Knowledge of hepatitis B
Mar
14
Nucleoside (acid) analogues are currently on the treatment of hepatitis B clinical important antiviral drugs, these drugs directly inhibit HBV DNA replication, thereby improving liver histological lesions, delaying the progress of hepatitis B disease and reduce the occurrence of complications. However, long-term treatment of HIV drug resistance happen these drugs are facing common problems. Resistance to antiviral drugs can lead to virologic rebound and health to deteriorate. NIH in the United States in 2006 Conference on the diagnosis and treatment of hepatitis B (Lok A, et al. Program of the 2006 management of Hepatitis B virus meeting, 2006), as well as up in 2006 by the American Society for some experts to digest a set of "standardized diagnosis and treatment of hepatitis B" Medium (Keeffe E, et al. Clin Gastroenterol Hepatol, 2006), the virus was agreed that the definition of resistance (Figure 1): Genotypic resistance refers to PCR product direct sequencing method HBV polymerase mutation; Phenotypic resistance refers to in vitro cell culture or enzyme activity proved resistant variation; virologic rebound refers to treatment than the treatment of HBV DNA increase in the minimum value of ≥ 1 log; chemical reaction refers to achieve the initial response to treatment after the ALT increase in one of genes type resistance is usually preceded virologic rebound, but also the first virological rebound rebound in biochemistry.
HBV resistance of clinical impact
Drug-resistant hepatitis B are long-term anti-viral treatment of serious clinical problem. HBV to nucleoside (acid) analogues after resistance have clinical consequences are as follows: can lead to virologic rebound, rebound Biochemistry; happened serological relapse; liver disease progress, such as acute exacerbation of liver disease may occur and liver failure and required liver transplantation or death; to make hepatitis B liver transplant due to anti-viral drug resistance and failure. Follow-up drug-resistant virus can also affect the efficacy of antiviral therapy, so that the poor efficacy of treatment or follow-up rate increased resistance; also may lead to drug-resistant virus to spread.
Liaw and other studies have shown that lamivudine-resistant mutations can lead to long-term treatment efficacy in patients with liver cirrhosis and disease decline. Another lamivudine (Liaw et al. N Eng J Med, 2004) long-term treatment in patients with cirrhosis of the study results showed that sustained virologic response was significantly higher than the survival rate of patients with YMDD mutation and drug resistance has not been virology response of patients (P = 0.001), which prompts the occurrence of resistance reduces the efficacy of reduced survival time in patients with liver cirrhosis. Hepatitis B treatment methods>>>
Potent inhibitor of viruses and genetic barriers on the impact of drug resistance
Colonno at 2006 AASLD annual meeting mentioned in the report, when complete virus suppression, on the one hand, drug-sensitive strain was the maximum inhibition, on the other hand, drug-resistant mutant viruses have also significantly reduced; When the virus is not completely inhibited, the virus also in the copy, so increase the likelihood of drug resistance mutations. Potent antiviral drug-resistant virus with the "high barrier", one refers to pharmacokinetic barriers, that is, arrival target organ drug concentrations and the concentration required to inhibit virus ratio, arrival target organ drug concentrations higher inhibiting virus concentration required to lower their ratio of older, was "high pharmacokinetic barriers"; two are referring to high genetic barrier required multiple loci simultaneously in order to produce drug-resistant mutations; three refers to the viability of mutant strain of the virus.
Diagnosis and monitoring of drug resistance
Digestion 2006 American Institute of published norms for the diagnosis and treatment of hepatitis B virus resistant to the diagnostic criteria: PCR method proved to serum HBV DNA level than the minimum treatment levels ≥ 1 log, can be identified as virologic rebound. The standardized diagnosis and treatment recommendations on the acceptance of patients treated with lamivudine should be every 3 to 6 months to monitor the one time; adefovir dipivoxil or entecavir treatment one year after every six month to monitor one time; of progressive liver ill, should be kept under surveillance, that is, every 3 months to monitor the one time. At the current widely used clinical and laboratory monitoring of HIV drug resistance due to a rebound of HBV DNA nucleic acid hybridization methods and PCR method, the higher the sensitivity of the method to monitor the more can be done sooner to the resistance. Foreign genotype resistance testing method for the INNO-LiPA HBV DR2 and PCR direct sequencing, the former high sensitivity, but can only detect known resistance gene loci have been used in clinical Kit; latter sensitivity lower, but can detect known and emerging drug resistance gene locus, mainly for laboratory research.
At present, HBV to nucleoside (acid) analogue-resistant characteristics
At present, in vivo and in vitro experiments have demonstrated the emergence of drug resistance and P gene variants related to different nucleotides (acid) analogs resistant strains of the variable site is not consistent (Figure 2), such as lamivudine resistance-associated mutations for the M204V / I, L180M, etc. related to adefovir dipivoxil for the N236T mutation, etc. telbivudine for the M204I, in other words, the virus only needs a bit point mutation can happen to these drug resistance, and Baraclude happened virus rebound is necessary L180M and M204I / V + T184 or S202 or M250 the 3-bit point mutation that entecavir resistance gene with a high barrier; another lead entecavir resistant mutations in three loci, including two pull set resistance mutations, that is to say of entecavir resistance in lamivudine-resistant must be set up based on lamivudine therapy can elect lamivudine-resistant mutation, but also the election out Baraclude resistance mutation.
Treated with lamivudine-resistant 5-year rate of nearly 70%, adefovir dipivoxil treatment resistance appeared later than the time of lamivudine, but 5 years of treatment, HBeAg-negative patients with newly diagnosed rate of genotypic resistance 29%, HBeAg-positive patients led to drug-resistant virus rebound happen rate of 20%; telbivudine treatment of one year, the initial treatment of patients with resistance-associated happen rebound rate of 4.4% (HBeAg positive), 2.7% (HBeAg-negative ), 2 year, rising to 21.6%, 8.6%.
Baraclude treatment-resistant 3-year data show that treatment of 3 years a total of three cases of newly diagnosed patients entecavir resistance mutations, the three cases of patients at baseline on the existence of lamivudine-resistant mutations or ex for lamivudine-resistant drugs site mutation, resulting in 3 years because of drug-resistant virological rebound in <1% (Table 1). The reasons for the low rate of resistance in the first attributed to entecavir has potent antiviral activity, followed by a high barrier resistance gene, required three sites simultaneously to produce drug-resistant mutations.
The prevention of drug resistance
Based on the occurrence of HIV drug resistance and inhibition of the virus is closely related to viral load can be reduced down to unmeasurable levels of resistance may occur and should therefore be the use of potent antiviral drugs, rapid and sustained viral load suppression to unpredictable levels of ; at the same time, selection with a high barrier resistance gene of antiviral drugs; In addition, improve patient compliance, early response to unsatisfactory dressing change and avoid the timely sequential single-drug therapy, but also help prevent the occurrence of drug resistance.
Treatment-resistant
After the emergence of HIV drug resistance usually have the following treatment methods: an end to the current treatment; continue the current treatment; add another antiviral drugs; switch to another antiviral drugs. At present, consider an end to the current treatment and to continue the current treatment, have been reported in the literature can lead to acute exacerbation of hepatitis or even liver decompensation, should not be used. Currently recommend the use of the latter two methods, a specific approach: ① happen lamivudine resistance, they can add or switch to adefovir dipivoxil, or switch to entecavir; ② adefovir dipivoxil resistance, the add to lamivudine or to switch to entecavir; ③ Baraclude resistance can add or adefovir dipivoxil alone. Hepatitis patients how to use>>
Summary
Antiviral resistance in long-term treatment of hepatitis B are a major clinical problem, virus resistance will lead to severe clinical outcome, the need for close monitoring. Baraclude (Broadbus be) are currently the lowest incidence of drug-resistant nucleoside analogs. Nucleoside analogues in previously untreated patients, through the use of potent antiviral drugs, the use of high barrier resistance gene of antiviral drugs, as well as improve patient compliance and so on, can be resistant HBV time delay and reduce drug resistance rate. When resistance occurred, should consider the use of potent antiviral drugs or combination therapy.
HBV resistance of clinical impact
Drug-resistant hepatitis B are long-term anti-viral treatment of serious clinical problem. HBV to nucleoside (acid) analogues after resistance have clinical consequences are as follows: can lead to virologic rebound, rebound Biochemistry; happened serological relapse; liver disease progress, such as acute exacerbation of liver disease may occur and liver failure and required liver transplantation or death; to make hepatitis B liver transplant due to anti-viral drug resistance and failure. Follow-up drug-resistant virus can also affect the efficacy of antiviral therapy, so that the poor efficacy of treatment or follow-up rate increased resistance; also may lead to drug-resistant virus to spread.
Liaw and other studies have shown that lamivudine-resistant mutations can lead to long-term treatment efficacy in patients with liver cirrhosis and disease decline. Another lamivudine (Liaw et al. N Eng J Med, 2004) long-term treatment in patients with cirrhosis of the study results showed that sustained virologic response was significantly higher than the survival rate of patients with YMDD mutation and drug resistance has not been virology response of patients (P = 0.001), which prompts the occurrence of resistance reduces the efficacy of reduced survival time in patients with liver cirrhosis. Hepatitis B treatment methods>>>
Potent inhibitor of viruses and genetic barriers on the impact of drug resistance
Colonno at 2006 AASLD annual meeting mentioned in the report, when complete virus suppression, on the one hand, drug-sensitive strain was the maximum inhibition, on the other hand, drug-resistant mutant viruses have also significantly reduced; When the virus is not completely inhibited, the virus also in the copy, so increase the likelihood of drug resistance mutations. Potent antiviral drug-resistant virus with the "high barrier", one refers to pharmacokinetic barriers, that is, arrival target organ drug concentrations and the concentration required to inhibit virus ratio, arrival target organ drug concentrations higher inhibiting virus concentration required to lower their ratio of older, was "high pharmacokinetic barriers"; two are referring to high genetic barrier required multiple loci simultaneously in order to produce drug-resistant mutations; three refers to the viability of mutant strain of the virus.
Diagnosis and monitoring of drug resistance
Digestion 2006 American Institute of published norms for the diagnosis and treatment of hepatitis B virus resistant to the diagnostic criteria: PCR method proved to serum HBV DNA level than the minimum treatment levels ≥ 1 log, can be identified as virologic rebound. The standardized diagnosis and treatment recommendations on the acceptance of patients treated with lamivudine should be every 3 to 6 months to monitor the one time; adefovir dipivoxil or entecavir treatment one year after every six month to monitor one time; of progressive liver ill, should be kept under surveillance, that is, every 3 months to monitor the one time. At the current widely used clinical and laboratory monitoring of HIV drug resistance due to a rebound of HBV DNA nucleic acid hybridization methods and PCR method, the higher the sensitivity of the method to monitor the more can be done sooner to the resistance. Foreign genotype resistance testing method for the INNO-LiPA HBV DR2 and PCR direct sequencing, the former high sensitivity, but can only detect known resistance gene loci have been used in clinical Kit; latter sensitivity lower, but can detect known and emerging drug resistance gene locus, mainly for laboratory research.
At present, HBV to nucleoside (acid) analogue-resistant characteristics
At present, in vivo and in vitro experiments have demonstrated the emergence of drug resistance and P gene variants related to different nucleotides (acid) analogs resistant strains of the variable site is not consistent (Figure 2), such as lamivudine resistance-associated mutations for the M204V / I, L180M, etc. related to adefovir dipivoxil for the N236T mutation, etc. telbivudine for the M204I, in other words, the virus only needs a bit point mutation can happen to these drug resistance, and Baraclude happened virus rebound is necessary L180M and M204I / V + T184 or S202 or M250 the 3-bit point mutation that entecavir resistance gene with a high barrier; another lead entecavir resistant mutations in three loci, including two pull set resistance mutations, that is to say of entecavir resistance in lamivudine-resistant must be set up based on lamivudine therapy can elect lamivudine-resistant mutation, but also the election out Baraclude resistance mutation.
Treated with lamivudine-resistant 5-year rate of nearly 70%, adefovir dipivoxil treatment resistance appeared later than the time of lamivudine, but 5 years of treatment, HBeAg-negative patients with newly diagnosed rate of genotypic resistance 29%, HBeAg-positive patients led to drug-resistant virus rebound happen rate of 20%; telbivudine treatment of one year, the initial treatment of patients with resistance-associated happen rebound rate of 4.4% (HBeAg positive), 2.7% (HBeAg-negative ), 2 year, rising to 21.6%, 8.6%.
Baraclude treatment-resistant 3-year data show that treatment of 3 years a total of three cases of newly diagnosed patients entecavir resistance mutations, the three cases of patients at baseline on the existence of lamivudine-resistant mutations or ex for lamivudine-resistant drugs site mutation, resulting in 3 years because of drug-resistant virological rebound in <1% (Table 1). The reasons for the low rate of resistance in the first attributed to entecavir has potent antiviral activity, followed by a high barrier resistance gene, required three sites simultaneously to produce drug-resistant mutations.
The prevention of drug resistance
Based on the occurrence of HIV drug resistance and inhibition of the virus is closely related to viral load can be reduced down to unmeasurable levels of resistance may occur and should therefore be the use of potent antiviral drugs, rapid and sustained viral load suppression to unpredictable levels of ; at the same time, selection with a high barrier resistance gene of antiviral drugs; In addition, improve patient compliance, early response to unsatisfactory dressing change and avoid the timely sequential single-drug therapy, but also help prevent the occurrence of drug resistance.
Treatment-resistant
After the emergence of HIV drug resistance usually have the following treatment methods: an end to the current treatment; continue the current treatment; add another antiviral drugs; switch to another antiviral drugs. At present, consider an end to the current treatment and to continue the current treatment, have been reported in the literature can lead to acute exacerbation of hepatitis or even liver decompensation, should not be used. Currently recommend the use of the latter two methods, a specific approach: ① happen lamivudine resistance, they can add or switch to adefovir dipivoxil, or switch to entecavir; ② adefovir dipivoxil resistance, the add to lamivudine or to switch to entecavir; ③ Baraclude resistance can add or adefovir dipivoxil alone. Hepatitis patients how to use>>
Summary
Antiviral resistance in long-term treatment of hepatitis B are a major clinical problem, virus resistance will lead to severe clinical outcome, the need for close monitoring. Baraclude (Broadbus be) are currently the lowest incidence of drug-resistant nucleoside analogs. Nucleoside analogues in previously untreated patients, through the use of potent antiviral drugs, the use of high barrier resistance gene of antiviral drugs, as well as improve patient compliance and so on, can be resistant HBV time delay and reduce drug resistance rate. When resistance occurred, should consider the use of potent antiviral drugs or combination therapy.
Mar
14
Some time ago, a lot of media coverage of our country has 103 patients with chronic hepatitis B achieve clinical cure, this message has led to a lot of people doubt. What truth do? Investigate the journalist point of view.
Zhou Yu-lin: Here are subsidiary Beijing Capital Medical University hospital in the recent period have been reported in 103 patients with hepatitis B cases were clinically cured, some patients from this hospital, chief physician Professor Chen Xinyue told me that they through treatment, have emerged in hepatitis B surface antigen negative, while the body also appeared protective antibodies.
The emergence of protective antibodies, means that the body of the hepatitis B virus have immunity. In the past six years, at hospital 23 cases of chronic hepatitis B patients observed that this antibody.
Related reports
Hepatitis B has been misunderstood, "can cure"
Cure for hepatitis B is reported about the statement
subsidiary Beijing Capital Medical University hospital, director of special needs crescent Chen: We have acute hepatitis B, adult won after more than 90 percent said that can be cured, are in fact clinically cured, then such an acute hepatitis B are consider clinical governance more, so we made the same chronic hepatitis B on these results, in my opinion can be considered to be clinically cured.
However, Dr. Chen Xinyue also acknowledged that clinical cure does not mean completely cured, it is completely cured because it means that a virus in liver tissue did not, and hospital did not make this check. In addition they are used nucleoside (acid) analogues and interferon combination treatment approach, these two drugs is also commonly used antiviral drugs, is not what the "new therapy." As the cure rate, because this period did not make the base for the treatment of statistics, so out of the question. Overall, the proportion of clinical cure are very low.
As for the part of patients with chronic hepatitis B can be clinically cured, experts have said this in the medical profession is not nothing new.
Chinese Medical Association chairman liver credits Ji-Dong Jia: After effective treatment, there is approximately 3% -5% of the (chronic HBV) surface antigen person can happen to overcast, and some can even appear surface antibodies, which are in the industry is not news, it is our professional knowledge workers.
Chinese Academy of Engineering, experts said, even had a protective antibody, also known as clinical cure, patients should insist on regular inspections.
ZHUANG Hui Chinese Academy of Engineering: This course, some patients are more ideal, but it can not be completely cured Say yes must, because these patients would have a part of the body of patients of hepatitis B virus may also be hidden, when the body to resist him decline, he may relapse.
Well, the treatment of chronic hepatitis B in the end it has no medicine? ZHUANG Hui give a negative answer.
ZHUANG Hui Chinese Academy of Engineering: now there is not a very good, special effects, fully able to heal (chronic) hepatitis B in such a therapy, is currently approved by the state five antiviral drugs, interferon ordinary, long-acting interferon, lamivudine, adefovir, entecavir, then this five kinds of medicine, now is not very satisfactory effect.
ZHUANG Hui said that currently the treatment of chronic hepatitis B is mainly the use of nucleoside (acid) analogues and interferon for antiviral therapy. Domestic and foreign studies have proved that if the use of these two drugs together, and should not improve efficacy, but also expensive because of the price will increase the economic burden of patients.
In October last year, the State Ministry of Science and Technology has informed the Chinese treatment of hepatitis B vaccine made significant progress. After we know that this vaccine has just concluded a clinical trial, but also the need for Phase II and III clinical trials can prove whether it is effective, the most optimistic estimate is also required for more than 5 years time. Experts remind that the vast numbers of patients with liver disease, not to put their hopes of cure for hepatitis B at a certain drug on, but I would like to doctor, patient recuperate.
Zhou Yu-lin: Here are subsidiary Beijing Capital Medical University hospital in the recent period have been reported in 103 patients with hepatitis B cases were clinically cured, some patients from this hospital, chief physician Professor Chen Xinyue told me that they through treatment, have emerged in hepatitis B surface antigen negative, while the body also appeared protective antibodies.
The emergence of protective antibodies, means that the body of the hepatitis B virus have immunity. In the past six years, at hospital 23 cases of chronic hepatitis B patients observed that this antibody.
Related reports
Hepatitis B has been misunderstood, "can cure"
Cure for hepatitis B is reported about the statement
subsidiary Beijing Capital Medical University hospital, director of special needs crescent Chen: We have acute hepatitis B, adult won after more than 90 percent said that can be cured, are in fact clinically cured, then such an acute hepatitis B are consider clinical governance more, so we made the same chronic hepatitis B on these results, in my opinion can be considered to be clinically cured.
However, Dr. Chen Xinyue also acknowledged that clinical cure does not mean completely cured, it is completely cured because it means that a virus in liver tissue did not, and hospital did not make this check. In addition they are used nucleoside (acid) analogues and interferon combination treatment approach, these two drugs is also commonly used antiviral drugs, is not what the "new therapy." As the cure rate, because this period did not make the base for the treatment of statistics, so out of the question. Overall, the proportion of clinical cure are very low.
As for the part of patients with chronic hepatitis B can be clinically cured, experts have said this in the medical profession is not nothing new.
Chinese Medical Association chairman liver credits Ji-Dong Jia: After effective treatment, there is approximately 3% -5% of the (chronic HBV) surface antigen person can happen to overcast, and some can even appear surface antibodies, which are in the industry is not news, it is our professional knowledge workers.
Chinese Academy of Engineering, experts said, even had a protective antibody, also known as clinical cure, patients should insist on regular inspections.
ZHUANG Hui Chinese Academy of Engineering: This course, some patients are more ideal, but it can not be completely cured Say yes must, because these patients would have a part of the body of patients of hepatitis B virus may also be hidden, when the body to resist him decline, he may relapse.
Well, the treatment of chronic hepatitis B in the end it has no medicine? ZHUANG Hui give a negative answer.
ZHUANG Hui Chinese Academy of Engineering: now there is not a very good, special effects, fully able to heal (chronic) hepatitis B in such a therapy, is currently approved by the state five antiviral drugs, interferon ordinary, long-acting interferon, lamivudine, adefovir, entecavir, then this five kinds of medicine, now is not very satisfactory effect.
ZHUANG Hui said that currently the treatment of chronic hepatitis B is mainly the use of nucleoside (acid) analogues and interferon for antiviral therapy. Domestic and foreign studies have proved that if the use of these two drugs together, and should not improve efficacy, but also expensive because of the price will increase the economic burden of patients.
In October last year, the State Ministry of Science and Technology has informed the Chinese treatment of hepatitis B vaccine made significant progress. After we know that this vaccine has just concluded a clinical trial, but also the need for Phase II and III clinical trials can prove whether it is effective, the most optimistic estimate is also required for more than 5 years time. Experts remind that the vast numbers of patients with liver disease, not to put their hopes of cure for hepatitis B at a certain drug on, but I would like to doctor, patient recuperate.
Mar
14
Against hepatitis B antiviral new therapies emerge in the past few years have proven the improvement in HIV suppression and liver damage of chronic hepatitis B have a very good therapeutic effect. At present, the United States FDA approved antiviral therapy for adult hepatitis B has six kinds of drugs: interferon α-2b, peginterferon α-2a and lamivudine, adefovir, entecavir, oral anti-viral agents for more than stavudine.
Not long ago, the United States at Boston, Massachusetts, held in the United States Association for the Study of Liver Diseases 57th Annual Meeting, communicate the clinical progress of hepatitis B treatment. Scholars through clinical research on several commonly used anti-viral treatment of hepatitis B were evaluated.
■ adefovir and lamivudine combined with more effective
Lamivudine is an effective nucleoside analogues, is the first approved for the treatment of hepatitis B of oral nucleoside drugs. However, as the emergence of YMDD mutations, even in the short-term lamivudine therapy can occur after the high rate of HIV drug resistance (1 year the proportion of emerging drug-resistant up to 24%, 4 years is as high as 70%), it unsatisfactory clinical results. Even though such a high rate of HIV drug resistance, but because of its relatively low cost of treatment, and easy to get, lamivudine is still widely used around the world.
Adefovir is also a nucleoside analogue, has anti-YMDD lamivudine-resistant strain of the virus an effective anti-viral activity. On previous clinical if found in patients with resistance to lamivudine, and started treatment with adefovir, lamivudine and adefovir often overlap at some time after application to stop using. However, recent research data shows that adding adefovir to lamivudine program, in lieu of conversion from lamivudine to adefovir single treatment, to prevent the incidence of adefovir resistance may be more effective. The researchers studied a group of 52 cases of clinical or genotypic lamivudine-resistant patients, adding adefovir treatment and conversion of the role of inhibition of HBV. Patients were randomized to receive a single treatment of adefovir dipivoxil or lamivudine (ie, adefovir and lamivudine is the treatment of United) treatment. The researchers report that a single treatment with adefovir lamivudine combination therapy Veiga total HIV virus at a relatively low level of response in patients with similar, but with a high viral load (HBVDNA> 5 times of the number of copies / ml) of patients using a single conversion of adefovir treatment to achieve viral suppression less, has happened a higher risk of adefovir resistance. The researchers believe that adefovir and lamivudine combination therapy, either as happened after the remedial strategy for resistance or as initial treatment of patients with, for the prevention of drug resistance may be beneficial.
Hepatitis B virus e antigen (HBeAg)-negative patients with chronic hepatitis B treatment is currently aimed at an indefinite continuation of virus inhibition, once the cessation of antiviral therapy, the relapse rate will be high. The researchers evaluated the long-term adefovir therapy in patients with HBeAg-negative hepatitis B recurrence. The study involved the treatment of adefovir 4 ~ 5 years to reach and maintain biochemical remission (ATL normal), virus inhibition (HBVDNA less than 1000 copies / ml) and did not find mutations in patients with adefovir resistance. The results show that, although all patients have some evidence of virus rebound (HBVDNA ≤ 50000 copies / ml), but 67% of patients able to maintain normal serum ALT. Biochemical recurrence in patients with the use of re-treatment can successfully re-treatment. Therefore, the basis of these findings, it is difficult to deal with the HBeAg-negative chronic hepatitis B patients with antiviral therapy may be suspended are viable, although all patients will have recurrence of virus recurrence and the possibility of chemical and biological.
■ Baraclude resistance occurred in a lower risk of
Baraclude was approved in 2005 for hepatitis B treatment, the prognosis of patients with long-term data have been reported. A comparative entecavir with lamivudine in the treatment of HBeAg-positive patients with newly diagnosed stage Ⅲ randomized study lasted a total of 96 weeks. Since then, permit to achieve virologic suppression (HBVDNA <0.7Meq / ml), but HBeAg seroconversion in patients that have not yet entered a rolling research, continue to be monitored. A total of 122 patients were included in this follow-up study, study endpoints, including serum HBeAg negative, normal serum ALT, viral suppression HBVDNA <300 copies / ml. Rolling because of study design, these patients than in the initial study to give a higher dose of entecavir (1 mg and 0.5 mg). The results show that the 144 weeks, continue to receive entecavir-treated patients were 90% complete viral suppression, 80% ALT normal, while 33% HBeAg negative; 16% of patients with negative serum in the treatment of the third year (did not report the cumulative serum negative rate). The safety area with the original research report is similar to Baraclude no significant changes in the safety area. Therefore, nucleoside analogues at the beginning of the governance of HBeAg-positive patients continued entecavir treatment to 3 years seem to have a higher rate of viral suppression and serum ALT normal rate, and improve opportunities for HBeAg negative serum.
The use of any anti-virus will have a long-term treatment of HIV drug resistance mutations, failure and histological and biochemical rebound concern. As mentioned above, with the YMDD mutation, has confirmed that 4 years of lamivudine-resistant up to 70%; now report on the treatment of adefovir resistant to 5-year 29%. Researchers who have reported the use of entecavir resistance in the treatment of 3-year data. At Baraclude treatment for all could be detected HBVDNA (> 300 copies / ml) of the patients and viral rebound occurred in> 1 times the logarithm of the patients, both for the entecavir resistance genotype mutation analysis. Researchers report that nucleoside analogues in previously untreated patients, 3 years each of entecavir resistance is less than 1%. Accumulated in the entecavir treatment 1,2,3 years, pre-treatment baseline in patients with lamivudine-resistant genotype Baraclude mutation rate of 6%, 14% and 29%. Therefore, entecavir in nucleoside analogues in previously untreated patients with an excellent 3-year drug-resistant characteristics, treatment-resistant annual rate of <1%. And lamivudine-resistant patients had Baraclude resistance occurred in the higher risks.
■ telbivudine superior to lamivudine clinical results
Telbivudine are FDA recently approved for chronic HBV infection in patients with therapeutic drugs, which can inhibit the HBV polymerase nucleoside analogues. During the meeting, researchers introduce a telbivudine compared with lamivudine therapy for chronic hepatitis B in stage Ⅲ trial (GLOBE) two-year results. 1367 cases of patients randomly assigned to receive telbivudine 600 mg oral, once daily or lamivudine 100 mg once daily treatment, according to the custom of the inclusion criteria (ALT greater than normal upper limit of 1.3 ~ 10-fold; HBVDNA than 6 times on a few copies / ml; decompensated liver disease) treated patients. The results showed that at 104 weeks in the treatment, HBeAg-negative patients with chronic hepatitis B at HBVDNA inhibition, the efficacy of telbivudine superior to lamivudine (HBVDNA should not be detected were 82% and 57%); in HBeAg-positive queue, that should not inhibit at HBVDNA measured levels and normal serum ALT, the telbivudine more effective than lamivudine; 104 weeks, the telbivudine group of patients with serum negative rate of 30 percent, and Latin America fixed group 25%; to accept two types of drug treatment of patients, HBeAg-negative telbivudine group the incidence of resistance to 8.1%, HBeAg-positive group was 21%. Are interesting study found that at 24 weeks to achieve rapid virus suppression in patients with telbivudine resistance is relatively low, HBeAg-negative cohort was 2%, HBeAg-positive cohort was 4%.
Studies have shown that telbivudine treatment at the end of the majority of clinical efficacy is superior to lamivudine. Because of drug resistance caused by virological breakthrough in telbivudine patients treated with lamivudine in the statistical data is lower than in patients treated with 24 weeks in accordance with the early viral response may be in a way the possibility of drug resistance prediction . In addition, telbivudine at 24 weeks and 52 weeks of virus suppression is superior to adefovir, although the serum HBeAg negative and ALT normal rate there was no significant difference.
■ peginterferon should not be used in conjunction with its drug
Peginterferon for treatment of chronic hepatitis B, but because of the costs and side effects related problem, there is no oral antiviral drugs are widely used. However, for some patients, limited course of treatment and not have to worry about drug-resistant virus continues to make interferon therapy as a viable treatment option.
Researchers have reported an HBeAg-negative chronic hepatitis B patients with large-scale tests, they had the use of peginterferon with (or with) United and lamivudine with lamivudine alone a total of 48 weeks treatment. Previously reported the initial 48 weeks treatment showed that peginterferon plus lamivudine combined with peginterferon alone, compared with no additional effect. Evaluation of the current study peginterferon with (or not) treated with lamivudine response duration of up to two years after treatment. They found that peginterferon at a single treatment group, 24 months after treatment, 28% of patients HBVDNA be able to maintain the level of less than 10000 copies / ml, 32% of patients able to maintain normal ALT levels. Research data also confirmed that adding peginterferon and lamivudine should not provide any sustained virologic or biochemical response effect.
HBeAg-negative patients with chronic hepatitis B on behalf of more difficult to treat because it is after treatment have a high relapse rate. The use of interferon therapy one year Immunoregulation at 28% of patients have a positive effect, even after treatment at 24 months.
Not long ago, the United States at Boston, Massachusetts, held in the United States Association for the Study of Liver Diseases 57th Annual Meeting, communicate the clinical progress of hepatitis B treatment. Scholars through clinical research on several commonly used anti-viral treatment of hepatitis B were evaluated.
■ adefovir and lamivudine combined with more effective
Lamivudine is an effective nucleoside analogues, is the first approved for the treatment of hepatitis B of oral nucleoside drugs. However, as the emergence of YMDD mutations, even in the short-term lamivudine therapy can occur after the high rate of HIV drug resistance (1 year the proportion of emerging drug-resistant up to 24%, 4 years is as high as 70%), it unsatisfactory clinical results. Even though such a high rate of HIV drug resistance, but because of its relatively low cost of treatment, and easy to get, lamivudine is still widely used around the world.
Adefovir is also a nucleoside analogue, has anti-YMDD lamivudine-resistant strain of the virus an effective anti-viral activity. On previous clinical if found in patients with resistance to lamivudine, and started treatment with adefovir, lamivudine and adefovir often overlap at some time after application to stop using. However, recent research data shows that adding adefovir to lamivudine program, in lieu of conversion from lamivudine to adefovir single treatment, to prevent the incidence of adefovir resistance may be more effective. The researchers studied a group of 52 cases of clinical or genotypic lamivudine-resistant patients, adding adefovir treatment and conversion of the role of inhibition of HBV. Patients were randomized to receive a single treatment of adefovir dipivoxil or lamivudine (ie, adefovir and lamivudine is the treatment of United) treatment. The researchers report that a single treatment with adefovir lamivudine combination therapy Veiga total HIV virus at a relatively low level of response in patients with similar, but with a high viral load (HBVDNA> 5 times of the number of copies / ml) of patients using a single conversion of adefovir treatment to achieve viral suppression less, has happened a higher risk of adefovir resistance. The researchers believe that adefovir and lamivudine combination therapy, either as happened after the remedial strategy for resistance or as initial treatment of patients with, for the prevention of drug resistance may be beneficial.
Hepatitis B virus e antigen (HBeAg)-negative patients with chronic hepatitis B treatment is currently aimed at an indefinite continuation of virus inhibition, once the cessation of antiviral therapy, the relapse rate will be high. The researchers evaluated the long-term adefovir therapy in patients with HBeAg-negative hepatitis B recurrence. The study involved the treatment of adefovir 4 ~ 5 years to reach and maintain biochemical remission (ATL normal), virus inhibition (HBVDNA less than 1000 copies / ml) and did not find mutations in patients with adefovir resistance. The results show that, although all patients have some evidence of virus rebound (HBVDNA ≤ 50000 copies / ml), but 67% of patients able to maintain normal serum ALT. Biochemical recurrence in patients with the use of re-treatment can successfully re-treatment. Therefore, the basis of these findings, it is difficult to deal with the HBeAg-negative chronic hepatitis B patients with antiviral therapy may be suspended are viable, although all patients will have recurrence of virus recurrence and the possibility of chemical and biological.
■ Baraclude resistance occurred in a lower risk of
Baraclude was approved in 2005 for hepatitis B treatment, the prognosis of patients with long-term data have been reported. A comparative entecavir with lamivudine in the treatment of HBeAg-positive patients with newly diagnosed stage Ⅲ randomized study lasted a total of 96 weeks. Since then, permit to achieve virologic suppression (HBVDNA <0.7Meq / ml), but HBeAg seroconversion in patients that have not yet entered a rolling research, continue to be monitored. A total of 122 patients were included in this follow-up study, study endpoints, including serum HBeAg negative, normal serum ALT, viral suppression HBVDNA <300 copies / ml. Rolling because of study design, these patients than in the initial study to give a higher dose of entecavir (1 mg and 0.5 mg). The results show that the 144 weeks, continue to receive entecavir-treated patients were 90% complete viral suppression, 80% ALT normal, while 33% HBeAg negative; 16% of patients with negative serum in the treatment of the third year (did not report the cumulative serum negative rate). The safety area with the original research report is similar to Baraclude no significant changes in the safety area. Therefore, nucleoside analogues at the beginning of the governance of HBeAg-positive patients continued entecavir treatment to 3 years seem to have a higher rate of viral suppression and serum ALT normal rate, and improve opportunities for HBeAg negative serum.
The use of any anti-virus will have a long-term treatment of HIV drug resistance mutations, failure and histological and biochemical rebound concern. As mentioned above, with the YMDD mutation, has confirmed that 4 years of lamivudine-resistant up to 70%; now report on the treatment of adefovir resistant to 5-year 29%. Researchers who have reported the use of entecavir resistance in the treatment of 3-year data. At Baraclude treatment for all could be detected HBVDNA (> 300 copies / ml) of the patients and viral rebound occurred in> 1 times the logarithm of the patients, both for the entecavir resistance genotype mutation analysis. Researchers report that nucleoside analogues in previously untreated patients, 3 years each of entecavir resistance is less than 1%. Accumulated in the entecavir treatment 1,2,3 years, pre-treatment baseline in patients with lamivudine-resistant genotype Baraclude mutation rate of 6%, 14% and 29%. Therefore, entecavir in nucleoside analogues in previously untreated patients with an excellent 3-year drug-resistant characteristics, treatment-resistant annual rate of <1%. And lamivudine-resistant patients had Baraclude resistance occurred in the higher risks.
■ telbivudine superior to lamivudine clinical results
Telbivudine are FDA recently approved for chronic HBV infection in patients with therapeutic drugs, which can inhibit the HBV polymerase nucleoside analogues. During the meeting, researchers introduce a telbivudine compared with lamivudine therapy for chronic hepatitis B in stage Ⅲ trial (GLOBE) two-year results. 1367 cases of patients randomly assigned to receive telbivudine 600 mg oral, once daily or lamivudine 100 mg once daily treatment, according to the custom of the inclusion criteria (ALT greater than normal upper limit of 1.3 ~ 10-fold; HBVDNA than 6 times on a few copies / ml; decompensated liver disease) treated patients. The results showed that at 104 weeks in the treatment, HBeAg-negative patients with chronic hepatitis B at HBVDNA inhibition, the efficacy of telbivudine superior to lamivudine (HBVDNA should not be detected were 82% and 57%); in HBeAg-positive queue, that should not inhibit at HBVDNA measured levels and normal serum ALT, the telbivudine more effective than lamivudine; 104 weeks, the telbivudine group of patients with serum negative rate of 30 percent, and Latin America fixed group 25%; to accept two types of drug treatment of patients, HBeAg-negative telbivudine group the incidence of resistance to 8.1%, HBeAg-positive group was 21%. Are interesting study found that at 24 weeks to achieve rapid virus suppression in patients with telbivudine resistance is relatively low, HBeAg-negative cohort was 2%, HBeAg-positive cohort was 4%.
Studies have shown that telbivudine treatment at the end of the majority of clinical efficacy is superior to lamivudine. Because of drug resistance caused by virological breakthrough in telbivudine patients treated with lamivudine in the statistical data is lower than in patients treated with 24 weeks in accordance with the early viral response may be in a way the possibility of drug resistance prediction . In addition, telbivudine at 24 weeks and 52 weeks of virus suppression is superior to adefovir, although the serum HBeAg negative and ALT normal rate there was no significant difference.
■ peginterferon should not be used in conjunction with its drug
Peginterferon for treatment of chronic hepatitis B, but because of the costs and side effects related problem, there is no oral antiviral drugs are widely used. However, for some patients, limited course of treatment and not have to worry about drug-resistant virus continues to make interferon therapy as a viable treatment option.
Researchers have reported an HBeAg-negative chronic hepatitis B patients with large-scale tests, they had the use of peginterferon with (or with) United and lamivudine with lamivudine alone a total of 48 weeks treatment. Previously reported the initial 48 weeks treatment showed that peginterferon plus lamivudine combined with peginterferon alone, compared with no additional effect. Evaluation of the current study peginterferon with (or not) treated with lamivudine response duration of up to two years after treatment. They found that peginterferon at a single treatment group, 24 months after treatment, 28% of patients HBVDNA be able to maintain the level of less than 10000 copies / ml, 32% of patients able to maintain normal ALT levels. Research data also confirmed that adding peginterferon and lamivudine should not provide any sustained virologic or biochemical response effect.
HBeAg-negative patients with chronic hepatitis B on behalf of more difficult to treat because it is after treatment have a high relapse rate. The use of interferon therapy one year Immunoregulation at 28% of patients have a positive effect, even after treatment at 24 months.
Mar
14
Active specific immunotherapy is the best treatment for hepatitis B
Treatment of hepatitis B method a lot of a few, why the unique "Active specific immunotherapy" in 2004 as the latest treatment for hepatitis B? General evaluation of all aspects, mainly has the following points:
1, specific active immunotherapy is based on "clear the hepatitis B virus Doctrine" developed hepatitis B therapy.
Early in 1975, the world famous experts and professors of liver disease on a well-known "theory of liver virus removal." The doctrine, the key to the treatment of hepatitis B are clearance of hepatitis B virus, hepatitis B virus has not been completely cleared, it can not be said of hepatitis B has been cured. Therefore, the treatment of hepatitis B, the most critical thing is to be able to clear the selection of hepatitis B virus drugs. "Active specific immunotherapy of hepatitis B" is on the basis of "hepatitis B virus clearance Doctrine," after 10 years of comparative experiment and developed to effectively clear the hepatitis B virus Liver therapy.
2, hepatitis B specific active immunotherapy can effectively clear the hepatitis B virus
More than one year in patients with chronic hepatitis B liver cells by hepatitis B virus has been the depth of erosion, and are constantly copying and reproduction, which give the treatment a great trouble. On the one hand, because of their own to protect the liver, liver cells to hepatitis B virus does not produce the immune response, which is in a period of hepatitis B virus immune tolerance, which is difficult to heal the past, hepatitis B fundamental questions. Conventional drugs should not identify liver cells of hepatitis B virus, it can not be removed; the other hand, if the direct killing of hepatitis B virus, it will simultaneously damage and even kill their combined liver cells, causing liver damage.
Active specific immunotherapy to overcome the drawbacks of the traditional treatment, targeted to break immune tolerance to hepatitis B virus to stimulate immune response, so that the body produce its own high concentration of endogenous interferon, without harm to its own premise, the elimination of hepatitis B virus. Therefore, in solving this "dilemma" when the problem shows the incomparable superiority. Active specific immunotherapy to make the body produce high concentrations of endogenous interferon on the hepatitis B virus has a strong ability to identify clearly and fully activate the body's T lymphocytes, activate the liver's own immune system, so that the " drug force with immunity, immunity to promote pharmacological "effect. Both inside and outside the two-way with complete clearance of hepatitis B virus, to repair damaged liver cells and promote new cell growth.
3, clinical cure high, more convincing
Specific active immunotherapy, in the international workshop on viral hepatitis has been liver disease from various countries all over the world recognized the authority of experts and applications. This therapy in clinical trials designated base hospital to do the 3-year clinical trials. The results showed that: take the initiative-specific active immunization therapy of chronic liver disease the total effective rate was 98.8%, the cure rate was 70.3%. From 2001 to 2003, only a year's time, the treatment of hepatitis B in China Research Committee under the jurisdiction of the various clinical governance collaborative base then tens of thousands of hepatitis B patients. Including cirrhosis, liver ascites, alcoholic liver, fatty liver patients, the experts on the efficacy of various patients to track the entire process. After more than a year of treatment, the fundamental have been very good results, one more than half of patients with healed.
The treatment of chronic hepatitis B are the ultimate goal:
First, clear the virus;
Two, to prevent or delay the occurrence of liver fibrosis and prevent further deterioration of liver cirrhosis and hepatocellular carcinoma.
A, in particular the emphasis is: a lot of people think that the fundamental purpose of the treatment of hepatitis B are "negative", in fact this view is not correct, are the process of changing, this is not the purpose. Antiviral therapy is the main purpose: Inhibition of hepatitis B virus DNA replication and prevent the progress of hepatitis B virus to prevent hepatitis B to develop into liver cirrhosis or cancer.
B, the market on a wide variety of drug treatment of hepatitis B, some patients with small cheap greedy, I believe that false advertisement, resulting in blind patients with medication, not only failed to achieve the therapeutic effects wronged squandering money, or even heavier burden on the liver, and further lead to liver lesions, delaying treatment opportunities, too late often!
C, from the anti-virus treatment in terms of the overall therapy, at present the most scientific treatment is from the United States, Japan, Britain, China and other liver-disciplinary experts to study the "breaking the hepatitis B virus immune tolerance therapy" (ie, specific initiatives immunotherapy). To this end, the Chinese hepatitis B treatment research committee set up throughout the country hundreds of Al-liver disease clinical collaboration, and comprehensive application of the latest therapy - hepatitis B specific active immunotherapy, it can break immune tolerance, thereby enabling the body to B exert specific immune function, to achieve the purpose of a thorough treatment of HBV.
D, the use of Chinese and Western medicine combined with symptomatic treatment (anti-liver fibrosis treatment), timely body symptoms improve, repair, liver function, and promote health as well as liver cells, a timely and effective manner to prevent the emergence of liver cirrhosis or cancer.
Liver disease treatment must go to hospital to receive formal treatment of the informal, or vulnerable to relapse and are not easy to cure.
Treatment of hepatitis B method a lot of a few, why the unique "Active specific immunotherapy" in 2004 as the latest treatment for hepatitis B? General evaluation of all aspects, mainly has the following points:
1, specific active immunotherapy is based on "clear the hepatitis B virus Doctrine" developed hepatitis B therapy.
Early in 1975, the world famous experts and professors of liver disease on a well-known "theory of liver virus removal." The doctrine, the key to the treatment of hepatitis B are clearance of hepatitis B virus, hepatitis B virus has not been completely cleared, it can not be said of hepatitis B has been cured. Therefore, the treatment of hepatitis B, the most critical thing is to be able to clear the selection of hepatitis B virus drugs. "Active specific immunotherapy of hepatitis B" is on the basis of "hepatitis B virus clearance Doctrine," after 10 years of comparative experiment and developed to effectively clear the hepatitis B virus Liver therapy.
2, hepatitis B specific active immunotherapy can effectively clear the hepatitis B virus
More than one year in patients with chronic hepatitis B liver cells by hepatitis B virus has been the depth of erosion, and are constantly copying and reproduction, which give the treatment a great trouble. On the one hand, because of their own to protect the liver, liver cells to hepatitis B virus does not produce the immune response, which is in a period of hepatitis B virus immune tolerance, which is difficult to heal the past, hepatitis B fundamental questions. Conventional drugs should not identify liver cells of hepatitis B virus, it can not be removed; the other hand, if the direct killing of hepatitis B virus, it will simultaneously damage and even kill their combined liver cells, causing liver damage.
Active specific immunotherapy to overcome the drawbacks of the traditional treatment, targeted to break immune tolerance to hepatitis B virus to stimulate immune response, so that the body produce its own high concentration of endogenous interferon, without harm to its own premise, the elimination of hepatitis B virus. Therefore, in solving this "dilemma" when the problem shows the incomparable superiority. Active specific immunotherapy to make the body produce high concentrations of endogenous interferon on the hepatitis B virus has a strong ability to identify clearly and fully activate the body's T lymphocytes, activate the liver's own immune system, so that the " drug force with immunity, immunity to promote pharmacological "effect. Both inside and outside the two-way with complete clearance of hepatitis B virus, to repair damaged liver cells and promote new cell growth.
3, clinical cure high, more convincing
Specific active immunotherapy, in the international workshop on viral hepatitis has been liver disease from various countries all over the world recognized the authority of experts and applications. This therapy in clinical trials designated base hospital to do the 3-year clinical trials. The results showed that: take the initiative-specific active immunization therapy of chronic liver disease the total effective rate was 98.8%, the cure rate was 70.3%. From 2001 to 2003, only a year's time, the treatment of hepatitis B in China Research Committee under the jurisdiction of the various clinical governance collaborative base then tens of thousands of hepatitis B patients. Including cirrhosis, liver ascites, alcoholic liver, fatty liver patients, the experts on the efficacy of various patients to track the entire process. After more than a year of treatment, the fundamental have been very good results, one more than half of patients with healed.
The treatment of chronic hepatitis B are the ultimate goal:
First, clear the virus;
Two, to prevent or delay the occurrence of liver fibrosis and prevent further deterioration of liver cirrhosis and hepatocellular carcinoma.
A, in particular the emphasis is: a lot of people think that the fundamental purpose of the treatment of hepatitis B are "negative", in fact this view is not correct, are the process of changing, this is not the purpose. Antiviral therapy is the main purpose: Inhibition of hepatitis B virus DNA replication and prevent the progress of hepatitis B virus to prevent hepatitis B to develop into liver cirrhosis or cancer.
B, the market on a wide variety of drug treatment of hepatitis B, some patients with small cheap greedy, I believe that false advertisement, resulting in blind patients with medication, not only failed to achieve the therapeutic effects wronged squandering money, or even heavier burden on the liver, and further lead to liver lesions, delaying treatment opportunities, too late often!
C, from the anti-virus treatment in terms of the overall therapy, at present the most scientific treatment is from the United States, Japan, Britain, China and other liver-disciplinary experts to study the "breaking the hepatitis B virus immune tolerance therapy" (ie, specific initiatives immunotherapy). To this end, the Chinese hepatitis B treatment research committee set up throughout the country hundreds of Al-liver disease clinical collaboration, and comprehensive application of the latest therapy - hepatitis B specific active immunotherapy, it can break immune tolerance, thereby enabling the body to B exert specific immune function, to achieve the purpose of a thorough treatment of HBV.
D, the use of Chinese and Western medicine combined with symptomatic treatment (anti-liver fibrosis treatment), timely body symptoms improve, repair, liver function, and promote health as well as liver cells, a timely and effective manner to prevent the emergence of liver cirrhosis or cancer.
Liver disease treatment must go to hospital to receive formal treatment of the informal, or vulnerable to relapse and are not easy to cure.
Mar
14
A new biology of hepatitis B treatment therapy - anti-HBV (hepatitis B virus) specific active immunotherapy, after 8 years at nearly 100 clinical hospital efficiency has more than 50%, one of more than 8500 cases of clinical observation of patients, no serious adverse reaction. However, the therapy has suffered because the market medication Drug Department "combination packaging" the provisions of the policy bottlenecks, not to promote the listing.
A few days ago, the medical department of Peking University, Professor Tian Shan, Chinese Academy of Medical Sciences researcher Zhu equal 11 the authority of medical experts, calls for the authorities to re-examine and amend the relevant provisions, at the same time, it is recommended that the country has potential for therapy as to support research projects.
A lot of people are aware, mother to child transmission of hepatitis B are the most important route of transmission of one. However, yesterday reporter from the City Hospital for Infectious Diseases, Center Three hospital was informed that the current clinical practice has 3 / 4 of the hepatitis B infection in pregnant women has never been any pre-treatment, rather than ignore the pre-blocking treatment ... ... [how to block mother to child transmission of hepatitis B]
Ministry of Health found safe and effective new biological therapies
Anti-HBV specific active immunotherapy, meaning that by breaking the chronic hepatitis B virus carriers and patients with immune tolerance, activation, restoration of the human body to hepatitis B virus-specific immune function, combined with antiviral drugs to suppress and eliminate B The purpose of the treatment of liver virus.
"It's a modern immunological theory, is a promising treatment for hepatitis B." Chinese Center for Disease Control and Prevention, Professor virus said Hepatitis B virus carriers in our country about 120 million chronic hepatitis B patients 3900 million. Existing antiviral drugs for chronic hepatitis B virus carriers without a satisfactory effect on patients with chronic hepatitis B despite a certain role in inhibiting HBV replication, but there is a high rate of drug relapse and long-term drug use and other issues lead to drug resistance .
The inventor of the therapy was Professor Su Sheng Beijing Ditan hospital chief physician, has long been engaged in research and clinical viral hepatitis, founded in Zhongguancun, Beijing hippo medical technology development company, specializing in treatment of hepatitis B immunization . Since 1998, at the Ministry of Health and Chinese Medicine Association, the organization of biotechnology under the guidance of our country self-selection of B-listed five kinds of preventive vaccines and many cell factor (adjuvant) as a clinical treatment combination medication, was liver scholars known as the "anti-HBV specific active immunotherapy."
Biotechnology Association of Chinese Medicine in 2003 and in 2006 the organization of two clinical appraisal, Tian Shan composed of the Expert Group confirmed the therapy. December 2003, the Ministry of Health Science and Education Division sent a letter to confirm: Beijing hippo Medical Technology Development Co., Ltd. developed "anti-HBV specific active immunotherapy" treatment of chronic HBV infection are safe and effective new biological therapies, agreed with China Association of Pharmaceutical Biotechnology the formation of "anti-HBV specific active immunotherapy" Net collaboration to expand the clinical application of verification.
Compared with existing anti-viral drugs have obvious advantages
Professor Liu Chongbo take part in two of the therapy clinical verification will. He said that after 8 years of clinical validation, the existing anti-viral therapy compared with the current has the following advantages:
First, efficacy and stability. Infectious diseases hospital in Changsha, Hunan, 97 hospital, such as the National 8-year case collection of statistics show that of existing antiviral drugs ineffective treatment of chronic hepatitis B virus carriers have significant effect, 60% of patients may be to break the immune tolerance; long-term efficacy well, after stopping 3-5 year follow-up, an annual decline in viral load, hepatitis B virus surface antigen, core antigen-negative rate has been increasing trend.
Second, security is good, no serious adverse reactions.
Three, the treatment of low-cost, about 5,000 yuan per person per year, the majority of patients easily accepted; with antiviral therapy can significantly shorten the course of treatment, cost-saving. Of countries, has obvious significance of health economics.
Four, the selected combination of drugs are approved by National Drug Department listed drugs, made full use of existing resources.
V. Treatment of a wide range, covering all patients with chronic hepatitis B and hepatitis B virus carriers. A long time, the medical profession will be excluded from the Hepatitis B virus carriers in clinical treatment, the treatment can not think, in fact 40% of carriers such as non-effective treatment will develop into cirrhosis and liver cancer.
Ping Zhu Chinese Academy of Medical Sciences researcher believes that the emergence of this therapy not only in the chronic treatment of chronic hepatitis B carriers, as well as the area adds a new means, and through the joint application with the existing anti-viral, can significantly improve long-term efficacy and therapeutic effect and reduce medical costs.
Urgent need to promote and follow-up study of state support
This was a unique combination of drug use in August this year formally approved by the national patent. For the protection of patents and ease of use, combined package medication to be a unified portfolio. However, this package form (package) in the country are difficult to obtain the approval of Drug Department. State Food and Drug Administration in March 2004 introduced the "on the strengthening of pharmaceutical packaging portfolio management notice" requirements, "the combination of packaging should be the agents of production enterprises." This is the invention of the hippo therapy company in Beijing, including a preventive hepatitis B vaccine and the five kinds of combination cytokine adjuvant drugs, it simply can not meet the above conditions.
Effective prevention and control methods: the current national need to replant 60% children with hepatitis B vaccine, four hepatitis B virus into adults without the antibodies the status quo, the Chinese Ministry of Health immunization program expert Advisory Committee Diao even a professor at East Canton appeal should be universal for adults hepatitis B vaccination ... ... [more control methods]
Informed sources told a reporter, a few years ago that many domestic pharmaceutical companies through "drug combinations packaging" in disguise "to raise prices," was once chaos. In this regard, Drug Department issued the above requirements, the chaotic situation, although rapidly contained, but valuable and necessary to do a combination of medication packaging formed insurmountable "threshold." Practice medicine because of the decentralized development and production of, in essence, basic to sever the "combination packaging" of this form of medication at the possibility of declaration of our country.
Package unable to obtain legitimacy, leading to the combination of drugs can only be limited to collaboration within the hospital network and impede the "therapy" to promote the use and combination of drug use exist at any time may be banned. Biotechnology Association of Chinese Medicine, vice chairman and secretary general of Hai-Lin Liu said that China is a big country B, the vast majority of hepatitis B patients in immune tolerance phase, a variety of therapeutic effects of antiviral drugs are not too satisfactory. This therapy on the treatment of hepatitis B in China is of great significance, the proposed Drug Administration Department to re-examine the "drug package" requirement.
At the same time, experts believe that there is hope that this therapy as an "extremely valuable" in the treatment of hepatitis B vaccine. SU Sheng said that the next Task Force plans to set up a unique and precise clinical testing, clinical evaluation index system, the existing portfolio of clinical medicine in order to best prepare a combination of the ratio of the composite effect of better biochemical agents (hepatitis B therapeutic vaccine), but only the enterprise's own forces are difficult to complete.
Liver of 11 academic experts call for the lifting of the therapy "combination packaging" and "cursed", make this therapy available to more patients. At the same time, suggest that the Government departments concerned and the prospects of this highly potential to be the subject of support, and as soon as possible to demonstrate the therapy, and further in the health care system to promote and enhance the level of China's hepatitis B treatment.
A few days ago, the medical department of Peking University, Professor Tian Shan, Chinese Academy of Medical Sciences researcher Zhu equal 11 the authority of medical experts, calls for the authorities to re-examine and amend the relevant provisions, at the same time, it is recommended that the country has potential for therapy as to support research projects.
A lot of people are aware, mother to child transmission of hepatitis B are the most important route of transmission of one. However, yesterday reporter from the City Hospital for Infectious Diseases, Center Three hospital was informed that the current clinical practice has 3 / 4 of the hepatitis B infection in pregnant women has never been any pre-treatment, rather than ignore the pre-blocking treatment ... ... [how to block mother to child transmission of hepatitis B]
Ministry of Health found safe and effective new biological therapies
Anti-HBV specific active immunotherapy, meaning that by breaking the chronic hepatitis B virus carriers and patients with immune tolerance, activation, restoration of the human body to hepatitis B virus-specific immune function, combined with antiviral drugs to suppress and eliminate B The purpose of the treatment of liver virus.
"It's a modern immunological theory, is a promising treatment for hepatitis B." Chinese Center for Disease Control and Prevention, Professor virus said Hepatitis B virus carriers in our country about 120 million chronic hepatitis B patients 3900 million. Existing antiviral drugs for chronic hepatitis B virus carriers without a satisfactory effect on patients with chronic hepatitis B despite a certain role in inhibiting HBV replication, but there is a high rate of drug relapse and long-term drug use and other issues lead to drug resistance .
The inventor of the therapy was Professor Su Sheng Beijing Ditan hospital chief physician, has long been engaged in research and clinical viral hepatitis, founded in Zhongguancun, Beijing hippo medical technology development company, specializing in treatment of hepatitis B immunization . Since 1998, at the Ministry of Health and Chinese Medicine Association, the organization of biotechnology under the guidance of our country self-selection of B-listed five kinds of preventive vaccines and many cell factor (adjuvant) as a clinical treatment combination medication, was liver scholars known as the "anti-HBV specific active immunotherapy."
Biotechnology Association of Chinese Medicine in 2003 and in 2006 the organization of two clinical appraisal, Tian Shan composed of the Expert Group confirmed the therapy. December 2003, the Ministry of Health Science and Education Division sent a letter to confirm: Beijing hippo Medical Technology Development Co., Ltd. developed "anti-HBV specific active immunotherapy" treatment of chronic HBV infection are safe and effective new biological therapies, agreed with China Association of Pharmaceutical Biotechnology the formation of "anti-HBV specific active immunotherapy" Net collaboration to expand the clinical application of verification.
Compared with existing anti-viral drugs have obvious advantages
Professor Liu Chongbo take part in two of the therapy clinical verification will. He said that after 8 years of clinical validation, the existing anti-viral therapy compared with the current has the following advantages:
First, efficacy and stability. Infectious diseases hospital in Changsha, Hunan, 97 hospital, such as the National 8-year case collection of statistics show that of existing antiviral drugs ineffective treatment of chronic hepatitis B virus carriers have significant effect, 60% of patients may be to break the immune tolerance; long-term efficacy well, after stopping 3-5 year follow-up, an annual decline in viral load, hepatitis B virus surface antigen, core antigen-negative rate has been increasing trend.
Second, security is good, no serious adverse reactions.
Three, the treatment of low-cost, about 5,000 yuan per person per year, the majority of patients easily accepted; with antiviral therapy can significantly shorten the course of treatment, cost-saving. Of countries, has obvious significance of health economics.
Four, the selected combination of drugs are approved by National Drug Department listed drugs, made full use of existing resources.
V. Treatment of a wide range, covering all patients with chronic hepatitis B and hepatitis B virus carriers. A long time, the medical profession will be excluded from the Hepatitis B virus carriers in clinical treatment, the treatment can not think, in fact 40% of carriers such as non-effective treatment will develop into cirrhosis and liver cancer.
Ping Zhu Chinese Academy of Medical Sciences researcher believes that the emergence of this therapy not only in the chronic treatment of chronic hepatitis B carriers, as well as the area adds a new means, and through the joint application with the existing anti-viral, can significantly improve long-term efficacy and therapeutic effect and reduce medical costs.
Urgent need to promote and follow-up study of state support
This was a unique combination of drug use in August this year formally approved by the national patent. For the protection of patents and ease of use, combined package medication to be a unified portfolio. However, this package form (package) in the country are difficult to obtain the approval of Drug Department. State Food and Drug Administration in March 2004 introduced the "on the strengthening of pharmaceutical packaging portfolio management notice" requirements, "the combination of packaging should be the agents of production enterprises." This is the invention of the hippo therapy company in Beijing, including a preventive hepatitis B vaccine and the five kinds of combination cytokine adjuvant drugs, it simply can not meet the above conditions.
Effective prevention and control methods: the current national need to replant 60% children with hepatitis B vaccine, four hepatitis B virus into adults without the antibodies the status quo, the Chinese Ministry of Health immunization program expert Advisory Committee Diao even a professor at East Canton appeal should be universal for adults hepatitis B vaccination ... ... [more control methods]
Informed sources told a reporter, a few years ago that many domestic pharmaceutical companies through "drug combinations packaging" in disguise "to raise prices," was once chaos. In this regard, Drug Department issued the above requirements, the chaotic situation, although rapidly contained, but valuable and necessary to do a combination of medication packaging formed insurmountable "threshold." Practice medicine because of the decentralized development and production of, in essence, basic to sever the "combination packaging" of this form of medication at the possibility of declaration of our country.
Package unable to obtain legitimacy, leading to the combination of drugs can only be limited to collaboration within the hospital network and impede the "therapy" to promote the use and combination of drug use exist at any time may be banned. Biotechnology Association of Chinese Medicine, vice chairman and secretary general of Hai-Lin Liu said that China is a big country B, the vast majority of hepatitis B patients in immune tolerance phase, a variety of therapeutic effects of antiviral drugs are not too satisfactory. This therapy on the treatment of hepatitis B in China is of great significance, the proposed Drug Administration Department to re-examine the "drug package" requirement.
At the same time, experts believe that there is hope that this therapy as an "extremely valuable" in the treatment of hepatitis B vaccine. SU Sheng said that the next Task Force plans to set up a unique and precise clinical testing, clinical evaluation index system, the existing portfolio of clinical medicine in order to best prepare a combination of the ratio of the composite effect of better biochemical agents (hepatitis B therapeutic vaccine), but only the enterprise's own forces are difficult to complete.
Liver of 11 academic experts call for the lifting of the therapy "combination packaging" and "cursed", make this therapy available to more patients. At the same time, suggest that the Government departments concerned and the prospects of this highly potential to be the subject of support, and as soon as possible to demonstrate the therapy, and further in the health care system to promote and enhance the level of China's hepatitis B treatment.
