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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]

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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