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