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Información médica

Safety & Tolerability

TRIUMEQ* Was Generally Better Tolerated vs Atripla® up to 144 Weeks with Fewer Discontinuations 1

Discontinuations due to Adverse Events

SINGLE - Proportion of patients with adverse events leading to discontinuation at 48, 96, and 144 weeks 1-3

Discontinuations due to AEs--SINGLE trial: Triumeq vs Atripla at 48 (2% vs 10%), 96 (3% vs 10%), and 144 weeks (4% vs 10%).
  • Fewer treatment-naïve patients taking TRIUMEQ® discontinued treatment due to AEs up to 144 weeks compared with Atripla® 1-3

Adverse Events ≥5%

SINGLE - Most common treatment-related adverse events ≥5% in either arm up to 96 weeks 3

Adverse Events ≥5% in SINGLE trial (Triumeq vs Atripla): Triumeq is generally well tolerated vs Atripla through 96 weeks

Changes in laboratory chemistries

Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 96 weeks (Mean change from baseline to 96 weeks: 12.6 μmol/L) 4

  • These changes are not considered to be clinically relevant as the glomerular filtration rate remained unchanged

HLA-B*5701 Screening

Review the requirements for HLA-B*5701 screening and reducing the risk of abacavir-related hypersensitivity reactions.

For further information, please see the Summary of Product Characteristics. 

*In studies supporting TRIUMEQ, DTG 50 mg + ABC 600 mg/ 3TC 300 mg were used. Bioequivalence has been demonstrated. 2

In some markets, Atripla® is not licensed for initial use in treatment-naive patients.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

DTG=dolutegravir.
ABC=abacavir.
3TC=lamivudine.
EFV=efavirenz.
TDF=tenofovir.
FTC=emtricitabine.

References:

  1. Walmsley S, Antela A, Clumeck N, et al; for the SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807-1818.
  2. Walmsley S, Berenguer J, Khuong-Josses M, et al. Dolutegravir regimen statistically superior to efavirenz/tenofovir/emtricitabine: 96-week results from the SINGLE study (ING114467). Poster presented at: 21st Conference on Retroviruses and Opportunistic Infections; March 3-6, 2014; Boston, MA. Poster 543.
  3. Pappa K, Baumgarten A, Felizarta F, et al. Once-daily dolutegravir + abacavir/lamivudine is superior to efavirenz/tenofovir/emtricitabine in treatment-naïve HIV subjects: 144-week results SINGLE (ING114467). Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 5-9, 2014; Washington, DC, USA.
  4. TRIUMEQ Summary of Product Characteristics.

TRIUMEQ, TIVICAY, ZIAGEN, EPIVIR, KIVEXA, EPZICOM, TRIZIVIR, COMBIVIR
son marcas registradas del grupo de compañías ViiV Healthcare