Managing HIV/AIDS Therapy in Special Populations How should patients with Hepatitis B coinfection be treated?
	Enlarged Version of Graphics Below	Dr. Bellos (OC): Approximately 85% of the patients with hepatitis B are going to be able to clear their infection on their own, whereas about 15% of the patients, again, roughly, are going to need some form of therapy in the future. Dr. Kwakwa (OC): We are seeing an increase in the number of patients that we are seeing who have hepatitis B-active hepatitis B infection. I will say that about 50% of these patients are of African descent, and newly immigrated. This is a population that makes up about 10% of who we see. Dr. Wohlfeiler (OC): Virtually all of the antiretrovirals that we use are metabolized through the liver. And so if you have an already compromised liver, you can see a lot more problems with liver toxicity after a patient goes on antiretrovirals. And there are a number of other drugs that we use frequently in our patients that may not be antiretrovirals, but are also metabolized through the liver, whether they're antifungals or statins or whatever it might be. So anything that's affecting the liver at baseline becomes a particular problem for patients who need HIV treatment. Dr. Bellos (OC): With hep B, I think that the treatment issues are actually not as significant as they can be with hepatitis C. Fortunately, tenofovir has been released, and it does have activity against hepatitis B, and so we are able to essentially place patients on dual therapy at the time of their diagnoses with 3TC or Epivir and tenofovir, and we have two drugs on board for the hepatitis B, and in my experience, with those two drugs on board, those patients will do relatively well. Our goal with hepatitis B is obviously to keep their viral load below 100,000, and if we can, then I think we have achieved our goal. Experientially, I can tell you that in patients who are coinfected with hepatitis B and that have received a regimen containing tenofovir and 3TC, there are patients who have done well with respect to a drop in both their HIV viral loads and their hepatitis B viral loads. Dr. Bellos (VO): In those patients with precore mutants that are e antigen negative, those patients are a little bit more difficult to treat in terms of maintaining their negative hep B viral load, and then, we're looking at long-term suppression of those patients, which actually, with respect to HIV infection, is the other thing that we do.   See Slide Dr. Bellos (OC): We are obviously looking at long-term suppression in our patients, so most of those patients will maintain on a regimen that will not only suppress their HIV, but also their hepatitis B. Dr. Wohlfeiler (OC): The approach, especially with coinfected patients, really had been using antiretrovirals that also had some impact on HBV and would suppress HBV activity, HBV replication. So those medications like 3TC or lamivudine, tenofovir can be very potent suppressors of hepatitis B activity. Dr. Kwakwa (OC): With hepatitis B coinfection, we tend to use as their antiretroviral therapy lamivudine or emtricitabine with tenofovir combination in such patients. Announcer (VO): Various nucleoside and nucleotide analogs have activity against HBV as well as against HIV. Both lamivudine and adefovir are approved for treating HBV. Two others, tenofovir and emtricitabine also have activity against HBV, although limited data exists.   See Slide Dr. Wohlfeiler (OC): If you've got a coinfected patient why not use an HIV regimen that's also going to have an impact on the hepatitis B. It makes sense. And because the HIV medications that are suppressive of hepatitis B are medications that can usually be part of almost any regimen. And so they can be used almost universally as part of an antiretroviral regimen. And then you get both benefits. Announcer (VO): The DHHS Guidelines have issued treatment recommendations based on various patient scenarios. In the case of treating HIV but not HBV, one should consider withholding antiretrovirals with anti-HBV activity for future use. If treating both infections, consideration should be given to using these antiretrovirals, such as 3TC, TDF, or FTC.   See Slide Announcer (VO): If HBV needs treatment and not HIV, adefovir or interferon should be considered. 3TC, TDF, and FTC should be avoided unless used as part of a fully-suppressive HAART regimen. If the patient is on these drugs, they should be discontinued if only treating HBV.   See Slide Dr. Kwakwa (OC): We generally just go ahead and treat both, because treating the HIV, unless there are specific contraindications to those medications, tends to treat the hepatitis B as well, and because the doses for hepatitis B tend to be lower than the doses for HIV, you run the risk of resistance to HIV just treating the hepatitis B, yes. Dr. Wohlfeiler (OC): I would probably actually use entecavir first line if I had a patient who was HIV positive, but didn't need to start on HIV treatment yet. If I were going to use a dual drug regimen as opposed to monotherapy for the hepatitis B, I would probably look into the possibility of combining the entecavir with adefovir. I would think that that would give the least risk of compromising future HIV treatments. Dr. Wohlfeiler (VO): I've had one or two patients where I've had to address that. And it's actually an interesting and difficult issue. I have one patient in particular who definitely needed suppression of his hepatitis B. He had significantly elevated liver enzymes. And there was clearly ongoing damage to his liver. When you looked at his HIV viral load and his CD4 count, both were in a range that you would not normally recommend HIV treatment.   See Slide Dr. Wohlfeiler (VO): So one of the questions I had was if I put this patient, for instance, on hepatitis B doses of lamivudine, which would be 100 mg a day as opposed to 300 a day, could I treat his hepatitis B without HIV resistance to the lamivudine developing. It was a big concern because lamivudine has got a very low barrier to the development of HIV resistance.   See Slide Dr. Wohlfeiler (VO): Similarly, I had a question, if I were to use adefovir, which is a similar compound to tenofovir, but is a compound that's indicated for hepatitis B, was there any risk of developing resistance that would then create cross resistance to tenofovir if the patient were to need that.   See Slide Dr. Wohlfeiler (OC): And interestingly, I couldn't get really good answers. The data doesn't really exist looking at those particular situations. The feeling when I spoke to the medical information departments of the respective pharmaceutical companies that made the products was that, with regard to the lamivudine, they felt that there was not a high likelihood that an M184V HIV resistant mutation would develop in response to 100 mg a day of lamivudine. And a bit stronger feeling on the part of Gilead that there should not be worry about developing tenofovir resistance by using adefovir. Dr. Wohlfeiler (VO): One thing that may make this particular situation a little bit easier to deal with is that there is now another new hepatitis B drug out called entecavir, which has no HIV activity at all. So that would be a drug that you could use in someone who was HIV positive but didn't need HIV treatment yet. And you wouldn't have to worry about compromising future HIV treatment.   See Slide Dr. Bellos (OC): Again, it would depend on their viral load and T-cell at the time of presentation. In a patient who in my opinion is relatively intact immunologically, and whose viral load does not necessarily warrant treatment, that's a patient that might benefit from either entecavir, or adefovir. Neither one of those drugs really has activity against their HIV, and if they are immunologically intact, then I'm not sure that I would want to expose them to a single agent that we would potentially develop a resistance pattern to, or could potentially develop resistance to as we proceed with treatment, so in that setting, if I am choosing to treat only the hepatitis B because their HIV is relatively well-controlled on their own without therapy, then I would lean more towards a drug such adefovir or entecavir, which has recently been released, simply for control of their hepatitis B, while I monitor their HIV infection. Dr. Wohlfeiler (OC): There is some more recent evidence from some more recent clinical trials that have come out really showing some benefit from using interferon as a way to get eradication of hepatitis B, and not just suppression of hepatitis B. So I think that that's a therapy that we're going to be seeing a lot more about in the future. There was certainly use of interferon years and years ago as a hepatitis B treatment. But the problem had been tolerability issues. And though interferon still has got a lot of side effects associated with it, we've been able to come up with ways to make it much more tolerable. So I think it really is time to revisit the idea of really curative treatment with interferon.
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