142nd APHA Annual Meeting and Exposition

Annual Meeting Recordings are now available for purchase

Switch from NNRTI plus TVD to STB Maintains HIV Suppression and is Well- Tolerated

142nd APHA Annual Meeting and Exposition (November 15 - November 19, 2014): http://www.apha.org/events-and-meetings/annual
Monday, November 17, 2014 : 1:30 PM - 1:45 PM

Thanes Vanig, MD , Spectrum Medical Group, P.C., Phoenix, AZ
Anton Pozniak, MD , Chelsea and Westminster NHS Foundation Trust Hospital, London, United Kingdom
Jason Hindman, PharmD, MBA , Gilead Sciences, Foster City, CA
Will Garner, PhD , Gilead Sciences, Foster City, CA
David Piontkowsky, JD, MD , Gilead Sciences, Foster City, CA
Background:  We report Week (W) 48 results of a prospective, randomized, open-label trial of switching to elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) from non-nucleoside reverse transcriptase inhibitor (NNRTI) plus emtricitabine/tenofovir DF (TVD) in HIV subjects.

Methods:  Subjects suppressed on NNRTI + TVD for ≥ 6 months were randomized (2:1) to switch to STB or remain on their regimen. Eligibility criteria included CrCl ≥ 70 mL/min, no resistance to FTC and TDF, exposure ≤2 prior ARV regimens and no history of virologic failure.  Primary endpoint was the proportion of subjects who maintained HIV-1 RNA < 50 c/mL at W48 by FDA snapshot.

Results: 434 subjects were randomized and treated (291 STB; 143 NNRTI).  Baseline characteristics were similar between the two groups. STB was noninferior to NNRTI regimens, as 93% and 88% respectively maintained HIV-1 RNA < 50 c/mL at W48 (difference 5.3%, 95% CI -0.5%, +12.0%). Virologic failure rates were 1% with no resistance detected in either group. Mild and transient headache and nausea occurred at slightly higher rates in the STB than NNRTI group. Grade 3 or 4 adverse events were low and similar in both groups.  Median changes in CrCl (mL/min) at W48 were -11.6 and -0.2 respectively. Subjects who switched to STB reported lower rates of neuropsychiatric symptoms compared to baseline and to those remaining on NNRTI. They also reported more treatment satisfaction.

Conclusions: Switching to STB was associated with high rates of virologic suppression, no resistance development, favorable tolerability, and improved treatment satisfaction.

Learning Areas:

Basic medical science applied in public health
Chronic disease management and prevention
Other professions or practice related to public health
Provision of health care to the public

Learning Objectives:
Describe the efficacy, safety and patient benefits of switching from a NNRTI-based regimen to the single-tablet-regimen of STRIBILD (STB) in pts with HIV-1 infection.

Keyword(s): HIV/AIDS, Treatment

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: STB does not currently have a "switch" indication in the FDA label, however this data is being submitted now to request this label change.

Qualified on the content I am responsible for because: I was a study investigator for this study "121," aka the switch from NNRTI plus TVD to Stribild. I have over 16 years practicing medicine with specialty training in infectious diseases, especially HIV medicine. I am certified by the American Academy of HIV Medicine and I have given numerous talks at international conferences on HIV.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Gilead Sciences HIV Advisory Committee/Board, Consultant, Speaker's bureau and teaching engagements and Stock Ownership
Abbott/AbbVie HIV Advisory Committee/Board and Consultant
ViiV HIV Advisory Committee/Board, Consultant and Speaker's bureau and teaching engagements
Bristol-Myers Squibb HIV Advisory Committee/Board and Consultant

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.