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  • European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya®

    Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU).

    23 November 2015 | Gilead press release
  • Genvoya added to US recommended first-line options for HIV treatment

    Based on efficacy and safety data from phase 3 randomized clinical trials, EVG/c/FTC/TAF will be added as one of the Recommended Initial Regimens for ART-naive adults and adolescents with estimated creatinine clearance ≥ 30 mL/min (AI).

    23 November 2015 | AIDSinfo
  • FDA approves new treatment for HIV

    The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

    06 November 2015 | FDA press release
  • Long-acting injectable HIV treatment shows promise in early study results

    A future of HIV treatment that doesn’t depend on daily dosing seemed to move a little closer today with an announcement that early findings show an injected combination of two antiretroviral medicines given monthly or every two months effective in controlling HIV among people whose virus was already suppressed.

    04 November 2015 | Science Speaks
  • ViiV Healthcare announces positive headline results from a study of two drug injectable regimen for HIV maintenance therapy

    ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today announced that the Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32 weeks. These results show that the investigational, long acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). The 32 week results of LATTE 2 will be presented at a forthcoming scientific conference.

    03 November 2015 | ViiV Healthcare
  • TAF and TDF Compared for Kidney, Bone Toxicity in Black HIV+ Patients

    Including tenofovir alafenamide (TAF) in single-tablet elvitegravir/cobicistat/emtricitabine (E/C/F/TAF) is associated with reduced renal and bone toxicity compared to tenofovir disoproxil fumarate (TDF)-containing single-tablet (E/C/F/TDF) therapy, according to an analysis of data from two Phase 3 trials, reported at IDWeek 2015.

    12 October 2015 | Monthly Prescribing Reference
  • European CHMP adopts positive opinion for Gilead’s single tablet regimen Genvoya® (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide) for the treatment of HIV

    Gilead’s first TAF-based regimen to receive CHMP positive opinion. An FDA decision is expected in November.

    01 October 2015 | EATG
  • New Phase IIIb/IV Data Show Switching to Once-Daily Triumeq® Maintains HIV Viral Suppression

    ViiV Healthcare today announced 24-week data from the Phase IIIb/IV STRIIVING study, an open-label study evaluating the efficacy, safety and tolerability of switching from an antiretroviral therapy (ART) to the once-daily, fixed-dose dolutegravir-based regimen, Triumeq® (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1.

    23 September 2015 | Viiv Healthcare press release
  • HIV Patients Successfully Reach One Year of Virologic Suppression in PRO 140 Monotherapy Study

    CytoDyn's PRO 140 Phase 2b study was concluded in January 2015. Following the initial 13-week treatment period, patients with viral load suppression could continue receiving weekly PRO 140 monotherapy in an extension study. The PRO 140 monoclonal antibody targets CCR5 with high affinity and potently blocks HIV infection.

    22 September 2015 | Cytodyn press release
  • Sangamo BioSciences Reports Updated Clinical Data from ZFP Therapeutic® Program for HIV/AIDS

    Sangamo BioSciences, Inc. presented data demonstrating sustained functional control of viral load in the absence of antiretroviral drugs (ART) in two of three HIV-infected subjects treated in Cohort 3* of its Phase 1/2 study (SB-728-1101) of its ZFP Therapeutic (SB-728-T) for the treatment of HIV/AIDS. The data, which led to expanded enrollment of this Cohort, were presented at the 2015 Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego from September 17-21.

    22 September 2015 | Sangamo press release
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