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. 2018 Jun 29;11(5):561–573. doi: 10.1007/s40271-018-0322-8

Table 4.

Summary of results from adjusted logistic regression analyses at weeks 4, 12, and 48 and longitudinal analyses in Study GS-US-380-1489 (treatment-naïve)

HIV-SI bothersome symptom Week 4 Week 12 Week 48 Longitudinal model Description of longitudinal findings
Fatigue/loss of energy Decreased prevalence in B/F/TAF group maintained over study period without any changes in prevalence from week 4 to week 48 for either group
Dizzy/lightheadedness Decreased prevalence in B/F/TAF group, ABC/DTG/3TC group with fluctuating prevalence
Nausea/vomiting Increased initial prevalence in ABC/DTG/3TC group (at week 4) maintained over study period with decreasing prevalence in both groups from week 4 to week 48
Difficulty sleeping No differences in prevalence observed between groups from week 4 to week 48
Headaches Decreased prevalence in B/F/TAF group from week 4 to week 48
Loss of appetite Decreased prevalence in B/F/TAF group, ABC/DTG/3TC group with fluctuating prevalence
Bloating/pain/gas in stomach No differences in prevalence observed between groups from week 4 to week 48
Changes in body composition Slight increased prevalence in B/F/TAF group and a greater increased prevalence in ABC/DTG/3TC group
Weight loss/wasting No differences in prevalence observed between groups from week 4 to week 48
Poor sleep quality (from PSQI) Decreased prevalence in B/F/TAF group starting from week 4 and maintained over study period with minimal changes in ABC/DTG/3TC group

ABC/DTG/3TC co-formulated abacavir, dolutegravir, and lamivudine, B/F/TAF co-formulated bictegravir, emtricitabine, and tenofovir alafenamide, HIV-SI HIV Symptom Index, PSQI Pittsburgh Sleep Quality Index

✓ = Statistically significant favoring the B/F/TAF group; ‡ = statistically significant time-by-treatment interaction (i.e., changes over time depend on treatment)