Deciding when to start treatment

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

@Wadani1
I am NOT an expert…
question for u……Have you checked if you have a fatty liver?.. this could be the cause for the AFP elevation.
If I were u, I would definitely get Fibroscan with CAP score quickly…

If you are in N. America, I suggest you should consult with Dr Robert Gish…it’s worth time and money to talk to this Dr…

Thanks
Nas

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Dear @mantana,

Great question. There are a few recent papers suggesting that treatment with antivirals slowly reduces the number of integrations (~2-fold reduction each year under antivirals):

Thomas

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Please have a look at my results, should I really have to start treatment?

Hi dianawhite,
Welcome to the HepBcommunity platform. One of our experts will review your results and offer their advice or opinion on your question. Welcome once again. Bright.

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Expert opinion would be very much appreciated :pray:

Hi dianawhite
I have gone through your results and they look ok. However, these results are of tests done on 04.10.2022, exactly eight months ago. Remember you are already doing extra two months without surveillance. I would recommend you sent us current results and our community will review UpTo date results. Our review of what you have attached may not help because probably things have changed since then.
Moreover, welcome to this great community and let’s walk together so that we can walk far.
Kinoti

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Hi, I appreciate your input. I had more recent blood tests that had similar results. In fact all my results from last couple of years have been in similar range. What would you say by looking at these test results?

Dear @dianawhite,

Starting treatment should be a decision that you and your doctor make together, so it is difficult for us on the forum to tell you either way that you have to start treatment. But you should have the best data available to you.

There is increasing data showing that patients that don’t fit into any particular textbook “phase” (e.g. inactive carrier, immune tolerant, etc.) can:

Your ALT is above some normal thresholds (20 in some countries).

That said, the decision to start treatment requires more than just this data; it also should take into account your particular situation and decision about your own body.

Hope this helps a bit,
Thomas

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