Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 May 11;15(5):1470.
doi: 10.3390/pharmaceutics15051470.

Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ and DOVATO in Healthy Adult Participants

Hardik Chandasana  1 , Ryan Marnoch  2 , Michael McKenna  3 , Julia Double  3 , Ciara Seal  4 , Gilda Bontempo  5 , Allen Wolstenholme  6 , Ann Buchanan  7
Affiliations

Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ and DOVATO in Healthy Adult Participants

Hardik Chandasana et al. Pharmaceutics. .

Abstract

This randomized food effect study in healthy adult participants examined dispersible tablet formulations of fixed-dose combinations of dolutegravir/abacavir/lamivudine (TRIUMEQ) and dolutegravir/lamivudine (DOVATO). While adult tablet formulations of these combinations are currently approved for the treatment of human immunodeficiency virus, alternate formulations for children are urgently needed to facilitate appropriate pediatric dosing for patients who may have difficulty swallowing a conventional tablet. This study compared the effect of a high-fat, high-calorie meal on the pharmacokinetics, safety, and tolerability of dispersible tablet (DT) formulations of the two-drug and three-drug regimens, with administration under fasting conditions. Both the two-drug and three-drug dispersible tablet formulations, administered under fasting conditions and following a high-fat, high-calorie meal, were well tolerated in healthy participants. There were no clinically relevant differences in drug exposure for either regimen when administered with a high-fat meal as compared to under fasting conditions. Safety observations were similar for both treatments, either in the fed or fasted state. Both TRIUMEQ DT and DOVATO DT formulations can be administer with or without food.

Keywords: HIV/AIDS; dispersible tablet; fixed-dose combination; food effect(s); pediatric; pharmacokinetics.

PubMed Disclaimer

Conflict of interest statement

The study was funded by ViiV Healthcare. H.C., M.M., J.D., A.W. and C.S. are employees of GSK and own stock in GSK. G.B. and A.B. are employees of ViiV Healthcare and own stock in GSK. R.M. is a former employee of GSK and may hold company stock. The authors were not paid for their publication contributions.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Ratios of GLS means and 90% CIs (TRIUMEQ DT Fed (Treatment A) vs. TRIUMEQ DT Fasted (Treatment B)) for primary PK parameters. Treatment A = TRIUMEQ (dolutegravir 5 mg/abacavir 60 mg/lamivudine 30 mg) 6 DTs dispersed in 20 mL water (fed); Treatment B = TRIUMEQ (dolutegravir 5 mg/abacavir 60 mg/lamivudine 30 mg) 6 DTs dispersed in 20 mL water (fasted); CI = confidence interval.
Figure 3
Figure 3
Ratios of GLS means and 90% CIs (DOVATO DT Fed (Treatment C) vs. DOVATO DT Fasted (Treatment D)) for primary PK parameters. Treatment C = DOVATO (dolutegravir 5 mg/lamivudine 30 mg) 6 DTs dispersed in 20 mL water (fed); Treatment D = DOVATO (dolutegravir 5 mg/lamivudine 30 mg) 6 DTs dispersed in 20 mL water (fasted); CI = confidence interval.
See this image and copyright information in PMC

References

    1. UNAIDS . Global HIV & AIDS Statistics—Fact Sheet. UNAIDS; Geneva, Switzerland: 2021.
    1. ViiV Healthcare . TRIUMEQ Tablets [Package Insert] Food and Drug Adminstration; Silver Spring, MD, USA: 2014.
    1. ViiV Healthcare . DOVATO Tablets [Package Insert] Food and Drug Adminstration; Silver Spring, MD, USA: 2019.
    1. US FDA Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. [(accessed on 3 February 2021)];2002 Available online: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....
    1. Weller S., Chen S., Borland J., Savina P., Wynne B., Piscitelli S.C. Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food. J. Acquir. Immune Defic. Syndr. 2014;66:393–398. doi: 10.1097/QAI.0000000000000193. - DOI - PubMed