BC Week In Review | Nov 2, 2018
Clinical News

ViiV's two-drug HIV regimen meets again in Phase III

ViiV Healthcare Ltd. (Brentford, U.K.) said a once-monthly two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III FLAIR trial as maintenance treatment in HIV-1-infected, antiretroviral therapy-naïve patients who are...
BC Week In Review | Jun 1, 2018
Clinical News

FDA issues MedWatch safety alert for dolutegravir

FDA issued a MedWatch safety alert for antiretroviral drug dolutegravir in which the agency stated that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies...
BC Week In Review | Mar 9, 2018
Clinical News

Gilead reports additional Phase III data from HIV switching trial of Biktarvy

Gilead Sciences Inc. (NASDAQ:GILD) reported additional data from the Phase III GS-US-380-1844 trial in 563 virologically suppressed adults with HIV-1 infection showing that switching from either Tivicay dolutegravir plus abacavir/lamivudine or Triumeq dolutegravir/abacavir/lamivudine to once-daily...
BC Week In Review | Sep 22, 2017
Clinical News

China FDA approves ViiV's HIV drug Triumeq

China FDA approved Triumeq dolutegravir/abacavir/lamivudine (Triumec, 572-Trii, S-349572/S-265744/S-247303) from ViiV Healthcare Ltd. (Brentford, U.K.) to treat HIV/AIDS. Triumeq is a once-daily tablet that comprises Tivicay dolutegravir, an HIV integrase inhibitor, plus the nucleoside reverse transcriptase...
BC Week In Review | Jun 2, 2017
Clinical News

Gilead reports Phase III data for HIV combo in virologically suppressed patients

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the Phase III GS-US-380-1844 and GS-US-380-1878 trials in virologically suppressed patients with HIV-1 infection showing that once-daily 50/200/25 mg bictegravir/emtricitabine/tenofovir alafenamide met the primary endpoint in both trials...
BC Week In Review | Jun 2, 2017
Clinical News

Gilead reports Phase III data for HIV combo in treatment-naïve patients

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the Phase III GS-US-380-1489 and GS-US-380-1490 trials in treatment-naïve patients with HIV-1 infection showing that once-daily 50/200/25 mg bictegravir/emtricitabine/tenofovir alafenamide met the primary endpoint in both trials of...
BC Extra | May 30, 2017
Clinical News

Gilead’s HIV combo non-inferior in four Phase III trials

Gilead Sciences Inc. (NASDAQ:GILD) said a fixed-dose combination of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was non-inferior to combinations including Tivicay dolutegravir from ViiV Healthcare Ltd. (Brentford, U.K.), meeting the primary endpoints in three Phase III trials to...
BC Week In Review | Nov 30, 2016
Clinical News

Cabotegravir: Ph III started

ViiV began the open-label, international Phase III FLAIR trial to evaluate switching to cabotegravir plus Edurant rilpivirine following a 20-week induction therapy with once-daily oral Triumeq dolutegravir/abacavir/lamivudine in about 600 treatment-naïve patients. After induction, patients...
BC Week In Review | Aug 1, 2016
Clinical News

Triumeq dolutegravir/abacavir/lamivudine: Phase IIIb data

Top-line data from the open-label, international Phase IIIb ARIA trial in 495 antiretroviral therapy (ART)-naive women with HIV-1 infection showed that once-daily oral Triumeq met the co-primary endpoints of non-inferiority and superiority to ritonavir-boosted Reyataz...
BC Week In Review | Nov 9, 2015
Clinical News

Edurant rilpivirine: Phase IIb data

The 96-week, open-label, international Phase IIb LATTE 2 trial in 286 evaluable patients with HIV-1 infection showed that a long-acting intramuscular regimen of cabotegravir plus rilpivirine given every 4 or 8 weeks as suppressive maintenance...
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