CORK, Ireland, June 12, 2014 /PRNewswire/ --
Janssen R&D Ireland Ltd announced today that they have entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen's Non-Nucleoside Reverse Transcriptase Inhibitor rilpivirine (marketed as EDURANT(R)) and ViiV's Integrase Inhibitor dolutegravir(marketed as TIVICAY(R)) as the sole active ingredients for the maintenance treatment of people living with Human Immunodeficiency Virus (HIV). The companies will further investigate development of this drug combination for pediatric use.
If successfully developed and approved by regulatory authorities, this treatment could offer people living with HIV who are virologically suppressed an option to switch from a standard three-drug therapy to a two-drug, Nucleoside Reverse Transcriptase Inhibitor (NRTI)-sparing antiviral regimen.
"HIV remains a significant medical challenge, and our goal is to find new treatment regimens for patients," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. "We are pleased to collaborate with ViiV Healthcare in pursuing this shift in the HIV treatment paradigm and reaffirm our commitment to collaborate and develop new HIV treatments and fixed-dose regimens."
Formulation and clinical development for the single tablet regimen will begin in the coming months.
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.[1] It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.[1],[2],[3]
Standard HIV-drug therapy contains three active components: a backbone of two NRTIs, plus either a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Protease Inhibitor (PI) or Integrase Inhibitor (INI).
About EDURANT(R)
EDURANT(R) (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)in adults:
- 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/mL. Your healthcare professional will measure your viral load
- EDURANT(R) should be taken in combination with other HIV medicines. Your
healthcare 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(R)
- EDURANT(R) is not recommended for patients less than 18 years of age
EDURANT(R) 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. Ask your healthcare professional about how to prevent passing HIV to other people.
Please read Important Safety Information below, and talk to your healthcare professional to learn if EDURANT(R) is right for you.
Important Safety Information
Can EDURANT(R) be taken with other medicines?
EDURANT(R) may affect the way other medicines work and other medicines may affect how EDURANT(R) works and may cause serious side effects. If you take certain medicines with EDURANT(R), the amount of EDURANT(R) in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT(R) or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT(R) with a meal. A protein drink alone does not replace a meal.
Do not take EDURANT(R) if:
Your HIV infection has been previously treated with HIV medicines
You are taking any of the following medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol(R), Equetro(R),
Tegretol(R), Tegretol-XR(R), Teril(R), Epitol(R)), oxcarbazepine (Trileptal(R)),
phenobarbital (Luminal(R)), phenytoin (Dilantin(R), Dilantin-125(R), Phenytek(R))
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater(R), Rifamate(R),
Rimactane(R), Rifadin(R)), rifapentine (Priftin(R))
- Proton pump inhibitor (PPI) medicine for certain stomach or intestinal
problems: esomeprazole (Nexium(R), Vimovo(R)), lansoprazole (Prevacid(R)), omeprazole
(Prilosec(R), Zegerid(R)), pantoprazole sodium (Protonix(R)), rabeprazole (Aciphex(R))
- 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(R), a medicine to treat some bacterial infections).
Talk to your doctor or pharmacist about the right amount of EDURANT(R) you should take
if you also take rifabutin.
- Medicines used to treat HIV
- An antacid medicine that contains aluminum, magnesium hydroxide, or calcium
carbonate. Take antacids at least 2 hours before or at least 4 hours after you take
EDURANT(R)
- Medicines to block acid in your stomach, including cimetidine (Tagamet(R)),
famotidine (Pepcid(R)), nizatidine (Axid(R)), or ranitidine hydrochloride (Zantac(R)).
Take these medicines at least 12 hours before or at least 4 hours after you take
EDURANT(R)
- Any of these medicines (if taken by mouth or injection): clarithromycin
(Biaxin(R)), erythromycin (E-Mycin(R), Eryc(R), Ery-Tab(R), PCE(R), Pediazole(R),
Ilosone(R)), fluconazole (Diflucan(R)), itraconazole (Sporanox(R)), ketoconazole
(Nizoral(R)), methadone (Dolophine(R)), posaconazole (Noxafil(R)), telithromycin
(Ketek(R)),voriconazole (Vfend(R))
This is not a complete list of medicines. Before starting EDURANT(R), 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(R), also tell your healthcare 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(R) will harm your unborn baby.
You and your healthcare professional will need to decide if taking EDURANT(R)is right for you.
- Do not breastfeed if you are taking EDURANT(R). You should not breastfeed
if you have HIV because of the chance of passing HIV to your baby
What are the possible side effects of EDURANT(R)?
EDURANT(R) can cause serious side effects including:
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