Кто знает, чем нынче занимется вирусология по нашей теме.
Неужели только интерфероны, есть ли другие пути? А как обстоят дела с интерферонами?
Ждать ли прорыва в этой области в ближайшие годы?
Просто не верится, что бы МЫ с таким оромным багажом знаний, на нашем уровне технологий, не можем справиться с примитивным организмом.
Если кто то что то нароет по теме, ложите сюда плз.
А что наука?
-
isaura
вот тебе список всех препаратов, которые сеичас разрабатываются.
в основном альфа интерфероны и ингибиторы протеаз
Table of Hepatitis C Drugs in Current Clinical Development Drug Name Drug Category Pharmaceutical Company Clinical Phase
HCV-086 ViroPharma/Wyeth Phase
I
Albuferon Longer Acting Interferon Human Genome Sciences Phase
II
Comments: Fusion of the genes for human interferon and albumin. Interim results of phase 1/II studies demonstrate that it is well-tolerated, has a long half-life (up to 158 hours), and is biologically active in adults with chronic HCV.
Oral Interferon alpha Oral Interferon Amarillo Biosciences Phase
I
Comments: Testing low dose oral administration of alpha interferon absorbed through mucosal membranes.
VX-950 Protease Inhibitor Vertex Phase
I
Comments: VX 950 has demonstrated good cellular activity in two assays. The anti viral activity can be sustained in viral clearance assays resulting in a continuing decline of HCV RNA for 9 days. Phase I studies expected to begin in 2004. VX-950 is advancing to Phase Ib. Part of the trial will enroll healthy volunteers and patients with chronic hepatitis C virus infection. The trial will follow subjects on a 14-day dosing regimen of the drug
JTK 003 Polymerase Inhibitor AKROS Pharma Phase
I
Comments: Inhibits HCV genotype 1 polymerase
R803 Non-nucleoside HCV Polymerase Inhibitor Rigel Pharmaceuticals Phase
I
Comments: Clinical data indicates that R803 is well tolerated with no notable adverse effects reported in the dose levels that Rigel plans to use moving forward. Phase I/II efficacy trials for the U.S. planned to commence during the second quarter of 2004.
HCV/MF59 Vaccine Chiron Phase
I
Comments: In collaboration with CSL Ltd. and St. Louis University.
SCH-6 Serine Protease Schering Phase
I
Comments: In tests it was found the SCH-6 could protect the cell's defenses and actually may prevent the HCV virus from blocking the immune response and restoring body's natural antiviral response.
ANA245 Isatoribine ANADYS Phase I/II
Comments: Interim results of the Phase 1B clinical trial show that isatoribine is biologically active in adults with chronic HCV infection and results from dosing a cohort of six HCV infected patients with 800mg of isatoribine showed a statistically significant reduction of viral load (p=0.03) at the end of one week, with a median change in viral load from baseline of -0.94 log10 units. Anadys is currently enrolling patients for an isatoribine Phase I/II study.
ANA971 Isatoribine ANADYS Phase I
Comments: A prodrug of isatoribine. A recent clinical study of 48 subjects, including 28 patients infected with hepatitis C reported that the intravenous administration of ANA971 was well tolerated and safe at all doses tested and has shown biological activity against hepatitis C as well significant reductions in HCV RNA (viral load).
Rituximab (Rituxam) Anti-CD20 Monoclonal Antibody Genetech/IDEC Phase I/II
Comments: Under investigation for treatment of cryoglobulinemia. Currently approved for non-Hodgkin's lymphoma.
NM283 Polymerase Inhibitor Idenix Pharmaceuticals Phase I/II
Comments: Phase IIa trials have demonstrated dramatic viral load reductions when used as a monotherapy or in combination with pegylated interferon. NM283 demonstrated a good safety profile. The original clinical trials were so successful that the trial design was extended from 28 days to 3 months. Data from the extended protocol are expected in 2005.
HepXT-C Monclonal Antibody XTL Phase I/II
Comments: Phase I studies on 35 chronic HCV patients indicated good safety and bioactivity. Phase II study of HCV prophylaxis on post liver transplant patients underway.
IDN-6556 Caspase Inhibitor Idun Pharmaceuticals Phase II
Comments: Caspase inhibitors do not have any direct antiviral properties, but are believed to preserve the cell structure and protect the liver from damage caused by HCV. Phase I study completed in May 2002 which included patients with stable hepatitis C infection. Data from a Phase 2a clinical trial of an oral formulation of IDN-6556 in patients infected with HCV reported positive safety and tolerability of the drug as well as its ability to reduce elevated aminotransferase (ALT and AST) levels.
ISIS 14803 Antisense Isis Pharmaceutical / Elan Phase II
Comments: Genetically inhibits translation (production) of disease-causing proteins. This compound appears to be well-tolerated, with minimal adverse effects. A larger trial combining ISIS 14803 with pegylated/ribavirin is currently underway.
E-1 Therapeutic Vaccine Innogenetics Phase II
Comments:Phase III expected 2004-2005. Study results indicated that 38% of patients showed improvement in liver fibrosis score
Civacir Polyclonal Antibody NABI Phase II
Comments: Prevention of post-transplant recurrence of HCV. Preliminary results show positive safety and pharmacokinetics results.
Merimebodib
VX-497
IMPDH inhibitor Vertex Phase II
Comments: The preliminary results of a phase II study showed the combination of VX-497, pegylated interferon and ribavirin was safe and well-tolerated, and VX-497 exhibited an anti-viral effect against HCV.
Interferon gamma-1b Anti-fibrotic InterMune Phase II
Comments: The primary endpoint of the study, reversal of liver fibrosis as determined by the Ishak histology scoring system, was not met. Studies for milder disease and longer duration of therapy are pending.
Omega Interferon Interferon BioMedicine Phase II
Comments: New formulation intended to target the liver specifically in order to reduce the side effects in other tissues.
Multiferon-
Natural Interferon Interferon, Long Acting Interferon Viragen Phase II
Comments: Company is making long-acting pegylated version of product in cooperation with Valantis.
Ceplene Histamine Maxim Phase II
Comments: Completed phase II studies. Currently in clinical trials with pegylated interferon.
BILN 2061
Serine Protease Boehringer - Ingelheim Phase II
Comments: Intended to block viral replication. Shows dramatic decrease in HCV viral load with only 48 hours of therapy. One of the most promising potential new HCV therapies. However, phase II trials were put on hold until potential toxicities seen in monkeys taking high doses are resolved.
REBIF
Interferon beta-1a
Interferon Ares-Serono Phase III
IP-501 Anti-fibrotic Indevus Phase III
Comments: Anti-fibrotic agent to treat/prevent cirrhosis. Seems to stimulate collagenase to breakdown collagen-a component of scar tissue.
Viramidine Nucleoside Analogue Valeant Pharmaceuticals Int'l Phase
III
Comments: Pro-drug that results in a version of ribavirin that specifically targets liver cells, which could potentially reduce the incidence of hemolytic anemia that is usually seen with ribavirin. In a recent study of pegylated interferon plus either ribavirin or viramidine, the incidence of hemolytic anemia of viramidine at 600 mg/twice daily was 2% compared to 27% in the ribavirin arm. SVR data from this study is pending.
Zadaxin
(thymosin alfa-1)
Immunomo-dulator SciClone Phase
III
Comments: Boosts the immune system. Use in combination with interferons. Initial results from several clinical trials look encouraging when used in combination with pegylated interferon plus ribavirin.
Infergen Interferon, Long Acting Interferon InterMune Phase
IV
Comments: PEG-Alfacon (Interferon alfacon-1) is a long acting version of Infergen. In January 2003, InterMune announced that it has initiated a Phase I clinical trial as a potential new treatment for HCV.
Amantadine Broad Antiviral Endo Labs Solvay Phase
IV
Comments: Anti-flu agent on the market. Has shown mixed results of efficacy in combination with interferons.
Medusa Interferon Longer acting interferon Flamel Technologies Phase
II
Comments: Enrollment of patients in phase I/II clinical study to demonstrate the safety profile and define the maximum tolerable dose of this long acting interferon. The study will alsol compare the pharmacokinetic profile of the long-acting interferon, compared with interferon.
Recently cancelled clinical trials:
Drug Name Drug Category Pharmaceutical
Company
Clinical Phase
Heptazyme RNA inhibitor RPI Studies Cancelled
Levovirin Nucleoside Analogue Valeant Pharma-ceuticals Int'l Studies Cancelled
Interleukin-10 Anti-fibrotic Schering-Plough Studies Cancelled
в основном альфа интерфероны и ингибиторы протеаз
Table of Hepatitis C Drugs in Current Clinical Development Drug Name Drug Category Pharmaceutical Company Clinical Phase
HCV-086 ViroPharma/Wyeth Phase
I
Albuferon Longer Acting Interferon Human Genome Sciences Phase
II
Comments: Fusion of the genes for human interferon and albumin. Interim results of phase 1/II studies demonstrate that it is well-tolerated, has a long half-life (up to 158 hours), and is biologically active in adults with chronic HCV.
Oral Interferon alpha Oral Interferon Amarillo Biosciences Phase
I
Comments: Testing low dose oral administration of alpha interferon absorbed through mucosal membranes.
VX-950 Protease Inhibitor Vertex Phase
I
Comments: VX 950 has demonstrated good cellular activity in two assays. The anti viral activity can be sustained in viral clearance assays resulting in a continuing decline of HCV RNA for 9 days. Phase I studies expected to begin in 2004. VX-950 is advancing to Phase Ib. Part of the trial will enroll healthy volunteers and patients with chronic hepatitis C virus infection. The trial will follow subjects on a 14-day dosing regimen of the drug
JTK 003 Polymerase Inhibitor AKROS Pharma Phase
I
Comments: Inhibits HCV genotype 1 polymerase
R803 Non-nucleoside HCV Polymerase Inhibitor Rigel Pharmaceuticals Phase
I
Comments: Clinical data indicates that R803 is well tolerated with no notable adverse effects reported in the dose levels that Rigel plans to use moving forward. Phase I/II efficacy trials for the U.S. planned to commence during the second quarter of 2004.
HCV/MF59 Vaccine Chiron Phase
I
Comments: In collaboration with CSL Ltd. and St. Louis University.
SCH-6 Serine Protease Schering Phase
I
Comments: In tests it was found the SCH-6 could protect the cell's defenses and actually may prevent the HCV virus from blocking the immune response and restoring body's natural antiviral response.
ANA245 Isatoribine ANADYS Phase I/II
Comments: Interim results of the Phase 1B clinical trial show that isatoribine is biologically active in adults with chronic HCV infection and results from dosing a cohort of six HCV infected patients with 800mg of isatoribine showed a statistically significant reduction of viral load (p=0.03) at the end of one week, with a median change in viral load from baseline of -0.94 log10 units. Anadys is currently enrolling patients for an isatoribine Phase I/II study.
ANA971 Isatoribine ANADYS Phase I
Comments: A prodrug of isatoribine. A recent clinical study of 48 subjects, including 28 patients infected with hepatitis C reported that the intravenous administration of ANA971 was well tolerated and safe at all doses tested and has shown biological activity against hepatitis C as well significant reductions in HCV RNA (viral load).
Rituximab (Rituxam) Anti-CD20 Monoclonal Antibody Genetech/IDEC Phase I/II
Comments: Under investigation for treatment of cryoglobulinemia. Currently approved for non-Hodgkin's lymphoma.
NM283 Polymerase Inhibitor Idenix Pharmaceuticals Phase I/II
Comments: Phase IIa trials have demonstrated dramatic viral load reductions when used as a monotherapy or in combination with pegylated interferon. NM283 demonstrated a good safety profile. The original clinical trials were so successful that the trial design was extended from 28 days to 3 months. Data from the extended protocol are expected in 2005.
HepXT-C Monclonal Antibody XTL Phase I/II
Comments: Phase I studies on 35 chronic HCV patients indicated good safety and bioactivity. Phase II study of HCV prophylaxis on post liver transplant patients underway.
IDN-6556 Caspase Inhibitor Idun Pharmaceuticals Phase II
Comments: Caspase inhibitors do not have any direct antiviral properties, but are believed to preserve the cell structure and protect the liver from damage caused by HCV. Phase I study completed in May 2002 which included patients with stable hepatitis C infection. Data from a Phase 2a clinical trial of an oral formulation of IDN-6556 in patients infected with HCV reported positive safety and tolerability of the drug as well as its ability to reduce elevated aminotransferase (ALT and AST) levels.
ISIS 14803 Antisense Isis Pharmaceutical / Elan Phase II
Comments: Genetically inhibits translation (production) of disease-causing proteins. This compound appears to be well-tolerated, with minimal adverse effects. A larger trial combining ISIS 14803 with pegylated/ribavirin is currently underway.
E-1 Therapeutic Vaccine Innogenetics Phase II
Comments:Phase III expected 2004-2005. Study results indicated that 38% of patients showed improvement in liver fibrosis score
Civacir Polyclonal Antibody NABI Phase II
Comments: Prevention of post-transplant recurrence of HCV. Preliminary results show positive safety and pharmacokinetics results.
Merimebodib
VX-497
IMPDH inhibitor Vertex Phase II
Comments: The preliminary results of a phase II study showed the combination of VX-497, pegylated interferon and ribavirin was safe and well-tolerated, and VX-497 exhibited an anti-viral effect against HCV.
Interferon gamma-1b Anti-fibrotic InterMune Phase II
Comments: The primary endpoint of the study, reversal of liver fibrosis as determined by the Ishak histology scoring system, was not met. Studies for milder disease and longer duration of therapy are pending.
Omega Interferon Interferon BioMedicine Phase II
Comments: New formulation intended to target the liver specifically in order to reduce the side effects in other tissues.
Multiferon-
Natural Interferon Interferon, Long Acting Interferon Viragen Phase II
Comments: Company is making long-acting pegylated version of product in cooperation with Valantis.
Ceplene Histamine Maxim Phase II
Comments: Completed phase II studies. Currently in clinical trials with pegylated interferon.
BILN 2061
Serine Protease Boehringer - Ingelheim Phase II
Comments: Intended to block viral replication. Shows dramatic decrease in HCV viral load with only 48 hours of therapy. One of the most promising potential new HCV therapies. However, phase II trials were put on hold until potential toxicities seen in monkeys taking high doses are resolved.
REBIF
Interferon beta-1a
Interferon Ares-Serono Phase III
IP-501 Anti-fibrotic Indevus Phase III
Comments: Anti-fibrotic agent to treat/prevent cirrhosis. Seems to stimulate collagenase to breakdown collagen-a component of scar tissue.
Viramidine Nucleoside Analogue Valeant Pharmaceuticals Int'l Phase
III
Comments: Pro-drug that results in a version of ribavirin that specifically targets liver cells, which could potentially reduce the incidence of hemolytic anemia that is usually seen with ribavirin. In a recent study of pegylated interferon plus either ribavirin or viramidine, the incidence of hemolytic anemia of viramidine at 600 mg/twice daily was 2% compared to 27% in the ribavirin arm. SVR data from this study is pending.
Zadaxin
(thymosin alfa-1)
Immunomo-dulator SciClone Phase
III
Comments: Boosts the immune system. Use in combination with interferons. Initial results from several clinical trials look encouraging when used in combination with pegylated interferon plus ribavirin.
Infergen Interferon, Long Acting Interferon InterMune Phase
IV
Comments: PEG-Alfacon (Interferon alfacon-1) is a long acting version of Infergen. In January 2003, InterMune announced that it has initiated a Phase I clinical trial as a potential new treatment for HCV.
Amantadine Broad Antiviral Endo Labs Solvay Phase
IV
Comments: Anti-flu agent on the market. Has shown mixed results of efficacy in combination with interferons.
Medusa Interferon Longer acting interferon Flamel Technologies Phase
II
Comments: Enrollment of patients in phase I/II clinical study to demonstrate the safety profile and define the maximum tolerable dose of this long acting interferon. The study will alsol compare the pharmacokinetic profile of the long-acting interferon, compared with interferon.
Recently cancelled clinical trials:
Drug Name Drug Category Pharmaceutical
Company
Clinical Phase
Heptazyme RNA inhibitor RPI Studies Cancelled
Levovirin Nucleoside Analogue Valeant Pharma-ceuticals Int'l Studies Cancelled
Interleukin-10 Anti-fibrotic Schering-Plough Studies Cancelled
-
(tyler)
вопрос -када дойдет до Росси ну и основное -почём это удовольствие нам предложат:))
-
isaura
Таилер, Омега Интерферон и Вирамидин сеичас испытываются в России, есть бесплатные программы.
Инферген и Задаксин уже в продаже.
ПЕГ-Алфакон скоро появится.
Амантадин уже в продаже и стоит копеики.
Но в основном все сводится к альфа интерферонам. Ингибиторы протеаз тоже испытываются, но там побочек еще больше чем у интерферона.
Инферген и Задаксин уже в продаже.
ПЕГ-Алфакон скоро появится.
Амантадин уже в продаже и стоит копеики.
Но в основном все сводится к альфа интерферонам. Ингибиторы протеаз тоже испытываются, но там побочек еще больше чем у интерферона.
-
Vadim
Изаура, будьте добры, а по потробнее о побочках у ингибиторов. Я вот слышал, что там обезьянка умерла от сердечной недостаточности, а что еще слышно? Так много писали о BILN 2061... Да с английским у меня (думаю и не только) туго, если есть ссылки, то уж на русскоязычную информацию.
-
AHTOH
Vadim,
Тема ингибиторов кстати обсуждалась на этом форуме:
http://www.gepatita.net/forum/read.php? ... 76&t=40022
Правда свелось обсуждение как обычно к трепотне о диете, алкоголе и пречее...
Тема ингибиторов кстати обсуждалась на этом форуме:
http://www.gepatita.net/forum/read.php? ... 76&t=40022
Правда свелось обсуждение как обычно к трепотне о диете, алкоголе и пречее...
-
Vadim
Антон, спасибо за ссылочку, но хотелось бы немного другой информации, более что-ли "обнаученой". Ну типа, испытываем на обезьянках такое лекарство, наблюдаем такую картинку, а в контрольной группе такая вот картинка. Есть например, информация о разработках генной-инженерии аденовируса, который вызывает самоубийство клеток содержащих вирус, а следовательно прекрашении его репликации.
Но как я понимаю это еще далекое будущее. Интерес представляет, то что так сказать "на подходе".
Но как я понимаю это еще далекое будущее. Интерес представляет, то что так сказать "на подходе".
-
рыжая amoureuse
научные работники.
я голосую за омегу как наиболее реальную разработку в ближ времени.
БИЛНом уже в германии прокололи экпериментальную групу. на соседнем форуме человек есть из той группы. сказал что результаты буду известны в амрте вроде.
неделю его кололи... поищите тему там. найдете.
грил что от билна никаких побочек не было вообще.
а то что обезянка померла от него.. я читала. но видать люди выносливеее бибизянок. или доработали мож чуток БИЛН
я голосую за омегу как наиболее реальную разработку в ближ времени.
БИЛНом уже в германии прокололи экпериментальную групу. на соседнем форуме человек есть из той группы. сказал что результаты буду известны в амрте вроде.
неделю его кололи... поищите тему там. найдете.
грил что от билна никаких побочек не было вообще.
а то что обезянка померла от него.. я читала. но видать люди выносливеее бибизянок. или доработали мож чуток БИЛН
-
(tyler)
рыжая -так кого тама колют-чем говориш---говориш нет никаких побочек---;))гы
11 января 28 день- первый ПЦР тада и поговорим!!!! правда чет с общей биохимией хреново -ещё снимут с программы
знаю что омегой в Израиле лечат -там статистика есть -он типа спец разрабатывался для 1 генотипа ..
и в россии его уже кололи-только другими дозами чем у меня-не каждый день а раз в 3 дня помоему- у врача над спросить будет статистику по терапии если есть
11 января 28 день- первый ПЦР тада и поговорим!!!! правда чет с общей биохимией хреново -ещё снимут с программы
знаю что омегой в Израиле лечат -там статистика есть -он типа спец разрабатывался для 1 генотипа ..
и в россии его уже кололи-только другими дозами чем у меня-не каждый день а раз в 3 дня помоему- у врача над спросить будет статистику по терапии если есть
-
AHTOH
Vadim, очень интересно, про аденовирус, впервые слышу. Я поищу информацию, будем здесь обмениваться.
-
Vadim
Рыжая, прошу прощения, как кололи? Он же, вроде, оральный препарат и имел таблитированную форму? Что на мой взгляд может оказаться эффективней чем иньекции.
-
рыжая в тумане
Арктик у мя твоя регистрация 
)))))) полностию автоматом ставится ))))))))))))))))))))
вот это я убилась хахахахахаха
)))))) полностию автоматом ставится )))))))))))))))))))) вот это я убилась хахахахахаха