خواص دارویی و گیاهی
High Proportion of Patients Achieve Undetectable Viral Loads after Rapidly Starting SYMTUZA®1
قرص janssen
Click to Tweet: Janssen announces new #HIV data for patients rapidly starting treatment at #ACTHIV2019. Read full press release here: http://po.st/LK3iIr
Click to Tweet: @JanssenUS announces exciting new data for SYMTUZA® that is being presented at a conference in Miami. Learn more: http://po.st/LK3iIr. Click here for full Prescribing Information for SYMTUZA®, including Boxed WARNING: http://po.st/Tix2oN
“Rapid initiation of antiretroviral treatment is becoming the recognized standard of care for newly diagnosed HIV-1 patients, as it has the potential to improve treatment outcomes, including the probability of a person adhering to treatment and staying in care, and could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals as outlined by UNAIDS,” said Moti Ramgopal, M.D., Infectious Disease Director, Midway Immunology and Research Center, Fort Pierce, Florida.* “The DIAMOND study is the first evidence-based STR-specific trial in a rapid initiation model of care. SYMTUZA® was well-tolerated, and a high proportion of patients achieved undetectable viral loads of less than 50 c/mL after 48 weeks.”
DIAMOND is a Phase 3, single-arm, open-label, prospective, multicenter 48-week study evaluating the efficacy and safety of rapidly initiating SYMTUZA®.1 These 48-week data, which follow on from the interim 24-week results presented at the 2018 International AIDS Conference (AIDS 2018), confirm the safety, efficacy and tolerability profile of rapidly starting SYMTUZA® as a treatment for antiretroviral treatment (ART)-naïve adults with HIV-1.[1]
Through 48 weeks, almost 90% (97/109) of patients enrolled in DIAMOND completed the study.1 In the primary intent-to-treat (ITT) analysis, 84% (92/109) of patients achieved undetectable viral loads (viral load <50 c/mL; FDA-snapshot), and 8% (9/109) of patients had virologic failure (viral load ≥50 c/mL; FDA-snapshot) at 48 weeks.1
Additionally, in an observed analysis – which excluded those with missing data – 96% (92/96) of patients achieved undetectable viral loads, and 100% (96/96) of patients achieved viral loads of <200 c/mL at Week 48, with no patients discontinuing treatment with SYMTUZA® due to lack of efficacy.1
SYMTUZA® was well-tolerated with no serious related adverse events (AEs). Most AEs were grade 1 or 2 in severity, and only two patients experienced a grade 3 drug-related AE, with one patient discontinuing the trial due to adverse events.1 The most common adverse drug reactions related to SYMTUZA® (all grades, ≥2% of adults) were diarrhea, nausea, rash, vomiting and fatigue.1 Grade 3 and 4 laboratory abnormalities, occurring in ≥2% of patients, included increases in aspartate aminotransferase (5%), alanine aminotransferase (3%) or bilirubin (3%).1
Prior to or when initiating SYMTUZA®, patients should undergo testing for hepatitis B virus (HBV) and renal function. Appropriate laboratory tests, including liver testing, hepatitis serology and HIV genotypic resistance testing, should be conducted, and patients should be monitored during treatment as clinically appropriate.1
As another key endpoint, the DIAMOND study also collected the first-known patient-reported outcomes in a Phase 3 rapid initiation trial via a validated HIV Treatment Satisfaction Questionnaire. On a 60-point scale, patients in the DIAMOND trial consistently reported high satisfaction scores (average scores ranging from 56 to 58) regarding treatment with SYMTUZA®.1 When asked specifically about their current treatment (SYMTUZA®), 97% of patients reported they were satisfied with their treatment.1
“When you’re first diagnosed with HIV, your entire world changes, and there are so many questions and uncertainties. However, one thing I did know was that getting on treatment as soon as possible was the most important thing for me to do so I could keep living,” said Brandon B., DIAMOND clinical trial patient. “As a participant in the DIAMOND trial, I was grateful for the opportunity to make treatment part of my daily routine with SYMTUZA®.”
Darunavir has been studied in more than 5,500 patients in 14 clinical trials with data up to 192 weeks.[2],[3] The U.S. Department of Health and Human Services (DHHS) guidelines recommend darunavir-based regimens, such as SYMTUZA®, for patients who may require the rapid initiation of ART before full blood work is available.[4] The International Antiviral Society (IAS)-USA guidelines also recommend darunavir-based regimens for rapidly initiating treatment.[5] Additionally, the DHHS guidelines recommend darunavir-based regimens for those who may have suboptimal adherence and face the risk of developing HIV drug resistance, which is when a medication stops working to fight the virus.4
Several studies examining rapid initiation in newly diagnosed adults with HIV-1 have previously underscored the benefits of linking people with HIV to treatment services soon after diagnosis, including improved virologic outcomes, retention in care and decreased morbidity/mortality.[6],[7],[8] While achieving viral suppression is always a main goal of treatment for individuals, these studies have also found that rapid initiation may get patients to undetectable viral loads more quickly and sustain them over time.
“At Janssen, we’re committed to the research and development of medicines and solutions that have the potential to change the treatment paradigm for people living with HIV – across the care continuum,” said Richard Nettles, M.D., Vice President, Medical Affairs, Janssen Infectious Diseases, Janssen Scientific Affairs, LLC. “The DIAMOND study mirrors real clinical scenarios that physicians face today – including the need to start treatment before lab or baseline resistance test results are available – and highlights the benefits this model of care can bring to those newly diagnosed with HIV. SYMTUZA® is the only single-tablet regimen proven in a Phase 3 clinical trial studying the rapid initiation of treatment, further demonstrating it as a treatment option for people new to HIV therapy.”
SYMTUZA® has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. European approval allows Janssen to market SYMTUZA® in all member states of the European Union and the European Economic Area. Janssen plans additional regulatory filings in other markets worldwide.
SYMTUZA® does not cure or prevent HIV-1 or AIDS.
Please see Important Safety Information below, including Boxed Warning for SYMTUZA®.
To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
*Dr. Ramgopal has received research support from Janssen and has served as a paid consultant to the company.
About DIAMOND1
DIAMOND is a Phase 3, single‐arm, open‐label, prospective, multicenter, 48-week study assessing the efficacy/safety of rapidly initiating SYMTUZA® 800/150/200/10 mg. Adults diagnosed with HIV‐1 infection within 14 days were enrolled and started on SYMTUZA® without screening/baseline laboratory or HIV genotypic resistance information available. Investigators reviewed screening/baseline laboratory and resistance findings as results became available; patients not meeting predefined safety or resistance stopping rules continued treatment. قرص janssen
Resistance was evaluated based on predicted genotypic sensitivity (there was no exclusion based on the presence of specific resistance-associated mutations). Patients who did not show full genotypic sensitivity to the components of SYMTUZA® (assessed using GenoSure PRIme®) would be required to stop the study; an exception was resistance to lamivudine/emtricitabine associated with the M184I or V mutation alone.
Screening/baseline safety laboratory findings were evaluated on Day 3 (±1 week), with the following stopping criteria:
For more information on this clinical trial, please visit: www.clinicaltrials.gov
WHAT IS SYMTUZA®?
SYMTUZA® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMTUZA®?
SYMTUZA® can cause serious side effects including:
Who should not take SYMTUZA®?
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
HOW SHOULD I TAKE SYMTUZA®?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SYMTUZA®?
SYMTUZA® may cause serious side effects including:
The most common side effects of SYMTUZA® are: Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA®.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 full Product Information, including Boxed Warning for SYMTUZA®.
Notes to editors
Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc. On December 23, 2014, Janssen and Gilead Sciences, Inc. amended a licensing agreement for the development and commercialization of a once-daily single-tablet regimen combination of darunavir and Gilead’s TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialization of this single-tablet regimen worldwide.
###
References
[1] Huhn GD, Grofoot G, Ramgopal M, et al. Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Rapid Initiation for HIV-1 Infection: Primary Analysis of the DIAMOND Study. Presented at the 13th Annual American Conference for the Treatment of HIV (ACTHIV 2019), Miami, April 11-13, 2019. [2] Data on file. Janssen Therapeutics, Division of Janssen Products, LP. [3] Prezista US Patient Information Leaflet. Revised: September 2016. https://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf. Last accessed March 2019. [4] Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Last accessed October 2018. [5] Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA panel. JAMA. 2018;320:379-396. [6] Pilcher CD, Ospina‐Norvell C, Dasgupta A, et al. The effect of same‐day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a U.S. public health setting. J Acquir Immune Defic Syndr. 2017;74(1):44–51. [7] Rosen S, Maskew M, Fox MP, et al. Initiating antiretroviral therapy for HIV at a patient’s first clinic visit: the RapIT randomized controlled trial. PLoS Medicine. 2016;13(5):1‐19. [8] Koenig SP, Dorvil N, Devieux JG, et al. Same‐day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: a randomized unblinded trial. PLoS Medicine. 2017;14(7):1‐15. [9] Eron JJ, Orkin C, Gallant J, et al. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. AIDS. 2018;32:1431-1442. [10] Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;(1):e23-e34.5. [11] Eron J, Orkin C, Cunningham D, et al. Efficacy and safety of switching from boosted-protease inhibitors (bPI) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF) regimens to the once daily (QD), single-tablet regimen (STR) of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in virologically-suppressed, HIV-1-infected adults: week 96 results of the phase 3, randomized, non-inferiority EMERALD trial. Presented at IDWeek 2018, San Francisco, CA, USA, October 3-7, 2018; abstract 1768. https://idsa.confex.com/idsa/2018/webprogram/Paper72755.html. Last accessed October 2018. [12] Orkin C, Eron JJ, Rockstroh J, et al. Efficacy and safety of the once-daily, darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen (STR) in antiretroviral treatment (ART)-naïve, HIV-1-infected adults: AMBER Week 96 results. Presented at HIV Glasgow 2018, Glasgow, October 28-31, 2018. https://onlinelibrary.wiley.com/doi/full/10.1002/jia2.25187. Last accessed October 2018.
Click to Tweet #NEWS: FDA approves new @JanssenUS treatment for HIV. Read full press release here: http://po.st/LK3iIr
Click to Tweet @JanssenUS announces #FDA approval for SYMTUZA. See full PI incl Boxed Warning: http://po.st/kuzDlg قرص janssen
“As clinicians, we may not always have the full picture of a patient’s health or their risk for developing resistance when making treatment decisions. In key Phase 3 clinical trials, SYMTUZATM successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) therapy – including patients with more complex treatment histories or previous virologic failure – demonstrating its potential as an important new treatment option for a wide variety of patients,” said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C.
The U.S. Department of Health and Human Services guidelines1 recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.
“Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication – or even an entire class of medications – to stop working,” continued Dr. Eron.
SYMTUZATM received FDA approval based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy of SYMTUZATM versus a control regimen in adults with no prior ARV history (AMBER) and in virologically suppressed adults (EMERALD). Results from both trials demonstrated that SYMTUZATM was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL).
“For more than 25 years, Janssen has been committed to the research and development of transformational medical innovation across the continuum of HIV care. The FDA approval of SYMTUZATM marks another important milestone in our quest to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV,” said Brian Woodfall, M.D., Global Head of Late Development, Infectious Diseases, Janssen Pharmaceutica NV. “There is more to be done in our fight to make HIV history, and we will not stop here. We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine.”
The recommended dosage of SYMTUZATM is one tablet taken once-daily with food. SYMTUZATM is not recommended in patients with creatinine clearance below 30 mL per minute or those with severe hepatic impairment.
According to the Prescribing Information, prior to or when initiating treatment with SYMTUZATM, patients should be tested for hepatitis B virus (HBV) infection and renal function, and renal function should be monitored as clinically appropriate during therapy. See below for Important Safety Information.
SYMTUZATM has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. European approval allows Janssen to market SYMTUZATM in all member states of the European Union and the European Economic Area. Janssen plans additional regulatory filings in other markets worldwide, and additional SYMTUZATM data, including data from an ongoing Phase 3 rapid initiation study (DIAMOND) will be presented at AIDS 2018 in Amsterdam, The Netherlands in late July.
Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.
Full Prescribing Information is available here. To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
###
Notes to editors Cobicistat, emtricitabine and TAF are from Gilead Sciences, Inc. On December 23, 2014, Janssen and Gilead Sciences Inc. amended a licensing agreement for the development and commercialization of a once-daily, darunavir-based STR including Gilead’s TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialization of SYMTUZATM worldwide.
WHAT IS SYMTUZA™?SYMTUZA™ is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
IMPORTANT SAFETY INFORMATION What is the most important information I should know about SYMTUZATM? SYMTUZA™ can cause serious side effects including:
SYMTUZATM may cause severe or life-threatening skin reactions or rashes which may sometime require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking SYMTUZATM and call your healthcare provider right away if you develop any skin changes with symptoms below:
• Fever
• Tiredness
• Muscle or joint pain
• Blisters or skin lesions
• Mouth sores or ulcers
• Red or inflamed eyes, like “pink eye” (conjunctivitis)
Who should not take SYMTUZATM?
Before taking SYMTUZATM, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZATM. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.How should I take SYMTUZA™?• Take SYMTUZA™ 1 time a day with food.
What are the possible side effects of SYMTUZATM?SYMTUZA™ may cause serious side effects including:
The most common side effects of SYMTUZA™ are: Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.These are not all of the possible side effects of SYMTUZA™.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 full Product Information, including Boxed Warning for SYMTUZA™.
قرص janssen
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development and benefits of new treatment options of SYMTUZATM for HIV-1. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Therapeutics, Division of Janssen Products, LP, any of the other Janssen Pharmaceutical Companies and/or Johnson
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https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf
25 سپتامبر 2017
Janssen امروز اعلام کرد که آن را ارسال شده است کاربرد مواد مخدر جدید به FDA برای یک بار در روز، darunavir بر اساس رژیم اچ آی وی برای بزرگسالان و کودکان سن 12 سال و مسن تر.
قرص janssen
رژیم تک قرص حاوی 800 میلی گرم از darunavir 150 ميلي گرم Tybost (cobicistat، علوم Gilead)، 200 میلی گرم از emtricitabine و 10 ميلي گرم Vemlidy (tenofovir alafenamide، Gilead علوم; D/C/F/TAF)، با توجه به شرکت آزادی مطبوعات.
“پر کردن این نقطه عطف مهمی در ادامه به نیازهای افراد حامل ویروس ایدز هستند که مبارزه با پایبندی و خطر ابتلا به مقاومت در برابر دارو علائم” ریچارد Nettles معاون امور پزشکی در Janssen، گفت: در نسخه. “اگر تایید شده, این درمان ما را امیدوار کننده از محصولات برای کسانی که حامل ویروس ایدز هستند شامل پزشکی است که برای اولین بار با هم مانع ژنتیکی بالا darunavir را به ارمغان می آورد به مقاومت با مشخصات ایمنی tenofovir فعال خواهد شد alafenamide, در رژیم روزانه یک بار، قرص تک دوز.”
پر کردن داده ها از دو noninferiority بر است، فاز 3 محاکمه — زمرد و کهربا — در که D/C/F/TAF گفت: آزادی با نرخ بالا سرکوب virologic همراه بود. محاکمه زمرد شامل 763 virologically سرکوب بيمار به D/C/F/TAF تغییر و 378 بيمار ادامه درمان در مهار کننده پروتئاز افزایش به علاوه emtricitabine و Viread (tenofovir disoproxil فومارات، Gilead علوم; F/TDF). رنگ کهربایی كارآزمايي شامل 362 بیماران درمان ساده و بی تکلف است که D/C/F/TAF و 363 که D/C با F/TDF.
با توجه به داده های 24 هفته از دادگاه EMARLD در کنفرانس جامعه بین المللی ایدز در ژوئیه 96.3 در بيماران D/C/F/TAF مصرف و 95.5 درصد در کنترل گروه تجربه سرکوب virologic، با virologic شکست در 0.5 درصد و 0.8 درصد ارائه شده از بيماران بود. داده های اضافی از زمرد در IDWeek ارائه خواهد شد، برگزار شد اکتبر 4 به 8 و 48 هفته داده کهربا در اروپا، از اکتبر 25 تا 27 برگزار ارائه خواهد شد.
با توجه به Janssen، D/C/F/TAF در حال حاضر تحت بررسی های نظارتی اروپا توسط آژانس داروهای اروپا تحت نام تجاری Symtuza است. Janssen و وابسته به آن را برای ساخت ثبت نام توزیع و تجاری D/C/F/TAF به عنوان یک رژیم قرص تک در سراسر جهان از طریق توافقنامه مجوز بین Janssen و علوم Gilead نگه دارید.
یک جفت: پیشگیرانه Tenofovir می رود سر علیه آباکاویر در اچ آی وی
بعدی: BHIVA چالش 1840، توصیه در هنر در دوران بارداری: Tenofovir هنوز به شدت توصیه می شود
TENOFOVIR INTERIMEDIATES 35180-01-9
TENOFOVIR INTERMEDIATES 16606-55-6
TENOFOVIR INTERVEDIATES 147127-20-6
TENOFOVIR INTEREDEDATES 3084-40-0
CIPROFIBRATE 144900-34-5
CIPROFIBRATE 40641-93-8
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– SYMTUZA™ (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg) offers new treatment option for adults living with HIV-1 infection
– Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the safety profile of tenofovir alafenamide (TAF)
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Jul 17, 2018, 17:31 ET
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Click to Tweet #NEWS: FDA approves new @JanssenUS treatment for HIV. Read full press release here: http://po.st/LK3iIr
Click to Tweet @JanssenUS announces #FDA approval for SYMTUZA. See full PI incl Boxed Warning: http://po.st/kuzDlg
“As clinicians, we may not always have the full picture of a patient’s health or their risk for developing resistance when making treatment decisions. In key Phase 3 clinical trials, SYMTUZA™ successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) therapy – including patients with more complex treatment histories or previous virologic failure – demonstrating its potential as an important new treatment option for a wide variety of patients,” said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C.
The U.S. Department of Health and Human Services guidelines1 recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.
“Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication – or even an entire class of medications – to stop working,” continued Dr. Eron.
SYMTUZA™ received FDA approval based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy of SYMTUZA™ versus a control regimen in adults with no prior ARV history (AMBER) and in virologically suppressed adults (EMERALD). Results from both trials demonstrated that SYMTUZA™ was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL).
“For more than 25 years, Janssen has been committed to the research and development of transformational medical innovation across the continuum of HIV care. The FDA approval of SYMTUZA™ marks another important milestone in our quest to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV,” said Brian Woodfall, M.D., Global Head of Late Development, Infectious Diseases, Janssen Pharmaceutica NV. “There is more to be done in our fight to make HIV history, and we will not stop here. We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine.”
The recommended dosage of SYMTUZA™ is one tablet taken once-daily with food. SYMTUZA™ is not recommended in patients with creatinine clearance below 30 mL per minute or those with severe hepatic impairment.
According to the Prescribing Information, prior to or when initiating treatment with SYMTUZA™, patients should be tested for hepatitis B virus (HBV) infection and renal function, and renal function should be monitored as clinically appropriate during therapy. See below for Important Safety Information.
SYMTUZA™ has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. European approval allows Janssen to market SYMTUZA™ in all member states of the European Union and the European Economic Area. Janssen plans additional regulatory filings in other markets worldwide, and additional SYMTUZA™ data, including data from an ongoing Phase 3 rapid initiation study (DIAMOND) will be presented at AIDS 2018 in Amsterdam, The Netherlands in late July.
Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.
Full Prescribing Information is available here. To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
Notes to editors
Cobicistat, emtricitabine and TAF are from Gilead Sciences, Inc. On December 23, 2014, Janssen and Gilead Sciences Inc. amended a licensing agreement for the development and commercialization of a once-daily, darunavir-based STR including Gilead’s TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialization of SYMTUZA™ worldwide.
WHAT IS SYMTUZA™?
SYMTUZA™ is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SYMTUZA™?SYMTUZA™ can cause serious side effects including:
SYMTUZA™ may cause severe or life-threatening skin reactions or rashes which may sometime require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking SYMTUZA™ and call your healthcare provider right away if you develop any skin changes with symptoms below:
Who should not take SYMTUZA™?
Before taking SYMTUZA™, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA™. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
How should I take SYMTUZA™?
What are the possible side effects of SYMTUZA™?
SYMTUZA™ may cause serious side effects including:
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The most common side effects of SYMTUZA™ are: Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA™.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 full Product Information, including Boxed Warning for SYMTUZA™.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development and benefits of new treatment options of SYMTUZA™ for HIV-1. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Therapeutics, Division of Janssen Products, LP, any of the other Janssen Pharmaceutical Companies and/or Johnson
MEDIA CONTACTS: Rebecca Genin +1 215-620-8721 Rgenin1@its.jnj.com
Kristina Chang +1 201-213-4115 Kchang12@its.jnj.com
INVESTOR RELATIONS: Lesley Fishman +1 732-524-3922
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Janssen and Gilead combination first to reach patients
Janssen has gained NHS England funding for its HIV treatment combination Symtuza, which combines a four drug regimen in a single tablet.
Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]).is once-daily darunavir-based single tablet regimen (STR), for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with a body weight of at least 40 kg.
The global HIV market is dominated by Gilead and ViiV (majority controlled by GSK), but NHS England’s decision is a coup for Janssen, as Symtuza becomes the first STR available to patients who need a protease inhibitor treatment.
Symtuza was approved a year ago in Europe, and brings together Janssen’s protease inhibitor darunavir with Gilead’s cobicistat/emtricitabine/tenofovir alafenamide, a licensing deal agreed between the companies in 2014.قرص janssen
“We are delighted that NHSE has provided vital funding for this treatment option; enabling access for individuals who require a darunavir-based STR to effectively control their HIV, with the potential to support adherence to treatment,” says Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen-Cilag Ltd.
“This milestone reflects our efforts to help simplify the way in which HIV is treated, supporting people living with HIV to achieve an undetectable viral load while enjoying an improved quality of life. We are thankful for NHSE’s collaboration throughout this process.”
The company’s phase 3 EMERALD study showed that virologically-supressed treatment-experienced patients who switched to Symtuza from boosted protease-inhibitor (bPI) based regimens maintained similar virologic response rates and virologic rebound compared to continuing a regimen of boosted PI emtricitabine and TAF.
The ruling puts Symtuza ahead of newly EU-approved rivals in the single tablet regimen field.
Gilead gained European approval for its own new single table regimen, Biktarvy in June, hot on the heels of ViiV’s rival Juluca.
Biktarvy is a combination of integrase inhibitor bictegravir with Gilead’s existing blockbuster Descovy, a combination of emtricitabine (FTC) and tenofovir alafenamide (TAF).
Analysts predict big things for Biktarvy, forecasting revenues of around $896mn this year and $3.7bn for 2022, making long-term HIV treatment more convenient for patients, and showing itself to prevent any cases of drug resistance.
ViiV meanwhile has a monthly injection in its late stage pipeline which could also play a big role in the future development of HIV therapy, while Janssen is also advancing a HIV vaccine.
In England, NHS England tightly control spending on HIV drugs, and has looked to drive down costs in recent years by using more generic treatments. A recent court case also saw Gilead’s patent on Truvada overturned in the UK – which HIV campaigners hope will see greater use of the drug to prevent HIV infections.
Article byAndrew McConaghie
2nd October 2018
Article by
Andrew McConaghie
2nd October 2018
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Brown K(1), Thomas D(2), McKenney K(2), Reeder M(3), Simonson RB(1), Bicer C(4),
Nettles RE(1), Crauwels H(5).
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is an oral
once-daily single-tablet regimen for the treatment of human immunodeficiency
virus-1 infection. Different administration modalities for the D/C/F/TAF
fixed-dose combination tablet were explored in this phase 1 randomized,
open-label, 3-period, 3-treatment crossover study enrolling 30 healthy adults.
The primary objective was to assess the relative bioavailability of each
component after a single dose of D/C/F/TAF (800/150/200/10 mg) administered as a
split or crushed tablet (tests) versus swallowed whole (reference).
Pharmacokinetic parameters (noncompartmental analysis; logarithm-transformed) for
each component were compared using linear mixed-effects modeling. For the split
versus whole tablet, the bioavailabilities (maximum plasma concentration [Cmax ]
and area under the plasma concentration-time curve [AUClast ]) of each D/C/F/TAF
component were comparable. For the crushed versus whole tablet, the
bioavailabilities of darunavir, cobicistat, and emtricitabine were comparable,
except for a 17% decrease in emtricitabine Cmax ; the relative bioavailability of
tenofovir alafenamide decreased by 29% and 19% for Cmax and AUClast ,
respectively. All intakes were safe and generally well tolerated. In summary,
there was no clinically relevant impact on the bioavailability of D/C/F/TAF
components when administered as a split tablet compared with a tablet swallowed
whole. Administration of a crushed tablet resulted in a modest decrease in
tenofovir alafenamide bioavailability; the clinical relevance of this change has
not been assessed but is expected to be minimal based on the wide therapeutic
window for this agent.
© 2018, The American College of Clinical Pharmacology.
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