Wednesday, April 1, 2015

Tenofovir Also Effective Against Adefovir and Multi-drug Resistance

— Christine M. Kukka, Project Manager, HBV Advocate

In an unrelated study published in the March issue of the journal Liver International, researchers reported that tenofovir was highly effective in 165 patients who had developed drug resistance to one or more antivirals, including adefovir (Hepsera.)

After 36 months of tenofovir treatment, 94% of adefovir-resistant patients achieved undetectable viral load and 79% of those with hard-to-treat multi-drug resistance achieved undetectable HBV DNA.


Five-year Study Shows Tenofovir Dramatically Improves Cirrhosis

— Christine M. Kukka, Project Manager, HBV Advocate

In one of the largest studies of its kind, a group of international researchers have confirmed that five years of treatment with the potent antiviral tenofovir (Viread) in patients with liver scarring (cirrhosis) dramatically improved their liver health and survival.

According to the study, published in the March issue of the journal Hepatology International, researchers performed liver biopsies on 348 HBeAg-positive and HBeAg-negative patients with cirrhosis at the start of their tenofovir treatment and then five years later.

They found that 99.2% of the cirrhotic patients achieved undetectable viral load and 79.7% had normal ALT levels after five years of treatment. About 4% of the patients developed liver cancer, but this incidence is low over the five-year period, given the high cancer risk cirrhotics face. Among the HBeAg-positive patients, 14.4% lost HBsAg over the five-year treatment period.

"This represents the largest analyses to date of chronic hepatitis B patients with sequential liver biopsies demonstrating that treatment with tenofovir for up to five years is associated with favorable virologic, serologic, and histologic outcomes, regardless of baseline cirrhosis status," researchers wrote."


Half of Patients with HBV Genotype C Will Lose HBsAg

— Christine M. Kukka, Project Manager, HBV Advocate

Researchers predict half of people infected with genotype C of the hepatitis B virus (HBV) will clear the hepatitis B surface antigen (HBsAg) over their lifetimes. This strain of HBV is found primarily in Asia and among Asian-Americans. Clearing HBsAg reduces a patient's risk of liver damage and cancer.

In this study, researchers followed 2,121 patients between the ages of 28 and 75 who tested negative for the hepatitis B "e" antigen (HBeAg). Based on the 338 patients who cleared HBsAg over the course of the study, researchers predicted that 56.4% of patients with genotype C would lose HBsAg over their lifetimes, compared to patients with genotype B, who had a 45.7% lifetime clearance rate.
In addition to having genotype C, being male, having elevated ALT levels and lower viral load and HBsAg levels helped increase the patients' odds of clearing HBsAg.

The researchers, reporting in the March 2015 journal of Alimentary, Pharmacology & Therapeutics, wrote, "We found that patients with genotype C infection cleared HBsAg earlier than genotype B (age 49 vs. age 55)."


Friday, March 13, 2015

HBV genotype C HBeAg seroconversion rate ‘negligible’

Patients with chronic hepatitis B virus (HBV) genotype C infection who are positive for hepatitis B e antigen (HBeAg) should not delay antiviral treatment in the hope of seroconversion, Korean researchers recommend.

Over 6 months, just one (1.1%) of 90 patients, all of whom had HBV DNA levels above 20,000 IU/mL and alanine aminotransferase (ALT) levels more than twice the upper limit of normal, showed both spontaneous loss of HBeAg and detection of anti-HBe, reports the team from Jeju National University School of Medicine.

The study protocol recommended antiviral treatment for all patients showing biochemical deterioration during follow-up; 18.9% of patients had entecavir or tenofovir treatment initiated on the development of acute exacerbations, aggravation of jaundice or both.


Long-term entecavir, TDF effective in chronic HBV in real-world setting

A Turkish clinical practice study shows that entecavir and tenofovir disoproxil fumarate (TDF) can effectively maintain long-term virological and biochemical responses in patients with chronic hepatitis B virus (HBV) infection, both in those with and without cirrhosis.

Hepatocellular carcinoma (HCC) did develop in a proportion of patients, but the rate was lower than that reported in previous studies, say the researchers, adding that owing to the lack of a control group, they “cannot prove” that HCC prevention was a consequence of antiviral therapy.

Virological response, defined as a serum HBV DNA level below 20 IU/mL, and normalisation of alanine aminotransferase (ALT) levels were achieved by a similar proportion of the 183 entecavir- and the 172 TDF-treated patients who were followed up for a minimum of 6 months. And the presence of cirrhosis did not adversely affect viral suppression.


WHO issues first-ever HBV treatment guidelines

The World Health Organization has issued guidelines for the first time for the treatment of chronic hepatitis B virus infection, according to a news release from the organization.

“Deciding who needs treatment for hepatitis B depends on a number of factors,” Stefan Wiktor, MD, leader of the WHO’s Global Hepatitis Program, said in the release. “These new guidelines, which give treatment recommendations that rely on simple, inexpensive tests, will help clinicians make the right decisions.”

The guidelines, entitled “WHO guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection,” lay out a simplified approach to the care of people living with chronic HBV, particularly in settings with limited resources, according to the release. Important recommendations mentioned in the release include: the use of a few simple non-invasive tests to assess the stage of liver disease to identify who needs treatment; prioritizing treatment for those with cirrhosis; use Viread (tenofovir disoproxil fumarate, Gilead Sciences) or Baraclude (entecavir, Teva Pharmaceutical Industries) for the treatment; and monitor patients for early detection of liver cancer to determine if treatment is working and if treatment can be stopped.  

For More Information: View the guidelines at

Thursday, March 12, 2015

Action Alert! | Urge Your House Representative To Support Increased Hepatitis B and C Funding!


March 12, 2015

NVHR – National Viral Hepatitis Roundtable 
Representatives Mike Honda, Hank Johnson, and Judy Chu are asking all House Representatives to sign an important letter supporting a doubling in funding for hepatitis B and C programs in the Fiscal Year 2016 appropriations bill (see text of letter below). This is the same increase in funding that President Obama recommends in his proposed budget, which was released last month. The deadline for Representatives to sign the letter is end of day, March 19, 2015.

This is an extraordinary opportunity to ask our House Representatives for leadership in the fight against the hepatitis B and C epidemics. The more signatures on this letter, the better chance of securing badly needed funding to expand testing, linkage to care, surveillance, and other vital services.

Please take a few minutes before March 19th to call your House Representative’s office in Washington, DC and ask/him to sign this letter.

How you can help:
You can reach your Representative through the Congressional Switchboard at (202) 224-3121.
Ask to be connected to your Representative. Once you are connected to the office, ask to speak to the staff person who handles health care issues. Whether you speak to that person live or leave a voicemail, tell them (1) your name, (2) where you live and that you are a constituent, (3) that you would like the Representative to sign the “Dear Colleague” letter from Representatives Honda, Johnson, and Chu supporting increased funding for viral hepatitis and (4) a brief message why this issue is important to you. Tell them they can sign the letter by contacting Helen Beaudreau in Representative Honda’s office or Scott Goldstein in Representative Johnson’s office.

Text of “Dear Colleague” letter:

The Honorable Tom Cole
Subcommittee on Labor, Health and Human Services
United States House
Washington, D.C., 20515

The Honorable Rosa DeLauro
Ranking Member
Subcommittee on Labor, Health and Human Services
United States House
Washington, D.C., 20515

Dear Chairman Cole and Ranking Member DeLauro:

As you begin deliberations on the Fiscal Year 2016 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill, we respectfully request that you allocate $62.8 million for the Division of Viral Hepatitis (DVH) at the Centers for Disease Control and Prevention (CDC), consistent with the President’s FY2016 budget request and an increase of $31.5 million over the FY2015 level.

The CDC’s 2010 professional judgment (PJ) budget recommended $90.8 million annually from FY2011-FY2013, $170.3 million annually from FY2014-FY2017, and $306.3 million annually from FY2018-FY2020 in order for DVH to comprehensively address the viral hepatitis epidemics. While past increases have been helpful, these have only been small steps toward building a more comprehensive response to viral hepatitis. Our recommendation of $62.8 million is in line with the needs determined by the PJ and the goals of the Viral Hepatitis Action Plan, but pales in comparison to the CDC’s PJ. These increased funds would be used to:
  • Expand adoption of CDC/United States Preventive Services Task Force (USPSTF) recommendations for hepatitis B and hepatitis C testing and linkage to care by health systems and providers to prevent disease and premature death;
  • Develop monitoring systems and prevention strategies to stop the emerging hepatitis C epidemic among young persons and others at risk;
  • Enhance vaccination-based strategies to eliminate mother-to-child transmission of hepatitis B; and
  • Strengthen state and local capacity to detect new infections, coordinate prevention activities, provide feedback to providers for quality improvement, and track progress toward prevention goals.
The need to enhance and expand these prevention efforts is growing more urgent. The hepatitis B virus (HBV) and hepatitis C virus (HCV) are the leading causes of liver cancer – one of the most lethal, expensive and fastest growing cancers in America. As many as 5.3 million people in the U.S. are living with HBV and/or HCV and 65-75% of them are undiagnosed. Approximately 175,000 veterans are living with HCV, and at least 30,000 of them have liver cirrhosis (scarring of the liver); yet as many as 40,000 veterans may be infected with HCV and not know it. Without an adequate comprehensive surveillance system, these estimates are only the tip of the iceberg. There are at least 18,000 deaths annually attributed to hepatitis-related liver disease or liver cancer, and hepatitis is the leading non-AIDS cause of death in people living with HIV. In fact, nearly 25 percent of HIV-positive persons are also infected with HCV and nearly 10 percent with HBV.

These epidemics are particularly alarming because of the rising rates of new infections and high rates of chronic infection among disproportionately impacted racial and ethnic populations. They present a dramatic public health inequity. For example, Asian Americans comprise more than half of the known hepatitis B population in the United States and, consequently, maintain the highest rate of liver cancer among all ethnic groups. American Indian/Alaska Native communities have the highest incidence rates of HCV among all races and ethnicities. HCV is twice as prevalent among African Americans as among Caucasians. Additionally, African American and Latino patients are less likely to be tested for HCV in the presence of a known risk factor, less likely to be referred to treatment for subspecialty care and treatment, and less likely to receive antiviral treatment. Recent alarming epidemiologic reports indicate a rise in HCV infection among young people throughout the country. Some jurisdictions have noted that the number of people ages 15 to 29 being diagnosed with HCV infection now exceeds the number of people diagnosed in all other age groups combined. Alarmingly, 35 out of 41 responding states reported increases in persons newly infected with HCV from 2010-2012.

Further, the “baby boomer” population (those born between 1945 through 1965) currently accounts for three out of every four cases of chronic HCV. As these Americans continue to age, they are likely to develop complications from HCV and require costly medical interventions that can be avoided if they are tested earlier and provided with curative treatment options. It is estimated that this epidemic will increase costs to private insurers and public systems, such as Medicare and Medicaid, from $30 billion in 2009 to over $85 billion in 2024, and account for additional billions of lost productivity due to the millions of workers suffering from chronic HBV and HCV. Over the last three years, CDC and the USPSTF have worked to align their recommendations for hepatitis screening, recommending screening vulnerable groups for HCV and one-time testing of all baby boomers.

We appreciate the Committee’s support for viral hepatitis prevention, in particular the increased support to prioritize the identification of people living with HBV and HCV who are unaware of their status. We strongly encourage you to sustain your commitment this year. We have the tools to prevent the major causes of liver disease and liver cancer – a hepatitis B vaccine and effective treatments that reduce disease progression, new diagnostics for HCV and treatments that increase cure rates to over 90%, and even more medical advances for HBV and HCV in the research pipeline. Making this relatively modest investment in the prevention and detection of viral hepatitis represents a key component in addressing a vital public health inequity and will ensure more Americans receive the appropriate health care, strengthen our public health infrastructure, and combat the devastating and expensive complications caused by viral hepatitis.