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Podívejte se na výsledky 2DR studií ARV terapie představené na IAS konferenci v Mexiku

Historické milníky, které vedly k 2složkovému režimu.
PM-CZ-DLT-VID-190001

Vyjádření Prof. Pedro Cahna k výsledku studií GEMINI
PM-CZ-DLM-VID-190007

Základní informace k fungování 2složkového režimu

 TIVICAY is subject to additional monitoring.

Dolutegravir and lamivudine: The two-drug regimen of dolutegravir 50 mg once daily and lamivudine 300 mg once daily is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine. 1-2

TIVICAY (dolutegravir) is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age. TIVICAY co-administration with dofetilide is contraindicated. Use of TIVICAY is also contraindicated in case of hypersensitivity to the active agents or to any of the excipients. 2 Dolutegravir should not be prescribed to women seeking to become pregnant. Women who can become pregnant should use effective contraception while taking dolutegravir. 4

EPIVIR (lamivudine) is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. Use of EPIVIR is contraindicated in case of hypersensitivity to the active substance or to any of the excipients. 3

TIVICAY (dolutegravir) + lamivudine was studied in HBV-negative patients with viral loads up to 500,000 copies/mL. The GEMINI-1 and GEMINI-2 studies are identically designed, 148-week, treatment-naïve, phase III, randomized, double-blind, parallel-group, ​multicenter, non-inferiority studies​ evaluating efficacy, safety and tolerability of once-daily dolutegravir (DTG) 50 mg plus lamivudine (3TC) 300 mg versus DTG 50 mg + TDF/FTC 300 mg/200 mg. At week 48, 91% (655/716) of participants on DTG+3TC and 93% (669/717) of participants on 3-drug regimen had HIV-1 RNA level of <50 copies/ml (pooled analysis of the ITT-E population). Adjusted treatment difference -1.7%, 95% CI: -4.4, 1.1. 1
Adverse events reported in ≥5% of subjects in the DTG+3TC arm: headache (10%), diarrhoea (9%), nasopharyngitis (8%), upper respiratory tract infection (8%), pharyngitis (5%), and back pain (5%). 1

References:

  1. Cahn P et al. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands.
  2. TIVICAY Summary of Product Characteristics November 2018.
  3. EPIVIR Summary of Product Characteristics December 2018.