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HBV Journal Review

HBV Journal Review
September 1, 2010, Vol 7, no 9

by Christine M. Kukka

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Study Finds Interferon Ineffective Against HBeAg-Negative Hepatitis B
Researchers, writing in the August 2010 issue of the American Journal of Gastroenterolgy, reported disappointing results in a recent randomized trial that tested the effectiveness of pegylated interferon (Pegasys) in people infected with hepatitis B “e” antigen (HBeAg)-negative hepatitis B.

An accompanying editorial questioned the effectiveness of the interferon in this patient group based on the study results.

Pegylated interferon, delivered in a weekly injection, had been recently recommended as a first-choice treatment for HBeAg-negative patients based on results from a single randomized trial, which used a control group.

But results from a second randomized controlled trial, involving 138 HBeAg-negative patients, were disappointing. Only 7.5% of the study’s participants achieved undetectable hepatitis B virus (HBV) DNA (less than 400 copies/mL) at 24 weeks over a 48-week course of pegylated interferon. None lost hepatitis B surface antigen (HBsAg), which indicates clearance of the infection.

“This study challenges the value and limits the appeal of pegylated interferon therapy for HBeAg-negative chronic hepatitis B,” the editorial noted.

HBsAg Levels after 12 Weeks of Interferon Will Indicate Treatment’s Success or Failure
A separate study on pegylated interferon treatment in HBeAg-negative patients, published in the August 2010 issue of Hepatology, found that doctors can tell within 12 weeks whether the drug will be effective in patients. The study followed 107 patients who were treated for 48 weeks and then followed for an additional 72 weeks.

They tracked HBsAg and HBV DNA levels in the patients who did respond to treatment and found that by week 12, HBsAg declined markedly in those who ultimately responded to interferon treatment.

They reported that 24 patients (22%) achieved a low viral load and normal alanine aminotransferase (ALT) levels, which indicates no liver damage, at week 72 from treatment. Starting at week 8, responders showed decreases in HBsAg levels. However, the combination of lowered HBsAg and HBV DNA levels at week 12 was a clear indicator that the patient would respond.

Patients who do not show declines in viral load and HBsAg at week 12 should stop treatment, researchers instructed.

In a similar study that focused on HBsAg levels in HBeAg-positive patients treated with pegylated interferon, researchers similarly recommended that treatment should be stopped if there were not significant HBsAg declines after 12 weeks of treatment. They reported in the journal Hepatology that 97% of patients who had no declines in HBsAg at week 12 ultimately did not respond.

Experts Recommend Conservative Approach to Treating Children with HBV—and No Treatment during Immune-Tolerant Stage
In the absence of clear treatment guidelines for children and teens infected with HBV, an expert team of pediatric liver specialists drafted recommendations addressing which children should be treated and when.

The panel, organized by the Hepatitis B Foundation, noted that doctors have few treatment options for children today. Pegylated interferon, considered one of the best first-line treatments in adults, has not yet been approved for children. Doctors are left with two antivirals (lamivudine and adefovir--both of which have high rates of drug resistance) and conventional interferon in their treatment arsenal.

Given the limited options, the panel concluded that, at this time, there is no effective drug treatment for children in the immune-tolerant stage of hepatitis B, marked by high viral load (HBV DNA), normal ALT levels, and HBeAg-positive infection.

Additionally, they noted that prolonged antiviral treatment with the available antivirals would leave children at high risk of developing drug resistance over time.

However, they did recommend a conservative approach to children whose immune systems were fighting the infection and who had liver damage, elevated ALT levels, or a family history of liver cancer.

“Outside of clinical trials, (conventional) interferon is the agent of choice in most cases,” they wrote. Antivirals are second-choice therapies, but children who are treated with antivirals require careful monitoring for development of drug resistance, they cautioned.

“(Until) more clinical data and therapeutic options are available, a conservative approach is warranted,” they noted in the August 2010 issue of the journal Hepatology.

HBIG May Play a Role in Transmitting HBV Infection in Transplant Patients
Transplanting liver organs from donors who tested positive for the hepatitis B core antibody (which shows a past, resolved hepatitis B infection) to patients who are infection-free often results in HBV infections in transplanted patients. Doctors in the past have used hepatitis B immunoglobulin (HBIG) immediately after transplantation to prevent infection.

Now, a group of French researchers suggest that HBIG itself may be the culprit in possibly transmitting hepatitis B to transplanted patients. They studied the transplantation of 77 anti-HBc-positive liver organs into 21 HBsAg-positive patients and 56 HBsAg-negative recipients.

The HBsAg-positive patients were treated with HBIG and antivirals. Forty-five of the uninfected received only HBIG and 11 HBsAg-negative recipients received no HBIG.

Sixteen months after the transplants, 15 HBsAg-negative recipients (19.4%) tested positive for hepatitis B. HBV infections occurred in nearly one-third of the uninfected who received HBIG. But only 7.7% of those previously infected who also received antivirals became re-infected. Mutations in the HBsAg were found in nine HBIG patients who became infected.

“Our study has confirmed the high risk of HBV transmission to naïve (uninfected, transplant) recipients,” the researchers wrote in a recent issue of Hepatology. “HBIG (when used without antivirals) was associated with a significant risk of de novo HBV infection and HBV escape mutations. In these patients, we therefore recommend (treatment) with lamivudine or new (antivirals). The potential benefits of HBIG prophylaxis combined with antiviral drugs require further evaluations.”

Liver Cells Created from Patients' Skin Cells Could Lead to New Liver Disease Treatments
British scientists have created liver cells from a small sample of human skin, which promises to increase research capabilities into liver disease and potential treatments, according to a report published in the Aug. 25, 2010, issue of the Journal of Clinical Investigation.

Because liver cells (hepatocytes) cannot be grown in the laboratory, researching liver disorders has been extremely difficult. But the development of liver cells from human skin provides a mechanism to create diseased liver-like cells from patients suffering from a variety of liver disorders so researchers can use them to study what happens in a diseased or damaged liver cell and to develop potential treatments.

Scientists took skin biopsies from seven patients who suffered from a variety of inherited liver diseases and from three healthy control individuals. They reprogrammed cells from the skin samples back into stem cells, which were used to generate liver cells that mimicked a broad range of liver diseases--the first time a patient’s liver diseases have been modeled using stem cells--and to create 'healthy' liver cells from the control group.

The study improves the possibility that such liver cell programming can be used to produce new drugs or new cell-based treatments for liver disease.

HBeAg Seroconversion from Antivirals Is Rarely Permanent
Dutch researchers followed 132 HBeAg-positive patients who were treated with antivirals and experienced HBeAg seroconversion (loss of HBeAg and development of “e” antibodies) to see how sustained the response was.

HBeAg seroconversion occurred in 46 of 132 patients, and researchers followed 42 of those who seroconverted over an average of 59 months. Thirty-three of 42 subjects (79%) continued antiviral treatment after seroconversion, and 67% of them experienced a resurgence in viral load.

Nine of the 42 (21%) discontinued treatment about six months after HBeAg seroconversion. Only two patients who stopped treatment sustained their seroconversion and low viral load.

“…HBeAg seroconversion by (antivirals) is temporary in most patients with chronic HBV infection,” they wrote in the August 2010 issue of Gastroenterology. “Long-term continuation of antiviral treatment, irrespective of the occurrence of HBeAg seroconversion, appears to be necessary.”

Elevated cccDNA Levels in HBeAg-Negative Patients Indicates Active Liver Disease
HBV’s covalently closed circular DNA (cccDNA) contributes to high rates of viral replication, and is also believed to contribute to development of liver cancer. Chinese researchers investigated the role cccDNA plays in HBeAg-negative disease progression.

They monitored 33 HBeAg-negative patients, with and without active liver disease—which was defined as ALT rates of less than 40 IU/L and HBV DNA levels less than 10,000 copies/mL. They found a “significant” correlation between elevated HBV DNA and cccDNA levels—which resulted in active liver disease. They found no significant correlation between HBsAg and cccDNA.

“The HBV replicative efficiency, defined as the ratio of HBV DNA to cccDNA, was approximately 20% higher in patients with active disease,” they wrote in the September 2010 issue of the Journal of Medical Virology. “In conclusion, serum HBV DNA, but not HBsAg, reflects the amount of cccDNA and the replication efficiency of HBV in patients with HBeAg-negative chronic hepatitis B.”

Health Care Providers Inconsistently Use Gloves to Reduce Sharps Injuries
A multinational team evaluated the effectiveness of glove usage in health care settings in preventing injury—and potential transmission of bloodborne diseases such as hepatitis B and C and HIV—from needle sticks and sharps.

They studied 13 medical centers in the United States and Canada and surveyed 636 health care workers who had suffered a sharps injury on the job. Among the workers, 195 were in an operating room or procedure suite when injured, and 441 were injured elsewhere. Those outside operating rooms were more commonly gloved when treating patients who were perceived to have a high risk of HIV, HBV, or HCV infection than when treating patients who were not perceived as a risk.

Nurses and other employees had lower gloved rates when injured than physicians and physician trainees. Gloves reduced injury risk markedly, and double-gloving reduced risk even more.

“Although the use of gloves reduces the risk of sharps injuries in health care, use among health care workers is inconsistent and may be influenced by risk perception and health care culture,” researchers wrote in the Journal of Infection Control and Hospital Epidemiology. “Glove use should be emphasized as a key element of multimodal sharps’ injury reduction programs.”

Hepatitis B Patients Twice as Likely to Develop Lymphoma
People infected with hepatitis B virus are around twice as likely to develop non-Hodgkin lymphoma, according to a report published in Lancet Oncology. Lymphomas are cancers that develop in lymphocytes, a type of white blood cell.

U.S. and Korean researchers studied the records of more than 600,000 people in South Korea, where hepatitis B is common. Of these, 53,000 or about 9% were infected with HBV. After 14 years, rates of non-Hodgkin lymphoma were more common among the HBV-infected people—at a rate of 19.4 cases per 100,000 HBV-infected people, compared to 12.3 per 100,000 uninfected people.

Researchers think both hepatitis B and C may cause lymphoma by over-stimulating the immune system as it tries to fight the liver infection.

Alpha Fetoprotein Could Be New Indicator When Treatment Is Needed
Doctors continue to struggle to identify which HBeAg-negative patients need treatment. Korean doctors followed 152 HBeAg-negative patients, who had never been treated, who received liver biopsies to see if there were any common factors among those who needed treatment.

They defined patients who required treatment as having ALT levels that were twice normal and HBV DNA levels greater than 2,000 IU/mL. They analyzed the patients’ test results to see if there was some other factor--other than biopsy results--that indicated when liver damage was occurring and treatment was warranted.

They found that patients who meet the treatment criteria tended to be older than 52 and had alpha fetoprotein (AFP) levels greater than 7 µg/mL (up to 10 µg/L is considered normal). AFP levels historically have been used as a tumor marker--when AFP rates rise, liver tumors may be present.

When ALT, HBV DNA, and AFP levels (higher than) 7 µg/mL are all combined to determine if treatment is needed, the accuracy for predicting when treatment is needed improves, they noted.

“AFP level is associated with liver (damage) in HBeAg-negative chronic hepatitis B,” the researchers wrote in the September issue of the journal Liver International. The addition of an AFP level can serve as a “surrogate indicator” to identify patients who need antiviral treatment.

Immunization of Infants Born to HBV-Positive Mothers Effective 93% of the Time
Czech Republic researchers followed children born to HBsAg-positive women from birth into their teens to see how effective immediate immunization was in preventing mother-to-child transmission of HBV.

They followed 640 newborns--29 were born to HBeAg-positive mothers and the rest were born to HBsAg-positive women. The immunization program included a dose of HBIG and immunization at birth, one and six months of age.

Protective surface antibodies were found in 574 of 620 children (93%), and they persisted in 70%, 40%, and 25% of children at ages 5, 10 and 15.

Two of the infants in the study developed chronic hepatitis B. Ten children were infected with HBV (with detectable core antibodies) between ages 3 to 15 years of age, but successfully fought off the infection. Natural “boosting” with surface antibodies through the immune system was detected in 38 children (twice in one child).

“Our results show that combined active-passive immunization of newborns against hepatitis B provides persistent protection up to adolescence despite a frequent waning of surface antibodies, suggesting there is no need for booster vaccination during adolescence,” researchers wrote in the journal Infection.

Antioxidants Appear to Have No Beneficial Impact on Liver Disease
European researchers examined 20 randomized clinical trials, involving 1,225 patients, to see if antioxidants, including beta-carotene, vitamin A, C, E and selenium, had any positive impact on liver disease.

They reported in the journal Alimentary Pharmacology & Therapeutics that the supplements had no significant effect on survival from a variety of liver diseases, including viral hepatitis.



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