Deciding when to start treatment

My name is Elnext I’m so glad to be part of this forum.
In November 2021, I was diagnosed with Chb. My ultrasound was okay but i don’t know if my ALT and AST below is okay too. I am in Nigeria I can’t afford DNA test it is too costly here. Things are very expressive in Nigeria.
I finally found a pharmacy were i got Tdf (mylan).
Can I start taking this drug now, I have waited long for this drug. I don’t really know how my liver is doing now.
I am also concerned that my spleen has grown large I can feel it.
I have waited long for this. We are already in October now. I can’t wait anymore since I have the drug now.

ALT 41IU/L
AST 27IU/L
Date of test March 2022

Do you have any thing to say about this drug

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I am about to go see my doctor but I have a followup question. With low viral load etc, apart from the usual side effects of drugs and cost issues, is there evidence pointing towards it being more advantageous to begin treatment even when you don’t meet WHO guidelines? Others can bear in too. If I knew starting treatment aids in stopping progression, I would consider to start right away. Anyone who was confronted with such a decision?

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@CNN i have the same question.

I have an appointment next Friday with a liver specialist because I don’t know if being on medication is better. I read prior Doctor @Suwang88 was advised to be on TAF with a low viral load (~2000iu) and no raised ALTs and @availlant recommends it even with a low viral load because of evidence of DNA integration. But the guidelines (which my doctor - gastroenterologist- follows) don’t recommend it so I have a follow up meeting with a different doctor he recommended for me as a second opinion.

But I’m confused.

Dear @Albasil808 @9ext @CNN,

Thank you for raising what I think is a very important question: should I start antiviral earlier than is recommended by current guidelines?

These guidelines are there for a reason and they are backed by clinical trial evidence as well as cost-effectiveness studies. These are generally conservative (only change when there is strong evidence, e.g. randomised control trials with detectable easily measured biomedical benefits). However, there is also recent data showing that things like HBV DNA integration occur very early on, there can be inflammation even with normal ALTs, etc. that suggest earlier treatment may have benefits later on in life. There are also likely some benefits in limiting onward transmission.

The recommendations may not change until there are enough clinical trials to show these benefits (which will likely need to look at many many people and/or take a long time), but many people are suggesting earlier treatment might be better based on the information we know now.

In the meantime while this discussion takes place, you want to make a decision now. It is very difficult for me to tell you specifically what to do because the risks and benefits are different with each person. There are particular issues that are important to keep in mind:

You have to keep taking it. You will need to keep taking the antivirals for what might be many years or decades; it can be very dangerous and even deadly to stop taking it (even if you are feeling good) unless under close monitoring by your doctor. This means you need to make sure you can afford it and it is available where you are. This might get complicated when you move to different countries. If you don’t fall under the current guidelines, the costs may not be covered by insurance or subsidies.

Taking antivirals doesn’t mean stopping your monitoring. It is still very important that you undergo monitoring to see if the antivirals are working, and if there are other causes of liver disease that might be building on top of your hep B. It is also worthwhile checking out your viral markers to see what stage your infection is in.

Side effects. Though these are very safe drugs, you can see from the other threads, some people do experience some side effects. I myself haven’t, but we do hear from people who do.

I also want to rush to say, do not take any of these (or others’) posts here as medical advice. We are simply here to provide information. Any decision should be taken between you and your health professional.

Thomas

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Hi Ccheng, I have ~2.8cm hemangioma on the right lobe of my liver since 1997 when it was firs time discovered. It stays pretty much the same size for many years. I know some other people for years, who have a multiple of hemangiomas of different size and are doing ok so far. It is more common and benign condition, then I realized before.

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Hi- I posted a year ago about my young adult daughter who contracted HBV as an infant, likely from her birth mother in Asia. I have been having trouble getting gastro/hepatologists to seriously consider antivirals because of her young age, and because paradoxically her ALT and DNA levels seesaw, sometimes in opposite directions.

  • Her DNA in the past 5 years has varied from a low of 700 to a current 4300.
  • Her ALT has varied from 49 to a current 23 (it seems to be lower with one particular lab).
  • Fibroscan score of 4.4 and “0” fibrosis. The ultrasound showed fatty liver and “probable fibrosis,” but no lesions. Her doc said the fibroscan is more accurate about the fibrosis.
  • She has been e-antigen negative and e-antigen positive for about 10 years, after gaining and losing clinically significant surface antibodies in her teens.
  • Her quantitative surface antigen (drawn for the first time after I pressed for it) was more than 14,000 !!!

Based on these labs, her current doc is willing to start antivirals. I have a few questions:

  1. He would like to do another liver biopsy first, just to get a better picture of her liver. Her previous biopsy around 4 years ago was normal and showed no inflammation. Would anything be gained by putting her through this again? She is resistant to it and it is of course not risk free.

  2. I’m concerned about the extremely high quantitative surface antigen level. (It is odd because the lab took 6 weeks to deliver the result, so I wonder if it is accurate.) Does the SAg titer track the DNA level (which was 1200-1600 in the past year, and now jumped to 4300)?

  3. Once started, we understand that she will likely have to take antivirals for decades. Is there any evidence that antivirals will not be effective in reducing the odds of HCC or fibrosis with a surface antigen titer that high? I’ve tried to research studies online, but haven’t found anything directly on point.

Sorry about the long post. Any thoughts will be so appreciated.

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Dear @EBAB,

Welcome back and thanks for your questions. You are understandably concerned, but it looks like you are doing the right things with your daughter maintaining monitoring.

  1. Inflammation and fibrosis can occur within those 4 years. But do consider whether it would change the decision either way to start antivirals.
  2. It is common for young people to have high HBsAg levels (myself included). HBsAg titre does not necessarily track with HBV DNA levels (in any case, your daughter’s is still fairly low at 4300).
  3. Yes, antivirals do reduce the odds of HCC and fibrosis even with high HBsAg levels. Most people’s HBsAg level does not change during treatment, but it does almost always lower the risk of liver disease progression.

Hope this helps,
Thomas

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Thomas, as usual your responses are clear and extremely helpful. Thank you so much. I’m relieved that antivirals can still be protective despite high HBsAG levels, and that younger people tend to have higher levels anyway. I will ask her doc for more clarity on the goal of the repeat liver biopsy.
I read all the posts religiously and can’t imagine what I would do without the support of the science experts and community members who share their knowledge and experiences on this board. Thanks again.

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Hi everyone, I hope you are all doing well, and Happy New Year!!

My husband who is a 36 year-old hep B positive just got his lab results back, and this is what the doctor said: “The liver enzymes are as follows: ast 22, alt 30 alk phos 140. The alkaline phosphatase is elevated at 140. The hbv dna 4000 and still recommend treatment. The CBC was normal.”

My husband’s lab results have been in that range for years, with the DNA fluctuating up and down. We talked to the doctor about Vemlidy, but we are worried about the cost even with insurance, so they are helping us find out. I guess what I wanted to ask is:

  1. If we start on something less expensive now, such as Viread or TDF, can we switch to Vemlidy later if it ever becomes less expensive? What are the cons of switching antivirals we should know about?

  2. I know Vemlidy is the newest drug of choice with the least side effects. If we start on something else now, what are the possible side effects we should be aware of in the long terms? My husband is relatively healthy, besides hep B for now he does not have any other comorbidities.

  3. Do antivirals interfere with male fertility. We are hoping to conceive so that is a big factor for us to consider…

Also does anyone has any idea how much Vemlidy would cost with United Healthcare insurance, just so I have an estimate number while we wait on the doctor. I also want to say I am really thankful for our community. Navigating through the disease process and making decisions about it are very difficult at times, but I consider my husband and myself lucky to have resources to turn to, made possible by members of this group. Thank you all so much!

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Hi @Tran-ng ,

I am not a science expert or a medical professional but I do have some personal experience in regards to your questions. That in mind, please take my answers as my personal conclusions based solely on my own experiences. I am sure the experts will correct anything wrong or supplement with further information.

  1. About two years ago, my hepatologist switched me from Vemlidy to Entecavir and then to Viread (TDF) and then back to Vemlidy all within about a year’s time. We were trying to lessen some of the side-effects but there were no significant changes from one antiviral to another for me. From my experience, I don’t think switching antivirals will cause any major issues generally. However, this needs to be done under diligent monitoring with your doctor. I had to do bloodwork and other labs a lot more frequently to make sure there were no spikes or other issues with my numbers.

  2. My answer to question one, sort of answers this question. I don’t think there will be much difference in side-effects from one antiviral to another, especially since your husband is generally healthy and still young (I know young is relative). Of course there is always the potential of side-effects that are listed for each medication but I don’t think that switching would cause any more side-effects (again, this is just general, there are always specific individual situations). The benefit with Vemlidy is that it is easier on the kidneys and there is less chance of bone degeneration as you get older and also that there is less overall drug in the dosage? I don’t know if I am saying that right.

  3. I can’t speak to this other than to say that I am sure that there are many men within this community that are on antivirals and have had children. Maybe some of them can pitch in here and share their experience. Also, the experts can give an expert answer here.

As to your final question, there are some variables within this equation that only you would know the answers to. So there is no single set answer to give. I will assume you are in the U.S., so I will list those variables based on that premise.

  1. The company that you have for insurance isn’t a variable, but the type of insurance you are getting from said company is. So United, Kaiser, Molina, etc. only matters based on what insurance plan you have and what the plan entails. The major part being the drug coverage. Most plans have a drug co-pay of let’s say $5-$50 depending on the plan. Both ETV and TDF should be available with your standard drug co-pay.since there are generics.

  2. The drug portion of your health plan will have a formulary – which is a list of accepted drugs within that plan. You will notice that there are 5 different tiers of drugs within those plans. Since Vemlidy is still on patent, there are no generics available. Thus, you will probably have to get pre-authorization each year from your doctor and that will raise the tier level of drug and probably increase the co-pay. Some drug plans use a % instead of flat dollar amount. For example, Vemlidy can run from $1000-$1300 per month from the reports I get. So let’s say your plan covers 80%, then you would pay around $200-$260 per month. Here is a link to United Healthcare’s formulary and a lot more information specific to their drug plans: https://www.uhc.com/member-resources/pharmacy-benefits/prescription-drug-lists however, you will have to login with your member information to actually see the actual drug list that pertains to you.

  3. There are other factors that can come into play: Is the plan through work, is it a regular individual or family plan or is it through the ACA (Affordable Care Act) martketplace or through Medicaid or Medicare (probably not since he’s only 36). It can possibly even make a difference what state you reside in.

Hopefully you have flat dollar rate for drug coverage co-pay and Vemlidy isn’t in too high a tier. The best way to find out is to call the insurance company and ask them if Vemlidy is on their formulary and what tier level it falls under and how much would that tier level drug cost. If you find that it is still not cost effective for you, there is always the co-pay coupon program through Gilead: https://www.vemlidy.com/savings/co-pay-coupon-program

I hope this helps and I am so glad that this community is a support to you and your husband.

-Paul

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I’m taking Vemlidy for more than 2 years now and we have a beautiful >1 yr old daughter. Good luck!

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Hi @Tran-ng, great questions.

I think @PuallyHBV has answered these well. I just wanted to note that most people who take entecavir or TDF don’t report any side-effects, and they are effective at lowering the viral load.

Regarding fertility, there are studies from the HIV field that have shown tenofovir has no detectable effects on male fertility - Pre-exposure prophylaxis (PrEP) does not affect the fertility of HIV-1 uninfected men - PMC

Thomas

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I always value your contributions to the forum, but this was especially helpful to me. I’m at the point where I’ll most likely be starting treatment, and my new job will have me on United Healthcare–so thanks for the link. :slightly_smiling_face:

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@PuallyHBV @ThomasTu @mantana

I can’t thank you enough for how informative your response is! I really appreciate it!

We heard back from the pharmacy, and my husband’s insurance plan does not cover Vemlidy. Out of pocket it costs $1350 per month and that’s a little too much for us, so we’re gonna give Viread a go. Praying that it will work well for my husband and that everything will be okay. Hopefully in the near future they will have a generic version for Vemlidy.

I will keep updating about how it goes when my husband starts taking Viread. I hope it gives some more insights for anyone who is still considering whether to start treatment or not. It can be nerve wracking taking on a new daily routine, but we’re staying positive and praying for the best!

Again thank you so much for your responses! And Happy Lunar New Year (it’s this Sunday) to anyone who celebrates!! -All the best!

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Dear @Tran-ng,

Hope everything works out with you and keep us updated. Many of us have had to rearrange our lives to accommodate the daily meds and regular check-ups, so might be able to provide some tips.

Happy Lunar New Year to you too! All the best to you and your family.

TT

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Hi Dr Thomas Tu.
My HBV DNA is less than 20 IU/ML.
Hbsag > 1000.
ALT/AST normal.
Bilirubin direct high.
AFP increases by the day. It’s 30 now.
Itchy skin mostly the head. still the Dr would not let me start treatment. What could be the basis?

Hi @Wadani1,

It’s nice to have you back around. Please be patient and give Thomas a couple of more days and he will be able to respond. Although, he will have much to catch up on. So thank you for your patience in advance.

-Paul

Dear @Wadani,

Most (all?) guidelines do not suggest treating patients with HBV DNA less than 20 IU/mL. The antivirals act to reduce viral DNA load, but if yours is already so low there is not much further it can be reduced. This is likely the basis for not starting you on treatment.

Hope this helps,
Thomas

Outside of guidelines - was there any research showing taking antivirals early may reduce HBV DNA integration?

Hi wadani1
I am happy to hear from you. Avelant and Thomas have always argued here that it is important to be on treatment no matter your viral load.
I am concerned about your slightly elevated AFP because HCC does occur on bases of your viral load but once you have hepb you are at risk. When did you do ultrasounds? Kindly remember my AFP was 30 no undetectable viral DNA when I was found to have HCC. It’s good to catch it on time. I don’t mean you have it but with an elevated AFP, it’s wise to rule it out through Ultrasound test
Kinoti