A comparison between the single-tablet HIV regimen Stribild (elvitegravir/cobicistat/tenofovir/emtricitabine) with a new version of the tablet that includes a revised form of tenofovir has found that the new tablet suppresses the virus as well and is less toxic to kidneys and bones, aidsmap reports. A poster at the 15th European AIDS Conference in Barcelona presented updated, 96-week findings from two international, randomized Phase III studies comparing the two tablets.
Stribild contains 300 milligrams of tenofovir disoproxil fumarate, or TDF, while the new version of the tablet replaces the TDF with 10 mg of tenofovir alafenamide, or TAF. Gilead Sciences applied for U.S. Food and Drug Administration approval of the TAF-inclusive Stribild in April; the tablet has already been approved in Europe under the brand name Genvoya.
The two Phase III studies included 1,733 treatment-naive people with HIV who had near-normal kidney function.
After 96 weeks of treatment, 1.2 percent of those taking Stribild and 0.9 percent of those taking Genvoya experienced virologic failure along with drug resistance.
Each tablet proved generally safe and well-tolerated, with Genvoya less harmful to the kidneys and bones. Two people taking Stribild developed a category of kidney disease known as renal tubulopathy, compared with no one who took Genvoya. The respective percentage drops in bone mineral density for those on Genvoya and Stribild were 0.96 percent and 2.79 percent at the lumbar spine, and 0.67 percent and 3.28 percent at the hip.
A total of 1.2 percent of those on Genvoya and 2.3 percent of those taking Stribild stopped treatment. The most common side effects were headache, diarrhea and nausea.
To read the aidsmap article, click here.
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