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ViiV Healthcare receives CHMP Positive Opinion for Tivicay (dolutegravir) EU label update with GEMINI study data for the 2-drug regimen of Tivicay + lamivudine

December 2018

   

ON the 16th of November, 2018, ViiV Healthcare announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion on a Type II variation regulatory application for Tivicay (dolutegravir). The label update includes data from the phase III GEMINI 1 & 2 studies, which evaluated the safety, efficacy and tolerability of the 2-drug regimen of dolutegravir + lamivudine compared to a three-drug regimen of dolutegravir and tenofovir disoproxil fumarate/emtricitabine in more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL.1 This CHMP Positive Opinion provides further support for the efficacy of dolutegravir in treating HIV as a 2-drug regimen (2DR).

“Today, thanks to advances in treatment, people living with HIV (PLHIV) can now expect to live as long as the general population. However, we know that they still face a lifetime of antiretroviral therapy in order to maintain viral suppression. Our 2DR programme looks to reduce the impact of a lifetime of medication, without compromising on treatment efficacy, as we believe no one should take more medicines than they need.This CHMP Positive Opinion is a key milestone in the dolutegravir 2DR journey.” said Deborah Waterhouse, CEO ViiV Healthcare.

The regulatory submission for the update to the Tivicay EU label includes 48-week data from the phase III GEMINI 1 & 2 studies, which were presented earlier this year at the 22nd International AIDS Conference. The studies met their week 48 primary objective of non-inferiority based on plasma HIV-1 RNA <50c/mL, a standard measure of HIV control, with broadly consistent results for viral suppression across high and low viral load strata. At 48 weeks, no patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance. Overall, comparable rates of adverse events were seen in both treatment arms, with the most common (≥5%) reported being headache, diarrhoea and nasopharyngitis.2

ViiV Healthcare submitted regulatory applications with the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Health Canada and Australian Therapeutic Goods Administration in September and October 2018 for a fixed-dose combination, single pill formulation of dolutegravir and lamivudine. Regulatory decisions are expected in 2019.3,4

References:

  1. ViiV Healthcare. Data on file. 16th November 2018
  2. Cahn P, et al. 2018 Non-Inferior Efficacy of Dolutegravir (DTG) Plus Lamivudine (3TC) vs DTG Plus Tenofovir/Emtricitabine (TDF/FTC) Fixed-Dose Combination in Antiretroviral Treatment–Naive Adults With HIV-1 Infection—Week 48 Results From the GEMINI Studies. Presented at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, Amsterdam, The Netherlands.
  3. ViiV Healthcare. 2018 Press Release. ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. Available at: https://www.viivhealthcare.com/media/press-releases/2018/viiv-healthcare-submits-regulatory-application-to-european-medicines-agency-for-single-tablet-two-drug-regimen-of-dolutegravir-and-lamivudine-for-treatment-of-hiv.aspx Last accessed November 2018.
  4. ViiV Healthcare. 2018 Press Release. ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. Available at: https://www.viivhealthcare.com/media/press-releases/viiv-healthcare-submits-new-drug-application-to-us-fda-for-single-tablet-two-drug-regimen-of-dolutegravir-and-lamivudine-for-treatment-of-hiv.aspx Last accessed November 2018.