Dosing Recommendations

Dosing recommendations for TIVICAY in combination with other ARV agents in adults

*Alternative combinations that do not include metabolic inducers should be considered where possible.

ARV=antiretroviral; INSTI=integrase strand transfer inhibitor.

Dosing recommendations for TIVICAY in combination with other ARV agents in pediatric patients

If certain UGT1A or CYP3A inducers are coadministered, then increase the weight-based dose of TIVICAY to twice daily.

Safety and efficacy of TIVICAY have not been established in pediatric patients who are INSTI experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

Drug Interactions

Dosing considerations with other medications

The lower dolutegravir exposures observed in INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) upon coadministration with certain inducers may result in loss of therapeutic effect and development of resistance to TIVICAY or other coadministered ARV agents.

r=ritonavir; Mg=magnesium; Al=aluminum.

TIVICAY has no known clinically relevant effects on the pharmacokinetics of the following agents based on available drug interaction studies

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

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

Characteristics

Dosing characteristics of selected ART for adults1

§One 50-mg tablet, twice daily is recommended for treatment-naïve or treatment-experienced, INSTI-naïve adults when coadministered with certain UGT1A or CYP3A inducers (see Drug Interactions, Section 7.3, of full Prescribing Information for relevant inducers) and INSTI-experienced adults with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance. Alternative combinations that do not include metabolic inducers should be considered where possible.

ART=antiretroviral therapy; c=cobicistat.

  • 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

Dolutegravir-based regimens are a booster-free treatment option14

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


Please see full Prescribing Information for TIVICAY.

Please see full Prescribing Information for TIVICAY.

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.