Subject: Re: Re: just found out that I have hep B

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: just some opportunities: : Best Hepatitis B Treatment – Interferons// Antivirals// Thymosin alpha 1 (Zadaxin) : The following analysis provides largely unknown actual publications, which are not yet given to the press. : Comparing Zadaxin vs Interferon and the Lamivudine trials: : (1) : http://www.wjgnet.com/1007-9327/7/411.htm : : A randomized controlled clinical trial on the treatment of Thymosin a1 versus interferon-a in patients with hepatitis B : : Jing You, Lin Zhuang, Bao Zhang Tang, Wei Bo Yang, Su Ying Ding, Wu Li, Rong Xue Wu, Hong Li Zhang, Yan Mei Zhang, : Shao Ming Yan, Lu Zhang : : HBeAG positive patients (response is defined by seroconversion = HBeAg loss): : >>The results of the present randomized, controlled trial have shown that T-a1 therapy at a dose of ?1.6mg?via subcutaneous injection twice a week for 6 months is effective and safe in patients with chronic hepatitis B, because nearly 60% of the treated patients became HBeAg- and HBV DNA-seronegative 6 months after the end of therapy. This response rate was not only significantly higher than that of the spontaneous seroconversion rate (3.3% in this study), but also obviously higher than the response to IFN-a therapy alone (27.3%) assessed 6 months after the end of therapy. The study showed that, at the dose tested, T-a1 has the same efficacy as IFN-a in inducing clinical and virological remission. The rate of response in terms of ALT normalization and/or HBV DNA and/or HBeAg loss was not significantly different in the T-a1 group compared with the IFN-a group at the end of the treatment (P>0.05). But there was significantly difference on the rate of response between the two groups at the end of the follow-up periods (P<0.05). The normalization of serum ALT and loss of HBV DNA and HBeAg were observed more frequently in the IFN-a group at the end of therapy and in the T-a1 group at the end of the follow-up. Furthermore, in the T-a1 group the response to the treatment was observed also during the follow-up period, but not in the IFN-a group.<< : (2) : http://www.wjgnet.com/1007-9327/7/407.htm : Preliminary results of Thymosin-a1 versus interferon-a-treatment in patients with HBeAg negative and serum HBV DNA positive chronic hepatitis B : Lin Zhuang, Jing You, Bao Zhang Tang, Su Ying Ding, Kui Hua Yan, Dan Peng, Yan Mei Zhang, Lu Zhang : HBeAg negative patients (response is defined by HBV DNA negativity by PCR and ALT normalization): : >> The results of the present randomized, controlled trial have shown that T-a1 therapy at a dose of ?1.6mg? via subcutaneous injection twice a week for 6 months is effective and safe in anti-HBe? and HBV DNA-positive chronic hepatitis B, because nearly 60% of the treated patients became HBV DNA-seronegative 6 months after the end of therapy. This response rate is not only significantly higher than that of the spontaneous seroconversion rate (3.3% in this study), but also obviously higher than the response to IFN-a therapy alone (23.3%) assessed 6 months after the end of therapy.<< : (3) : Wu FQ, Yu HL, Huang SK. Related Articles : [Effects of lamivudine and thymosin alpha1 combination therapy on patients with chronic hepatitis B] : Zhonghua Gan Zang Bing Za Zhi. 2002 Jun 20;10(3):218-219. (Chin J Hepatol) Chinese. : HbeAg positive patients: : >>Comparison of the conversion rate of serum HBeAg/anti-HBe (cases (% of cases)) : n 6 months therapy 12 months therapy 6 months follow-up 12 months follow-up : Combination group 29 14(48.2) 15(51.7) 15(51.7) 14(48.2) : Lamivudine group 31 2(6.4) 3(9.6) 3(9.6) 3(9.6)<< : http://zhgzbzz.periodicals.com.cn/default.html : (4) : ICC: Chronic Hepatitis Responds To Lamivudine/Thymosin Alpha-1 combo Therapy : >> AMSTERDAM, THE NETHERLANDS -- July 4, 2001 -- Chronic hepatitis B is a widespread disease which responds to monotherapy with lamivudine, interferon or thymosin alpha-1. The relapse rate when treatment stops, however, is very high. In addition, the response to monotherapy is poorer in patients with cirrhosis of the liver. : Dr M.T. Chan and colleagues (University of Hong Kong and Center for Viral Hepatitis Research, Hong Kong, China) investigated the long term effect of combining lamivudine with thymosin alpha-1 for the treatment of patients with chronic hepatitis B, some of whom were cirrhotic. They presented the current results of an ongoing trial at 22nd International Congress of Chemotherapy, Amsterdam, July 1st-3rd, 2001. : They recruited 18 patients (14 males and 4 females) ranging in age between 17 and 83 years. All were HbsAg positive for more than six months and were HbeAg negative. The presence of DNA of hepatitis B virus (HBV) was detected in all patients and there were abnormalities in liver enzymes indicative of liver damage in all patients. Six patients had evidence of cirrhosis judged on clinical symptoms and ultrasound or CT scans. Only two patients had received interferon previously. : All received lamivudine 100-150 mg/day for 12 months. Six patients also received thymosin alpha-1 1.6 mg twice weekly for six months and two patients received thymosine alpha-1 for 12 months. Nine of the patients have been followed for 12-18 months and four for 18-36 months. : By the end of the 12 months of therapy, 14/17 (82 percent) patients had greatly improved or had normal liver enzyme tests and, at follow-up (18-36 months), 10/13 (76 percent) still had good liver function. The virus DNA titre dropped to below 1 pg. (regarded as negative) in 16/17 patients, measurements were unable to be made in the remaining patient. By six months post therapy 11/15 were negative and by the follow up 7/13 were still negative. : Most importantly, the six cirrhotic patients responded well to the treatment and 4/6 still have negative HBV DNA titre and have normal liver enzyme levels. Over half of the patients have had a sustained response to the combination therapy with negative viral load and good liver function. << : Background: Lamivudine durable response after 12 months follow-up by seroconversion: 16%, Interferons up to 40% (not long lasting). Zadaxin monotherapy: 25-50% response (very long lasting durable seroconversion). Combinations of Zadaxin with interferons and antivirals (lamivudine) yield even higher response rates). : Combination therapy of Zadaxin with Interferon: The original data were presented at Digestive Disease Week in May of 2001. The original study analyzed patients in Turkey with antiHBe-positive chronic hepatitis B, a very difficult to treat group infected with the precore mutant of the hepatitis B virus, for which no therapy is consistently effective. Interferon is one of the most widely used approved therapies for the treatment of hepatitis B virus. : >> In the original study, 21 patients received 26 weeks of ZADAXIN plus interferon followed by 26 weeks of interferon monotherapy and 10 patients received 52 weeks of interferon monotherapy alone. At the end of the 6-month, treatment-free follow-up period, 76% of patients receiving ZADAXIN plus interferon showed a sustained response, as measured by normalization of ALT and disappearance of hepatitis B virus DNA. By comparison, only 40% of patients receiving interferon monotherapy showed a sustained response after the 6-month follow-up period. When patients were observed for an additional 12-month follow-up period, 71% of patients receiving ZADAXIN plus interferon still showed a sustained response, versus only 10% of the patients receiving interferon monotherapy. : A Japanese phase 3 pivot trial with monotherapy of zadaxin in 300 patients with hepatitis B is finished this year. The last patient will finish 12 months follow-up in December. The trial will give a definitive answer about efficacy of zadaxin monotherapy. Data from 1/3 of these patients had been published. << : Published results: : http://www.sciclone.com/NewsRoom/index.html : : Most recent press release, important for asian patients and adopted children from asia: : ZADAXIN PRODUCES SUSTAINED RESPONSES : IN MOST DIFFICULT TO TREAT HEPATITIS B PATIENTS : San Mateo, CA, July 16, 2002 - SciClone Pharmaceuticals, Inc. (Nasdaq: SCLN) announced the results of a new study demonstrating that ZADAXIN® (thymalfasin, thymosin alpha 1) helps clear the hepatitis B virus in the most difficult to treat patients, those in the immune tolerant phase of this viral infection. Until this ZADAXIN clinical trial, virtually no treatment has been able to effectively cure hepatitis B in patients in the immune-tolerant phase of the viral infection. : At the end of the 26 weeks of therapy and 52 weeks of follow-up observation, 15.6% of 32 hepatitis B immune-tolerant patients demonstrated a complete response to ZADAXIN therapy in combination with the nucleoside analogue famciclovir. By comparison, there were no responders among the 32 patients in each group that received either famciclovir monotherapy or placebo. A successful response was determined by a sustained seroconversion of hepatitis B e-antigen (loss of HBeAg and the development of antibody to HBeAg) and the disappearance of hepatitis B viral DNA. The study discussion also highlighted the uniqueness of the ZADAXIN-related delayed mechanism of action as well as the importance of the ZADAXIN-related up regulation of the Th2 response and down regulation of the Th2 response which is associated with T-cell mediated eradication of viruses. : This study was led by Dr. George Lau at Queen Mary Hospital in Hong Kong and was published in the July issue of the Journal of Viral Hepatitis. Dr. Lau concluded, “Our study supports the use of combination therapy of an immunomodulatory agent and a nucleoside analogue in enhancing the rate of seroconversion in immune-tolerant patients.” : Treatment of hepatitis B patients in the immune-tolerant phase is important because it may eradicate the virus from the body before significant liver damage is caused by inflammation when the body’s immune system attempts to clear the virus. Over 350 million people worldwide are infected with the hepatitis B virus, primarily in Asia, where the virus is often transmitted from mother to child at birth. Since the child is born with the virus, the immune system does not recognize the hepatitis B virus as foreign and does not mount the proper immune system response. Therefore, the hepatitis B virus can replicate for 20 years or more in this immune-tolerant phase before it manifests itself in damaging inflammations of the liver and makes later treatment more difficult. Until now, no treatment has been able to effectively cure hepatitis B when the patient is in the immune-tolerant phase. : Dr. Alfred Rudolph, M.D., Chief Operating Officer of SciClone, noted, “This study again demonstrates ZADAXIN’s ability as an immune system enhancing drug to successfully resolve some of the most difficult to treat cases of hepatitis B. This is an exciting discovery for the millions of people infected with the hepatitis B virus and particularly for those with the immune-tolerant phase of the virus.” : SciClone Pharmaceuticals, Inc.’s lead Immune System Enhancing drug ZADAXIN is currently in phase 3 hepatitis C clinical trials in the U.S., a phase 3 hepatitis B clinical trial in Japan and a phase 2-3 cancer program in Europe. ZADAXIN is approved for sale in 27 countries and has been administered without clinically significant side effects to over 10,000 patients. : ( For background information on Sciclone (SCLN) and Zadaxin (synthetic thymosin alpha 1) see http://www2.emedsecurities.com/trade/WRH/snapshot.asp?tick=SCLN )

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