Испытания нового препарата
Модераторы: bobcat2, Модераторы
Re: Испытания нового препарата
я 15 минут назад с врачом своим (другим) говорил про Виреад, так он мне такое понарассказывал про резистентность к нему что аж новую тему на эту тему создал. Вот это выразился....не гони, это - виреад
ХHBV, HBeAg "-". нагрузка 1,84х10*3. F0>F1, лечить или пока нет?!
Re: Испытания нового препарата
Пол года прошло. Может кто имеет новую ифу???== 06 дек 2013, 18:14 ==
Что сейчас имеется.
GS9620, Gilead Sciences, заканчивают 1 фазу
ARC-520, Arrowhead Research Corporation, заканчивают первую фазу на здоровых, планируется вторая
GS4774, Gilead Sciences, 2 фаза
REP9AC - продолжают на единицах больных
Myrcludex B - Гепатера, 2 фаза
В ближайшие годы надеяться не на что.
ХHBV, HBeAg "-". нагрузка 1,84х10*3. F0>F1, лечить или пока нет?!
Re: Испытания нового препарата
да нового вроде мало
по http://www.hepb.org/professionals/hbf_drug_watch.htm
NVR-1221 (NVR 3-778) первая фаза
и HAP Compound Bay 41-4109 первая фаза
по http://www.hepb.org/professionals/hbf_drug_watch.htm
NVR-1221 (NVR 3-778) первая фаза
и HAP Compound Bay 41-4109 первая фаза
Re: Испытания нового препарата
http://www.thestreet.com/story/12906965 ... _ven=YAHOO - по ARC-520
== 09 окт 2014, 20:19 ==
1855
Profound Reduction of HBV Covalently Closed Circular DNA with Long-term Nucleoside / tide Analogue Therapy
1
Medicine, TheUniversity of Hong Kong, Hong Kong SAR, Hong Kong;
2
State Key
Laboratory for Liver Research, The University of Hong Kong, Hong
Kong SAR, Hong Kong;
3
Pathology, The University of Hong Kong,
Hong Kong SAR, Hong Kong;
4
Medicine, Johns Hopkins University
School of Medicine, Baltimore, MD;
5
Medicine, Columbia College
of Physicians and Surgeons, New York City, NY
Background:. Long-term nucleoside / tide analogue (NA) treatment suppresses serum HBV DNA to undetectable levels in a majority of patients We aimed to investigate the effect of long-term NA on the suppression of covalently closed circular DNA (cccDNA) and intrahepatic HBV DNA (ihHBV-DNA).
Methods:
We recruited 40 patients (median age 44.2 years, range 24.3-63.2) who had been on continuous long-term (5 - 10 years) NA All patients had 3 liver biopsies:. At baseline, after 1 year of treatment and at the last follow-up. Serum HBV DNA
and HBsAg were measured by the COBAS TaqMan HBV Test and the Elecsys HBsAg II Assay, respectively (both Roche Diagnostics). ihHBV-DNA and cccDNA were assayed by real-time PCR, with lower limits of detection of 0.001 and 0.005 copies / cell, respectively.
Results: The median duration of treatment was 10.5 years. (Range: 6.0 - 11.9 years) At baseline, 13 patients had 100mg lamivudine, 11 had 600mg telbivudine,
9 had 0.5mg entecavir, 4 had 30mg clevudine, and 3 had 10mg adefovir. At the last follow up, these patients were on 0.5-1.0mg entecavir (n = 23), 600mg telbivudine (n = 9), 10mg adefovir (n = 4), 300mg tenofovir (n = 2), or combination therapy of lamivudine plus adefovir / tenofovir (n = 2). Histology of the third biopsy showed complete resolution of interface hepatitis in 60% of patients with the remainder showing mild-to -moderate activity. Persistent immunoreactivity for HBsAg was found in 80%, the mean number of hepatocytes positive for HBsAg
being 10.4% (range 1-80%). All but 1 (2.5%) was immunoreactive for HBcAg. At baseline, the median serum HBV DNA, HBsAg, ihHBV-DNA and cccDNA levels were 6.84 logIU / mL, 3.38 logIU / mL , 286 copies / cell, and 7.3 copies / cell,
respectively At the time of the last biopsies, 36 (90%) patients had undetectable serum HBV DNA (<20 IU / mL), all but one patient still had detectable HBsAg. (median: 2.74 logIU / mL), all had detectable ihHBV -DNA. (median: 0.4 copies / cell), but 18 (45%) patients had undetectable cccDNA There was a trend of reduction of HBsAg, ihHBV-DNA and cccDNA levels from baseline to 1 year to last follow-up (all p <0.0001). The median log drop of HBsAg at last biopsy was 0.55 logIU / mL.
The median percentage reductions of HBsAg, ihHBV-DNA and cccDNA at last biopsies were 71.46%, 99.85% and 99.89%, respectively.
Conclusions:
Long-term NA treatment significantly reduced cccDNA and ihDNA. 45% of patients had undetectable cccDNA, although small amount of ihHBV-DNA were still
detectable in all patients. Integrated HBV DNA may be a possible source of detectable ihHBV-DNA and HBsAg. Continuous long-term NA therapy can reduce cccDNA to undetectable levels, suggesting a possible end-point of treatment.
== 09 окт 2014, 20:19 ==
1855
Profound Reduction of HBV Covalently Closed Circular DNA with Long-term Nucleoside / tide Analogue Therapy
1
Medicine, TheUniversity of Hong Kong, Hong Kong SAR, Hong Kong;
2
State Key
Laboratory for Liver Research, The University of Hong Kong, Hong
Kong SAR, Hong Kong;
3
Pathology, The University of Hong Kong,
Hong Kong SAR, Hong Kong;
4
Medicine, Johns Hopkins University
School of Medicine, Baltimore, MD;
5
Medicine, Columbia College
of Physicians and Surgeons, New York City, NY
Background:. Long-term nucleoside / tide analogue (NA) treatment suppresses serum HBV DNA to undetectable levels in a majority of patients We aimed to investigate the effect of long-term NA on the suppression of covalently closed circular DNA (cccDNA) and intrahepatic HBV DNA (ihHBV-DNA).
Methods:
We recruited 40 patients (median age 44.2 years, range 24.3-63.2) who had been on continuous long-term (5 - 10 years) NA All patients had 3 liver biopsies:. At baseline, after 1 year of treatment and at the last follow-up. Serum HBV DNA
and HBsAg were measured by the COBAS TaqMan HBV Test and the Elecsys HBsAg II Assay, respectively (both Roche Diagnostics). ihHBV-DNA and cccDNA were assayed by real-time PCR, with lower limits of detection of 0.001 and 0.005 copies / cell, respectively.
Results: The median duration of treatment was 10.5 years. (Range: 6.0 - 11.9 years) At baseline, 13 patients had 100mg lamivudine, 11 had 600mg telbivudine,
9 had 0.5mg entecavir, 4 had 30mg clevudine, and 3 had 10mg adefovir. At the last follow up, these patients were on 0.5-1.0mg entecavir (n = 23), 600mg telbivudine (n = 9), 10mg adefovir (n = 4), 300mg tenofovir (n = 2), or combination therapy of lamivudine plus adefovir / tenofovir (n = 2). Histology of the third biopsy showed complete resolution of interface hepatitis in 60% of patients with the remainder showing mild-to -moderate activity. Persistent immunoreactivity for HBsAg was found in 80%, the mean number of hepatocytes positive for HBsAg
being 10.4% (range 1-80%). All but 1 (2.5%) was immunoreactive for HBcAg. At baseline, the median serum HBV DNA, HBsAg, ihHBV-DNA and cccDNA levels were 6.84 logIU / mL, 3.38 logIU / mL , 286 copies / cell, and 7.3 copies / cell,
respectively At the time of the last biopsies, 36 (90%) patients had undetectable serum HBV DNA (<20 IU / mL), all but one patient still had detectable HBsAg. (median: 2.74 logIU / mL), all had detectable ihHBV -DNA. (median: 0.4 copies / cell), but 18 (45%) patients had undetectable cccDNA There was a trend of reduction of HBsAg, ihHBV-DNA and cccDNA levels from baseline to 1 year to last follow-up (all p <0.0001). The median log drop of HBsAg at last biopsy was 0.55 logIU / mL.
The median percentage reductions of HBsAg, ihHBV-DNA and cccDNA at last biopsies were 71.46%, 99.85% and 99.89%, respectively.
Conclusions:
Long-term NA treatment significantly reduced cccDNA and ihDNA. 45% of patients had undetectable cccDNA, although small amount of ihHBV-DNA were still
detectable in all patients. Integrated HBV DNA may be a possible source of detectable ihHBV-DNA and HBsAg. Continuous long-term NA therapy can reduce cccDNA to undetectable levels, suggesting a possible end-point of treatment.
Все сказанное - личное мнение.
Re: Испытания нового препарата
Прокомментируйте кто то для не англоязычных пожалуйста.
ХHBV, HBeAg "-". нагрузка 1,84х10*3. F0>F1, лечить или пока нет?!
Re: Испытания нового препарата
Онлайн переводчики существуют, если тебе это действительно интересно.
Геп В, тенофовир алафенамид
Re: Испытания нового препарата
Существует. Пробовал до того как написать. Ничего внятного не перевило. Потому и прошу хотя бы двумя словами прокомментировать.Онлайн переводчики существуют, если тебе это действительно интересно.
ХHBV, HBeAg "-". нагрузка 1,84х10*3. F0>F1, лечить или пока нет?!
Re: Испытания нового препарата
вот и я про тоже - нужны некоторые начальные знания, чтобы было понятно , о чем идет речь. Если в двух словах - тебе оно не нужно, это лишняя информация для тебя, в данный момент времени.
Геп В, тенофовир алафенамид
Re: Испытания нового препарата
в общем и целом, не в даваясь в детали можно сказать, что чем продолжительней пвт, тем глубже идет очищение от вирусняка на клеточном уровне...и следовательно, где в перспективе, в конце туннеля мутным пятном маячит полное элиминация вируса, а значит и выздоровление...ну, и где-то через лет 50-70 будет нам счастье...
По вич идет уже пошла тема начинать пвт настолько раньше насколько возможно, ну и если длительное пвт бараклюдом/вириадом не выявит опасных побочных эффектов, у нас будет тоже самое...
По вич идет уже пошла тема начинать пвт настолько раньше насколько возможно, ну и если длительное пвт бараклюдом/вириадом не выявит опасных побочных эффектов, у нас будет тоже самое...
ГБ, Виреад
Re: Испытания нового препарата
Юра, проверяешь кол-во НВs, есть динамика?
Все сказанное - личное мнение.
Re: Испытания нового препарата
Пока нет, жду чтобы год с прошлого раза прошел.
Денег не жалко, а как бы промежуток увеличиваю между анализами.
Сдам в инвитро и цмд.
Денег не жалко, а как бы промежуток увеличиваю между анализами.
Сдам в инвитро и цмд.
Геп В, тенофовир алафенамид
Re: Испытания нового препарата
Я через три года приема сдавала, ничего не изменилось). Теперь уже 5 лет прошло, можно посмотреть.
Final ID: LB-20
A proof-of-concept Phase 2a clinical trial with HBV/HDV entry inhibitor Myrcludex B
S. Urban; 2; P. Bogomolov; 4; N. Voronkova; 4; L. Allweiss; 3; M. Dandri; 3; M. Schwab; 6, 7; F. A. Lempp; 2; M.
Haag; 6; H. Wedemeyer; 5; A. Alexandrov; 1;
1. MYR GmbH, Bad Homburg, Germany.
2. University Hospital Heidelberg, Heidelberg, Germany.
3. University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
4. Moscow Regional Research Clinical Institute, Moscow, Russian Federation.
5. Hannover Medical School, Hannover, Germany.
6. Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.
7. Department of Clinical Pharmacology, University Hospital Tübingen, Tübingen, Germany.
Abstract Body: Introduction: Current therapies for chronic hepatitis B rarely induce cure. Moreover, no effective treatment for the majority of hepatitis D patients is available. Myrcludex B is a first-in-class entry inhibitor inactivating the HBV/HDV receptor NTCP, thereby addressing a replication step possibly required for curative therapy. We here present findings of the first clinical trials of Myrcludex B in chronic hepatitis B and D.
Aim: To evaluate safety and tolerability, as well as antiviral efficacy of Myrcludex B.
Methodology: Cohort A: 40 chronically HBV infected, HBeAg negative patients (all HBV DNA >2000 IU/ml median HBV DNA 4.7 log10 IU/ml; no cirrhosis) were treated for 12 weeks with once daily sc 0.5mg, 1mg, 2mg, 5mg and 10mg Myrcludex B for 12 weeks (8 patients per dose). Treatment was extended to 24 weeks in patients receiving 10mg. Cohort B: 24 patients with hepatitis delta (compensated liver disease; 12.5% cirrhosis) scheduled for 48 weeks
of pegylated interferon alpha (PEG-IFNα) therapy. 8 hepatitis delta patients are receiving pre-treatment with 2mg Myrcludex B alone for 24 weeks (B1); Myrcludex B was added to (PEG-IFNa) for the first 24 weeks to another 8 patients (B2) while 8 patients are treated with PEG-IFNa alone (B3).
Results:
Myrcludex B was very well tolerated, injection side dermatitis occurred in 3 patients (10mg group) of Myrcludex B, regressed on treatment. A psoriasis exacerbation occurred in one HDV patient (B2) leading to discontinuation.
>1log10 HBV DNA decline at week 12 was observed in 6/8 (75%) patients receiving 10mg Myrcludex B while this occurred less often in the remaining dose groups (7/40; 17%). ALT normalized in 22/40 (55%) patients, median ALT values declined from 76 U/l before therapy to 36 U/l at week 12 (p1log10 HDV RNA decline at week 24 during Myrcludex B monotherapy (B1) or combination therapy (B2) while this response was observed in 7/7 of B3 patients at week 12. HDV RNA became negative in 2 (B1) and 5 (B2) patients at week 24. ALT values declined at week 24 in 6/7 (B1), 4/7 (B2) and 3/7 (B3, week 12) patients. One patient in B1 and one in B2 had negative HDV RNA and normal ALT at week 24. One patient (B2) experienced 1log10 HBsAg decline at week 24. Myrcludex B treatment induced preS-specific antibodies and bile acid elevation at doses >1mg.
Conclusion: Myrcludex B is safe and well tolerated in HBsAg positive patients with or without HDV coinfection. HBV entry inhibition seems to be associated HBV DNA and HDV RNA declines and improvement of biochemical disease activity.
Tags: Myrcludex
Final ID: LB-20
A proof-of-concept Phase 2a clinical trial with HBV/HDV entry inhibitor Myrcludex B
S. Urban; 2; P. Bogomolov; 4; N. Voronkova; 4; L. Allweiss; 3; M. Dandri; 3; M. Schwab; 6, 7; F. A. Lempp; 2; M.
Haag; 6; H. Wedemeyer; 5; A. Alexandrov; 1;
1. MYR GmbH, Bad Homburg, Germany.
2. University Hospital Heidelberg, Heidelberg, Germany.
3. University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
4. Moscow Regional Research Clinical Institute, Moscow, Russian Federation.
5. Hannover Medical School, Hannover, Germany.
6. Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.
7. Department of Clinical Pharmacology, University Hospital Tübingen, Tübingen, Germany.
Abstract Body: Introduction: Current therapies for chronic hepatitis B rarely induce cure. Moreover, no effective treatment for the majority of hepatitis D patients is available. Myrcludex B is a first-in-class entry inhibitor inactivating the HBV/HDV receptor NTCP, thereby addressing a replication step possibly required for curative therapy. We here present findings of the first clinical trials of Myrcludex B in chronic hepatitis B and D.
Aim: To evaluate safety and tolerability, as well as antiviral efficacy of Myrcludex B.
Methodology: Cohort A: 40 chronically HBV infected, HBeAg negative patients (all HBV DNA >2000 IU/ml median HBV DNA 4.7 log10 IU/ml; no cirrhosis) were treated for 12 weeks with once daily sc 0.5mg, 1mg, 2mg, 5mg and 10mg Myrcludex B for 12 weeks (8 patients per dose). Treatment was extended to 24 weeks in patients receiving 10mg. Cohort B: 24 patients with hepatitis delta (compensated liver disease; 12.5% cirrhosis) scheduled for 48 weeks
of pegylated interferon alpha (PEG-IFNα) therapy. 8 hepatitis delta patients are receiving pre-treatment with 2mg Myrcludex B alone for 24 weeks (B1); Myrcludex B was added to (PEG-IFNa) for the first 24 weeks to another 8 patients (B2) while 8 patients are treated with PEG-IFNa alone (B3).
Results:
Myrcludex B was very well tolerated, injection side dermatitis occurred in 3 patients (10mg group) of Myrcludex B, regressed on treatment. A psoriasis exacerbation occurred in one HDV patient (B2) leading to discontinuation.
>1log10 HBV DNA decline at week 12 was observed in 6/8 (75%) patients receiving 10mg Myrcludex B while this occurred less often in the remaining dose groups (7/40; 17%). ALT normalized in 22/40 (55%) patients, median ALT values declined from 76 U/l before therapy to 36 U/l at week 12 (p1log10 HDV RNA decline at week 24 during Myrcludex B monotherapy (B1) or combination therapy (B2) while this response was observed in 7/7 of B3 patients at week 12. HDV RNA became negative in 2 (B1) and 5 (B2) patients at week 24. ALT values declined at week 24 in 6/7 (B1), 4/7 (B2) and 3/7 (B3, week 12) patients. One patient in B1 and one in B2 had negative HDV RNA and normal ALT at week 24. One patient (B2) experienced 1log10 HBsAg decline at week 24. Myrcludex B treatment induced preS-specific antibodies and bile acid elevation at doses >1mg.
Conclusion: Myrcludex B is safe and well tolerated in HBsAg positive patients with or without HDV coinfection. HBV entry inhibition seems to be associated HBV DNA and HDV RNA declines and improvement of biochemical disease activity.
Tags: Myrcludex
Все сказанное - личное мнение.
Re: Испытания нового препарата
Все сказанное - личное мнение.
Re: Испытания нового препарата
не чего не понятно? когда будет чудо таблетка, я так жду эту радостную новость.
Re: Испытания нового препарата
http://www.cbs8.com/story/28208089/abiv ... epatitis-b
Первая вакцина, которая дала реальный результат. Это кубинская NASVAC.
Первая вакцина, которая дала реальный результат. Это кубинская NASVAC.
Все сказанное - личное мнение.
Re: Испытания нового препарата
Вроде там не таблетка, а подкожная инъекция. Думаю будет скоро, только цена точно будет не для нас.
ХHBV, HBeAg "-". нагрузка 1,84х10*3. F0>F1, лечить или пока нет?!
Re: Испытания нового препарата
http://tetralogicpharma.com/hbv/
Birinapant HBV Program: In a mouse model we have generated data demonstrating that birinapant induces apoptosis in mouse hepatocytes infected with hepatitis B, while sparing normal hepatocytes. In the mouse model we have seen clearance of HBsAg. We are commencing enrollment in a multiple ascending dose study of birinapant in subjects with chronic hepatitis B in the fourth quarter of 2014. We currently expect data to be generated around the middle of 2015. The trial will be conducted in subjects over the age of 18 with hepatitis B who are receiving treatment with either tenofavir or entecavir and who are HBsAg positive. The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio. The study is being conducted at multiple clinical sites in Australia and New Zealand. Although predominantly a safety and tolerability study, patients will also be monitored for reductions in hepatitis B surface antigen as an indication of therapeutic activity.
Birinapant HBV Program: In a mouse model we have generated data demonstrating that birinapant induces apoptosis in mouse hepatocytes infected with hepatitis B, while sparing normal hepatocytes. In the mouse model we have seen clearance of HBsAg. We are commencing enrollment in a multiple ascending dose study of birinapant in subjects with chronic hepatitis B in the fourth quarter of 2014. We currently expect data to be generated around the middle of 2015. The trial will be conducted in subjects over the age of 18 with hepatitis B who are receiving treatment with either tenofavir or entecavir and who are HBsAg positive. The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio. The study is being conducted at multiple clinical sites in Australia and New Zealand. Although predominantly a safety and tolerability study, patients will also be monitored for reductions in hepatitis B surface antigen as an indication of therapeutic activity.
Все сказанное - личное мнение.
Re: Испытания нового препарата
друзья, посмотрел вчера из интереса цены на бараклюд в аптеках онлайн. В мск чуть более 7 тыс за 0,5 мг. И это несмотря на валютный курс. Я чего ты не знаю? патент закончился и появились официальные дженерики по цене зеффикса? Он же до кризиса стоил более 10 тыс.
HBV,ИГА6,F1
Re: Испытания нового препарата
вот статья, в которой пишут что патент истекает в 2015 году в сша и в 2016 году в других частях мира
http://www.forbes.com/sites/greatspecul ... on-growth/
наверное они учитывают покупательную способность населения,
когда официальные дженерики появятся цена круче должна упасть,
я ламивудин пил за 6500 р/упаковка. в 2003 году, сейчас 900 рублей стоит (в 2003 ламивудин только был).
Скорей бы эти патенты заканчивались, тогда у них стимул будет новое делать, а то пишут на энтекавире больше 1млрд.$ в год зарабатывал производитель.
http://www.forbes.com/sites/greatspecul ... on-growth/
наверное они учитывают покупательную способность населения,
когда официальные дженерики появятся цена круче должна упасть,
я ламивудин пил за 6500 р/упаковка. в 2003 году, сейчас 900 рублей стоит (в 2003 ламивудин только был).
Скорей бы эти патенты заканчивались, тогда у них стимул будет новое делать, а то пишут на энтекавире больше 1млрд.$ в год зарабатывал производитель.