Dosing Recommendations

Dosing recommendations for TRIUMEQ for HLA-B*5701–negative adults

r=ritonavir.

Drug Interactions

Dosing considerations with other medications

Mg=magnesium; Al=aluminum.

Contraindication for use of dolutegravir with other medications

Coadministration is not recommended with the following agents

  • TRIUMEQ is a fixed-dose regimen and should not be administered concomitantly with other products containing abacavir or lamivudine
  • See Dosing Recommendations section for dosing adjustments with efavirenz, fosamprenavir/r, tipranavir/r, carbamazepine, or rifampin

TRIUMEQ had no clinically relevant effects on the pharmacokinetics of the following agents in drug interaction studies

Please see the Drug Interactions table above for additional drug interaction information.

TRIUMEQ has no clinically relevant effects on the pharmacokinetics of the following agents based on known metabolic pathways and/or available drug interaction studies1,2

Characteristics

Dosing characteristics of selected ART1

Characteristics

*TRIUMEQ alone is not recommended for use in patients with current or past history of resistance to any components of TRIUMEQ. TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. Coadministration of TRIUMEQ with efavirenz, fosamprenavir/r, tipranavir/r, carbamazepine, or rifampin requires an additional dolutegravir 50-mg tablet, separated by 12 hours from TRIUMEQ.

ART=antiretroviral therapy; TDF/FTC=tenofovir/emtricitabine; c=cobicistat; TAF=tenofovir alafenamide; NRTIs=nucleoside reverse transcriptase inhibitors; INSTI=integrase strand transfer inhibitor.

  • Direct comparisons of the safety and efficacy of these products should not be made. Please refer to the Prescribing Information for each product for additional information

Booster Free

TRIUMEQ Is a booster-free treatment option14

Administer TRIUMEQ 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TRIUMEQ and supplements containing calcium or iron can be taken with food.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.

References

  1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. Department of Health and Human Services. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed July 18, 2016.
  2. HCV guidance: recommendations for testing, managing, and treating hepatitis C. American Association for the Study of Liver Diseases and Infectious Diseases Society of America. http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-hivhcv-coinfection. Accessed July 18, 2016.
  3. Luetkemeyer AF, McDonald C, Ramgopal M, et al. 12 weeks of daclatasvir in combination with sofosbuvir for HIV-HCV coinfection (ALLY-2 study): efficacy and safety by HIV combination antiretroviral regimens. Clin Infect Dis. 2016;62(12):1489-1496.
  4. Garrison K, Custodio J, Pang P, et al. Drug interactions between anti-HCV antivirals ledipasvir/sofosbuvir and integrase strand transfer inhibitor-based regimens [abstract 71]. Presented at:16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; May 26-28, 2015; Washington, DC.
  5. Harvoni [package insert]. Gilead Sciences, Inc.: Foster City, CA; June 2016.
  6. Olysio [package insert]. Janssen Therapeutics: Titusville, NJ; May 2016.
  7. Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2(8):e319-e327.
  8. Yeh W, Feng HP, Guo Z, et al. Drug-drug interaction between HCV inhibitors grazoprevir/elbasvir with dolutegravir [abstract 522]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 23-26, 2015; Seattle, WA.
  9. Song I, Jerva F, Zong J, et al. Evaluation of drug interactions between dolutegravir and daclatasvir in healthy subjects [abstract 79]. Presented at: 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; May 26-28, 2015; Washington, DC.
  10. Daklinza [package insert]. Bristol-Myers Squibb Company: Princeton, NJ; April 2016.
  11. Khatri A, Trinh R, Zhao W, et al. Drug-drug interactions of ombitasvir/paritaprevir/r plus dasabuvir with dolutegravir or abacavir plus lamivudine. Presented at: Clinical Pharmacology of HIV and Hepatitis Therapy; May 26-28, 2015; Washington, DC.
  12. Viekira Pak [package insert]. AbbVie Inc: North Chicago, IL; June 2016.
  13. Epclusa [package insert]. Gilead Sciences, Inc.: Foster City, CA; June 2016.
  14. Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1):254-258.