ViiV HEALTHCARE RECEIVES CHMP POSITIVE OPINION FOR TIVICAY EU LABEL UPDATE WITH GEMINI STUDY DATA FOR THE 2-DRUG REGIMEN OF TIVICAY + LAMIVUDINE (1)
London, 16th November 2018 – ViiV Healthcare announces that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion on a Type II variation regulatory application for Tivicay (
“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
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,
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
– Ends –
Notes to editors
Dolutegravir (Tivicay) is an integrase inhibitor (INI) for use in combination with other antiretroviral agents for the treatment of HIV.  Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa
Lamivudine, commonly known as 3TC, is a nucleoside
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
GEMINI 1 & 2 study design
GEMINI 1 (204861) and GEMINI 2 (205543) are
For more information please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on www.clinicaltrials.gov.
Important Safety Information for Tivicay 50mg tablets and Epivir 300mg tablets in the EU
The following Important Safety Information is based on a summary of the Summary of Product Characteristics for both Tivicay (
For Tivicay and Epivir
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis,
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.
Patients should be advised that
Tivicay 50mg tablets
Tivicay is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients any of the excipients.
Tivicay should not be co-administration with dofetilide
Hypersensitivity reactions have been reported with
The decision to use
Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of
Factors that decrease
Dolutegravir increased metformin concentrations. A dose adjustment of metformin should be considered when starting and stopping co-administration of
All factors that decrease
Epivir 300mg tablets
Epivir (lamivudine) is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
Lamivudine is not recommended for use as monotherapy.
Renal impairment: In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted
Pancreatitis: Cases of pancreatitis have occurred rarely. However, it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease. Treatment with lamivudine should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and
Liver disease: If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SPC.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
If lamivudine is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral
Drug Interactions: Lamivudine should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine. The combination of lamivudine with cladribine is not-recommended.
The following common adverse reactions have been reported during therapy for HIV disease with lamivudine. Common: (≥1/100 to <1/10); Headache, insomnia, cough, nasal symptoms, nausea, vomiting, abdominal pain or cramps,
Please refer to the full European Summary of Product Characteristics for both products for full prescribing information, including contraindications, special warnings
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and to take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
|ViiV Healthcare Media enquiries:
||+44 7341 079531
|GSK Global Media enquiries:
||+44 20 8047 5502
||+44 20 8047 5194
||+44 20 8047 7562
||+44 20 8047 2406
||+44 20 8047 0674
|Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2017.
|Registered in England & Wales:
980 Great West Road
ViiV Healthcare. Data on file. 16th November 2018
 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
 ViiV Healthcare. 2018 Press Release. ViiV Healthcare submits
 ViiV Healthcare. 2018 Press Release. ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of
 Tivicay (
ViiV Healthcare. Data on File
 European Medicines Agency. Epivir (lamivudine) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/epivir-
 ClinicalTrials.gov. 2016. An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1). Available at: https://clinicaltrials.gov/ct2/show/NCT02831673 Last accessed October 2018.
 ClinicalTrials.gov. 2016. An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 2). Available at: https://clinicaltrials.gov/ct2/show/NCT02831764 Last accessed October 2018.