Single-tablet HIV drug approved by FDA

August 26, 2014

FDA has approved abacavir 600 mg, dolutegravir 50 mg (Tivicay) and lamivudine 300 mg (Triumeq, ViiV Healthcare) as as a first-line therapy to treat HIV.

FDA has approved abacavir 600 mg, dolutegravir 50 mg (Tivicay) and lamivudine 300 mg (Triumeq, ViiV Healthcare) as as a first-line therapy to treat HIV.

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Triumeq is the second new treatment to be approved in the United States from the company’s drug pipeline, and is the first dolutegravir-based fixed-dose combination offering patients living with HIV 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.

“We believe that new treatment options offering efficacy, tolerability and convenience to patients are needed,” said Marc Meachem, ViiV Healthcare spokesman.

The Wholesale Acquisition Cost (WAC) for a bottle of 30 Triumeq tablets is $2,207/month (or $74/day, or $26,484/year).

“This is within the range of single-tablet regimens [STRs] used to treat HIV and reflects the fact that Triumeq is the first, single-pill dolutegravir-based regimen,” Meachem said.

“Longer life spans and more years spent on treatment regimens mean that until there is a cure, new HIV treatments will be needed to address the virus’s ability to develop resistance that are at least as effective as current options and that offer improvements in areas such as tolerability, safety, dosing schedules and convenience,” he said.


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The current state of HIV therapy