Aa
HepB Forum : Unofficial Research Thread (URT) Tx info
I am reposting articles / summaries on the treatment management of chronic HepB. "cajim" located these articles which are quite informative. I thought about putting them on a seaprate Health Page but didn't think it was appropriate since we didn't write them.
Let's make this a sort of "Unofficial Research Thread" or "URT" for this type of information. Let's keep this URT free of comments. For comments, start a new thread indicating that it's in reference to URT.
We'll see how it goes.
Let's make this a sort of "Unofficial Research Thread" or "URT" for this type of information. Let's keep this URT free of comments. For comments, start a new thread indicating that it's in reference to URT.
We'll see how it goes.
Notes on "Symptomatology and health attitudes of chronic hepatitis B patients in the USA, " Journal of Viral Hepatitis 15 (1), 42–51, 12/11/08.
This study was conducted to understand the symptomatology, attitudes, and behaviours of chronic hepatitis B (CHB) patients in the USA. CHB patients enrolled in this study were recruited through multiple methods, including newspaper advertisements. Interviews were conducted in multiple languages, and all participants had a history of CHB infection for at least 6 months. Patients with documented human immunodeficiency virus or hepatitis C virus coinfection were excluded from data analyses, resulting in a total study population of 258 respondents who completed interviews between April and June 2004. The majority of monoinfected patients were male (57%) and non-Asian (92%, including 52% Caucasian, 32% African American and others). Length of diagnosis was 5.8 years for all participants (9.1-year Asian and 5.1-year non-Asian). Ninety-five per cent of CHB patients reported symptoms of differing severity in the 12 months prior to the survey. The most common symptoms included fatigue/loss of energy (90%) and loss of appetite (79%). Non-Asian patients described greater symptomatology, and were more likely than Asians to consider CHB an overriding concern in their daily activities. Patients were treated either currently or previously with interferon (IFN) described greater symptomatology than those treated without IFN. Survey results indicate that CHB patients may have greater symptomatology than recognized. Disease perceptions and treatment attitudes differ between Asian and non-Asian ethnic groups, with the former appearing to be more accepting and less concerned about the disease. Additional research about CHB symptomatology and health attitudes by ethnicity is needed to ensure that individuals with CHB are educated on the potential health risks and the availability of current treatment options.
This study was conducted to understand the symptomatology, attitudes, and behaviours of chronic hepatitis B (CHB) patients in the USA. CHB patients enrolled in this study were recruited through multiple methods, including newspaper advertisements. Interviews were conducted in multiple languages, and all participants had a history of CHB infection for at least 6 months. Patients with documented human immunodeficiency virus or hepatitis C virus coinfection were excluded from data analyses, resulting in a total study population of 258 respondents who completed interviews between April and June 2004. The majority of monoinfected patients were male (57%) and non-Asian (92%, including 52% Caucasian, 32% African American and others). Length of diagnosis was 5.8 years for all participants (9.1-year Asian and 5.1-year non-Asian). Ninety-five per cent of CHB patients reported symptoms of differing severity in the 12 months prior to the survey. The most common symptoms included fatigue/loss of energy (90%) and loss of appetite (79%). Non-Asian patients described greater symptomatology, and were more likely than Asians to consider CHB an overriding concern in their daily activities. Patients were treated either currently or previously with interferon (IFN) described greater symptomatology than those treated without IFN. Survey results indicate that CHB patients may have greater symptomatology than recognized. Disease perceptions and treatment attitudes differ between Asian and non-Asian ethnic groups, with the former appearing to be more accepting and less concerned about the disease. Additional research about CHB symptomatology and health attitudes by ethnicity is needed to ensure that individuals with CHB are educated on the potential health risks and the availability of current treatment options.
Notes on "Hepatitis B virus DNA levels at week 4 of lamivudine treatment predict the 5-year ideal response," Yuen MF et al, Hepatology. 2007 Nov 20;46(6):1695-1703.
The best time and hepatitis B virus (HBV) DNA level during an early lamivudine treatment period for predicting the long-term outcome are unknown. We aimed to determine the optimal time and HBV DNA level during an early treatment period for the prediction of the response after a 5-year lamivudine treatment. The HBV DNA levels at the baseline, at weeks 2, 4, 8, 12, 16, 24, and 32, and at yearly intervals until year 5 were measured in 74 hepatitis B e antigen (HBeAg)-positive chronic HBV patients receiving lamivudine treatment. Seventeen patients achieved an ideal response [HBV DNA level < 2000 copies/mL (400 IU/mL), HBeAg seroconversion, normal alanine aminotransferase levels, and absence of tyrosine-methionine-aspartate-aspartate (YMDD) mutations] at year 5. Receiver operating characteristic curves showed good predictions as early as week 4. The areas under the curve for weeks 4 and 16 were 0.89 and 0.94, respectively. Predictive indices revealed 4 and 3.6 log copies/mL (2000 and 800 IU/mL, respectively) to be the best cutoff HBV DNA levels for these 2 times, respectively. All patients with HBV DNA levels lower than these respective cutoff levels at the 2 times achieved an ideal response at year 5. Patients with HBV DNA levels above these cutoff values had 83.8% and 87.7% chances of not achieving an ideal response at year 5, respectively.
Conclusion: The measurement of the HBV DNA levels at week 4 of lamivudine treatment should be performed in all patients to predict the long-term outcome. The treatment can be continued for those with HBV DNA levels of less than 4 log copies/mL (2000 IU/mL). The addition of or switch to alternative antiviral agents should be considered for patients who fail to achieve this early target.
The best time and hepatitis B virus (HBV) DNA level during an early lamivudine treatment period for predicting the long-term outcome are unknown. We aimed to determine the optimal time and HBV DNA level during an early treatment period for the prediction of the response after a 5-year lamivudine treatment. The HBV DNA levels at the baseline, at weeks 2, 4, 8, 12, 16, 24, and 32, and at yearly intervals until year 5 were measured in 74 hepatitis B e antigen (HBeAg)-positive chronic HBV patients receiving lamivudine treatment. Seventeen patients achieved an ideal response [HBV DNA level < 2000 copies/mL (400 IU/mL), HBeAg seroconversion, normal alanine aminotransferase levels, and absence of tyrosine-methionine-aspartate-aspartate (YMDD) mutations] at year 5. Receiver operating characteristic curves showed good predictions as early as week 4. The areas under the curve for weeks 4 and 16 were 0.89 and 0.94, respectively. Predictive indices revealed 4 and 3.6 log copies/mL (2000 and 800 IU/mL, respectively) to be the best cutoff HBV DNA levels for these 2 times, respectively. All patients with HBV DNA levels lower than these respective cutoff levels at the 2 times achieved an ideal response at year 5. Patients with HBV DNA levels above these cutoff values had 83.8% and 87.7% chances of not achieving an ideal response at year 5, respectively.
Conclusion: The measurement of the HBV DNA levels at week 4 of lamivudine treatment should be performed in all patients to predict the long-term outcome. The treatment can be continued for those with HBV DNA levels of less than 4 log copies/mL (2000 IU/mL). The addition of or switch to alternative antiviral agents should be considered for patients who fail to achieve this early target.
Notes on "Entecavir Shows High HBV Suppression, Low Resistance in Long-Term Studies," Tinker Ready, Release Date: November 9, 2007
The supporter had no role in selecting the study or interview sources for news coverage, and it did not review or approve the news article before publication. November 9, 2007 (Boston) — A follow-up study of entecavir (ETV) found that the drug remains effective through 4 years and eventually proved effective for a majority of the original 1-year study's nonresponders, according to 2 abstracts presented by Bristol-Myers Squibb (BMS) during a poster session here at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Fewer than 5% (30/679) of nucleoside-naive hepatitis B e antigen (HBeAg)–positive and HBeAg-negative patients from earlier BMS studies of the drug were nonresponders. Researchers then looked at 21 of the 1-year nonresponders during 4 years. At the start of the study, patients had median hepatitis B virus (HBV) DNA levels of 3.3 log10 copies/mL and alanine aminotransferase (ALT) levels of 37 U/L. During the study, 15 (71%) of 21 study subjects achieved HBV DNA levels less than 300 copies/mL, and 86% had ALT normalization. "The simple fact that they don't respond in a year or 2 years doesn't mean that they won't respond," said lead author Morris Sherman, MD, from Toronto General Hospital in Ontario, Canada. All but 1 patient achieved ALT normalization. Four patients who experienced virologic breakthrough were genotyped, and none had resistance, according to Dr. Sherman, who is a BMS consultant. "The big criticism was, if these are nonresponders, and we keep them on treatment, aren't they going to develop resistance?" he said. "The answer is, they don't." The second abstract presented long-term data from nucleoside-naive HBeAg-positive patients who rolled over from an earlier BMS protocol (ETV-022) comparing ETV favorably against lamivudine (LVD). In that study, 91% of patients who received ETV treatment during 4 years achieved undetectable HBV-DNA levels, and 95% had ALT normalization (ALT ≤ 1 × upper limit of normal) after 194 weeks. Patients continued to exhibit HBeAg loss and HBeAg seroconversion during the study's third and fourth years, according to the abstract. No new safety issues emerged in the follow-up study. The study is important in that "most of these patients need medication forever," said one of the study's authors, Hugo Cheinquer, MD, PhD, of Universidade Federal Do Rio Grande Do Sul in Porto Alegre, Brazil. Dr. Cheinquer is a consultant to BMS and Roche. For physicians worried about resistance, this research puts ETV at the top of the list of nucleoside analog HBV drugs, said Jake Liang, MD, a member of the AASLD board and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. "It's...probably one of the better approved drugs in terms of having a low rate of resistance," he noted. As mentioned above, the study was funded by BMS. Dr. Sherman is a BMS consultant, and Dr. Cheinquer is a consultant to BMS and Roche.
The supporter had no role in selecting the study or interview sources for news coverage, and it did not review or approve the news article before publication. November 9, 2007 (Boston) — A follow-up study of entecavir (ETV) found that the drug remains effective through 4 years and eventually proved effective for a majority of the original 1-year study's nonresponders, according to 2 abstracts presented by Bristol-Myers Squibb (BMS) during a poster session here at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Fewer than 5% (30/679) of nucleoside-naive hepatitis B e antigen (HBeAg)–positive and HBeAg-negative patients from earlier BMS studies of the drug were nonresponders. Researchers then looked at 21 of the 1-year nonresponders during 4 years. At the start of the study, patients had median hepatitis B virus (HBV) DNA levels of 3.3 log10 copies/mL and alanine aminotransferase (ALT) levels of 37 U/L. During the study, 15 (71%) of 21 study subjects achieved HBV DNA levels less than 300 copies/mL, and 86% had ALT normalization. "The simple fact that they don't respond in a year or 2 years doesn't mean that they won't respond," said lead author Morris Sherman, MD, from Toronto General Hospital in Ontario, Canada. All but 1 patient achieved ALT normalization. Four patients who experienced virologic breakthrough were genotyped, and none had resistance, according to Dr. Sherman, who is a BMS consultant. "The big criticism was, if these are nonresponders, and we keep them on treatment, aren't they going to develop resistance?" he said. "The answer is, they don't." The second abstract presented long-term data from nucleoside-naive HBeAg-positive patients who rolled over from an earlier BMS protocol (ETV-022) comparing ETV favorably against lamivudine (LVD). In that study, 91% of patients who received ETV treatment during 4 years achieved undetectable HBV-DNA levels, and 95% had ALT normalization (ALT ≤ 1 × upper limit of normal) after 194 weeks. Patients continued to exhibit HBeAg loss and HBeAg seroconversion during the study's third and fourth years, according to the abstract. No new safety issues emerged in the follow-up study. The study is important in that "most of these patients need medication forever," said one of the study's authors, Hugo Cheinquer, MD, PhD, of Universidade Federal Do Rio Grande Do Sul in Porto Alegre, Brazil. Dr. Cheinquer is a consultant to BMS and Roche. For physicians worried about resistance, this research puts ETV at the top of the list of nucleoside analog HBV drugs, said Jake Liang, MD, a member of the AASLD board and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. "It's...probably one of the better approved drugs in terms of having a low rate of resistance," he noted. As mentioned above, the study was funded by BMS. Dr. Sherman is a BMS consultant, and Dr. Cheinquer is a consultant to BMS and Roche.
Back to the former study, interesting that a study would try to convince those of us who are asymptomatic that we're sicker than we think we are. Maybe its not just "perception" that varies between ethnic groups...maybe there are differences in symptomatology. This study seems a little suspect to me.
Have an Answer?
You are reading content posted in the Hepatitis B Community
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
