Dosing Recommendations

Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential.

Dosing recommendations for TIVICAY in combination with other ARV agents

*Rilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine—must be taken with a meal.

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

From section 7.4 of the full Prescribing Information for TIVICAY.

Booster Free

Dolutegravir-based regimens are a booster-free treatment option16

#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 23, 2018.
  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. https://www.hcvguidelines.org/unique-populations/hiv-hcv. Accessed July 23, 2018.
  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; November 2017.
  6. Olysio [package insert]. Janssen Therapeutics: Titusville, NJ; November 2017.
  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; November 2017.
  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; November 2017.
  13. Epclusa [package insert]. Gilead Sciences, Inc.: Foster City, CA; November 2017.
  14. Vosevi [package insert]. Gilead Sciences, Inc.; Foster City, CA; November 2017.
  15. Mavyret [package insert]. Abbvie, Inc: North Chicago, IL; February 2018.
  16. 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.