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ViiV Healthcare has new data on its first HIV drug, fostemsavir, which reinforces its long-term effects and keeps it on track for first regulatory filings later this year.
The updated results of the BRIGHTE Phase 3 study show that the binding inhibitor, which binds to the glycoprotein 120 (gp120) of the HIV envelope, continues to suppress the virus at patients treated for a period of up to 96 weeks.
Fostemsavir is for people living with HIV who have been on medication for a long time and are struggling to keep the virus under control.
It complements ViiV's strategy of developing two-drug and delayed-injection products for newly diagnosed HIV patients and those wishing to change the regimen, as it fights for market share with Gilead .
Although new combinations of antiretroviral therapies have transformed the prospects of HIV-positive patients by simplifying their daily dosage and reducing side-effects, new options are still needed for those who have been living with the virus for a long time.
The new drug is designed as a complementary drug to the current patient regimen in cases where "resistance, safety, tolerability, contraindications, and previous treatment failures" compromise care, according to Kimberly Smith, who is responsible for research and medical strategy worldwide. ViiV.
The company, majority owned by GlaxoSmithKline, as well as Pfizer and Shionogi, presented the new findings at the International AIDS Science Conference (IAS 2019) organized by the AIDS Society in Mexico City, which kicked off yesterday.
"We think it's important to look for new ways to prevent the virus from replicating, particularly for people who develop resistance to their treatment regimens," Smith said.
Fostemsavir, a drug precursor that converts the active form of temsavir into the body, inhibits the interaction between HIV and CD4 + T cells, preventing the attachment and entry of viruses. Its mechanism of action means that there is no cross-resistance to other clbades of Antiretrovirals, ViiV says, can help patients who have become resistant to most other drugs.
After 96 weeks of BRIGHTE treatment, 60% of patients in the fostemsavir group had viral suppression, an increase of 6% over previous 48 weeks, and two-thirds had continuous immunologic improvement with an increase in of CD4 + T cells.
The study cohort had 29 deaths, of which 18 were considered to be related to AIDS or acute infections, with the risk of death being significantly increased in patients with low CD4 + counts.
ViiV Healthcare has announced its intention to begin filing a marketing application for fostemsavir later this year, from the United States.
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