+ الرد على الموضوع
صفحة 12 من 32 الأولىالأولى ... 2101112131422 ... الأخيرةالأخيرة
النتائج 111 إلى 120 من 318

الموضوع: دعوة للجميع للمشاركة في كل ما يستجد من علاجات ل فيروس سي ،،

  1. #111

    افتراضي الخميس، 9 يونيو 2011 - 18:52

    هل يمكن علاج فيروس "سى" بسم النحل؟



    الدكتور سعيد شلبى أستاذ الباطنة والكبد رئيس قسم الطب التكميلى بالمركز القومى للبحوث؟؟؟؟؟؟؟؟؟؟؟

    يسأل أحد القراء: هل يمكن علاج فيروس سى باستخدام سم النحل، وخاصة فى الحالات المبكرة والمتوسطة، حيث سمعنا أنه يعطى نتائج رائعة فى علاج الفيروس، خاصة وأن الإنترفيرون والريبافيرين لهما أعراض جانبية كثيرة؟

    يجيب الدكتور سعيد شلبى أستاذ الباطنة والكبد رئيس قسم الطب التكميلى بالمركز القومى للبحوث قائلا: النحل له 5 منتجات، وهى سم النحل والعسل والبر وبوليس والشمع وحبوب اللقاح، والعسل هو الذى فيه شفاء للناس من بعض الأمراض، أما المنتجات الأربعة الأخرى فهى تساعد على رفع المناعة وتحسين الحالة الصحية للمريض دون القضاء على الفيروسات أو غيرها من الأمراض الميكروبية.

    ويضيف أن سم النحل كان قد تم إنتاجه من قبل لعلاج الفيروس الكبدى سى، ولكن عند تجربته على بعض المرضى لم يأت بنتائج فعالة أو واعدة، ولكن هذا الخبر يعتبر نوعا من الدعاية لأحد منتجى هذا المنتج من حقن سم النحل، لهذا إذا كانت هناك نتائج جديدة عن سم النحل، فيجب على المنتج أن يرفقها على شبكة المعلومات حتى يمكن للمتخصصين دراسة هذه النتائج، وتقييمها بغرض الإدلاء بالرأى السديد للمرضى فيما يخص تناولهم لهذا العقار من عدمه، بناء على فعاليته ونسبة نجاحه التى تفوق العلاج الرسمى وهو الإنترفيرون والريبافيرين إن وجدت.

    ويحذر الدكتور شلبى من استخدام سم النحل بقوله إن سم النحل بالحقن يؤدى إلى الحساسية الجلدية فى بعض المرضى، ولهذا يجب عمل اختبار حساسية قبل حقنه حتى لا تتعرض حياة المريض للخطر، خاصة وأنه لا يعالج فيروس سى، مع ملاحظة أن هناك العديد من المستحضرات الطبية والمكملات الغذائية التى تساعد على رفع المناعة دون التعرض للآثار الجانبية لسم النحل مثل بعض الأعشاب النادرة، والتى توجد على شكل تركيبات تنتجها شركات الأدوية ومتداولة فى سوق الدواء المصرى، حيث إن بعض الأطباء يصفونها ضمن وصفاتهم الطبية، حيث تحتوى على حبة البركة والشمر والزنك والسلينيوم.

    ويؤكد أن العسل نفسه فيه شفاء للناس، وقد جاء ذلك فى القرآن والإنجيل، ولكن المشكلة أنه مطلوب عمل دراسات مستفيضة لتحديد الجرعة اللازمة من العسل لعلاج الأمراض المختلفة، مع تحديد أنواع العسل المناسبة لكل حالة مرضية، وهذا ما يسمى بعلم "العلاج بمنتجات النحل" أو "أبى ثربى".

    ـــــــــــــ
    ردود أحد الزوار على الدكتور سعيد شلبي:
    مهم جدااا
    ـــــــــــــ
    اللى مايعرفش يقول عدس

    بواسطة: د/نادر



    بتاريخ: الجمعة، 10 يونيو 2011 - 04:26

    ايه الكلام ده يادكتور
    1- يخرج من بطونها شراب مختلف الوانه فيه شفاء للناس
    الشراب المختلف الوانه وهو كل منتجات النحل ..... يعنى مش العسل بس اللى بيعالج الأمراض زى ما بتقول حضرتك
    وكل من هذه المنتجات لها استخداماتها الطبية والعلاجية
    2- منتجات النحل سبعة وليست خامسة يا ..دكتور
    حضرتك نسيت غذاء الملكات وخبز النحل ولا حضرتك ما أخدتش بالك
    3- سم النحل يادكتور يفيد جدا مريض الكبد حيث يرفع المناعة لدرجة أكبر من تأثير الانترفيرون
    وسم النحل تركيبة مدمرة للبكتيريا والفيروسات ومختلف الميكروبات
    ويوجد لدى كثير من الحالات تم علاجها بفضل الله من فيروسات الكبد باستخدام سم النحل ومختلف منتجات النحل
    4- جرعات ايه يادكتور وأنواع عسل ايه يادكتور... انت بتعقدها ليه الموضوع مش صعب للدرجة دى ... جرعات العسل وطرق تناولها معروفة ... والعسل باختلاف أنواعه جيد جدا ولا يهم النوع فالتركيب الكيميائى للعسل واحد ... مايختلف فقط هو مصدر تغية النحل
    لكن عسل النحل الطبيعى هو عسل النحل الطبيعى
    ولا يوجد شىء اسمه عسل معين لنوع معين من الأمراض !!!
    5- تم عرض عدة أبحاث وورقة عمل ووثائق طبية لمرضى تم شفائهم من عدة أمراض باستخدام منتجات النخل ...وقوبلت هذه الأبحاث من قبل مسئولى المركز القومى للبحوث
    وعلى فكرة يادكتور أنا متخصص فى هذا النوع من العلاج مع الحجامة والابر الصينية

    ـــــــــــــ
    المصدر :
    http://www.youm7.com/News.asp?NewsID=431848
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


  2. #112

    افتراضي

    ياخى والله انا باشكرك انت الوحيد باخبارك المفرحه اللى بتخلينا نخش المنتدى بعد ماترااااااااااااااجع كتير

  3. #113

    افتراضي

    <b>مفاجأة علمية من العيار الثقيل&rlm;,&rlm; فجرها معهد سكريبس للابحاث في ولاية كاليفورنيا وأحد أهم المراكز المتخصصة في ابحاث العلوم الطبية البيولوجية&rlm;,&rlm; باعلانه توصل الفريق البحثي به&rlm;,&rlm; لاجسام مضادة مناعية تمنع الاصابة بفصائل مختلفة من الفيروس الكبدي سي</b>
    <p>
    بل تدمر الفيروسات الموجودة اذا حدثت العدوي وذلك باستخدام نماذج معدلة جينيا من حيوانات التجارب المعملية وهو مايعني ان البشرية أصبحت تمتلك املا قريبا في ايجاد مصل للوقاية وعلاج الفيروس الكبدي الوبائي سي.<br />
    وتأتي اهمية هذه الابحاث بعدما اصبح هذا الفيروس المخادع علي قمة الاصابات الفيروسية في العالم ويتفوق عدد الاصابات به فيروس الايدز حيث انه يصيب أكثر من170 مليون انسان ويضيف كل عام4 ملايين مريض جديد. في حين يكمن نصيب مصر وتتواجد الاجسام المضادة للفيروس الكبدي سي فيما يتجاوز10% من أكباد المصريين بما يجعلنا من ضمن البؤرة الأعلي في معدلات الاصابة بفيروس سي عالميا.<br />
    فالي أي مدي قد تنجح محاولات لايجاد تطعيم ضد الاصابة بالفيروس الكبدي سي وما الصعوبات أمام انتاجه؟<br />
    الاجابة كما يوضحها الدكتور أحمد أبومدين رئيس قسم الامراض المتوطنة ومدير مركز الكبد الاسبق بطب القاهرة, هي انتشار فرص الاصابة بالمرض والتي اصبحت تهدد الانسان العادي في حياته اليومية نتيجة الاهمال في اتباع طرق الوقاية خاصة عند اختفاء الضمير في التعامل مع الادوات الطبية والدم ومكوناته او الآلات التي تخترق انسجة الانسان ولو بطريق الخطأ مثل موسي الحلاقة الملوث.<br />
    ولذلك أصبح إيجاد تطعيم ضد هذا الفيروس هو الوسيلة المثلي للبشر لمحاربته وحماية الاجيال القادمة للبشر من الاصابة. ولكن هذه المحاولات ظلت تبوء بالفشل لأسباب متعددة وهي عدم وجود حيوان تجريبي يقبل الإصابة بالفيروس الكبدي سي غير الشمبانزي الذي يستحيل استخدامه بصفة عالمية موسعة لانتاج طعم علي مستوي البشر وكذلك حيوان( التمارين) النادر وهو نوع من القرود صغير الحجم. والمشكلة الثانية هوالتغير الانتجيني لصفات الفيروس أثناء الاصابة والذي يجعل اي محاولة لايجاد مصل واق غير ذات فاعلية.<br />
    اما ابحاث التطعيم المكتشف حديثا فتستند الي الاساس العلمي وهو قدرة الفيروس الكبدي سي علي التعديل المتكرر لصفاته الانتجينية والتي تمنع تأثير الاجسام المناعية للجسم عليه وبهذا يواجه الاجسام المضادة ويجعلها غير ذات فاعلية. ولكن أبحاث معهد سكريبس اكتشفت مواقع لاتتغير انتجينيا تقع علي الغلاف الخارجي الذي يحمي الشريط الجيني للفيروس وبالتحديد تبين أن الاجسام المضادة التي تحمل البروتين المسمي كودياAR4A يملك نشاطا مناعيا فعالا ضد الفيروس سي وهذه الاجسام المضادة تملك القدرة علي الوصول الي المواقع الغير متغيرة جينيا للفيروس مدمرة لتكوينه البنائي.<br />
    وكما يشير الدكتور ابومدين يعتبر الغلاف الخارجي جزءا من الفيروس, ومن مكوناته أجزاء الالتصاق بالخلية الكبدية وتسميE1-E2complex وهذه المكونات بالتحديد تملك نقطا غير متغيرة انتجينيا عند التقائها بالغشاء الدهني للغلاف الفيروسي. وبالتالي فيمكن تدمير هذه المواقع بواسطة الامصال المكتشفة.<br />
    نتائج هذه الابحاث أيدتها جامعة كوبنهاجن مؤخرا بعد إعادة تجارب معهد سكيربس وأثبتت نجاحها أيضا. ومنذ عدة شهور اتسع الفريق البحثي ليضم باحثين من جامعة روكفيلر, بعدما قاموا بابتكار نمط من فئران التجارب المعملية والمعدلة جينيا لقبول العدوي بالفيروس الكبدي سي. وقد أثبتت النتائج أن استخدام الاجسام المضادة المسماةAR4A نجح في منع الاصابة بالفيروس الكبدي سي.</p>
    التعديل الأخير تم بواسطة almatador_2008 ; 26-Jun-2013 الساعة 09:34 PM

  4. #114

  5. #115

  6. #116

    افتراضي

    اقتباس المشاركة الأصلية كتبت بواسطة almatador_2008 مشاهدة المشاركة
    ياخى والله انا باشكرك انت الوحيد باخبارك المفرحه اللى بتخلينا نخش المنتدى بعد ماترااااااااااااااجع كتير
    بارك الله فيك أخي الكريم وبعتذر عن التأخير فالرد
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


  7. #117

    افتراضي الجمعة، 8 نوفمبر 2013 - 00:05

    عقاران جديدان لعلاج فيروس c بنسبة شفاء 95% يناير المقبل

    ـــــــــــــــــــــــــــــ الدكتور هشام أيوب استشارى أمراض الكبد و عضو الجمعية الأوربية لدراسة أمراض الكبد كتبت منى محمد أعلن الدكتور هشام أيوب استشارى أمراض الكبد، وعضوالجمعية الأوربية لدراسة أمراض الكبد، عن انتهاء الأبحاث الخاصة بعقارين جديدين من المضادات المباشرة للفيروس الكبدى (c) وهما sofsbuvir وSimprevir، واللذين أثبتا فاعلية كبيرة فى القضاء على فيروس (c) وخصوصا فى النوع الرابع المنتشر فى مصر بنسبة شفاء تتجاوز ٩٥٪ . وأضاف هشام، أنه سيتم تداول هذه الأدوية فى السوق الأمريكى فى يناير المقبل، مضيفا أن هناك جهود مصرية لتوفير هذه العقاقير بمصر خلال نفس العام و بأسعار تناسب المرضى. وأكد أيوب، أن الأبحاث أثبتت عدم وجود أى آثار جانبية للدواء، مشيرا إلى أن مدة العلاج ثلاثة أشهر، ويعطى هذا الدواء فى صورة أقراص بالفم ويصلح لجميع حالات الإصابة بالفيروس، وحتى الحالات التى لم تستجيب للعلاج بحقن الإنترفيرون، مؤكدا على أن هذا الدواء طفرة فى أسلوب علاج فيروس c، ومن المتوقع القضاء على الفيروس بهذا العلاج مع التركيز على رفع الوعى الصحى للوقاية من العدوى. جاء ذلك خلال المؤتمر السنوى للجمعية الأمريكية لدراسة أمراض الكبد بالعاصمة الأمريكية واشنطن والذى تنتهى فعاليته اليوم. ـــــــــــــــــــــــــــــ
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


  8. #118

    افتراضي Published: 05 November 2013

    Simeprevir + sofosbuvir produces high sustained response rates for hard-to-treat patients in COSMOS trial

    Hepatitis C treatment

    Simeprevir + sofosbuvir produces high sustained response rates for hard-to-treat patients in COSMOS trial

    Liz HighleymanProduced in collaboration with hivandhepatitis.com

    Published: 05 November 2013






    Ira Jacobson, of Weill Cornell Medical College, speaking at The Liver Meeting 2013. Photo by Liz Highleyman, hivandhepatitis.com

    A 12-week all-oral combination of simeprevir plus sofosbuvir led to sustained virological response in 93% of genotype 1 prior null responders with mild-to-moderate liver fibrosis, working as well as a longer course of treatment or triple therapy including ribavirin, according to late-breaking findings from the COSMOS trial presented yesterday at 'The Liver Meeting 2013', the 64th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC.
    The study also showed that 100% of treatment-naive patients and null responders with advanced fibrosis or cirrhosis achieved early sustained response at 4 weeks post-treatment using the same dual regimen.
    The advent of next-generation direct-acting antivirals (DAAs) has been described as a revolution in the treatment of chronic hepatitis C virus (HCV) infection. While the first of these new agents will initially be approved as add-ons to interferon-based therapy, people with hepatitis C and their clinicians are eagerly awaiting interferon-free regimens.
    Multiple DAAs developed by several major drug companies have performed well in all-oral regimens in trials to date, but their effectiveness varies based on a bewildering array of factors including HCV subtype (1b vs 1a), host IL28B gene pattern ('CC' vs non-'CC'), prior treatment status (untreated, relapser, prior partial or null responder) and extent of liver damage (absent, mild or moderate fibrosis vs advanced fibrosis or cirrhosis).
    Ira Jacobson of Weill Cornell Medical College presented findings from the phase 2a COSMOS trial, evaluating oral regimens containing Janssen/Medivir's HCV protease inhibitor simeprevir (formerly TMC435) and Gilead Science’s nucleotide polymerase inhibitor sofosbuvir (formerly GS-7977), taken with or without ribavirin.
    This open-label study enrolled two cohorts of patients with genotype 1 chronic hepatitis C:
    • Cohort 1: 80 prior interferon null responders with absent-to-moderate fibrosis (Metavir stage F0-F2);
    • Cohort 2: 87 treatment-naive individuals and prior null responders with advanced fibrosis or compensated cirrhosis (F3-F4).
    About 60% of participants in Cohort 1 were men, 29% were black and the median age was 56 years. Just over three-quarters had harder-to-treat HCV subtype 1a, and half of these had the Q80K resistance mutation at baseline. Only 6% had the favourable IL28B 'CC' gene variant associated with good interferon responsiveness – typical of null responders. About 40% had stage F0-F1 fibrosis while 60% had F2.
    In Cohort 2, two-thirds were men, 9% were black and the median age was 58 years. Again 78% had subtype 1a, 40% with the Q80K mutation. Participants were about evenly divided between treatment-naives and null responders, and 21% had the favourable 'CC' variant. Just over half had advanced fibrosis, the rest cirrhosis.
    Participants were randomly assigned to receive a dual regimen of 150mg once-daily simeprevir plus 400mg once-daily sofosbuvir, or else a triple regimen of these two drugs plus 1000-1200mg weight-based ribavirin taken twice-daily. In addition, they were randomised to receive these regimens for either 12 or 24 weeks.
    Jacobson presented results from a planned interim analysis. Cohort 1 started earlier and had long enough follow-up to determine sustained virological response at 12 weeks after completing treatment (SVR12), which is considered a cure. Cohort 2 started later and had 4-week post-treatment follow-up results (SVR4), which is too soon to declare them cured as relapses could still occur.
    All participants treated for 12 weeks completed therapy in both cohorts. In Cohort 1, about 87% treated for 24 weeks finished therapy. Two people in the dual therapy arm and three in the triple therapy arm stopped early, one in each arm due to adverse events. More than 90% of Cohort 2 participants treated for 24 weeks were still in treatment or follow-up; again one in each arm discontinued due to adverse events.
    All Cohort 1 participants who completed therapy had undetectable HCV RNA at the end of treatment and no viral breakthroughs occurred. Amongst those treated for 12 weeks, 93% taking simeprevir/sofosbuvir and 96% taking simeprevir/sofosbuvir/ribavirin achieved SVR12. There was one relapse in each regimen arm. Amongst those treated for 24 weeks, SVR12 rates were 93% and 79%, respectively. There was one relapser and four people with 'non-virological failure' in the ribavirin arm.
    In Cohort 2, all 14 participants who completed therapy had undetectable end-of-treatment viral load with no breakthroughs. One hundred per cent of both treatment-naive patients and null responders taking simeprevir/sofosbuvir who had adequate follow-up (seven of each) achieved SVR4, as did 100% of naive participants and 93% of null responders (all but one) treated with simeprevir/sofosbuvir/ribavirin.
    In both cohorts, 100% of people with HCV subtype 1b or with subtype 1a but lacking the Q80K mutation achieved SVR12 or SVR4. Three relapsers in Cohort 1 and one in Cohort 2 had subtype 1a with the mutation (SVR12 of 89% and SVR4 of 91%, respectively).
    The researchers looked at the effect of adding ribavirin to the 12-week course of therapy for difficult-to-treat subgroups in both cohorts combined. Amongst people with unfavourable IL28B status, 96% taking either the ribavirin-sparing or the ribavirin-containing regimen achieved SVR4. Amongst prior null responders the SVR4 rate was 95% using either regimen. Amongst people with cirrhosis, SVR4 rates were 100% without and 91% with ribavirin.
    Treatment was generally safe and well tolerated. Amongst people treated for 12 weeks in both cohorts combined, there were no serious adverse events, grade 3-4 laboratory abnormalities or discontinuations due to adverse events with either regimen. Amongst people treated for 24 weeks, serious adverse events were rare (3 to 4%) and there were two discontinuations due to adverse events in both regimen arms.
    The most common side-effects were fatigue, headache, nausea and insomnia, which occurred with similar frequency in both the ribavirin-sparing and ribavirin-containing arms. Anaemia and elevated bilirubin, however, were more common amongst ribavirin recipients.
    Based on these findings the researchers concluded that treatment with simeprevir plus sofosbuvir, with or without ribavirin, resulted in high SVR12 rates (79 to 96%) in HCV genotype 1 null responders with stage F0-F2 fibrosis, as well as high SVR4 rates (96 to 100%) in treatment-naive and null responder patients with stage F3 fibrosis or F4 cirrhosis.
    Addition of ribavirin to simeprevir and sofosbuvir "may not be needed to achieve high rates of SVR in this patient population," they added. "12 weeks of treatment may confer similar SVR rates compared with 24 weeks of treatment."
    Given last month's recommendation for approval of both simeprevir and sofosbuvir by a US Food and Drug Administration advisory committee, Jacobson was asked about the prospect of using these drugs together off-label as an interferon-free regimen, especially for patients with advanced disease who need treatment now but cannot tolerate ribavirin.
    "It's difficult to provide definitive guidance," Jacobson replied. "But all of us want to help our patients, and it's not difficult to imagine extrapolating from these data."


    Reference

    Jacobson IM, Ghalib RM, Rodriguez-Torres M et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study. 64th Annual Meeting of the American Association for the Study of Liver Diseases, Washington DC, abstract LB-3, 2013.




    http://www.aidsmap.com/Simeprevir-so.../page/2787623/
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


  9. #119

    افتراضي Posted Mon, 11/11/2013 - 8:59am by Ed Silverman

    How Much? A Battle Over The Cost Of The New Hepatitis C Drugs

    Posted Mon, 11/11/2013 - 8:59am by Ed Silverman 12dollar-scissor-istock.jpg

    dollar-scissor-istock.jpg






    As excitement mounts among physicians and investors over a new crop of drugs for treating hepatitis C, there is also concern that patients in developing countries may not have sufficient access due to high prices. But a recent poster presentation at a medical conference suggests that drugmakers can produce these new medicines for relatively little cost and should be compelled to do so.
    The analysis, which was displayed at the American Association for the Study of Liver Diseases gathering last week in Washington, DC, concluded that large-scale production of direct acting antivirals may be possible for as little as $100 to $200 for 12 weeks of treatment. The estimate cited HIV drugs, which initially cost tens of thousands of dollar per patient but have since dropped in price, as a framework.
    This group of drugs includes sofosbuvir, which is made by Gilead Sciences and was unanimously endorsed by an FDA panel last month. The treatment offers a higher cure rate with less toxicity and a shorter duration for treatment than a pair of medicines approved two years ago, which explains the enthusiasm on Wall Street, where pricing is expected to be $80,000 to $90,000 per patient in the US.
    The FDA panel voted in favor of approving sofosbuvir for patients with hepatitis C genotypes 2 and 3 in combination with an older medicine called ribavirin. If approved, the drug will be the first all-oral treatment for these strains. The panel also endorsed the drug for combating genotypes 1 and 4 in combination with ribavirin and interferon in patients who have not already received therapy. The vast majority of HCV cases involve genotype 1.
    “Gilead does not have expect to have high gross/net discounting in this segment, since they will not have a lot of competition initially and because the key driver of discounts is taking price increases over time,” wrote Citi analyst Yaron Werber in a recent investor note. The formal FDA approval date for this drug, by the way, is December 8.
    Such pricing estimates are prompting worries that such medical advances will be out of reach for patients in poor countries – and perhaps some in the US - unless Gilead and the other drugmakers that are developing DAAs, a group that includes Bristol-Myers Squibb (BMY) and AbbVie (ABBV), agree to sell their drugs for much lower prices.
    “It only takes a few grams of these drugs to cure hepatitis C,” says Andrew Hill of Liverpool University, one of the researchers. “Companies have a choice: continue treating a very small number of people with hepatitis C at a very high cost, or expanding access to these treatments, lowering treatment costs significantly, and working towards eradication of this disease” (here is the analysis).
    A key issue is that there are no international agencies or groups that purchase hepatitis C drugs for distribution to poor countries. Meanwhile, there are anywhere from 130 million to 150 million people are infected worldwide. In the US, there are approximately 3 million to 4 million people infected with hepatitis C in the US, but less than 60,000 are being treated, according to Gilead.
    In other words, demand is expected to mushroom, setting up a potential clash over availability. Even in the US, the situation is expected to become exacerbated as physicians await FDA approval for the newest drugs and more patients are found to be in need of treatment now that the US Preventive Services Task Force recommended testing for hepatitis C.
    “If the current high prices continue, it is likely that very few people will be treated and the overall epidemic of hepatitis C in the USA will continue unchecked,” Hill writes us. “It is only by lowering the prices, and treating more people, that there could be a real change in the USA.”
    In the analysis, Hill and a colleague assumed that the production cost per gram of a hepatitis C drug was between one to 10 times higher than the equivalent HIV antiretroviral, depending on the complexity of chemical synthesis. The production cost of sofosbuvir, for instance, was estimated at $68 to $136 for a 400mg dose for 12 weeks.
    We asked Gilead (GILD) for comment and will update you accordingly. [UPDATE: A Gilead spokeswoman declined to comment, but added that it is "premature" to discuss pricing.]
    In response, Doctors Without Borders, which hopes the oral DAAs can place the ease of treating hepatitis C on a par with treating HIV, issued a statement exhorting drugmakers to make their forthcoming medicines affordable on a large scale. If not, the advocacy group suggested that drugmaker may find themselves confronting countries willing to issue compulsory licenses.
    “We urge companies expected to bring these drugs to market soon to price new hepatitis C regimens at below $500 in developing countries, and for countries affected by the disease to consider ways to overcome patent barriers to allow the production of more affordable generic versions,” says Manica Balasegaram, who heads the group’s Access Campaign
    Hill acknowledged some limitations to the analysis. For instance, more precise estimates of production costs require pilot production batches and more detailed analysis of process chemistry. And access to DAAs at minimum prices in developing countries will depend on the level of enforcement of patent restrictions.
    STORY ENDS HERE

    12 Comments

    John
    Nov 11, 2013 - 9:51am
    I think the issue of access is a very important one, but I'm disappointed that once again critics try to develop a conversation on this issue by dragging out the red herring of production costs.

    Clinicaltrials.gov lists 781 industry funded clinical trials in HCV, counting only those initiated after 2003. These trials have enrolled 144,823 patients. At the end of a 8 year process that was undertaken with no assurance of eventual success, the first new drugs were approved in 2011. Research has continued and provided much better drugs that are now being approved on a quarterly basis.

    Most of the Phase 2 and Phase 3 trials performed to date involved a full year of treatment, with close monitoring of patients for adverse effects and time course of viral load changes. At an average cost of $100K (the data suggests that Vertex spent several times this amount) per patient, the cost of the Phase 2-3 development runs to 6.2 billon dollars.

    Put another way, the cost of running the trials is equivalent to the cost of manufacturing enough drugs to treat 62 million patients.

    There are important things to be said about providing access to medicines, but it would also be good if we could move beyond the tiresome and fallacious arguments that drugs should be sold for the cost of production. It's such a ridiculous argument that it raises questions about the honesty and/or intelligence of those raising it.
    Oops, transcription error. Make that 124 million patients.





    karmaswimswami
    Ed: A good discussion of the issues. The old standard was that HCV anti-viral therapy was considered cost effective at a breakpoint of $225,000. I suspect that newer all-oral 12 weeks courses will fall far short of that, but that they will still be pricey, as these have been aggressively developed and subjected simultaneously to so many clinical trials. The race for these has been much more keen than the HIV race, in my view, and it appears that Gilead, Merck, Abbvie and possibly BI have all arrived at the finish line around the same time. The race has been so hard fought that already, boecprevir and telaprevir are casualties and will probably not recoup development costs.
    What will be really interesting is Benitec's TT-034 RNA interference regimen and technology, which is now entering its first phase I/II trials in the US. Benitec's agent proposes to be a single-dose cure for HCV by administering a hepatotropic tamed adenovirus that will churn out sharp-hairpin anti-HCV RNA for up to a year. If it succeeds, how they price will be fascinating.

    original indust...

    “It only takes a few grams of these drugs to cure hepatitis C,” says Andrew Hill of Liverpool University, one of the researchers"
    One of the more ignorant statements I've heard in a long time. Must been long time since Hill took organic chemistry. He has no knowledge of the difficulty of the organic synthesis. If is entirely possible that to get his precious few grams of API the organic chemist may require kilogram quantities of starting material with a very low yield. This would be a long and expensive process if this were the case, thereby justifying the high cost. Of course the Pharmalot cynics believe that in my world anything justifies the sticker price.

    ChemGuy




    Hill's study is flawed on so many levels it's hard to know where to start. The most positive aspect is he has another presentation to add to his CV. So let's start with Gilead spending $11 B for Pharmassett to get Sofosbuvir. Perhaps the cost of the drug should include some payback of that to the company? Gilead conducted numerous clinical trials. Perhaps they should recoup those costs or is everyone working on this drug at Gilead and in the clinical trials doing their work gratis? Should Gilead be allowed to make a profit? Let's tack that on. I know some people with HCV and if you told them they could cure the disease for $80K they'd jump at the chance. HCV can lead to cirrhosis, liver cancer, liver transplants. How expensive are the last 2? Quite expensive I imagine. Hill's approach of wanting to allow Gilead to charge for the drug at an amount that approaches the incremental cost of the last gram produced is like paying an author for a book at the price of the ink and paper. It's naive at best.

    original indust...

    Don't forget that 25% of these burdens to society are also co-infected with HIV. Maybe we should spend more on high risk behavioral modification than on Friedel Crafts reactions.

    ChemGuy

    I can control a Friedel Crafts reaction. Not sure I can control someone else's high risk behavior.

    original indust..

    Lets start with clean needles and free Trojans and see where it goes.

    karmaswimswami
    It's quite boorish to write off all people with HCV as burdens to society. 75 per cent of people with it are part of a baby boom birth cohort, and a tremendous number of these people have no identifiable risk factors and could easily have been infected by dental instruments, air vaccine guns and manicure salons. As a hepatologist who treats these people, I chafe at the idea that irresponsibility got them all HCV. In a sizeable number of cases, it did not.

    Dr Andrew Hill

    There is a clear precedent here - we have already mass produced HIV drugs at minimum production prices. Over 10 million people are receiving life-saving treatment for HIV/AIDS in Africa and Asia, at these minimum prices. So why not do the same for Hepatitis C? There are hundreds of thousands of people dying from Hepatitis C every year in developing countries. They deserve to be treated fairly.
    Of course pharmaceutical companies should make profits on their R&D investment, - the question is, how much? Treating all 4 million people with Hepatitis C in the USA, for a cost of US $80,000 per person would cost $320 billion, for the drugs alone. Is this affordable within the US healthcare system? This will not be affordable for mass treatment in Europe. The percentage of people treated for Hepatitis C in USA and Europe remains low, mainly because of these very high prices.
    At a price of $10,000 per person, pharmaceutical companies could still make large profits treating Hepatitis C in North America and Europe, and make large profits, because these drugs are very cheap to make. This lower price has been discussed in the financial press as well. For developing countries, we should have prices close to the cost of production, as we do for HIV treatments.
    Only by treating large numbers of people will we have any real effect on the Hepatitis C epidemic.

    original indust...

    please provide your raw data that you used to calculate the cost of goods for the hepc drug so that those of us with manufacturing experience can reality test it.

    James Love

    According to clinical trials.gov, there are 32 trials involving Sofobuvir, all financed by Gilead. In terms of the number of patents, by the year when the trial began, they are as follows
    2010: 335 patients
    2011: 861 patients
    2012: 2,961 patients
    2013 so far: 4,214
    The $100k per patient number used by John seems like fiction to me, but maybe he can provide some more support for this claim.








    http://www.pharmalive.com/how-much-a...atitis-c-drugs
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


  10. #120

    افتراضي Published: November 4, 2013

    Hepatitis C, a Silent Killer, Meets Its Match

    Edward Linsmier for The New York Times Arthur Rubens, 63, of Naples, Fla., was cured of hepatitis C after taking part in a clinical trial for a new drug. By ANDREW POLLACK

    Published: November 4, 2013

    Determined to get rid of the hepatitis C infection that was slowly destroying his liver, Arthur Rubens tried one experimental treatment after another. None worked, and most brought side effects, like fever, insomnia, depression, anemia and a rash that “felt like your skin was on fire.” But this year, Dr. Rubens, a professor of management at Florida Gulf Coast University, entered a clinical trial testing a new pill against hepatitis C. Taking it was “a piece of cake.” And after three months of treatment, the virus was cleared from his body at last. “I had a birthday in September,” Dr. Rubens, 63, said. “I told my wife I don’t want anything. It would take away from the magnitude of this gift.” Medicine may be on the brink of an enormous public health achievement: turning the tide against hepatitis C, a silent plague that kills more Americans annually than AIDS and is the leading cause of liver transplants. If the effort succeeds, it will be an unusual conquest of a viral epidemic without using a vaccine. “There is no doubt we are on the verge of wiping out hepatitis C,” said Dr. Mitchell L. Shiffman, the director of the Bon Secours Liver Institute of Virginia and a consultant to many drug companies. Over the next three years, starting within the next few weeks, new drugs are expected to come to market that will cure most patients with the virus, in some cases with a once-a-day pill taken for as little as eight weeks, and with only minimal side effects. That would be a vast improvement over current therapies, which cure about 70 percent of newly treated patients but require six to 12 months of injections that can bring horrible side effects. The latest data on the experimental drugs is being presented at The Liver Meeting in Washington, which ends Tuesday. But the new drugs are expected to cost from $60,000 to more than $100,000 for a course of treatment. Access could be a problem, particularly for the uninsured and in developing countries. Even if discounts or generic drugs are offered to poor countries, there are no international agencies or charities that buy hepatitis C medications, as there are for H.I.V. and malaria drugs. And some critics worry that the bill will be run up when huge numbers of people who would have done fine without them turn to the drugs. That is because many people infected with hepatitis C never suffer serious liver problems. “The vast majority of patients who are infected with this virus never have any trouble,” said Dr. Ronald Koretz, emeritus professor of clinical medicine at the University of California, Los Angeles. It is impossible to tell in advance whether an infected individual will go on to suffer serious consequences. For patients who can afford them, the temptation to take the new drugs before trouble arises will be powerful. A Heavy Toll An estimated three to four million Americans are infected with hepatitis C, and about 150 million worldwide — three to five times the number who have H.I.V. Most people who are infected do not know it, because it can take decades for the virus to damage the liver sufficiently to cause symptoms. In the United States, the number of new infections has fallen to about 17,000 a year, from more than 200,000 per year in the 1980s, according to the Centers for Disease Control and Prevention. There has been a recent rise in cases among young people who inject pain medicines or heroin. About 16,600 Americans had hepatitis C listed as a cause of death on death certificates in 2010, though that might vastly understate the mortality linked to the disease, according to the C.D.C. Although there are fewer new infections, the number of deaths is expected to keep rising as the infections incurred years ago increasingly take their toll. Hepatitis C is spread mainly by the sharing of needles, though it can also be acquired during sex. The virus was transmitted through blood transfusions before testing of donated blood began in 1992. Dr. Rubens, the recently cured patient, believes he was infected when he worked as a paramedic long ago. The main treatment has been interferon alfa, given in weekly injections for 24 or 48 weeks, combined with daily tablets of ribavirin. Neither drug was developed specifically to treat hepatitis C. The combination cures about half the patients, but the side effects — flulike symptoms, anemia and depression — can be brutal. The new drugs, by contrast, are specifically designed to inhibit the enzymes the hepatitis C virus uses to replicate, the same approach used to control H.I.V. As with H.I.V., two or more hepatitis C drugs will be used together to prevent the virus from developing resistance. One big difference is that H.I.V. forms a latent reservoir in the body, so H.I.V. drugs must be taken for life to prevent the virus from springing back. Hepatitis C does not form such a reservoir, so it can be eliminated permanently. If no virus is detectable in the blood 12 weeks after treatment ends — a measure known as a sustained virologic response — there is almost no chance the virus will come back and the patient is considered essentially cured. The damaged liver can then heal itself somewhat, doctors say. Yet even if the virus is cleared, people who were once infected may still have an increased risk of liver cancer, especially if cirrhosis, a scarring of the liver, has set in. The new drugs now moving to market can achieve sustained viral responses in 80 to 100 percent of patients with treatment durations of 12 to 24 weeks, possibly shorter. For Tom Espinosa, a building inspector in Oakland, Calif., the new treatments cannot arrive fast enough. Mr. Espinosa, 59, has advanced cirrhosis and some spots on his liver that might be cancer. He is so fatigued that he spends all weekend in bed. He has tried all available treatments and nothing worked, making him envious of other patients who were cured. “I became resentful for a little while, but I got over it,” he said. With time possibly running out, he plans to try the first new drug to hit the market. To be sure, many of the new drug combinations have not been extensively tested yet. Side effects might still show up. And the drugs are not expected to work as well for patients with severe cirrhosis or those co-infected with H.I.V. “I just don’t think we know the answer until we get more widespread clinical experience,” said Charles M. Rice, a hepatitis C expert at Rockefeller University. “We may be in for some surprises still.” New Direction Researchers and patients have been disappointed before, when the first two direct-acting antiviral pills, telaprevir and boceprevir, reached the market in 2011. The drugs, which inhibited the virus’s protease enzyme, still required interferon and ribavirin, but they raised the cure rate to about 70 percent. There was a huge rush to treatment. But doctors now say that side effects were worse than expected, in part because the sickest patients had been excluded from the clinical trials of the drugs. “A lot of that didn’t come to light until after the drugs were approved,” said Dr. Brian R. Edlin, an associate professor of public health and medicine at Weill Cornell Medical College. “Then it turns out they were just horrible.” Among the new drugs, the one garnering the most excitement is sofosbuvir, from Gilead Sciences, which is expected to be approved by the Food and Drug Administration by Dec. 8. It inhibits the virus’s polymerase enzyme, which builds new genomes out of RNA so the virus can replicate. Sofosbuvir is an evil decoy of sorts. It looks like a building block of RNA. But once it is mistakenly incorporated into the RNA chain, the chain cannot grow and the virus cannot reproduce. The effectiveness of the new drugs can vary depending on which strain of hepatitis C, known as genotypes, the patient has. People infected with hepatitis C genotypes 2 and 3 — which account for 20 to 25 percent of cases in the United States — will take sofosbuvir with ribavirin but without interferon, making this the first all-oral treatment for hepatitis C. Treatment for genotype 2 will be 12 weeks, but for genotype 3 it will probably be 24 weeks. Genotype 1, which accounts for more than 70 percent of patients in the United States, will still require interferon and ribavirin along with sofosbuvir, but only for 12 weeks. In a clinical trial, about 90 percent of previously untreated patients taking this combination achieved a sustained virologic response. The combination is expected to be somewhat less effective in those for whom previous treatments did not work. Gilead hopes to have an all-oral treatment for genotype 1 approved by the end of 2014. It would be a once-a-day pill containing both sofosbuvir and another experimental Gilead drug, ledipasvir. This combination, used along with ribavirin, is what cured Dr. Rubens. Other companies, including AbbVie, Merck and Bristol-Myers Squibb, are in a heated race to also bring all-oral combinations to market in the next two years or so. Liver specialists will be able to put together an all-oral regimen for genotype 1 very soon, however, by prescribing both sofosbuvir and simeprevir, a Johnson & Johnson protease inhibitor that is expected to win approval soon. One study has shown this combination to be extremely effective, though insurers may balk at paying for two expensive drugs. Awaiting Better Options These new drugs are likely to alter the calculus about who gets treated and when. Many doctors are now “warehousing” their hepatitis C patients — urging them to forgo treatment until the new drugs are approved. “There’s no way I’m going to put them on an interferon regimen when we’re a year away from having interferon-free regimens,” said Dr. Scott Friedman, the chief of liver diseases at the Icahn School of Medicine at Mount Sinai. “It’s rare you have to pull the trigger and get them on treatment in that period of time.” Gilead estimates that only 58,000 Americans with hepatitis C are now undergoing treatment, a small fraction even of those who know they are infected. Wanting to avoid interferon’s side effects, some patients without symptoms try to monitor their liver and start treatment only if it shows signs of deterioration. But with the new more tolerable treatments, some experts say, it makes sense to treat early-stage disease to prevent cirrhosis and the accompanying risk of liver cancer. And it is likely that more pre-symptomatic patients will be found through wider screening. Both the United States Preventive Services Task Force and the C.D.C. have recently begun to recommend that all baby boomers — people born from 1946 to 1964 — be tested for infection with hepatitis C, since they represent about three quarters of all cases. “It will be test and treat,” said Dr. Eugene Schiff, the director of the liver diseases center at the University of Miami, who is a consultant to drug companies. Pharmaceutical companies, of course, have a financial interest in seeing that more people get screened and treated, and
    عن أبي هريرة ـ رضي الله عنه
    قال: أن رسول الله صلى الله عليه وسلم عاد مريضاً فقال: "أبشر فإن الله تعالى يقول: هي ناري أسلطها على عبدي المؤمن في الدنيا لتكون حظه من النار يوم القيامة".
    عن أبي هريرة ـ رضي الله عنه
    قال: قال رسول الله صلى الله عليه وسلم: "إن الله عز وجل ليرفع الدرجة للعبد الصالح في الجنة فيقول: يا رب أني لي هذه، فيقول: باستغفار ولدك لك".
    تحميل مصاحف كاملة برابط واحد مباشر
    http://el-moslem.com/completeQuraan.php


+ الرد على الموضوع
صفحة 12 من 32 الأولىالأولى ... 2101112131422 ... الأخيرةالأخيرة

معلومات الموضوع

الأعضاء الذين يشاهدون هذا الموضوع

الذين يشاهدون الموضوع الآن: 1 (0 من الأعضاء و 1 زائر)

المواضيع المتشابهه

  1. دعوة للمشاركة فى
    بواسطة ابو عبدالسلام في المنتدى الملتقى العام
    مشاركات: 0
    آخر مشاركة: 03-Apr-2011, 06:18 PM
  2. دعوة للمشاركة في أوراق المؤتمر الصيدلاني الأردني الثاني عشر
    بواسطة احمد بن منصور في المنتدى ملتقى التعليم المستمر
    مشاركات: 4
    آخر مشاركة: 30-Oct-2007, 12:41 AM
  3. ههههه..دعوة للجميع للضحك
    بواسطة Dr.BK في المنتدى الملتقى العام
    مشاركات: 16
    آخر مشاركة: 27-Jul-2007, 07:29 PM
  4. تجارة الأدوية ...قضية (دعوة للجميع)
    بواسطة لحظة في المنتدى الملتقى العام
    مشاركات: 9
    آخر مشاركة: 31-Jul-2005, 04:08 PM

مواقع النشر (المفضلة)

مواقع النشر (المفضلة)

ضوابط المشاركة

  • لا تستطيع إضافة مواضيع جديدة
  • لا تستطيع الرد على المواضيع
  • لا تستطيع إرفاق ملفات
  • لا تستطيع تعديل مشاركاتك

[أرشفة الدعم السعودي]