New Single-Tablet Regimen: FDA Approves Triumeq
ViiV Healthcare’s single-tablet regimen Triumeq won Food and Drug Administration approval on August 22, 2014. Triumeq is the first FDA-approved single-tablet regimen (STR) that does not contain tenofovir (Viread), a widely used antiretroviral drug linked with bone and kidney problems in some susceptible HIV-positive individuals.
Triumeq is also the first STR to contain the integrase inhibitor dolutegravir (brand name Tivicay), which was approved as a stand-alone drug in August 2013. Dolutegravir is still fairly new to the market, but in addition to favorable clinical trial results, anecdotally, “many patients and clinicians have had good experience using dolutegravir,” says Jennifer Cocohoba, clinical pharmacist for the Women’s HIV Program at the University of California, San Francisco.
In particular, dolutegravir is linked with few cases of drug resistance or drug-drug interactions, Cocohoba explains. Dolutegravir’s availability as part of a single-tablet regimen “may make it easier for patients to adhere and suppress their viral load,” adds Cocohoba. In addition to dolutegravir, Triumeq contains the nucleoside reverse transcriptase inhibitors abacavir (Ziagen) and lamivudine (Epivir).
The new drug’s approval stems largely from a clinical trial demonstrating shorter median time to viral suppression, greater increases in CD4 cell counts (a marker of immune system health), and greater proportions of individuals achieving a viral load below 50 copies/mL compared with individuals receiving an efavirenz/tenofovir/emtricitabine tablet (Atripla) once daily. In addition to superior efficacy, the safety profile favored Triumeq, with fewer drug-related adverse events overall, and fewer adverse events leading to discontinuation of the drug.
Triumeq may be appropriate for individuals who have normal kidney function (with a creatinine clearance greater than 50mL/minute), are not allergic to abacavir (as evidenced by a negative result of HLA*B5701 screening), and whose HIV drug resistance tests indicate minimal or no resistance to NRTIs or dolutegravir, according to Cocohoba.