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When Can Hepatitis B Patients Stop Taking Antivirals? Experts Finally Have Some Answers

Image courtesy of foto76 at FreeDigitalPhotos.net
Image courtesy of foto76 at FreeDigitalPhotos.net

By Christine Kukka

With the help of antivirals, many patients today have undetectable viral load (HBV DNA), a relatively healthy liver and cleared the hepatitis B “e” antigen (HBeAg). So when can they consider stopping their daily entecavir or tenofovir pill?

For years, experts have admitted the endgame of antiviral treatment has been “ill-defined.” While antivirals reduce viral load and the risk of liver damage, they rarely cure people. Recently, after years of observing patients and with the help of better diagnostic tools, experts are getting better at identifying when might be safe to stop.

Historically, in addition to reducing viral load to undetectable levels, the goals of antiviral treatment were:

  • Triggering HBeAg seroconversion: About 21 percent of HBeAg-positive patients with liver damage treated with either tenofovir or entecavir for 12 months are able to lose the hepatitis B “e” antigen (HBeAg) and develop the “e” antibody (HBeAb). This HBeAg “seroconversion” indicates the immune system is fighting the infection and slowing viral replication.
  • And reducing liver damage and even clearing the hepatitis B surface antigen (HBsAg): About 1-3 percent of patients treated with antivirals lose HBsAg after years of treatment. This is called a “functional cure.” Unfortunately, if you have HBeAg-negative hepatitis B, only 1-2 percent of you will lose HBsAg after five to eight years of antiviral treatment.*

If you are among the lucky few who achieve HBeAg seroconversion or clear HBsAg, when is it safe to stop your daily antiviral? Here are the newest guidelines detailing when it may be safe to stop from the 2017 European Association for the Study of the Liver (EASL).

Image courtesy of Taoty at FreeDigitalPhotos.net
Image courtesy of Taoty at FreeDigitalPhotos.net

When is it safe to stop antivirals after you’ve achieved HBeAg seroconversion? Stop too early, and HBeAg can reappear. EASL recommend non-cirrhotic patients who experience HBeAg seroconversion and continue to have undetectable HBV DNA for 12 months longer can stop antivirals, as long as there is frequent monitoring after.

When is it safe to stop if you have HBeAg-negative hepatitis B and have undetectable viral load after years of antiviral treatment? EASL guidelines say non-cirrhotic, HBeAg-negative patients who have had at least three years of antiviral treatment, undetectable viral load and no signs of liver damage can stop treatment, as long as there is frequent follow-up monitoring.

When is it safe to stop antivirals if you’ve lost HBsAg? EASL recommends stopping antivirals after losing HBsAg, even if a patient does not develop the hepatitis B surface antibody (HBsAb). Recently, experts have decided that patients who lose HBsAg may be “functionally” cured, even if no surface antibodies appear.

Researchers also have a new way to determine if it’s safe for patients who had HBeAg seroconversion to stop antivirals – by measuring their HBsAg levels. The lower your HBsAg levels, the more likely you are to maintain HBeAg seroconversion after you stop antivirals.

For example, patients may be HBeAg-negative and have no signs of liver damage, but if their HBsAg levels remain high, these patients remain at risk of reactivation and should continue antiviral treatment. (Read more about HBsAg quantification testing here.)

These antiviral “stopping rules” are still in development and are still frustratingly vague for many patients, but slowly researchers are developing tools and compiling more research in order to develop better guidelines when it’s safe to stop the daily antiviral treatment plan.

 *The statistics and recommendations cited are found at EASL2017 Clinical Practice Guidelines.

Shop Carefully for Lowest-Cost Hepatitis B Drugs When Signing Up for Medicare by Dec 7

Image courtesy of Witthaya Phonsawat at FreeDigitalPhotos.net
Image courtesy of Witthaya Phonsawat at FreeDigitalPhotos.net

By Christine Kukka

With the cost of healthcare and prescription drugs soaring, it’s important for people age 65 and older who live with hepatitis B to shop for Medicare coverage carefully before they sign up by Dec. 7, especially if they need costly antivirals and frequent lab tests.

As we age, our immune system weakens and loses its ability to suppress our hepatitis B infection. We may notice a gradual rise in our viral load (HBV DNA) and/or our liver enzymes (ALT/SGPT), which indicate liver damage.

We may also experience other medical conditions, such as cancer or arthritis that require immune-suppressing drugs that unfortunately enable our hepatitis B to reactivate. To lower our viral load and reduce the risk of liver damage, we’ll need antivirals, and they’re not cheap. Medicare recipients must shop carefully for the most affordable plan. Here are the three key Medicare coverage areas:

Part A is free. It covers most of hospital and nursing home care, however you still pay for some deductibles and copays. For example, if you go to a hospital for a liver biopsy, you will pay a portion of that cost if you only have Part A.

Part B covers doctor visits and lab tests, and it costs about $150 a month and increases based on your income. There is a deductible of $166 a year and you pay a 20 percent copay for many services. Instead of selecting Part B, you may instead choose a private or employer-sponsored Medicare advantage plan.

Part D covers your drug costs and it’s optional, but if you’re on antivirals, interferon or other medications, it important that you have drug coverage under this or a Medicare Advantage plan (such as HMOs or PPOs) that cover all Medicare benefits including drugs. If you have a low income, you may be eligible for assistance to help pay for your Part D plan.

Image courtesy of Ambro at FreeDigitalPhotos.net
Image courtesy of Ambro at FreeDigitalPhotos.net

It is critical that you shop around before selecting a drug plan. Just like the Affordable Care Act’s Health Exchange, there will be fewer drug programs available to you to choose from this fall. You also need to make sure your plan:

  • Has your specialist or primary care doctor and lab in its network, and
  • Offers the lowest copay for the drugs you need.

When you shop for a Medicare Part D drug plan: You select from plans based on where you live and what drugs you take. For example, if you’re shopping for a drug plan to cover tenofovir (Viread), plan prices can vary by more than $1,000 a year. Comparison shopping is critical!

To find a plan, go to Medicare Plan Finder and enter your zip code and select the drugs you expect to take during 2017. It’s a good idea to sit down with someone who can help you during your search or call a Medicare representative at 1-800-633-4227 (1-800-MEDICARE) as you search online.

The drug plans have different pricing tiers for prescription drugs, a simple generic antibiotic can be less expensive Tier 1 or 2 drug, while a brand name drug like tenofovir can be a more costly Tier 4 or 5 drug.  Without Part D drug coverage, a year’s supply of tenofovir could cost about $12,880 a year. Before you select a plan, here are some suggestions:

Check the fine print: Make a list of all of your medications and check how much each plan reimburses for each. Search for any “hidden extras” you’ll have to pay if you’re using a brand name or specialty drug. Some plans have separate, high copays for brand-name and specialty drugs, which can include hepatitis B drugs.

If you need a brand-name maintenance drug (like tenofovir) that isn’t available as a generic yet, you may want to focus only on plans that have the lowest co-pay for that drug. Your other drug needs may be less expensive, generic cholesterol- or blood pressuring-lowering medication.

Consider both the monthly premium and the copay. You must consider both costs when searching for the best plan.

Does the plan require you to use a specific pharmacy? An increasing number of plans require you to use a preferred pharmacy, or even a mail-order option. Factor in convenience and your premium and copay.

Can you get discounts because of your income? You may be eligible to get all or part of your Medicare premiums, deductibles or co-payments covered if you have limited income and resources. Individuals with incomes less than $17,820 and assets less than $13,640, and couples with incomes less than $24,030 and assets less than $27,250, qualify for subsidies. You also may qualify, even if your income is higher, if you support other family members who live with you. Call Social Security at 800-772-1213 for information.

The good news: The dreaded “doughnut hole” or the gap during which you must pay a higher percentage of your drug costs, continues to shrink next year and will be completely phased out in 2020.

Even if you’re happy with what you had last year, do your research: Kaiser Foundation research found only 10 percent of Medicare enrollees switched plans between 2007 and 2014. Those who switched on average saved about $16 a month just on premiums. It pays to shop around.

Like your doctor? Make sure he/she is in your provider networks: Advantage plans can shuffle their provider and hospital networks each year. And their provider lists may not be included in Medicare’s online Plan Finder or the basic plan documents.

Contact your plan and ask for their 2017 provider directory before making a decision. Check if specialty facilities like university-based teaching medical centers are included. Or, call your physician and ask if they will be in the plan you’re considering — and, if not, where they’re going. And be aware: While doctors can leave a plan in the middle of a year, you typically can’t.

Do You Forget Your Daily Hepatitis B Antiviral? Why We “Forget” Our Meds, and How to Improve Compliance

Image courtesy of foto76 at FreeDigitalPhotos.net
Image courtesy of foto76 at FreeDigitalPhotos.net

By Christine Kukka

Your daily antiviral pill can save your life when you have liver damage from chronic hepatitis B. Entecavir or tenofovir (Viread) quickly reduce the amount of virus in your liver and the damage it causes.

All you have to do is take it. Every day. But 20 to 30 percent of prescriptions are never filled, and about 50 to 70 percent of us don’t take our medications as prescribed. When we stop taking our daily antiviral, hepatitis B can reactivate and threaten our health.

In one study, researchers provided 100 hepatitis B patients with an entecavir pill dispenser that monitored whether or not they took their daily pill over a 16-week period. They found about 70 percent of patients took their antiviral pill as prescribed more than 80 percent of the time — which means these patients were “medication compliant.”

Those who missed taking their antivirals more than 20 percent of the time–and were “noncompliant”–tended to be younger and had indifferent attitudes about whether or not the antiviral was really needed or would work.

Image courtesy of Carlos Porto at FreeDigitalPhotos.net
Image courtesy of Carlos Porto at FreeDigitalPhotos.net

According to experts, whether we are “medication compliant” or not depends on how much trust we have in our doctors. If we like our healthcare provider and feel comfortable asking questions, we’re much more likely to take our medication on time. And, if our friends and family support and encourage us, we’re even more inclined to take our medication as prescribed.

“The trust I have in my doctor is a big factor,” said a member of the Hepatitis B Support List. “It is important to find a doctor who understands hepatitis B and is willing to work with me in terms of explaining what the options are and what the best approach is in managing my condition.”

“I know antivirals won’t cure me,” another email list member wrote, “but I’m committed to staying healthy and productive as long as God permits.” Continue reading "Do You Forget Your Daily Hepatitis B Antiviral? Why We “Forget” Our Meds, and How to Improve Compliance"

Taking Antivirals Long-Term for Hepatitis B? Should You Worry About Bone Loss?

Image courtesy of Sira Anamwong at FreeDigitalPhotos.net.
Image courtesy of Sira Anamwong at FreeDigitalPhotos.net.

By Christine Kukka

To prevent liver damage and cirrhosis and reduce the risk of liver cancer–especially in older patients who’ve had hepatitis B for decades–doctors often prescribe long-term antiviral treatment. But some antivirals cause minor bone loss, which poses a problem for older patients with osteoporosis.

According to experts, the risk of bone loss from long-term antiviral treatment is low, and in fact some antivirals do not cause any bone loss at all. But if you are starting antivirals at an older age, or if you have been on antivirals long-term, experts recommend you monitor your potassium and vitamin D levels and regularly test for bone loss in the hip area so you know if you are experiencing bone loss and need a calcium or vitamin D supplement. Continue reading "Taking Antivirals Long-Term for Hepatitis B? Should You Worry About Bone Loss?"

Can People with HBeAg-Negative Hepatitis B Ever Stop Taking Antivirals?

Image courtesy of rakratchada torsap, at FreeDigitalPhotos.net.
Image courtesy of rakratchada torsap, at FreeDigitalPhotos.net.

Medical guidelines suggest that individuals with HBeAg-negative hepatitis B with signs of liver damage face an “indefinite” or even lifetime commitment to taking daily antiviral pills.

In this week’s blog, we explore when—if ever—individuals with hard-to-treat HBeAg-negative hepatitis B can ever stop taking antivirals.

First of all, what is HBeAg-negative hepatitis B? Many people infected with hepatitis B at birth and who remain infected into their 40s, 50s or 60s, develop HBeAg-negative hepatitis B. Researchers believe that over time the virus mutates to evade the immune system. Though individuals may have lost the hepatitis B “e” antigen (HBeAg) and developed the “e” antibody, this mutated virus develops the ability to keep replicating despite the loss of HBeAg. And this mutated virus is capable of putting people at higher risk of liver damage.

Generally, doctors recommend treatment to HBeAg-negative patients when their viral load exceeds 2,000 IU/ML and their ALT liver enzyme levels, which rise when liver cells are damaged, are even moderately elevated. (Normal ALT levels are less than 30 for men and 19 for women.)

The most common antiviral treatments are either entecavir (Baraclude) or tenofovir (Viread). These two are considered the most powerful at quickly reducing viral load (HBV DNA) and have a very low risk of causing drug resistance, which is critical considering the long-term treatment required by HBeAg-negative patients.

But can individuals with HBeAg-negative hepatitis B ever stop treatment? Antivirals are expensive, without insurance tenofovir costs about $1,000 a month and generic entecavir costs about $407 in the U.S. Additionally, long-term antiviral treatment can cause bone loss.

Late last year, hepatitis B experts with the American Association for the Study of Liver Disease (AASLD) tackled this question and reviewed recent studies that followed HBeAg-negative hepatitis B patients who stopped antivirals. They found that even when these patients enjoyed two years of undetectable viral load and normal ALT levels during treatment, when they stopped only half of them were able to maintain a low viral low (below 2,000 IU/mL) and normal ALT levels.

The risk of dangerous “flares” after stopping treatment, “requires careful weighing of potential for harm and benefit,” the experts wrote. This is important because many HBeAg-negative patients are older and more vulnerable to liver damage and cancer.

In their new recommendations, AASLD experts make clear their findings are “conditional” and the quality of evidence found in the studies they reviewed is “low.” However, this is what they tentatively recommend:

  • Stopping treatment, “may be considered in persons who have (lost) the hepatitis B surface antigen (HBsAg). However, there is currently insufficient evidence to definitively guide treatment decisions for such persons.”
  • And, anyone who stops antiviral therapy should be monitored every three months for at least one year to see if their viral load rebounds or if they have signs of liver damage, including ALT flares.

Given the knowledge-gap about the long-term health consequences of HBeAg-negative hepatitis B, more research with longer durations of monitoring are needed, experts recommended. “Alternative treatment strategies for patients on long-term antiviral therapy, such as adding or switching to (pegylated interferon), warrant further study,” they concluded.

 

I’ve Lost the Hepatitis B “e” Antigen (HBeAg), So When Can I Stop Treatment?

Image courtesy of Naypong at FreeDigitalPhotos.net
Image courtesy of Naypong at FreeDigitalPhotos.net

Eighteen years ago, doctors started treating hepatitis B patients with antivirals and today liver specialists have a wealth of knowledge about how these drugs stop the virus from replicating and reduce viral load. But one thing they’re still not certain about is when patients can safely stop taking their daily antiviral pill.

In this week’s blog, we’ll explore when experts think it’s safe for patients, who have lost the hepatitis B “e” antigen (HBeAg) during antiviral treatment, to stop . Next week, we’ll look at when it’s safe for patients who were already HBeAg-negative when they began antiviral treatment to stop.

Today, doctors prescribe one of two antivirals—either entecavir (Baraclude) or tenofovir (Viread). Among the antivirals developed since 1998, these two are considered the most powerful in quickly reducing viral load (HBV DNA) and they carry the lowest risk of drug resistance. Doctors usually prescribe antivirals when our viral load is elevated and we have sign of liver damage–indicated by elevated liver enzymes (ALT or SGPT).

Antivirals quickly knock down viral load, which in turn is believed to lower our risk of liver damage and cancer. But antivirals work for only as long as we take them. When we stop, the virus usually reactivates although this is very rarely fatal or results in a liver transplant. Studies show that at least 78 percent of people who stop antivirals have an increase in viral load, 44 percent have a rise in ALT levels indicating liver damage, and among those who lose HBeAg during treatment, at least 9 percent experienced a return of HBeAg.

But what about individuals who take antivirals for long periods and enjoyed years of undetectable viral load, no signs of liver damage, loss of HBeAg, and development of the “e” antibody? Can they stop? After all, antivirals are expensive. Without insurance, a month’s supply of tenofovir costs about $1,000 and generic entecavir costs about $407 in the U.S., not to mention possible side effects such as bone loss or reduced kidney function with tenofovir..

Late last year, hepatitis B experts from the American Association for the Study of Liver Disease (AASLD) tackled this question and reviewed recent studies that followed patients who stopped antivirals after losing HBeAg. They found no clear answers and made clear their recommendations were “conditional” because the quality of evidence found in the studies was “low.” But here is what they recommend for patients who lost HBeAg during antiviral treatment and now have normal ALT levels:

  • Experts “suggest” that adults who don’t have cirrhosis (severe liver scarring) who lost HBeAg and developed “e” antibodies may stop treatment after a minimum of 12 months of normal ALT levels and undetectable viral load.
  • However, they recommend a longer “consolidation” treatment period might be better to reduce patients’ risk of relapse and a return of HBeAg after treatment stops. They suggested that an alternative approach would be to stay on antivirals until patients lose the hepatitis B surface antigen (HBsAg).

Decisions about how long to stay on antivirals require careful consideration of health risks and benefits, they wrote, including risks of relapse, liver damage, and liver cancer. Other considerations include the cost of treatment, the risk of developing drug resistance if people stop antivirals intermittently, and other side effects.

Anyone who stops taking antivirals, they advise, should be monitored frequently – at least every three months — for at least one year for liver damage and resurgence of viral load. Anyone with cirrhosis should continue treatment indefinitely because of their high risk of liver cancer.

For now, the message appears to error on the side of caution and continue on antivirals until you have cleared HBsAg for a prolonged period of time. Clearly this decision is one you must discuss carefully with your doctor.

In next week’s blog, we examine how long people who were HBeAg-negative when they started antivirals should remain on treatment.

Shop Carefully for the Best Insurance Plan When You Have Hepatitis B

Image courtesy of digitalart at FreeDigitalPhotos.net
Image courtesy of digitalart at FreeDigitalPhotos.net

With the cost of health care and prescription drugs soaring, it’s important to choose health insurance carefully when you take hepatitis B medications and need frequent check-ups and lab tests.

In the next two months, Medicare recipients, people who get insurance through their jobs and consumers buying coverage through the Affordable Care Act (Obamacare) will be selecting insurance plans during open enrollment.

If you take antivirals or interferon and have frequent lab tests and doctor visits, it’s important that you select the plan that:

  • Has your specialist or primary care doctor and lab in its network,
  • And offers the lowest copay for the drugs you need.

Continue reading "Shop Carefully for the Best Insurance Plan When You Have Hepatitis B"

HBV Journal Review – June 2015

ChrisKHBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
 latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

  • HBV Liver Cancer Requires Aggressive Treatment from the Start
  • Experts: Treat Cirrhotic Patients, Even if Viral Load Is Low
  • Some Patients Can Safely Stop Antiviral After Four Years
  • Tenofovir Safe and Effective in Pregnant Women with Drug Resistance
  • Researchers Discover Why Children Become Chronically Infected
  • Expert Recommends Treatment for Mental Confusion from Cirrhosis
  • Antivirals Increase Survival After Liver Cancer Treatment
  • HBV Patients with Diabetes Have a Higher Risk of Liver Cancer
  • Long-term Antiviral Use Increases Hip Fracture Rates Slightly
  • Second Vaccine Series May Be Needed for Children with Celiac Disease
  • Researchers Find HBV B Strain in Cuba Did Not Come from Africa

Continue reading "HBV Journal Review – June 2015"

HBV Journal Review – May 2015

ChrisKHBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
 latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

  • New Treatments Targeting Hepatitis B Start Clinical Trials Soon
  • Experts Urge Doctors to Screen Pregnant Women for Both Hepatitis B and High Viral Loads
  • Using Antivirals Early in a Pregnancy Reduces Infection of Newborns
  • Some Pregnant Women in U.S. Still Not Getting Screened for HBV and STIs
  • High Viral Loads in Men Increase the Amount of HBV DNA in Their Sperm
  • Despite Vaccine, Rural States See Rise in Hepatitis B Due to Heroin Use
  • More Than Half of Young Drug Users Are Not Vaccinated Against Hepatitis A and B
  • Shorter Vaccination Schedule Works to Prevent Infection Among Drug Users
  • Generic Entecavir Could Treat All Patients Worldwide for $36 a Year
  • Reformulated Tenofovir Appears Better at Fighting Infection in Liver Cells
  • Another Report Calls for Doctors to Screen All Patients for HBV Before Starting Chemotherapy
  • Study Confirms Aflatoxins Increase Liver Cancer in Hepatitis B Patients

Continue reading "HBV Journal Review – May 2015"

HBV Journal Review April 2015

ChrisKHBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
 latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

  • Half of Patients with HBV Genotype C Will Lose HBsAg
  • Five-year Study Shows Tenofovir Dramatically Improves Cirrhosis
  • Tenofovir Also Effective Against Adefovir and Multi-drug Resistance
  • Tenofovir Is Effective in Pregnant Women Who Have Resistance to Other Drugs
  • Estimates of Liver Cirrhosis in the U.S. Jump 50%
  • Taking Antivirals for Three Years After Undetectable Viral Load Reduces Relapse Risk
  • Study Finds Antivirals Can Replace Costly HBIG after Liver Transplant Surgery
  • Hospitalized Hepatitis B Patients Have Higher Death Rates and Longer Stays Than Hepatitis C Patients
  • Small Study Finds Psoriasis Treatment May Not Reactivate Hepatitis B
  • Emulsion Made from Ginkgo Leaves Shows Promise Against Hepatitis B
  • Experimental Treatment Boosts the Immune System and Slows Viral Replication
  • HIV-HBV Coinfected Patients Have High Rates of Hip Fractures

Continue reading "HBV Journal Review April 2015"