Gilead reports strong findings in HIV

Dive Brief:

  • Gilead Sciences released positive data Feb. 14 from two Phase 3 studies evaluating the safety and efficacy of its HIV drug Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide).
  • Through nearly three years of treatment, patients receiving Genvoya showed significantly higher rates of virologic suppression, along with favorable renal and bone lab parameters, as compared with patients getting Gilead’s Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate).
  • Gilead’s treatment targets HIV-1 in treatment-naïve adults and children 12 and older. Genvoya has a boxed warning in its product label on the risks of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B.

Dive Insight:

Gilead's news came in a wave, with three separate HIV treatment studies announced Feb. 13-14. Genoya capped the others.

With respect to Genvoya, the lead study investigator touted the potential benefits of its long-term use.

"As people grow older with HIV, physicians are increasingly looking for highly effective medications that may help address the evolving needs of their patients who face a lifetime of antiretroviral therapy," said lead study investigator Jose Arribas, associate professor of medicine at Hospital La Paz in Madrid, Spain. "These study results further demonstrate that Genvoya provides durable viral suppression and has demonstrated safety profile for long-term use by a range of appropriate HIV patients."

Separately, Gilead announced new Phase 2 data — showing 97% rates of virologic suppression — for bictegravir, an investigational integrase strand transfer inhibitor for HIV treatment now in Phase 3. Since bictegravir more than held its own against GlaxoSmithKline’s dolutegravir, FDA-approved in 2013, this could set up a larger-scale comparison in Phase 3.

Lastly, Gilead announced findings Feb. 13 from a new pre-clinical study looking into a novel class of HIV capsid inhibitors.

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Filed Under: Clinical Trials Corporate News
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