CORK, Ireland, November 3, 2015 /PRNewswire/ --
Injectable combinations once every 4 or 8 weeks show comparable efficacy versus daily
oral combination therapy
Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced that Phase IIb data studying a combination regimen of two investigational long acting, injectable formulations of HIV medicines-Janssen's rilpivirine and ViiV Healthcare's cabotegravir-given together every 4 or 8 weeks show comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). The full results of the study, named LATTE 2, co-funded by Janssen and ViiV Healthcare will be presented at a forthcoming scientific conference.
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"Despite great progress in HIV treatments, the burden of treating HIV patients remains high. Long-acting injectable drug formulations may offer another option for HIV maintenance therapy," says Paul Stoffels, M.D. Chief Scientific Officer and Worldwide Chairman Pharmaceuticals, Johnson & Johnson. "Our hope in studying such combinations is to make HIV infection manageable with a potentially transformational all injectable regimen."
If successfully developed and approved by regulatory authorities, this regimen could offer people living with HIV who are virologically suppressed an option to switch from a standard daily regimen of three-drug therapy to a long acting all-injectable regimen that could potentially maintain viral suppression with just six or twelve injections of each drug per year.
Following the results of the proof of concept two-drug oral dose-ranging study LATTE, LATTE 2 was initiated as a phase IIb, multicentre, open label 96 week study investigating the safety and efficacy of this first all-injectable long acting combination regimen of rilpivirine and cabotegravir to maintain suppression of viral load. LATTE 2 included adults (n=309) who, after reaching virologic suppression on oral therapy with once-daily investigational oral cabotegravir 30mg + 2 NRTIs (n=286, 93%), were subsequently randomized to one of three study arms to receive either CAB LA + RPV LA injections every 4 weeks (n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs (n=56).
Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for patients at 32 weeks receiving two drug maintenance therapy with investigational long acting cabotegravir (CAB LA) and long acting rilpivirine (RPV LA) whether dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the rate observed in patients continuing with a three-drug oral regimen of investigational CAB + NRTIs (91%). Patients switching to CAB LA and RPV LA administered Q4W reported more adverse events (AEs) leading to withdrawal (5%; n=6) compared with those receiving an injection Q8W (2%; n=2) or who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by patients was injection site pain (93% of injection recipients). Two patients in the Q8W arm (none in the Q4W arm) withdrew for injection intolerance. Two patients met protocol defined virologic failure criteria, Q8W (n=1), oral (n=1); neither patient had evidence of resistance at failure.
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 three-drug oral therapy contains three active components taken daily: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI) or integrase inhibitor (INI).
About EDURANT(R) (Rilpivirine)
EDURANT(R) (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/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 12 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:
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