Switching from twice-daily raltegravir plus tenofovir disoproxil fumarate/emtricitabine to once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate in virologically suppressed, HIV-1-infected subjects: 48 weeks data.
BACKGROUND
Pill burden, dosing frequency, and concerns about safety and tolerability are important obstacles to maintaining adequate medication adherence. Raltegravir (RAL) is indicated for twice-daily dosing and when taken with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), it becomes a twice-daily multiple-tablet regimen. Elvitegravir (EVG)/cobicistat (COBI)/FTC/TDF, STB, is the first approved once-a-day integrase strand transfer inhibitor (INSTI) containing single-tablet regimen that combines EVG, an INSTI, and COBI, a novel pharmacoenhancer, with the preferred nucleos(t)ide backbone of FTC/TDF.


METHODS
This was a 48-week prospective, single-arm open-label study of the switch to STB in virologically sup-pressed HIV-1-infected adult patients on FTC/TDF and twice-daily RAL for at least 6 months. Objectives were to evaluate the tolerability and safety of a regimen simplification to once-a-day STB, while maintaining viral suppression through 48 weeks.


RESULTS
Forty-eight individuals in the United States were enrolled. The median age was 44 years, 96% were male, and 83% were White. The median time on RAL + FTC/TDF treatment prior to enrollment was 34 months. Ninety-six percent of participants cited regimen simplification as the reason to enroll in the switch study. At base-line, the median CD4 count was 714 cell/µL and estimated glomerular filtration rate (eGFR) was 105 mL/min. At week 48, all assessed study participants remained viro-logically suppressed to the lower limit of quantification (HIV-1 RNA<50 copies/mL) and maintained high CD4 cell count (median, 751 cells/mL) and stable eGFR (median, 100.5 mL/min). STB was well tolerated with no discontinuations, no study drug-related serious adverse events, and no study drug-related grade 3/4 adverse events.


CONCLUSIONS
All participants switching to 1 tablet once-a-day STB from a twice-daily RAL + FTC/TDF regimen remained virologically suppressed. STB was well tolerated. Switching to STB may be a viable option for virologically suppressed patients wanting to simplify from a twice-daily RAL-containing regimen.
Anthony Mills MD, Los Angeles, California.
A
A
Mills
G. Crofoot, Houston, Texas.
G
G
Crofoot
Orlando Immunology Center, Orlando, Florida.
R
R
Ortiz
Capital Med Associates, Washington, DC.
B
B
Rashbaum
Kaiser Permanente, Los Angeles, California.
W
W
Towner
Dupont Circle Physician's Group, Washington, DC.
D
D
Ward
Central Texas Clinical Research, Austin, Texas.
C
C
Brinson
Gilead Sciences, Inc., Foster City, California.
R
R
Kulkarni
Gilead Sciences, Inc., Foster City, California.
W
W
Garner
Gilead Sciences, Inc., Foster City, California.
R
R
Ebrahimi
Gilead Sciences, Inc., Foster City, California.
H
H
Cao
Gilead Sciences, Inc., Foster City, California.
A
A
Cheng
Gilead Sciences, Inc., Foster City, California.
J
J
Szwarcberg
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects; D000069547:Cobicistat; D003404:Creatinine / Q000097:blood / Q000378:metabolism; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011760:Pyrrolidinones / Q000008:administration & dosage / Q000009:adverse effects; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects; D000068898:Raltegravir Potassium; D000068698:Tenofovir; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load
D019380:Anti-HIV Agents; D002219:Carbamates; D004338:Drug Combinations; D063065:Organophosphonates; D011760:Pyrrolidinones; D015363:Quinolones; D013844:Thiazoles; D003841:Deoxycytidine; D000068898:Raltegravir Potassium; C509700:elvitegravir; D000068698:Tenofovir; D003404:Creatinine; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat
HIV-1; antiretroviral regimen simplification; single-tablet regimen; treatment experienced