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Overview of Tivicay

Tivicay is the first once daily, unboosted integrase inhibitor.*

Tivicay is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adults, adolescents and children above 6 years of age.[1] Tivicay is contraindicated in patients with hypersensitivity to dolutegravir or to any of the excipients, and with co-administration with dofetilide.[1]

Tivicay has been extensively studied in a clinical programme involving 3,041 patients across five phase III trials (SINGLE, SPRING-2, FLAMINGO, SAILING, VIKING-3).[2-9]

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Reasons to rethink first line treatment with Tivicay for patients with HIV-1:

  • Rapid and sustained efficacy up  to 144 weeks[2-9]
  • High barrier to resistance to date[2-9]
  • Generally well tolerated with few discontinuations[2-9]
  • Once daily with few significant drug-drug interactions or dosing restrictions*[1]

Make dolutegravir▼ your core agent

A journey through ART innovation – how 3rd agents have become core to HIV therapy.

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* Tivicay is dosed 50 mg once daily for patients without documented or clinically suspected resistance to the integrase class. Tivicay should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). [1]

Tivicay is dosed 50 mg twice daily for patients with resistance to the integrase class (documented or clinically suspected). Co-administration of Tivicay with some medicines should be avoided in this population (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents and children. [1]

References:

  1. TIVICAY (dolutegravir) Summary of Product Characteristics.
  2. Walmsley S, et al. N Engl J Med. 2013;369(19):1807-1818.
  3. Raffi F, et al. Lancet. 2013;381(9868):735-743.
  4. Raffi F, et al. Lancet Infect Dis. 2013;13(11):927-935.
  5. Clotet B, et al. Lancet. 2014;383(9936):2222-2231.
  6. Cahn P, et al. Lancet. 2013;382(9893):700-708.
  7. Castagna A, et al. J Infect Dis. 2014; 210: 354-362.
  8. Pappa K, et al. Oral presentation at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 5-9, 2014; Washington, DC, USA.
  9. Molina J-M, et al. J Int AIDS Soc 2014; 17(Suppl 3): 19490.
  10. European AIDS Clinical Society. Guidelines. Version 7.1. November 2014. Available at: http://eacsociety.org/Guidelines.aspx Last accessed December 2014.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Tivicay & Triumeq is registered trademark of the GlaxoSmithKline Group of Companies