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AASLD 2013 Liver Meeting
HBV Coverage

by Christine M. Kukka


Top Ten Reports from the 64th Annual Liver Meeting 

Hepatitis B experts from around the world met at the 64th annual American Association for the Study of Liver Diseases (AASLD) conference in Washington D.C. this week to share the latest in hepatitis B treatment and research. Here are some of the highlights.

1. New Treatment for Hepatitis B: A Therapeutic Vaccine That May Finally Work
For years researchers have tried unsuccessfully to develop a "therapeutic" vaccine using different antigens from the hepatitis B virus (HBV) in hopes of finding one that would kickstart the immune system into fighting and eradicating the infection.

Japanese researchers may have finally found one. In a Phase III clinical trial, they treated 160 hepatitis B patients with either pegylated interferon (a drug currently used to strengthen the immune system) or the experimental vaccine containing both the hepatitis B surface antigen (HBsAg) and the core antigen to see if together they would trigger the immune system to fight the infection. Current hepatitis B vaccines used to protect uninfected people contain only the surface antigen to spur production of surface antibodies.

In the study, 75 people received five courses of the experimental two-antigen immunization, which was administered by both injection and a nasal spray over a 10-week period. In the interferon-treated control group, 76 people were treated for 48 weeks, then both groups were followed for 24 weeks after the treatment and immunizations ended.

Researchers reported that 75 (61%) of patients receiving the vaccine achieved undetectable viral load (HBV DNA ), and they remained undetectable during the 24-week follow-up period. Seventy-six patients (67%) receiving interferon achieved undetectable viral load, however, only 39% remained undetectable 24 weeks after treatment ended.

There were no dangerous rises in alanine transferase (ALT) levels, signaling liver damage, in the vaccine-treated group over the study period. "This study inspired optimism that ongoing protocols of immune therapy against chronic hepatitis B may be improved by altering (the) nature of antigens and route of administration," researchers wrote.

CONTROL ID 1734018. A phase III clinical trial with a therapeutic vaccine containing both HBsAg and HBcAg administered via both mucosal and parenteral routes in patients with chronic hepatitis B. (Abstract #923)


2. Doctors Still Fail to Treat Hepatitis B Correctly
Even at one of the nation's best teaching hospitals, hepatitis B patients aren't treated properly. Harvard Medical School researchers looked at the medical records of 985 hepatitis B patients treated in a Boston hospital between 2005 and 2012 and found most were not treated, monitored or assessed for liver cancer as recommended by current medical guidelines.

The average age of patients was 45, 78% were non-white and 22% spoke limited English. According to their findings:

  • 526 patients (54%) were treatment eligible, but 115 (22%) did not receive treatment. Most of these untreated patients tested negative for the hepatitis B "e" antigen and had HBeAg-negative hepatitis B.

  • 72% (708) of patients required annual liver cancer screening, but only 55% (386) received it. Physicians failed to order cancer screening in 46% (116) of the patients, and 54% of patients failed to get the screening because they failed to show up for appointments.

  • 34 (35%) of 96 patients did get liver biopsies, which were needed for treatment decisions. Of these, 27 (82%) were due to physician failure to order liver biopsies.

  • Of 389 "inactive" patients (without signs of liver damage or high viral load), 110 (28%) did not have an annual ALT assessment. Of these, 53 (48%) were due to physician error.

  • 35% were not tested for hepatitis A, to see if they needed a vaccine against this liver infection, and 54% and 24% of patients were not tested for either HIV nor hepatitis C, respectively, as required by medical guidelines.

Control ID 1731831. Poor adherence to AASLD guidelines for chronic hepatitis B management in a large academic medical center. (Abstract #902)


3. Think Normal ALT Levels Mean Your Liver Is OK? Think Again
According to current medical guidelines, hepatitis B patients with normal ALT levels—30 and 19 international units per milliliter (IU/mL) in men and women respectively) do not require treatment. However, U.S. researchers reviewed nine studies involving 830 patients with normal ALTs who had had liver biopsies and found that 27.8% had significant fibrosis (liver inflammation).

About one-fifth of patients with only slightly elevated ALT levels (about 40 IU/L), "... May have significant underlying fibrosis independent of HBeAg status, high HBV DNA levels, or Asian ethnicity," they wrote. "Approach to patients with normal ALT should be individualized as further evaluation and possibly antiviral therapy may be appropriate in a subset of these patients."

Control ID: 1739901 Significant fibrosis among patients with Chronic hepatitis B infection and only normal serum alanine transaminase levels: A systematic review and meta-analysis. (Abstract #921)


4. Could Vitamin A Protect Against Liver Cancer?
A joint U.S. and Finnish study followed 22,805 Finnish men 24 years and older to see what factors made some men susceptible to liver cancer (in the absence of viral hepatitis). They found that men with higher levels of β-carotene (found in fruits and vegetables and a vitamin A source) and retinol (also a vitamin A source) had a lower risk of liver cancer and liver failure, suggesting that higher concentrations of these micronutrients may protect against liver disease.

Control ID 1733002. Association of serum α-tocopherol, β-carotene and retinol with subsequent liver cancer incidence and chronic liver disease mortality in the ATBC Study. (Abstract #842)


5. A Snapshot of Who Is Infected and Who Is Dying from Hepatitis B
A study looked at the role hepatitis B played in deaths from cirrhosis and liver cancer worldwide and found that the infection was responsible for 45% of liver cancer deaths and 30% of cirrhosis deaths.

Hepatitis C causes 26% and 28% of cirrhosis and cancer deaths, respectively, and alcohol abuse causes one-quarter of the world's liver cancer and cirrhosis deaths.

Hepatitis C is the predominant cause of liver cancer/cirrhosis deaths in the U.S. (40/41%) with HBV infection predominating in cirrhosis and liver cancer deaths in China (54/46%) and India (48/35%). (1)

This data also yielded the finding that in 2010 in the U.S. there were approximately three-times as many deaths from viral hepatitis as there were HIV/AIDS infection. In Australia and Western Europe, 10-times as many people died from viral hepatitis than from HIV/AIDS.

These findings... "provide a unique opportunity to set global and local priorities for health, and address previous imbalances in addressing the major preventable causes of human death, among which hepatitis B and C must clearly now be counted," researchers wrote.(2)

A study of U.S. veterans who use VA clinics for health care found that when compared to the national average, veterans have twice the HBV exposure and infection rates. The rate of current hepatitis B infection and past (resolved) infection was 0.8% and 13.9% respectively among veterans. (3)

1. Control ID. 1738272 The global burden of liver disease attributable to hepatitis B, hepatitis C, and alcohol: increasing mortality, differing causes (Abstract #23)

2. Control ID 1737658. Shifting scales: comparing viral hepatitis and HIV/AIDS mortality data 1990-2010 in the Global Burden of Disease Study 2010 (Abstract #853)

3. Control ID 1740068. Elevated prevalence of hepatitis B chronic infection and exposure in users of United States. (Abstract #876)


6. The Benefits and Drawbacks of Antivirals Examined

  • Antivirals reduce death rates among hepatitis B patients: Researchers compared death rates in 472 patients treated with entecavir (Baraclude), 791 patients treated with lamivudine (Epivir-HBV) plus adefovir (Hepsera), and 1,141 untreated HBV patients for up to nine years to see if antivirals extended the lives of people infected with HBV.

    Over the course of the study, two patients (0.7%) in the entecavir group died, eight (2.9%) died in the lamivudine group, and 68 (24.9%) died in the control group. The five-year survival rates were 99.1%, 97.6% and 92.2% in the entecavir, lamivudine and control groups respectively.

    Japanese researchers concluded that antivirals (especially in cirrhotic patients) greatly reduce death rates in hepatitis B patients.
    Control ID 1736731. Long-term nucleos(t)ide analog treatment reduces liver related mortality in chronic hepatitis B patients. (Abstract #925)

  • But antivirals did not lower liver cancer: Researchers compared liver cancer rates in 132 patients treated with antivirals (lamivudine or entecavir) for 48 weeks and 132 untreated patients. Both groups were similar in disease state, age and gender.

    As expected, those treated with antivirals experienced declines in viral load and ALT levels, but liver cancer rates in the antiviral-treated group were surprisingly similar to the untreated control group. Liver cancer rates in the treated group were 1.6% at year 2, 3.5% at year 3, 4.5% at year 5, and 10.5% at year 10—similar to the control group's cancer rates of 0.7%, 2.3%, 3.2%, and 7.4% during the same time period.

    "Even with long-term (antiviral) treatment, the incidence of liver cancer development was not reduced significantly in HBV-infected patients," Japanese researchers wrote. "Though long-term (antiviral) treatment can bring back hepatic reserve effectively, careful observation with periodical liver cancer screening is recommended."

    Control ID 1734897. Nucleoside analogue treatment can not reduce the incidence of hepatocellular carcinoma in patients with chronic hepatitis B. (Abstract #965)

  • Patients who develop surface antibodies can quit antivirals: An Argentina study found that after two to three years of entecavir treatment, 23 of 183 (14%) patients became HBsAg-negative and 22 (13%) developed surface antibodies. More than a year after stopping treatment, 18 patients who were still followed continued to be surface antibody-positive.

    Control ID 1725304. Relapse rates in chronic hepatitis B naïve patients after entecavir discontinuation in real life. (Abstract #910)


7. More Studies Show Why Lamivudine Should No Longer Be Used

  • Lamivudine a poor choice for lowering viral load in pregnant women: Twenty-one women with high viral load were treated with lamivudine for about 53 days toward the end of their pregnancies. None transmitted the infection to their newborns, but they had only modest reductions in viral load and four women developed some form of drug resistance.

    Control ID 1735799. Short duration of lamivudine for prevention of HBV transmission in pregnancy: Lack of potency and selection of resistance mutations. (Abstract #1018)

  • Lamivudine treatment ineffective in cirrhotic patients, compared to other antivirals. Korean researchers followed 1,824 patients treated with either lamivudine or entecavir for more than five years and found that cirrhotic patients treated with entecavir had markedly lower rates of liver transplants or death from liver disease than those treated with lamivudine.

    Control ID 1735949. Comparative effectiveness of entecavir and lamivudine on survival of patients with chronic hepatitis B virus infection. (Abstract #32)


8. Long-Term Trials Show Tenofovir Effective.
In two trials, tenofovir was shown to be safe and effective over a seven-year treatment period with no signs of drug resistance despite long-term treatment. Studies also showed a relatively low rate of kidney damage or bone loss.

  • In one study, 154 patients were treated long-term had the following results:
    • 54% lost HBeAg

    • 40% lost HBeAg and developed "e" antibodies

    • 12% lost surface antigen (HBsAg) and 10% developed surface antibodies--and cleared the infection.

Control ID 1735577. Seven years of treatment with tenofovir DF for chronic hepatitis B virus infection is safe and well tolerated and associated with sustained virological, biochemical and serological responses with no detectable resistance. (Abstract #926)

  • Tenofovir reduces need for liver transplants: Another study found that tenofovir was so effective in improving liver health, even in patients who had develops severe liver scarring and damage from cirrhosis that it reduced the need for liver transplants in those patients. "Therefore, starting therapy with a potent agent as tenofovir offers reducing the transplantation requirement," they wrote.

    Control ID 1736186. Long-term tenofovir therapy reduces the need for liver transplantation in patients with cirrhosis. (Abstract #1749)

  • Tenofovir effective in patients with resistance to multiple antivirals: Tenofovir proved to be effective in 52 patients who had failed to respond to prior treatment due to development of drug resistance to lamivudine, adefovir and entecavir.

    Most of the patients were male and nearly all were HBeAg-positive with high viral loads. After four years of tenofovir treatment, researchers reported that 96.7% had achieved undetectable viral load. Seven of the 48 (14.6%) lost HBeAg and 27 of 31 patients who had elevated ALT levels at the start of treatment achieved normal ALTs.

    Control ID 1734808. Tenofovir rescue therapy after multiple nucleos(t)ide analogue treatment failure in chronic hepatitis B patients. (Abstract #906)


9. Research Confirms Antivirals Safe in Pregnant Women
Does antiviral treatment over an entire pregnancy harm the infant? Researchers followed infants born to 200 women treated with the antiviral telbivudine (Tyzeka) for most of their pregnancies for up to four years to see what impact the antiviral treatment had on the children's development. None of the 202 infants were infected with HBV and all developed normally, without any birth defects or abnormalities. (1)

Infants born to 14 women treated with tenofovir over the entire course of their pregnancy were all healthy without any side effects from their mothers' antiviral treatment. None became HBV-infected and there were no safety issues reported, even among women who breastfed their babies while taking tenofovir. (2)

1. Control ID: 1736328. Long-term safety and efficacy of infants born to telbivudine treated highly viremic mothers with HBeAg positive chronic hepatitis B (CHB) during 2nd or 3rd trimester. (Abstract #935)

2. Control ID 1737088. Efficacy and safety results of tenofovir DF (TDF) treatment from the first trimester in HBV pregnant women in real-life clinical practice. (Abstract #952)


10. Studies Confirm Doctors Must Screen All Patients for Hepatitis B Before Starting Chemotherapy
Chemotherapy drugs used to treat cancer and arthritis weaken the immune system and can cause a reactivation of HBV infection, even in people who have undetectable viral load and have cleared the hepatitis B surface antigen.

Unfortunately, many doctors still don’t screen cancer patients for current or resolved hepatitis B infections when prescribing rituximab chemotherapy for blood cancers. (This drug contains antibodies that suppress cancer cell reproduction.)

One study presented at AASLD found only 58% of patients were screened for HBsAg prior to chemotherapy and only 20% were screened for both HBsAg and hepatitis B core antibodies (showing a past, resolved infection) as recommended by international guidelines. This study found that life-threatening HBV reactivation occurred in patients whose only indication of past hepatitis B infection was the presence of core antibodies. (1)

Another impediment to proper treatment is that doctors don’t know which patients will experience an HBV reactivation when treated for blood cancers with rituximab chemotherapy. A Hong Kong study followed 210 patients treated with rituximab who had previously been infected with hepatitis B. They were all HBsAg-negative with undetectable HBV DNA.
About 27% of these patients had hepatitis B reactivation—evidenced by detectable viral load—most within six months of starting chemotherapy.

As soon as HBV DNA became detectable, the researchers treated them with the antiviral entecavir to suppress HBV. During the reactivation, HBsAg levels remained undetectable. It was an increase in the patient’s HBV DNA that was the first indication of hepatitis B reactivation. (2)

1. Control ID 1736332. Is isolated anti-HBc positivity a risk for reactivation in rituximab-treated patients? (Abstract #846)

2. Control ID 1736113. Interim analysis of hepatitis B reactivation in patients with prior HBV exposure undergoing rituximab-containing chemotherapy: a prospective study. (Abstract #34)





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