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      Janssen Data Focus On Tolerability and Treatment Simplification in HIV Compounds

      New HIV data to be presented at EACS 2011

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      Belgrade, Serbia, (October 13, 2011) – Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies (Janssen), presented new data across their HIV portfolio at the 13th annual European Aids Conference (EACS) demonstrating the company’s commitment to exploring and developing new HIV treatment options which could help improve treatment for patients at every stage of the disease. Key highlights include:

      • Sustained efficacy for EDURANT® (rilpivirine), significantlylower incidences of grade 2–4 overall adverse events (AEs) including better neuropsychiatric (dizziness, abnormal dreams/nightmares) and lipid profiles compared to efavirenz over 96 weeks[1]
      • No genotypic resistance with PREZISTA® (darunavir) monotherapy over 144 weeks, which supports the concept of monotherapy and class-sparing regimens[2]
      • 200mg INTELENCE® (etravirine) tablet preferred by a majority of patients over 100mg tablet, halving overall pill burden[3]

      These presentations follow positive opinions from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) for rilpivirine and etravirine.

      Pooled 96 Week Efficacy and Safety Results for Rilpivirine

      Pooled data from ECHO and THRIVE show rilpivirine demonstrated sustained efficacy over 96 weeks and was non-inferior to efavirenz (77.6% vs 77.6% respectively), with a more favourable tolerability profile. There were significantly lower incidences of grade 2–4 overall adverse events (AEs) including rash, dizziness, abnormal dreams/nightmares, and lower incidence of grade 3–4 lipid abnormalities. There were fewer AEs leading to discontinuation with rilpivirine compared to efavirenz. The virologic failure rate was higher with rilpivirine than with efavirenz up to 48 weeks (9.0% vs. 4.8% respectively). Between weeks 48 and 96, similar increases in virologic failure rates were observed (3.2% vs 2.3% respectively. At 96 weeks, the overall virologic failure rate was 14.0% with rilpivirine and 7.6% with efavirenz.

      ECHO and THRIVE are two pivotal Phase 3 clinical trials which evaluated the efficacy and safety of rilpivirine in 1,368 antiretroviral treatment-naïve HIV-1-infected adults with plasma HIV-1 RNA ≥ 5000 copies/mL.

      144 Week Monotherapy Resistance Data for Darunavir[2]
      A 144 week analysis from MONET showed no development of phenotypic resistance to darunavir in patients experiencing virologic failure during the trial (HIV RNA > 50 copies/mL, n=54). In these patients, no protease inhibitor resistance was detected, meaning further combination therapy with protease inhibitors could remain a viable treatment option for those experiencing virologic failure with darunavir monotherapy. The 2009 EACS clinical guidelines for the management and treatment of HIV-infected adults in Europe state that monotherapy may represent an option in patients with intolerance to NRTI or for treatment simplification.3 The MONET trial evaluated the efficacy of darunavir, either as a monotherapy or with two NRTIs in 256 patients with HIV RNA <50 copies/mL at baseline over 144 weeks. Data from the primary analysis were presented at the 6th International AIDS Society meeting in Rome, in July 2011. Darunavir is not currently approved for use as monotherapy in Europe and U.S. Darunavir is currently approved for use in combination with ritonavir and other ARV agents.

      Additional data being presented at EACS analysed costs of darunavir monotherapy compared to standard combination treatment at 144 weeks in the UK. Using prices published in the UK, the results showed based on 20,000 HIV-1 infected patients meeting the entry criteria for MONET, a switch to DRV/r monotherapy could cut the three year cost of HIV treatment from £412 million to £248 million per year (20,000 HIV infected patients meeting entry criteria for MONET trial out of estimated 50,000 HIV patients on standard combination treatment).[4]

      Patients Prefer Etravirine 200mg to 100mg tablets[3]
      In a blinded trial assessing ease in swallowing etravirine, the majority of patients rated the 200mg tablet higher than the currently available 100mg tablet as either easy or acceptable to swallow (non-coated 200mg, 69.4%; film-coated 200mg, 79.6%; non-coated 100mg, 42.9%). Etravirine 400mg was administered blinded as a non-coated followed by a film-coated 200mg tablet (within 30 minutes) and “swallowability” was assessed using a questionnaire completed immediately following each intake of drug. When etravirine was first available, the formulation required patients to take 36 tablets a day but the new 200mg formulation would reduce this to two tablets a day.

      “Over the last 15 years, we have made incredible progress in the treatment of HIV. With effective treatment, patients diagnosed today can now expect to live as long as someone without HIV. However, as patients live longer the need for long-term adherence to therapy becomes ever more important. Patients are more likely to adhere to treatments that fit in with their daily life – simple and effective regimens with a good tolerability profile play a part in this,” stated Jean-Michel Molina, MD, Professor of Infectious Diseases at University of Paris Diderot in Paris and ECHO/THRIVE study investigator.

      Poor adherence to treatment is associated with increased treatment emergent resistance, increased illness, progression to AIDS and death.5 The minimum level of adherence needed for HIV treatment to be effective is 95%, which this equates to missing (or taking incorrectly) no more than one dose a month in a once daily regimen or three doses a month in a twice daily regimen.[6]

      The CHMP recently adopted a positive opinion recommending the approval of EDURANT (rilpivirine), a 25 mg tablet, as a once-daily treatment in combination with other antiretroviral agents (ARVs), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/mL. Rilpivirine is also under review as part of Gilead’s EVIPLERA®, a fixed dose combination of rilpivirine and emtricitabine 200mg/tenofovir disoproxil fumarate 300mg, which also received a positive opinion from the CHMP.

      The CHMP also adopted a positive opinion recommending approval of an INTELENCE (etravirine) 200mg tablet, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of HIV-1 in antiretroviral treatment-experienced adult patients. If approved, the 200mg etravirine tablet will halve the current pill burden for treatment-experienced adults from two pills twice daily to one pill twice daily. The recommended dose of etravirine is 200mg twice daily with food.

      Wim Parys, MD, Global Head, Infectious Diseases, Janssen said, “We are very proud to be at the forefront of treatment advances in HIV. The recent positive opinions from the CHMP for rilpivirine and etravirine, followed by the data presented at EACS underscore our commitment to improving both convenience, tolerability and ultimately adherence in treatment without compromising efficacy. We continue to work towards improving the health and lives of people living with this devastating disease.”

      About Tibotec
      Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company’s main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.

      About Janssen
      The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.

      Driven by our commitment to patients, Janssen develops innovative products, services and healthcare solutions to help people throughout the world. More information can be found at


      Ines Hammer
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      [1]H J Stellbrink, C Cohen, JM Molina, et al. Pooled Week 96 efficacy and safety results from thedouble-blind, randomised, Phase III trials comparing rilpivirine (RPV;TMC278) versus efavirenz (EFV) in treatment-naïve, HIV-1-infected adults. Poster PE7.3/5 presented at the 13th annual European Aids Conference (EACS), 12-15 October 2011, Serbia.

      [2]A Hill, F Pulido, J Arribas, et al. No evidence for evolution of genotypic resistance after three years of treatment with darunavir/ritonavir, with or without nucleoside analogues: final week-144 analysis of the MONET trial. Poster PE5.3/1 presented at the 13th annual European Aids Conference (EACS), 12-15 October 2011, Serbia.

      [3]B Gazzard, S Curtis, A Anceau, A Hill et al. Three-year cost efficacy analysis of the MONET trial of darunavir/ritonavir monotherapy using UK antiretroviral drug prices. Poster PE10.4/4 presented at the 13th annual European Aids Conference (EACS), 12-15 October 2011, Serbia.

      [4]TN Kakuda, V Vyncke, S. Nijs et al. Assessment of the ease in swallowing etravirine tablets in HIV-1-infected patients. Poster PE7.9/18 presented at the 13th annual European Aids Conference (EACS), 12-15 October 2011, Serbia.

      [5]European Aids Clinical Society Clinical management and treatment of hiv-infected adults in Europe. Accessed 03 October 2011.

      [6]NAM Aidsmap, HIV and AIDS – sharing knowledge, changing lives. Adherence. Accessed 29 Sept 2011.

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