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Bone and Cancer

Clinical Trials

Triumeq (abacavir, dolutegravir, and lamivudine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2014

Specific Treatments:

HIV-1

General Information

Triumeq is a fixed-dose combination tablet containing dolutegravir, an integrase strand transfer inhibitor (INSTI) and abacavir and lamivudine, nucleoside reverse transcriptase inhibitors (NRTIs). 

Triumeq is specifically indicated for the treatment of HIV-1.

Triumeq is supplied as a tablet for oral administration. Before initiating Triumeq, screen for the HLA-B*5701 allele. Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. The recommended dose for adults is one tablet daily. May be taken with or without food. Dosing with certain concomitant medications: If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, then the recommended dolutegravir dosage regimen is 50 mg twice daily. An additional 50-mg dose of dolutegravir, separated by 12 hours from Triumeq, should be taken.

Clinical Results

FDA Approval

The FDA approval of Triumeq was based on SINGLE, a non-inferiority trial conducted in 833 treament naïve adults. The trial compared dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) to Atripla+ (efavirenz, emtricitabine and tenofovir), the most commonly used single-pill regimen. More subjects were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamivudine arm versus the Atripla arm. At 96 weeks, 80% of subjects were virologically suppressed compared to 72% of subjects on Atripla. This difference was statistically significant.

Side Effects

Adverse effects associated with the use of Triumeq may include, but are not limited to, the following:

  • insomnia
  • headache
  • fatigue

 

Mechanism of Action

Triumeq is a fixed-dose combination tablet containing dolutegravir, an integrase strand transfer inhibitor (INSTI) and abacavir and lamivudine, nucleoside reverse transcriptase inhibitors (NRTIs).  Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle. Abacavir is a carbocyclic synthetic nucleoside analogue. Abacavir is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP). CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Lamivudine is a synthetic nucleoside analogue. Intracellularly lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of RT via DNA chain termination after incorporation of the nucleotide analogue. 

Additional Information

For additional information regarding Triumeq or HIV-1, please visit https://us.triumeq.com/

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