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HBV Journal Review

HBV Journal Review
June 1, 2012, Vol 9, no 6
by Christine M. Kukka

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U.S. Residents with Hepatitis B May Exceed 2 Million
A report just published in Hepatology asserts that the true number of U.S. residents infected with the hepatitis B virus (HBV) may be as high as 2.2 million—far more than the U.S. Centers for Disease Control and Prevention’s current estimate of 800,000 to 1.4 million people.

Researchers from the Virginia Mason Medical Center in Seattle suggest the higher prevalence of hepatitis B is attributable to foreign-born residents who came from Asia and Africa and other regions with high rates of HBV. They represent close to 70% of the 1.32 million foreign-born persons living with chronic HBV in the U.S. in 2009.

Current CDC surveillance studies that measure hepatitis B prevalence have missed these high-risk, foreign-born residents, as well as homeless and institutionalized residents.

“Understanding the ethnic and cultural populations affected by chronic hepatitis B will provide more accurate estimates and help to develop programs for prevention, earlier diagnosis, and access to care for those at greatest risk,” explained Kris Kowdley, the study’s lead author and director of the Liver Center of Excellence at the Seattle medical center.

To assess the true prevalence of hepatitis B, researchers applied the hepatitis B infection rates from immigrants’ birth countries to the number of immigrants living in the U.S., as reported by the 2009 U.S. Census.

Their research calculated that between 1.04 and 1.61 million (average 1.32 million) foreign-born persons were living with chronic hepatitis B in the U.S. in 2009. Most infected emigrants were from Asia, Africa, and Central America, and accounted for 58%, 11% and 7% of infected immigrants in the U.S., respectively.

An accompanying editorial in the same issue of Hepatology noted, “The study by Kowdley and colleagues provides evidence that numerous and diverse foreign-born populations in the U.S. are at risk for chronic hepatitis B. Nearly 3.5% of all foreign-born persons in the U.S. are living with this disease—a rate more than 10-fold higher than the prevalence of the general U.S. population.”

The editorial called for culturally-specific prevention and treatment programs to reach these groups to prevent new infections, liver disease and cancer.

Infections, including Hepatitis B, Cause 16% of Cancers Worldwide
Using 2008 global cancer statistics, French researchers estimate that 2 million cancers each year--one in six of total cases--result from infections with the hepatitis B and C viruses, and other bacteria and viruses.

In women, cervical and uterine cancers that result from the human papillomaviruses account for half of all infection-related cancers. In men, liver and gastric cancers account for nearly 80% of cancers. Around 30% of infection-related cancers occur in people younger than age 50, according to the report published in the May issue of The Lancet Oncology.

"Application of existing public health methods for infection prevention, such as vaccination, safer injection practice, or antimicrobial treatments, could have a substantial effect on the future burden of cancer worldwide," researchers wrote.

Combination of Antiviral and Chinese Traditional Medicine Proves Effective
Chinese researchers treated 164 patients with either the antiviral entecavir (Baraclude) or a combination of entecavir and the Chinese traditional medicine Shenxian yiganling to see if the Western drug and traditional Chinese medicine together would be more effective than entecavir alone.

According to the report published in the Chinese journal of integrated traditional and Western medicine (PMID:22574588), the combination treatment was nearly twice as effective at clearing the hepatitis B "e" antigen (HBeAg) than entecavir alone.

Entecavir is an antiviral that meddles with the HBV genetic material so it cannot replicate.

After 48 weeks of treatment, there was little difference in two patient groups' alanine aminotransferase (ALT) levels (about 70% of both groups had normal ALTs, indicating no liver damage.) About 73% of both groups achieved undetectable HBV DNA. However, substantially more patients in the combined therapy group lost HBeAg and developed "e" antibodies, called seroconversion.

Researchers reported that 39.44% of the combination group lost HBeAg, compared to 23.75% of the entecavir-only group. Additionally, 32.39% lost HBeAg and developed "e" antibodies, compared to 15% in the entecavir-only group.

"Entecavir combined with Shenxian yiganling promoted the HBeAg ... conversion rate, possibly through the recovery of the immune functions," researchers wrote.

Another study in this publication described the treatment of 240 patients with either just the antiviral adefovir (Hepsera), or with adefovir combined with a baihua xianglian detoxification liquid for 48 weeks.

By the end of the treatment period, the undetectable HBV DNA rate was 29% in the adefovir-only group compared to 55% in the combined treatment group. The HBeAg seroconversion rate was 22% in the combination group and 12% in the adefovir-only group.

Researchers Discover How HBV Integrates to Cause Cancer
The Asian Cancer Research Group, a nonprofit research organization funded by an international consortium of pharmaceutical companies, has discovered exactly how the HBV integrates into liver cells' genetic blueprint to cause abnormal cell growth or cancer.

In this study, researchers sequenced the entire genome (which contains all the DNA and information needed to build and maintain an organism) of cancerous liver cells from people with hepatitis B to find out how the virus integrates into liver cells and causes cancer.

Researchers found HBV had integrated into 86.4% of liver tumors' cancer cells. Meanwhile, the integration rate was only 30.7% in adjacent, cancer-free liver cells.

Researchers also identified the genes—including three new ones—that appear to help HBV integrate into liver cells and spur tumor growth.

The discovery should help researchers better understand the molecular mechanisms and clinical impact of HBV integration, which could lead to more effective liver cancer treatments. In 2008, liver cancer killed 695,000 people worldwide.

Scientists Track Global Migration of HBV with Help from a 16th Century Mummy
Analysis of an ancient mummy in Korea, dating back to the 16th century, shows the presence of HBV genotype C 2 infection, which remains common in Southeast Asia today.

An Israeli-South Korean conducted a genetic analysis on samples from the mummified child's liver, which was in unusually good shape. Analysis of the ancient HBV genomes can now be used to study the evolution of virus, and how hepatitis B infection spread, possibly from Africa to East-Asia.

It may also shed light on the migratory pathway of hepatitis B from China and Japan to Korea as well as to other regions in Asia and Australia.

The reconstruction of the ancient HBV genetic code is the oldest full viral genome to date, according to the report in the May 21 edition of Hepatology. Using modern-day molecular genetic techniques, the researchers compared the ancient DNA sequences with those of contemporary HBV. The changes in the genetic code are believed to result from spontaneous mutations and possibly environmental pressures during the virus evolutionary process. Based on the mutations rates, researchers estimate that the mummy's HBV DNA originated between 3,000 to 100,000 years ago.

Cholesterol-Lowering Drugs Help Patients with Cirrhosis
A small study found that when patients with cirrhosis and heart disease were given statins (cholesterol-lowering drugs), the medication helped heart disease and it appears to reduce liver damage.

Brigham & Women’s Hospital researchers followed 81 patients with both cirrhosis (intense liver scarring) and heart disease who were given statins for three months and then followed for up to three years. Their health was compared to a control group of 162 patients who did not receive statins.

Only 38.2% of patients on statins experienced worsening liver disease, compared to 50.6% of patients in the untreated, control group. Additionally, there were fewer deaths in the statin-treated group.

"Contrary to the prior belief that statins aren't safe in patients with cirrhosis, we found they actually may be beneficial in this population," researchers noted, when they presented their findings at the Digestive Disease Week conference.

Doctors have feared statins were unsafe in patients with liver disease because statins are metabolized in the liver and may put patients at greater risk of liver disease and failure.

This and other recent studies suggest statins are safe and may even lessen liver decompensation.

New Hepatitis B Treatment Guidelines Released
The European Association for the Study of the Liver recently published new treatment guidelines in the Journal Hepatology, and experts have published new treatment recommendations in the May issue of Current Opinion in Gastroenterology. Here is a summary of both sets of recommendations:

  •  Should young, HBeAg-positive patients with normal ALT levels and high viral load be treated? The European guidelines suggest that patients under age 30 with no family history of liver cancer, do not need treatment nor a liver biopsy. However, monitoring their liver health is recommended every three to six months.

  • Should adult HBeAg-negative patients with normal ALTs and low viral load be treated? Test these patients every three months for one year, if their HBV DNA remain below 2,000 international units per milliliter (IU/mL), then neither a biopsy nor treatment is needed. If semi-annual testing reveals no liver damage over three years, then annual or semi-annual testing is recommended.

  • If viral load and ALTs are elevated, is a liver biopsy needed before starting treatment? No, but a non-invasive method for assessing fibrosis or cirrhosis may be useful.

  • Should patients with compensated cirrhosis and detectable HBV DNA be treated even if ALT levels are normal? Yes.

EASL Guidelines Chart Drug Treatment Success Rates in Hepatitis B Patients
The following success rates, published in the latest EASL Clinical Practice Guidelines, are for HBeAg-positive patients who received these drugs for 12 months.

Pegylated interferon:

  • HBeAg seroconversion (loss of "e" antigen, development of "e" antibody): 32%
  • Achieved undetectable HBV DNA: 14%
  • Achieved normal ALT levels, indicating no liver damage: 41%
  • Lost hepatitis B surface antigen (HBsAg): 3%

Lamivudine (Epivir-HBV), which is rarely used due to its high rate of drug resistance:

  • HBeAg seroconversion 16-18%.
  • Undetectable  HBV DNA: 36-44%
  • Normal ALTs: 41-72%
  • Loss of HBsAg: 0%

Telbivudine (Tyzeka):

  • HBeAg seroconversion: 22%
  • Undetectable  HBV DNA: 60%
  • Normal ALTs: 77%
  • Loss of HBsAg: 0.5%

Entecavir (Baraclude):

  • HBeAg seroconversion: 21%
  • Undetectable  HBV DNA: 67%
  • Normal ALTs: 68%
  • Loss of HBsAg: 2%

Adefovir (Hepsera):

  • HBeAg seroconversion: 22%
  • Undetectable  HBV DNA: 12-18%
  • Normal ALTs: 48-54%
  • Loss of HBsAg: 0%

Tenofovir (Viread):

  • HBeAg seroconversion: 21%
  • Undetectable  HBV DNA: 76%
  • Normal ALTs: 68%
  • Loss of HBsAg: 3%

Treatment outcomes for HBeAg-negative patients, after 12 months of treatment, by drug:

Pegylated interferon:

  • Undetectable  HBV DNA: 19%
  • Normal ALTs: 59%
  • Loss of HBsAg: 4%

Lamivudine (Epivir-HBV), which is rarely used due to its high rate of drug resistance:

  • Undetectable  HBV DNA: 72-73%
  • Normal ALTs: 71-79%
  • Loss of HBsAg: 0%

Telbivudine (Tyzeka):

  • Undetectable  HBV DNA: 88%
  • Normal ALTs: 74%
  • Loss of HBsAg: 0%

Entecavir (Baraclude):

  • Undetectable  HBV DNA: 90%
  • Normal ALTs: 78%
  • Loss of HBsAg: 0%

Adefovir (Hepsera):

  • Undetectable  HBV DNA: 51-63%
  • Normal ALTs: 72-77%
  • Loss of HBsAg: 0%

Tenofovir (Viread):

  • Undetectable  HBV DNA: 93%
  • Normal ALTs: 76%
  • Loss of HBsAg: 0%

Treatment for Pregnant Women:
According to the report in Current Opinion in Gastroenterology, of 2,356 children born to HBV-infection mothers, 9.26% of those born to HBeAg-positive mothers became infected despite receiving hepatitis B immunoglobulin (HBIG) and three hepatitis B vaccine doses.

The infection rate was so low (less than 1%) in children born to HBeAg-negative mothers that HBIG did not appear to offer any additional protection beyond vaccination.

In order to decrease mother-to-child transmission, HBeAg-positive mothers with high viral loads can be treated with either tenofovir or telbivudine during their third trimester, experts recommend in the "New Advanced in Chronic Hepatitis B." Pregnant women should not use interferon during pregnancy because of safety concerns.

According to the new EASL guidelines, if a woman receiving antiviral treatment for advanced fibrosis or cirrhosis becomes pregnant, she should continue treatment with either tenofovir or telbivudine. Both drugs have been shown to be very safe when used by HIV-infected women during pregnancy.

The safety of breastfeeding while taking antivirals is not clear, according to EASL. "Tenofovir concentrations in breast milk have been reported," but the amount is so small it should not pose any threats to infants," according to the report.

Doctors Still Not Screening Patients for HBV before Prescribing Rituximab
A study by the Karmanos Cancer Center in Detroit found that 30% of doctors did not screen cancer patients for hepatitis B before prescribing rituximab (MabThera), an immune-suppressing drug used to treat some lymphoma cancers and rheumatoid arthritis.

If patients have inactive hepatitis B infections (without signs of liver damage or high viral load) or have resolved hepatitis B infections, this immune-suppressing drug or chemotherapies can weaken the immune system and cause a life-threatening rebound in the infection.

For example, rituximab removes B-cells, which make antibodies to fight viruses.

In this study, only 70% of 280 patients who received rituximab were screened for hepatitis B. In this group, only 0.6% was HBsAg-positive, but 11.1% tested positive for the hepatitis B core antibody, which demonstrates a past hepatitis B infection.

One patient had a HBV reactivation despite lamivudine. The patient recovered after being switched to the more powerful antiviral tenofovir, according to the report published in the Journal of Oncology Pharmacy Practice.

"Education to clinicians is warranted to increase awareness and further improve adherence to the clinical guidelines," they wrote.

HIV Patients Face Higher Risk of Liver-Related Deaths from Hepatitis B Than Hepatitis C
Men living with HIV are twice as likely to die from a hepatitis B coinfection than from a hepatitis C coinfection, according to a report published in the journal of Clinical Infectious Diseases.

This study emphasizes the need for a more aggressive approach to the prevention, diagnosis and treatment of hepatitis B, researchers noted, including increasing vaccination rates among unvaccinated men, according to Johns Hopkins University researchers.

Prevention efforts are especially needed in Asian and African populations where there are high rates of HBV and HIV coinfections among men who have sex with men.

Before this study, it was not known which viral hepatitis carried the greatest risk of death from liver disease in the HIV-infected.

The researchers evaluated 680 patients, 337 of whom had chronic HBV infection and 343 of whom had chronic HCV. Roughly 70 percent of the men (472) were also coinfected with HIV. The participations were studied for up to 8.5 years, totaling 6,728 person years.

During this time period, there were 293 deaths, 51 of which were liver-related. Death rates from any cause were similar among both HCV and HBV patients, and as expected they were higher among HIV-positive patients.

When the researchers looked specifically at liver-related deaths, the rate was nearly doubled among people with chronic HBV infection: 9.6 per 1,000 person-years, compared with 5.0 per 1,000 person-years among those with chronic HCV infection. The relative risk in the HBV-HIV coinfected was nearly twice as the HCV-HIV coinfected.

Old age and an HIV-weakened immune system increased liver-related death rates.

During the study period, tenofovir which is effective against both HIV and hepatitis B began to be used, but it appeared not to make a significant difference in the mortality rates.

"More emphasis needs to be placed on more effective global HBV screening and increased efforts for vaccination and treatment of HBV infection worldwide," researchers wrote.

HIV Clinics Failing to Screen and Vaccinate Patients against Viral Hepatitis
Researchers, evaluating hepatitis B immunization at eight HIV clinics in the U.S. that served men who have sex with men (MSM), found that only 52% were screened for hepatitis B, even though these patients are at high risk for the infection, according to a report published in the journal of Sexually Transmitted Diseases.

Medical guidelines recommend hepatitis A, B and C testing in HIV patients, and immunization against hepatitis A and B if patients are susceptible to the infections.

The researchers examined medical records of 1,329 patients, who made 14,831 visits to the clinics between 2004 and 2006. They found that:

  • 47% were screened for hepatitis A (29% were vaccinated for hepatitis A)
  • 52% were screened for hepatitis B (25% were vaccinated against hepatitis B)
  • And, 54% were tested for hepatitis C.

Researchers noted there were significant variations in screening and vaccination rates between clinics.

"Awareness of hepatitis susceptibility and hepatitis co-infection status in HIV-infected patients is essential for optimal clinical management,” the researchers concluded. “Despite recommendations for hepatitis screening and vaccination of HIV-infected MSM, rates were suboptimal at all clinic sites. These low rates highlight the importance of routine review of adherence to recommended clinical services. Such reviews can prompt the development and implementation of simple and sustainable interventions to improve the quality of care.”

28% of Vaccinated Children Born to HBV-Positive Mothers Still Have HBV DNA
Iranian researchers screened 75 children for HBV DNA—expecting to find no signs of HBV infection—and INSTEAD found 28% testing positive despite the presence of the surface antibody.
All of the children had been born to HBV-positive mothers and had received both the vaccine and HBIG after birth. Due to the immunization, all tested positive for the surface antibody and researchers assumed they were free of infection.

However, when their blood was screened, HBV DNA was detected in 21 of the 75 children. Viral load was low, ranging from 77 to 9,240 copies/mL. Thirteen of the children had some type of viral mutation.

"HBV occult (hidden, without HBsAg) infection seems to be relatively frequent in immunized children born to HBsAg-positive mothers," the researchers reported in the May issue of the Journal of Hepatology. They encouraged doctors to screen children born to infected mothers for occult hepatitis B infections, even when they appeared to be free of infection and testing positive for the surface antibody.

HBV Genotype May Dictate Severity of Infection
Increasingly, researchers are studying what impact genotype plays in the progression of HBV infection.

Recently, Swedish researchers followed HBsAg, HBeAg, ALT and viral load over 9.2 years in 124 untreated adults. According to their report published in the Journal of Clinical Virology:

  • HBV DNA levels decreased significantly in patients with genotype A, B and D, but not in those with genotype C.
  • Loss of HBeAg was seen in 44% of patients with genotype C, compared with 92% of all other genotypes.
  • Loss of HBsAg was seen in 36% of patients with genotype A, 5% with genotype B, none with genotype C, and in 11% of those with genotype D.

Researchers speculated that HBV infections with genotypes C or D may remain highly active, "implying a risk for progressive liver damage."

First Tenofovir Trial for Adolescents Highly Successful
One of the first tenofovir clinical trials involving adolescents between the ages of 12 and 18 in the U.S. proved highly successful with 89% of those treated with tenofovir achieving undetectable viral load.

In this study, spearheaded by researchers at Seattle Children's Hospital, 52 adolescents took 300 mg daily of tenofovir for 72 weeks. Their results were compared with an untreated group of 54 teens who received placebo.

About 91% of patients were HBeAg-positive, and 85% had been previously treated with another antiviral or interferon.

Researchers reported in the journal Hepatology that 74% of tenofovir-treated patients achieved normal ALT levels, indicating no liver damage, compared to 32% in the placebo group.

Additionally, 89% of tenofovir-treated patients achieved viral load less than 400 copies/mL and 85% achieved a very low/undetectable viral load of 169 copies/mL. None of the control group achieved these low levels of HBV DNA.

"Tenofovir therapy in HBV-infected adolescents was well tolerated and highly effective at suppressing HBV DNA and normalizing ALT values in both (untreated) adolescents and those with prior exposure to HBV therapy," researchers wrote.




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