Three-in-one combo gets two green lights

ViiV Healthcare receives FDA approval and EU marketing authorization for Triumeq in treatment of HIV-1 infection

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LONDON—ViiV Healthcare recently announced a pair of approvals for Triumeq—a combination of dolutegravir, abacavir and lamivudine offering a once-daily regimen for the treatment of HIV infection—the first being U.S. Food and Drug Administration approval in the United States on Aug. 22 and the second being the European Commission (EC) granting marketing authorization on Sept. 3.
Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV infection the option of a single-pill regimen  that combines the integrase strand transfer inhibitor (INSTI) dolutegravir with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. ViiV Healthcare is a joint venture between GlaxoSmithKline, Pfizer and Shionogi.
“Today’s approval of Triumeq offers many people living with HIV in the U.S. the first single-pill regimen containing dolutegravir,” noted Dr. Dominique Limet, CEO of ViiV Healthcare, who added that his company “is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the U.S. from our pipeline of medicines.”
Limet likewise keyed in on the value of patients’ first-ever opportunity to get a single-pill regimen containing dolutegravir when he commented on the EC marketing authorization, but also added, “Triumeq is a direct result of ViiV Healthcare’s patient-centered approach to innovation. As a company that focuses 100 percent on HIV, our commitment is to continue to deliver new options for care and treatment for people living with HIV.”
In both the FDA and EC approvals, the positive decisions were based, ViiV Healthcare says, on two clinical trials. The first is a Phase 3 study (called SINGLE) of treatment-naïve adults that was conducted with dolutegravir and abacavir/lamivudine as separate pills; the second was a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and the NRTIs abacavir/lamivudine as separate pills.
In the SINGLE study, a non-inferiority trial with a prespecified superiority analysis, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) than in the Atripla (efavirenz, emtricitabine and tenofovir) arm, the most commonly used single-pill regimen. The difference was statistically significant, ViiV Healthcare reports, and met the prespecified test for superiority. The difference was driven by a higher rate of discontinuation due to adverse events in the Atripla arm, the company adds.
Atripla is a product of Foster City, Calif.-based biotech Gilead Sciences Inc.
At 96 weeks, 80 percent of participants on the dolutegravir-based regimen were virologically suppressed, compared to 72 percent of participants on Atripla. Grade 2 to 4 treatment-emergent adverse reactions that occurred in 2 percent or more of participants taking the dolutegavir-based regimen were insomnia (3 percent), headache (2 percent) and fatigue (2 percent).
ViiV Healthcare did offer several caveats for the promising therapeutic, though. Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance, because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Finally, products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele.
As already noted, Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine. Two essential steps in the HIV life cycle are replication, when the virus turns its RNA copy into DNA, and integration, which is the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and INSTIs interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.
ViiV Healthcare’s dolutegravir was approved in the United States in August 2013 and in Europe in January 2014 under the brand name Tivicay. The Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion on the Marketing Authorization Application for Triumeq on June 26 of this year. Regulatory applications are also being evaluated in other markets worldwide, including Australia, Brazil and Canada.
Commenting on the U.S. approval of the new three-drug pill, Zacks Investment Research was upbeat, noting, “We are pleased with the approval of Triumeq in the U.S. The single-pill regimen of Triumeq will reduce the pill burden on patients and improve convenience and compliance. It is also a step forward for Tivicay, having been approved last year as an add-on therapy to other antiretroviral agents.”
Infectious disease analyst Dr. Moritz Herrmann at GlobalData went so far as to say the approval of Triumeq “threatens Gilead’s monopoly,” adding, “Triumeq will be launched in the competitive FDC, single-tablet, anti-HIV market, which, so far, has been dominated by regimens developed and marketed by Gilead Sciences.”

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