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Información médica

Dosage & Administration

Once-Daily TRIUMEQ Makes Dosing and Administration Simple for Your Patients

Recommended dosing 1*†‡
(for adults and adolescents above 12 years of age weighing at least 40 kg)

One pill, once daily

TRIUMEQ is indicated for the treatment of HIV-infected adults and adolescents above 12 years of age weighing at least 40 kg.

Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Convenient dosing regimen 1

Convenient dosing: one pill, QD; No time or food restrictions; no boosting/additional renal monitoring; few significant DDIs

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

*TRIUMEQ is a fixed-dose pill and should not be prescribed for patients requiring dose adjustments. Separate preparations of dolutegravir, abacavir, and lamivudine are available in cases where discontinuation or dose adjustment is required. 1
†TRIUMEQ is not recommended for patients with integrase inhibitor resistance. 1
‡TRIUMEQ is not recommended for co-administration with efavirenz, nevirapine, rifampicin, or tipranavir/ritonavir. 1

References:

  1. TRIUMEQ Summary of Product Characteristics.

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 Has Few Significant DDIs 1

Commonly used medications  Interactions 
Oral contraceptives  No 
H2-antagonists (including ranitidine, cimetidine)  No 
Hepatitis C protease inhibitors (telaprevir, boceprevir)  No 
Prednisone  No 
Rifabutin  No 
Methadone  Dosing adjustment likely not needed for most patients 
Metformin  Close monitoring is recommended when starting or stopping TRIUMEQ and metformin together as a dose adjustment may be needed for metformin 
Multivitamins, calcium supplements, iron supplements  TRIUMEQ is recommended to be administered 2 hours before or 6 hours after taking these agents 
Magnesium/aluminium-containing antacids  TRIUMEQ is recommended to be administered 2 hours before or 6 hours after taking these agents 
Rifampicin, efavirenz, nevirapine, and tipranavir/r  Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with these agents, the use of TRIUMEQ is not recommended for patients taking these medicines 
  • Co-administration with dofetilide is contraindicated 1
  • Co-administration with oxcarbazepine, phenytoin, phenobarbital, carbamazepine, or St John’s Wort should be avoided because there are insufficient data to make dosing recommendations 1
  • Co-administration with etravirine is not recommended unless patient is also receiving atazanavir/r, lopinavir/r or darunavir/r 1

Dolutegravir is eliminated primarily by UGT1A1. Abacavir and lamivudine are not significantly metabolised by CYP enzymes. 1

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

DDIs=drug-drug interactions.

References:

  1. TRIUMEQ Summary of Product Characteristics.

Screening for the HLA-B*5701 Allele Should Be Performed Before Prescribing TRIUMEQ 1

HLA-B*5701 screening significantly reduces the risk of an ABC hypersensitivity reaction (HSR) 2

Prospective HLA-B*5701 screening: No immunologically confirmed HSR and significant reduction of clinically suspected HSR in the PREDICT-1 study 2

Clinical description of ABC HSRs: 1

  • Almost all patients developing ABC HSRs will have fever and/or rash
  • Other key symptoms include: gastrointestinal, respiratory, or constitutional symptoms such as lethargy and malaise

If suspected: 1

  • TRIUMEQ must be stopped without delay, even in the absence of the HLA-B*5701 allele
  • After stopping treatment with TRIUMEQ for a suspected HSR, TRIUMEQ or any other medicinal product containing ABC or DTG, must never be re-initiated

Guidelines recommended: 34

  • EACS and DHHS guidelines recommend screening for HLA-B*5701 before starting ABC-containing antiretroviral therapy, if not previously tested

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

ABC=abacavir.
DTG=dolutegravir.
EACS=European AIDS Clinical Society.
DHHS=Department of Health and Human Services.

References:

  1. TRIUMEQ Summary of Product Characteristics.
  2. Mallal S, Phillips E, Carosi G, et al; for the PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358:568-579.
  3. European AIDS Clinical Society Guidelines, version 7.02; http://www.eacsociety.org/Portals/0/140601_EACS%20EN7.02.pdf. Updated June 2014.
  4. 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://www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf. Updated May 1, 2014.

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