Domestic hepatitis C patients may use experts to discuss DAA applications next year
November 25, 2016 Source: China.com
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On November 13, the AASLD Annual Meeting was held in Boston, USA. At this meeting, experts discussed the future clinical experience of hepatitis C in the era of DAA treatment of hepatitis C.
Professor Jia Jidong from the Friendship Hospital of Beijing Capital Medical University, Professor Wei Lai from Peking University People's Hospital, Professor Wang Guiqiang from Peking University First Hospital, Professor Chen Liyuan from the Chinese University of Hong Kong Medical School and Professor Yu Hong from the Friendship Hospital of Beijing Capital Medical University gathered together to exchange Collision thought sparks, commenting on the hot spot of this session, depicting the blueprint for the treatment of hepatitis C in China, forming a different landscape of this AASLD.
Professor Chen Liyuan said, "The future DAA treatment will be more and more simple, the treatment will be shorter and shorter, and more and more effective." Professor Jia Jidong pointed out that "the range of treatable patients is wider and wider, and the situation is more and more complicated, so we The knowledge, experience and skills needed need to be continuously improved, and should not be taken lightly.†Professor Wang Guiqiang believes that “I look forward to the listing of DAA in China and strengthen the real world research after listing.†Professor Wei Lai believes that “focus on screening and service more. Patients, clear hepatitis C, reduce the incidence of liver cancer."
In addition, the experts also discussed several hot topics.
Topic 1: The development trend and application prospects of DAA in China?
Professor You Hong: The treatment of direct antiviral drugs (DAA) and hepatitis C is a continuing hot spot in recent academic conferences including AASLD. What is the development trend and application prospect of DAA in China?
Professor Jia Jidong: At the macro level, DAA has become the standard first-line treatment in many countries in Europe, America and Asia. Unfortunately, these drugs have not been listed in China. However, many patients purchase drugs from countries such as India through informal channels. Therefore, these drugs have been widely used in clinical practice in China, and this situation needs to be addressed.
At the operational level, a number of registered clinical trials in China are also in full swing. Some clinical trials have been completed and submitted to the State Food and Drug Administration for listing. It is expected that the DAA is expected to be approved for listing in China in the first half of 2017 and will be treated clinically. Practice has brought about tremendous changes.
Professor Wei Lai: On April 18, 2016, the Drug Evaluation Center of China Food and Drug Administration issued a notice on accelerating the approval of hepatitis C treatment drugs, which listed several products and multiple programs of domestic and foreign pharmaceutical companies. The overall feature of these programs is to achieve a sustained virological response (SVR) of 90% or more in Chinese patients.
For example, two 3D protocols (NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors) were reported on this AASLD by Chinese mainland, Taiwanese, and Korean scholars; Obi Palidaseb Wei; Aibowei) Clinical trial results of patients with type 1b treatment - ONXY-I (slow hepatitis C patients, n = 650) and ONXY-II (cirrhotic patients with compensated liver, n = 104). SVR12 was close to 100% regardless of whether the patient was initially treated or not, and only 1 patient did not achieve SVR due to poor compliance. At the same time, the safety is relatively good, the tolerance is good, and there is no drug withdrawal due to adverse reactions. The main adverse reactions are upper respiratory tract infection, headache, and fatigue.
At present, the clinical trials in China have been completed by Johnson & Johnson's dexamethasone in combination with peginterferon and ribavirin, savivavir's dalavitavir plus ashuribide, and Gilead's sophos. Wei combined with peginterferon ± ribavirin and Abbott's Obi Pali desebeway program, optimistic estimates can be completed before and after the 2017 Spring Festival. I hope that in the coming of the new year, I will bring a surprise to the patients and provide more help to the doctors.
Topic 2: What is the significance of the 8-week program?
Professor You Hong: A lot of information, including many reports reported at this conference, shows that hepatitis C may be cured through a shorter course of treatment, such as 8 weeks. What does 8 weeks mean?
Professor Wang Guiqiang: The current HCV response rate after DAA treatment has increased significantly, reaching almost 100%. In the case of the same effect, the course of treatment is also greatly shortened. There are many advantages to shortening the course of treatment. Firstly, from 24 weeks or 12 weeks to 8 weeks, the cost can be greatly reduced. Secondly, the shorter the course of treatment, the better the patient's compliance and the efficacy is guaranteed. Finally, a short course of treatment reduces the risk of side effects. From the experience of AIDS treatment, small molecule drugs still have the risk of drug resistance, and short-term virus elimination can reduce the possibility of drug resistance. Therefore, shortening the course of treatment is very important.
Professor Chen Liyuan: Shortening the course of treatment is a general trend. According to the report on AASLD, this trend has expanded from gene type 1 to other genotypes. In the future, we should explore more, which patients with easy treatment such as initial treatment, no cirrhosis, low viral load, etc., can shorten the course of treatment.
Topic 3: Real World Research
Professor You Hong: At this session, in addition to seeing a large number of randomized controlled clinical trials (RCT) data, we also saw a lot of "real worldstudy". How do we know?
Professor Wei Lai: Real world research is different from clinical trials. Can the effectiveness and safety of new drugs in selected populations in clinical trials be replicated in a wide range of populations? Real-world research can guide clinical drug use more objectively and comprehensively because of its large sample size and widespread use.
A representative representative of a real-world study from the US Veterans database was published in this session. A total of 17,847 patients received a regimen based on sophob-Bubwe, Harvard or 3D. In the treatment of patients, the SVR of the type 1 patients was 92.8%, and the Harvoni and 3D programs could achieve more than 95% of the responses. Moreover, these programs are well tolerated in the real world, and a small number of intolerable cases are mainly related to the combination of ribavirin.
Professor Chen Liyuan: The Hong Kong region has just published a real-world study using 3D treatment, which includes many types of patients. From the data point of view, the SVR of the drug is guaranteed, the DAA itself has few side effects, and the tolerance and safety are very good. Real-world data is critical to the authenticity and safety of a drug.
Professor Wang Guiqiang: A large-scale multi-center real-world study in Israel was reported at the meeting, incorporating 994 patients with type 1 gene and using the 3D regimen + ribavirin. 58% of these patients were treated with interferon and 59% had cirrhosis. It can be seen that the real-world response rate of treatment can reach 97%, and only a small number of patients discontinue the drug due to adverse reactions (2.4%). This suggests that we need to pay special attention to specific types of patients in clinical practice.
Topic 4: Long-term benefits of DAA treatment
Professor You Hong: The final outcome of patients after DAA treatment should be implemented on the “hard end point†question, namely, can DAA treatment bring long-term benefits, reduce mortality and reduce the incidence of HCC?
Professor Wei Lai: When treating hepatitis C, we emphasize the removal of the virus, that is, the acquisition of SVR. HCV infection can cause liver cirrhosis, liver cancer, and affect other patients' diseases (such as kidney, cerebrovascular, etc.), and reduce the quality of life of patients. Therefore, the elimination of the virus for the patient can delay the progression of liver cirrhosis, reduce the risk of HCC, reduce the incidence of other diseases related to hepatitis C, and improve the quality of life of patients. In addition, from the perspective of public health, the spread of disease can be reduced. Furthermore, from the perspective of the cost of the country, the elimination of the virus can reduce the cost of related treatments for complications and liver cancer in the future. However, it should be noted that screening for high-risk populations and the inclusion of more patients in the treatment system will ensure the benefits at the national level.
This session published some long-term evidence of benefit from the use of DAA, in which we saw the interim data of the 5-year follow-up study of the 3D program, the TOPAZ-1 study.
On November 13, the AASLD Annual Meeting was held in Boston, USA. At this meeting, experts discussed the future clinical experience of hepatitis C in the era of DAA treatment of hepatitis C.
Professor Jia Jidong from the Friendship Hospital of Beijing Capital Medical University, Professor Wei Lai from Peking University People's Hospital, Professor Wang Guiqiang from Peking University First Hospital, Professor Chen Liyuan from the Chinese University of Hong Kong Medical School and Professor Yu Hong from the Friendship Hospital of Beijing Capital Medical University gathered together to exchange Collision thought sparks, commenting on the hot spot of this session, depicting the blueprint for the treatment of hepatitis C in China, forming a different landscape of this AASLD.
Professor Chen Liyuan said, "The future DAA treatment will be more and more simple, the treatment will be shorter and shorter, and more and more effective." Professor Jia Jidong pointed out that "the range of treatable patients is wider and wider, and the situation is more and more complicated, so we The knowledge, experience and skills needed need to be continuously improved, and should not be taken lightly.†Professor Wang Guiqiang believes that “I look forward to the listing of DAA in China and strengthen the real world research after listing.†Professor Wei Lai believes that “focus on screening and service more. Patients, clear hepatitis C, reduce the incidence of liver cancer."
In addition, the experts also discussed several hot topics.
Topic 1: The development trend and application prospects of DAA in China?
Professor You Hong: The treatment of direct antiviral drugs (DAA) and hepatitis C is a continuing hot spot in recent academic conferences including AASLD. What is the development trend and application prospect of DAA in China?
Professor Jia Jidong: At the macro level, DAA has become the standard first-line treatment in many countries in Europe, America and Asia. Unfortunately, these drugs have not been listed in China. However, many patients purchase drugs from countries such as India through informal channels. Therefore, these drugs have been widely used in clinical practice in China, and this situation needs to be addressed.
At the operational level, a number of registered clinical trials in China are also in full swing. Some clinical trials have been completed and submitted to the State Food and Drug Administration for listing. It is expected that the DAA is expected to be approved for listing in China in the first half of 2017 and will be treated clinically. Practice has brought about tremendous changes.
Professor Wei Lai: On April 18, 2016, the Drug Evaluation Center of China Food and Drug Administration issued a notice on accelerating the approval of hepatitis C treatment drugs, which listed several products and multiple programs of domestic and foreign pharmaceutical companies. The overall feature of these programs is to achieve a sustained virological response (SVR) of 90% or more in Chinese patients.
For example, two 3D protocols (NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors) were reported on this AASLD by Chinese mainland, Taiwanese, and Korean scholars; Obi Palidaseb Wei; Aibowei) Clinical trial results of patients with type 1b treatment - ONXY-I (slow hepatitis C patients, n = 650) and ONXY-II (cirrhotic patients with compensated liver, n = 104). SVR12 was close to 100% regardless of whether the patient was initially treated or not, and only 1 patient did not achieve SVR due to poor compliance. At the same time, the safety is relatively good, the tolerance is good, and there is no drug withdrawal due to adverse reactions. The main adverse reactions are upper respiratory tract infection, headache, and fatigue.
At present, the clinical trials in China have been completed by Johnson & Johnson's dexamethasone in combination with peginterferon and ribavirin, savivavir's dalavitavir plus ashuribide, and Gilead's sophos. Wei combined with peginterferon ± ribavirin and Abbott's Obi Pali desebeway program, optimistic estimates can be completed before and after the 2017 Spring Festival. I hope that in the coming of the new year, I will bring a surprise to the patients and provide more help to the doctors.
Topic 2: What is the significance of the 8-week program?
Professor You Hong: A lot of information, including many reports reported at this conference, shows that hepatitis C may be cured through a shorter course of treatment, such as 8 weeks. What does 8 weeks mean?
Professor Wang Guiqiang: The current HCV response rate after DAA treatment has increased significantly, reaching almost 100%. In the case of the same effect, the course of treatment is also greatly shortened. There are many advantages to shortening the course of treatment. Firstly, from 24 weeks or 12 weeks to 8 weeks, the cost can be greatly reduced. Secondly, the shorter the course of treatment, the better the patient's compliance and the efficacy is guaranteed. Finally, a short course of treatment reduces the risk of side effects. From the experience of AIDS treatment, small molecule drugs still have the risk of drug resistance, and short-term virus elimination can reduce the possibility of drug resistance. Therefore, shortening the course of treatment is very important.
Professor Chen Liyuan: Shortening the course of treatment is a general trend. According to the report on AASLD, this trend has expanded from gene type 1 to other genotypes. In the future, we should explore more, which patients with easy treatment such as initial treatment, no cirrhosis, low viral load, etc., can shorten the course of treatment.
Topic 3: Real World Research
Professor You Hong: At this session, in addition to seeing a large number of randomized controlled clinical trials (RCT) data, we also saw a lot of "real worldstudy". How do we know?
Professor Wei Lai: Real world research is different from clinical trials. Can the effectiveness and safety of new drugs in selected populations in clinical trials be replicated in a wide range of populations? Real-world research can guide clinical drug use more objectively and comprehensively because of its large sample size and widespread use.
A representative representative of a real-world study from the US Veterans database was published in this session. A total of 17,847 patients received a regimen based on sophob-Bubwe, Harvard or 3D. In the treatment of patients, the SVR of the type 1 patients was 92.8%, and the Harvoni and 3D programs could achieve more than 95% of the responses. Moreover, these programs are well tolerated in the real world, and a small number of intolerable cases are mainly related to the combination of ribavirin.
Professor Chen Liyuan: The Hong Kong region has just published a real-world study using 3D treatment, which includes many types of patients. From the data point of view, the SVR of the drug is guaranteed, the DAA itself has few side effects, and the tolerance and safety are very good. Real-world data is critical to the authenticity and safety of a drug.
Professor Wang Guiqiang: A large-scale multi-center real-world study in Israel was reported at the meeting, incorporating 994 patients with type 1 gene and using the 3D regimen + ribavirin. 58% of these patients were treated with interferon and 59% had cirrhosis. It can be seen that the real-world response rate of treatment can reach 97%, and only a small number of patients discontinue the drug due to adverse reactions (2.4%). This suggests that we need to pay special attention to specific types of patients in clinical practice.
Topic 4: Long-term benefits of DAA treatment
Professor You Hong: The final outcome of patients after DAA treatment should be implemented on the “hard end point†question, namely, can DAA treatment bring long-term benefits, reduce mortality and reduce the incidence of HCC?
Professor Wei Lai: When treating hepatitis C, we emphasize the removal of the virus, that is, the acquisition of SVR. HCV infection can cause liver cirrhosis, liver cancer, and affect other patients' diseases (such as kidney, cerebrovascular, etc.), and reduce the quality of life of patients. Therefore, the elimination of the virus for the patient can delay the progression of liver cirrhosis, reduce the risk of HCC, reduce the incidence of other diseases related to hepatitis C, and improve the quality of life of patients. In addition, from the perspective of public health, the spread of disease can be reduced. Furthermore, from the perspective of the cost of the country, the elimination of the virus can reduce the cost of related treatments for complications and liver cancer in the future. However, it should be noted that screening for high-risk populations and the inclusion of more patients in the treatment system will ensure the benefits at the national level.
This session published some long-term evidence of benefit from the use of DAA, in which we saw the interim data of the 5-year follow-up study of the 3D program, the TOPAZ-1 study.
On November 13, the AASLD Annual Meeting was held in Boston, USA. At this meeting, experts discussed the future clinical experience of hepatitis C in the era of DAA treatment of hepatitis C.
Professor Jia Jidong from the Friendship Hospital of Beijing Capital Medical University, Professor Wei Lai from Peking University People's Hospital, Professor Wang Guiqiang from Peking University First Hospital, Professor Chen Liyuan from the Chinese University of Hong Kong Medical School and Professor Yu Hong from the Friendship Hospital of Beijing Capital Medical University gathered together to exchange Collision thought sparks, commenting on the hot spot of this session, depicting the blueprint for the treatment of hepatitis C in China, forming a different landscape of this AASLD.
Professor Chen Liyuan said, "The future DAA treatment will be more and more simple, the treatment will be shorter and shorter, and more and more effective." Professor Jia Jidong pointed out that "the range of treatable patients is wider and wider, and the situation is more and more complicated, so we The knowledge, experience and skills needed need to be continuously improved, and should not be taken lightly.†Professor Wang Guiqiang believes that “I look forward to the listing of DAA in China and strengthen the real world research after listing.†Professor Wei Lai believes that “focus on screening and service more. Patients, clear hepatitis C, reduce the incidence of liver cancer."
In addition, the experts also discussed several hot topics.
Topic 1: The development trend and application prospects of DAA in China?
Professor You Hong: The treatment of direct antiviral drugs (DAA) and hepatitis C is a continuing hot spot in recent academic conferences including AASLD. What is the development trend and application prospect of DAA in China?
Professor Jia Jidong: At the macro level, DAA has become the standard first-line treatment in many countries in Europe, America and Asia. Unfortunately, these drugs have not been listed in China. However, many patients purchase drugs from countries such as India through informal channels. Therefore, these drugs have been widely used in clinical practice in China, and this situation needs to be addressed.
At the operational level, a number of registered clinical trials in China are also in full swing. Some clinical trials have been completed and submitted to the State Food and Drug Administration for listing. It is expected that the DAA is expected to be approved for listing in China in the first half of 2017 and will be treated clinically. Practice has brought about tremendous changes.
Professor Wei Lai: On April 18, 2016, the Drug Evaluation Center of China Food and Drug Administration issued a notice on accelerating the approval of hepatitis C treatment drugs, which listed several products and multiple programs of domestic and foreign pharmaceutical companies. The overall feature of these programs is to achieve a sustained virological response (SVR) of 90% or more in Chinese patients.
For example, two 3D protocols (NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors) were reported on this AASLD by Chinese mainland, Taiwanese, and Korean scholars; Obi Palidaseb Wei; Aibowei) Clinical trial results of patients with type 1b treatment - ONXY-I (slow hepatitis C patients, n = 650) and ONXY-II (cirrhotic patients with compensated liver, n = 104). SVR12 was close to 100% regardless of whether the patient was initially treated or not, and only 1 patient did not achieve SVR due to poor compliance. At the same time, the safety is relatively good, the tolerance is good, and there is no drug withdrawal due to adverse reactions. The main adverse reactions are upper respiratory tract infection, headache, and fatigue.
At present, the clinical trials in China have been completed by Johnson & Johnson's dexamethasone in combination with peginterferon and ribavirin, savivavir's dalavitavir plus ashuribide, and Gilead's sophos. Wei combined with peginterferon ± ribavirin and Abbott's Obi Pali desebeway program, optimistic estimates can be completed before and after the 2017 Spring Festival. I hope that in the coming of the new year, I will bring a surprise to the patients and provide more help to the doctors.
Topic 2: What is the significance of the 8-week program?
Professor You Hong: A lot of information, including many reports reported at this conference, shows that hepatitis C may be cured through a shorter course of treatment, such as 8 weeks. What does 8 weeks mean?
Professor Wang Guiqiang: The current HCV response rate after DAA treatment has increased significantly, reaching almost 100%. In the case of the same effect, the course of treatment is also greatly shortened. There are many advantages to shortening the course of treatment. Firstly, from 24 weeks or 12 weeks to 8 weeks, the cost can be greatly reduced. Secondly, the shorter the course of treatment, the better the patient's compliance and the efficacy is guaranteed. Finally, a short course of treatment reduces the risk of side effects. From the experience of AIDS treatment, small molecule drugs still have the risk of drug resistance, and short-term virus elimination can reduce the possibility of drug resistance. Therefore, shortening the course of treatment is very important.
Professor Chen Liyuan: Shortening the course of treatment is a general trend. According to the report on AASLD, this trend has expanded from gene type 1 to other genotypes. In the future, we should explore more, which patients with easy treatment such as initial treatment, no cirrhosis, low viral load, etc., can shorten the course of treatment.
Topic 3: Real World Research
Professor You Hong: At this session, in addition to seeing a large number of randomized controlled clinical trials (RCT) data, we also saw a lot of "real worldstudy". How do we know?
Professor Wei Lai: Real world research is different from clinical trials. Can the effectiveness and safety of new drugs in selected populations in clinical trials be replicated in a wide range of populations? Real-world research can guide clinical drug use more objectively and comprehensively because of its large sample size and widespread use.
A representative representative of a real-world study from the US Veterans database was published in this session. A total of 17,847 patients received a regimen based on sophob-Bubwe, Harvard or 3D. In the treatment of patients, the SVR of the type 1 patients was 92.8%, and the Harvoni and 3D programs could achieve more than 95% of the responses. Moreover, these programs are well tolerated in the real world, and a small number of intolerable cases are mainly related to the combination of ribavirin.
Professor Chen Liyuan: The Hong Kong region has just published a real-world study using 3D treatment, which includes many types of patients. From the data point of view, the SVR of the drug is guaranteed, the DAA itself has few side effects, and the tolerance and safety are very good. Real-world data is critical to the authenticity and safety of a drug.
Professor Wang Guiqiang: A large-scale multi-center real-world study in Israel was reported at the meeting, incorporating 994 patients with type 1 gene and using the 3D regimen + ribavirin. 58% of these patients were treated with interferon and 59% had cirrhosis. It can be seen that the real-world response rate of treatment can reach 97%, and only a small number of patients discontinue the drug due to adverse reactions (2.4%). This suggests that we need to pay special attention to specific types of patients in clinical practice.
Topic 4: Long-term benefits of DAA treatment
Professor You Hong: The final outcome of patients after DAA treatment should be implemented on the “hard end point†question, namely, can DAA treatment bring long-term benefits, reduce mortality and reduce the incidence of HCC?
Professor Wei Lai: When treating hepatitis C, we emphasize the removal of the virus, that is, the acquisition of SVR. HCV infection can cause liver cirrhosis, liver cancer, and affect other patients' diseases (such as kidney, cerebrovascular, etc.), and reduce the quality of life of patients. Therefore, the elimination of the virus for the patient can delay the progression of liver cirrhosis, reduce the risk of HCC, reduce the incidence of other diseases related to hepatitis C, and improve the quality of life of patients. In addition, from the perspective of public health, the spread of disease can be reduced. Furthermore, from the perspective of the cost of the country, the elimination of the virus can reduce the cost of related treatments for complications and liver cancer in the future. However, it should be noted that screening for high-risk populations and the inclusion of more patients in the treatment system will ensure the benefits at the national level.
This session published some long-term evidence of benefit from the use of DAA, in which we saw the interim data of the 5-year follow-up study of the 3D program, the TOPAZ-1 study.
The study enrolled 1596 patients, currently 1573 patients completed treatment, and ITT analysis of SVR12 was 97%. Of these, 1374 (85%) patients were followed up for 24 weeks after treatment, and 644 (40%) patients were followed up for 52 weeks after treatment. The results showed that the average FibroScan results were gradually improved in patients with SVR, especially in the cirrhosis group; the incidence of any clinical endpoint was very low, only 0.7% (11 patients, 7 of whom were liver-related events).
In addition, preliminary data from the long-term outcome study of patients with cirrhosis based on the regimen of sofosbuvir also showed that more than 99% of patients with SVR can be maintained for a long time, the rate of new liver cancer is very low, and the CPT score of most patients remains unchanged. Or improve, the MELD score of patients with decompensated cirrhosis before treatment decreased.
Professor Jia Jidong: Whether it is hepatitis B or hepatitis C, starting from the source, it is the fundamental driving force to suppress or eliminate the virus and eliminate the disease. In the long run, the incidence of liver fibrosis, cirrhosis, and liver cancer will decrease after the virus is removed. However, it should be noted that some patients with cirrhosis have already been present at the time of treatment. Although the disease progression is controlled after the virus is removed, the existing lesions and portal hypertension in the liver cannot be eliminated in a short period of time, and complications may occur. Therefore, we must emphasize to patients that the anti-viral treatment of hepatitis C is very effective and can eliminate the virus, but even if the virus is cleared, it is necessary to pay attention to the treatment and monitoring of complications of cirrhosis and portal hypertension. In particular, the removal of the virus can reduce but not completely eliminate the risk of primary liver cancer, so it is still necessary to strengthen the regular screening and monitoring of HCC.
In short, antiviral therapy is the most fundamental, effective and important treatment, but for patients with cirrhosis, especially decompensated cirrhosis, comprehensive and comprehensive treatment is needed to truly improve the survival and life of patients. quality.
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