gilead: Employee and Shareholder , Salary