BACKGROUND: Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir 
disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a recommended integrase 
inhibitor-based regimen in treatment guidelines from the US Department of Health 
and Human Services and the British HIV Association. The purpose of this analysis 
was to determine the change in patient-reported symptoms over time among 
HIV-infected adults who switch to Stribild(®) versus those continuing on a 
protease inhibitor (PI) with FTC/TDF.
METHODS: A secondary analysis was conducted on the STRATEGY-PI study 
(GS-US-236-0115, ClinicalTrials.gov NCT01475838), a randomized, open-label, 
phase 3b trial of HIV-infected adults taking a PI with FTC/TDF who were randomly 
assigned (2:1) either to Stribild(®) (switch) or continuation of their existing 
regimen (no-switch). Logistic regressions and longitudinal modeling were 
conducted to evaluate the relationship of treatment with bothersome symptoms.
RESULTS: At week 4 as compared with baseline, the switch group experienced a 
statistically significantly lower prevalence in five symptoms (diarrhea/loose 
bowels, bloating/pain/gas in stomach, pain/numbness/tingling in hands/feet, 
nervous/anxious, and trouble remembering). The lower prevalence of 
diarrhea/loose bowels, bloating/pain/gas in stomach, and pain/numbness/tingling 
in hands/feet observed at week 4 was maintained over time. While there were no 
significant differences between groups in the prevalence of sad/down/depressed 
and problems with sex at week 4 or week 48, longitudinal models indicated the 
switch group had a statistically significantly decreased prevalence in both 
symptoms from week 4 to week 48. As compared with the no-switch group, higher 
levels of satisfaction with treatment were experienced by patients in the switch 
group at the first follow-up visit and at week 24.
CONCLUSIONS: In this study sample, a switch from a ritonavir-boosted PI, FTC, 
and TDF regimen to coformulated EVG/COBI/FTC/TDF was associated with more 
treatment satisfaction and a reduction in the prevalence of patient-reported 
diarrhea/loose bowel symptoms, which was maintained over the 48-week study 
period.