BACKGROUND: If HIV patients are unconscious or cannot swallow tablets for other 
reasons, antiretroviral medication is crushed and dissolved prior to 
administration. Crushing can alter drug exposure, possibly leading to treatment 
failure, development of resistance or toxicity. Currently, there is no 
information about crushing of the branded fixed-dose combination of 
dolutegravir/abacavir/lamivudine (Triumeq®, referred to as TRI); therefore, 
crushing of TRI is not recommended.
OBJECTIVES: To investigate whether the TRI fixed-dose combination tablet can be 
crushed and combined with enteral nutrition without influencing pharmacokinetics 
(PK).
METHODS: We carried out an open-label, three-period, randomized, single-dose, 
crossover trial in 22 healthy adult volunteers. Subjects randomly received 
whole-tablet TRI with fasting (reference), crushed and suspended TRI with 
fasting or crushed and suspended TRI with oral intake of enteral nutrition. 
Bioequivalence criteria (80%-125% acceptance range) of AUC0-∞ and Cmax were 
used. ClinicalTrials.gov: NCT02569346.
RESULTS: Crushing TRI leads to higher dolutegravir exposure (AUC0-∞: +26% and 
Cmax: +30%) and, if crushed TRI is combined with enteral nutrition, to a 
decrease in abacavir Cmax (-17%). Lamivudine concentrations were not affected as 
geometric mean ratios with 90% CIs fell within the 80%-125% range.
CONCLUSIONS: Bioequivalence could not be demonstrated for a crushed and 
suspended tablet or a crushed and suspended tablet with oral intake of enteral 
nutrition compared with whole-tablet TRI with fasting. Both scenarios led to 
higher dolutegravir exposure, but this did not exceed exposure after intake with 
food or in twice-daily dosing. In our opinion, TRI can be crushed for patients 
with swallowing difficulties and can be simultaneously administered with enteral 
nutrition.