ViiV HEALTHCARE SUBMITS REGULATORY APPLICATIONS FOR THE FIRST HIV MAINTENANCE REGIMEN COMPRISING ONLY TWO MEDICINES
EU and US submissions for single tablet combining
Priority review voucher submitted in
London, UK 01 June 2017 – GSK and ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of
The submissions are based on the SWORD studies that included more than one thousand patients who previously achieved viral suppression on a three- or four-drug (integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, or protease inhibitor-based) antiretroviral regimen. The results of these studies were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.
A recently acquired priority review voucher was submitted to the FDA along with the
Deborah Waterhouse, CEO ViiV Healthcare said, “As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment. At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection,
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV we must always question the status quo. We believed that
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a partnership to investigate the potential of combining
About the SWORD phase III programme for
The phase III programme evaluates the efficacy, safety, and tolerability of switching to
The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per
For more information on the trials please visit: www.clinicaltrials.gov
Tivicay is a registered trademark of the ViiV Healthcare group of companies
Edurant is a registered trademark of Janssen Sciences Ireland UC
Important Safety Information for TIVICAY® (
The following Important Safety Information (ISI) is based on the Highlights section of the US Prescribing Information for TIVICAY and local variations apply. Please consult the full Prescribing Information for all the labelled safety information for TIVICAY or please refer to applicable local
FDA INDICATIONS AND USAGE
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 30 kg.
Limitations of Use:
- Use of TIVICAY in integrase strand transfer inhibitor (INSTI)-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
- Previous hypersensitivity reaction to
- Coadministration with dofetilide.
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
- Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY is recommended in patients with
underlyinghepatic disease such as hepatitis B or C.
- Redistribution/accumulation of body fat and immune reconstitution syndrome have been reported in patients treated with combination antiretroviral therapy.
The most common adverse reactions of moderate to severe intensity and
- Drugs that are metabolic inducers may decrease the plasma concentrations of
- TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken together with food.
USE IN SPECIFIC POPULATIONS
- Pregnancy: TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk.
- Lactation: Breastfeeding is not recommended.
Please visit the following link for the full U.S. prescribing and patient information: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1
EDURANT® Consumer Indication and Important Safety Information(ISI)
- EDURANT®(rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:
– Who have never taken HIV medicines before, and
– Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/
- EDURANT®should be taken in combination with other HIV medicines
.Yourhealthcare professional will work with you to find the right combination of HIV medicines
- It is important that you remain under the care of your healthcare professional during treatment with EDURANT®
- EDURANT®is not recommended for patients less than 12 years of age
EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses
Please read Important Safety Information below
Important Safety Information
Can EDURANT® be taken with other medicines?
EDURANT® may affect the way other medicines work and other medicines may affect how EDURANT® works and may cause serious side effects. If you take certain medicines with EDURANT®
Do not take EDURANT® if:
- Your HIV infection has been previously treated with HIV medicines
- You are taking any of the following medicines:
– Anti-seizure medicines: carbamazepine (Carbatrol®,Equetro®,Tegretol®, Tegretol-XR®,Teril®,Epitol®),oxcarbazepine (Trileptal®),phenobarbital (Luminal®),phenytoin (Dilantin®,Dilantin-125®,Phenytek®)
– Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®,Rifamate®,Rimactane®, Rifadin®),rifapentine (Priftin®)
– Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole(Nexium®,Vimovo®),lansoprazole(Prevacid®),omeprazole (Prilosec®,Zegerid®),pantoprazole sodium(Protonix®),rabeprazole(Aciphex®)
– More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
– St. John’s wort (Hypericum perforatum)
Especially tell your doctor if you take:
- Rifabutin (Mycobutin®), a medicine to treat some bacterial infections). Talk to your doctor or pharmacist about the right amount of EDURANT® you should take if you also take rifabutin
- Medicines used to treat HIV
- An antacid medicine that contains aluminium, magnesium hydroxide, or calcium carbonate
.Takeantacids at least 2 hours before or at least 4 hours after you takeEDURANT®
- Medicines to block acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®)
,nizatidine(Axid®) ,orranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours afteryou take EDURANT®
- Any of these medicines(
if taken by mouth or injection):clarithromycin(Biaxin®), erythromycin(E-Mycin®,Eryc®,Ery-Tab®,PCE®,Pediazole®,Ilosone®), fluconazole (Diflucan®),itraconazole (Sporanox®),ketoconazole (Nizoral®), methadone (Dolophine®),posaconazole (Noxafil®),telithromycin (Ketek®), voriconazole (Vfend®)
This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Before taking EDURANT®, also tell your health-care professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT® will harm your unborn baby.
You and your health-care professional will need to decide if taking EDURANT®
is right for you.
– Do not
What are the possible side effects of EDURANT®? EDURANT® can cause serious side effects including:
- Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain)
- Depression or mood changes. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide), or have tried to hurt yourself
- Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment. Liver problems were also reported during treatment in some people without a history of liver disease
.Yourhealth-care professional may need to do tests to check liver function before and during treatment
- Changes in body shape or body fat have been seen in some patients taking HIV medicines
.Theexact cause and long-term health effects of these conditions are not known
- Changes in your immune system (immune reconstitution syndrome).
Your immune system may get stronger and begin to fight infections
Other common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).
Please see accompanying full Product Information for more details.