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This Month in HIV: Update on Hepatitis C/HIV Coinfection

September 2007

Greg Lamb
Dan Durbin

Welcome to This Month in HIV. I'm Terri Wilder. This month's topic is HIV and hepatitis C coinfection. Up to one third of people with HIV are estimated to also have hepatitis C, and living with both viruses is no picnic. The good news is that, unlike HIV, hepatitis C can be cured. The not-so-good news is that being cured is sometimes far from easy.

This podcast will focus on three people. I'll be talking to Tracy Swan, the Coinfection Project Director for the HIV activist organization Treatment Action Group. Tracy just finished cowriting a booklet about HIV/hepatitis C coinfection, and she will update us on the latest hepatitis C news and research.

But first, I'll speak with Greg Lamb and Dan Durbin, an HIV-positive couple who have been together for 10 years. Dan was diagnosed with HIV in 1998, while Greg has been living with HIV for 23 years. In 1993 he also discovered he had hepatitis C. Dan and Greg discuss how they've dealt with hepatitis C as a couple, from diagnosis to treatment to everyday support. Welcome Greg and Dan!

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Greg: Thank you, Terri. Thanks for having us on and hopefully the information will help somebody out.

Dan: Yes, thank you Terri. I'm glad to be here and talking with you.

Great. Let me start with Greg. Greg, can you just tell our readers and our listeners about your personal history with HIV? Specifically, how did you find out that you were living with HIV?

Greg: In 1984, I had broken my back. During the hospital visit there, they tested and found that I was also HIV positive. It seemed surreal at the time with the other things that were going on. However, it grew to be something a little different than that.

Greg, where were you when you were diagnosed? What state?

Greg: I was in Portland, Ore.

Did you go to a Health Department? Or was it a hospital?

Greg: No. It was a hospital. The doctors there, while they were just doing the general blood workup, decided to do a test, and bingo! There it was.

Dan, you were diagnosed in 1998 with HIV. Can you talk to us a little bit about that experience?

Dan: Sure. In 1997, I was living in Key West at the time. That August I had had a test and tested negative. So, anyway, I had a severe back problem arise, like, Nov. 19 of 1997, and left Florida to come up to live with my sister to get help with it. March of '98, when I went to the doctor, then I was HIV positive.

So, where were you when the doctor told you that you were HIV positive?

Dan: Actually, I was living in Farmington, Minn., which is near Minneapolis.

Greg, you are also living with hepatitis C, and you were diagnosed with that in 1993. Can you tell us a little bit about that experience?

Greg: That came as kind of a shock. I'm not quite sure [what you mean when you say] experience. You mean, how did I get through it?

How did you learn that you had hepatitis C?

Greg: I had come in contact with somebody that I had found out had hepatitis C, so I decided, just as a precaution, to go and get checked out. The first time I went, the tests were negative. Then, as a precaution on a regular blood work, approximately six months later I got one, and that's when they found it.

When you say you had contact with someone, this was a sexual partner of yours?

Greg: Yes.

Okay. And so, just to clarify, if I wasn't clear in the beginning, Greg and Dan are partners and they live together in Minneapolis. The reason why we have Greg and Dan together is, we thought it would be neat to share their experience as a couple living with HIV, and also the issues that may come up when one partner is coinfected with hepatitis C.

Greg, talk to me a little bit about after you got your diagnosis of hepatitis C. What happened after you got your diagnosis? What did the physician or the nurses tell you would be the next step, as far as dealing with the hepatitis C?

Greg: Well, I didn't get a great deal of help right off the bat. They told me to, of course, change my diet and any alcohol, stop any alcohol intake, change my lifestyle, try and get to bed early -- all of the normal things that keep a person healthy, they wanted me to do. But they didn't really have any treatments that they were going to put me on until two years ago. And living with hepatitis C, the one thing that stands out most of all is just the fatigue, unbelievable fatigue from it.

Greg, when you say living with the fatigue, is the fatigue from the actual hepatitis C, or is it from the treatment that you have been taking?

Greg: Both of them, recently. However, I had a treatment about a year and a half ago. They started a treatment on me, interferon [generic name: peginterferon alfa-2a; brand name: Pegasys] treatment. Prior to that, I would live with fatigue daily. I would have periods of a couple of hours where I felt good, but then I would have periods of several hours where I felt very overworked, overstressed, mood swings, tired, cranky ... the whole nine yards.

Greg, you said that one of the things that they talked to you about was changing your diet. Can you be a little bit more specific? What specifically did you do?

Greg: My diet consisted of eating one meal a day. They wanted me to change to eating three meals a day. At the time, I just really didn't pay much attention to my health, in general. They were very helpful in getting me nutrition, making sure that my nutrition levels were up, making sure that I ate three times a day -- that was a big one -- just, start taking better care of myself, overall. I had, prior to that, been consuming quite a bit of alcohol. I had to make some very serious changes on that very quickly. I had to knock that off.

So, Greg. Tell me about starting the treatment for hepatitis C. Talk me through that process of you deciding to start the treatment. Then, if you can talk to us about your experience taking the treatment. Particularly, we're interested in hearing about any side effects that you may have had.

Greg: Well, thank goodness, I had a wonderful doctor from Hennepin County Medical. She had been with me through the whole thing, prior to and post treatment. [Dr.] Kay Schwebke told me exactly what to expect. We spent an entire visit together. She outlined what to expect, what injections I would have to do at home, what the downsides were, and what the possible hopeful outcomes were.

It took me about two weeks to mull it over, and then, I had been going through such a hard time of fatigue and irritability that I figured that anything would be better than what I was going through.

I decided to go ahead and do it. It meant injections at home. It meant frequent doctor visits. And I was in bed most of the time. I would say I was probably in bed much more than I was out of bed.

I was vomiting, feeling very sick most of the time. As I said, having to give myself shots; that was no fun. And being monitored. This went on for about eight months, until they found that the treatment wasn't working as well as they would hope it would, so they took me off of it. Then it took me about another six months to get over the treatment, to get back to where I felt like a human being again.

Are there any special things that you figured out to do to help kind of alleviate some of those side effects that you were feeling during the times you were taking treatment?

Greg: Well, my partner, I've got to say, is just a gem. He was able to stay with me and calm me down during the rough times, and take care of most of the things that needed taking care of so I could sleep. Sleeping seemed to be the big thing that kept me going. Thank gosh that I didn't have a lot of responsibilities outside the home in any way to deal with. Stress was just something I could not handle.

Dan, talk to me about some of the things that you did to help Greg through that period when he was taking the treatment.

Dan: Okay. Well, let's see. Sometimes, with the mood swings, I had to quickly remind him that he was having a mood swing. It would get better. Other things were just making sure that he had plenty of fluids, and had good food to eat, and a wide variety of food ... whether he could keep it down or not. It was kind of tough finding things that he would be able to eat because of his nausea.

What were some of the foods that you found he was more tolerable of?

Dan: Generally, less spicy. If you could stick with traditional American food and pastas, things like that. Something easy on the stomach.

Then you also mentioned drinking water. Why was water important?

Dan: Well, I think water is important for anybody, just to keep their body flushed of things that shouldn't be there. But I drink a lot of water myself, and so I have a tendency to push it on somebody else, too.

Greg: If I may interject there: I was sweating a lot when I was in bed, sleeping. I was going through tremendous sweats. So keeping myself hydrated was real important.

Did you find that drinking a lot of water would help with your fatigue, Greg?

Greg: Yes, I did, as a matter of fact. It was sure a lot easier for them to get blood draws when I was hydrated than when I wasn't.

Greg, you mentioned that you stopped the treatment, and then it took you about six months to feel kind of back to normal, if you will. Talk to me now about what your focus is on your hepatitis C now, since you're not taking the treatment. How are you making sure that you're staying as healthy as possible?

Greg: Well, I do exercise a couple of times a week. I do things like garden around the house -- the normal things that people would do -- as well as, I take vitamins, especially calcium and a super B complex, along with Centrum. I make sure that I eat three meals a day. Dan is a wonderful cook, so that's a real easy thing to do. I try to keep my diet light in the way of pastas and rices, as opposed to beef roasts and more of your heavy foods. I eat more of the white meats and fish.

I know that exercise has helped my fatigue level quite a bit. And keeping a regimen going of that, just even simple exercising. I don't stiffen up. My willingness to want to do something is better. My ability to do something is better. And I can squeeze more in in a day.

Talk to me about the health of your liver right now. You said that the treatment for hepatitis C didn't really work for you. Are you still monitoring your liver? Or what kind of medical interventions are being done?

Greg: Well, according to the way I understand it, the treatment that I went on, because it didn't work, none of the other treatments would be helpful, especially with the side effects that are involved. Some of the side effects are pretty devastating. However, there are a lot of new things coming down the pipe that are coming up in the next couple of years that I know that Dr. Schwebke is quite excited about that show great promise, where the other, older forms of treatment didn't. And so we're waiting till about 2010 to try it again.

Is she monitoring your liver? Does she still do liver biopsies? How does she monitor your liver?

Greg: With blood work.

Oh, with blood work. And what does the blood work tell you?

Greg: Whether or not my liver is stabilized, if it's getting worse or if it's getting better. Right now, it's stabilized. It hasn't gotten any worse for the experience, thank goodness. Overall, it was a nasty experience to go through. The treatment is not something that I would recommend to anybody lightly. If I didn't have Dan, I think I would have gone crazy a couple of times. It's very, very hard on people connected with the person, as well as the person themselves. However, I pulled out of it fine. I feel just fine now.

Dr. Schwebke is giving you the inclination that it's possible that you could be fine without any kind of other treatment?

Greg: Well, that I didn't do any harm by having the treatment.

Dan: If I may interject here, Terri.

Sure.

Dan: That is that the doctor, when she first put him on the treatments, on a scale of 1 to 4 -- 4 being the worst -- he was at level 3, she said, as far as the condition of his liver. Even all through the treatment and everything, apparently, that didn't really change. So he's still hanging at about a 3. It's not cirrhosis, okay? It's the step before that ... if that helps any.

Dan, has she ever talked about if it does go to a higher level? Would you be talking about Greg going back on treatment? Or would we be talking about the possibility of a liver transplant?

Dan: Well, that she hasn't really said anything about. But it was kind of left up in the air. If his liver started getting worse again, we would attack that when it happened.

Dealing With Hepatitis C Treatment Side Effects

The most important thing to understand about hepatitis C infection is that, unlike HIV, it can be cured. It helps to keep this in mind while undergoing hepatitis C treatment, since treatment can be a challenge. Here are some tips if you do need to go through hepatitis C treatment.

  • Join a support group to hear how other people are dealing with their side effects and for reassurance that what you're feeling is normal.
  • Plan ahead in order to have a support network in place during your treatment.
  • For itchy skin, take a bath with oatmeal or baby oil and soak to relieve the symptom.
  • If you experience hair loss, try using baby shampoo. Don't shampoo your hair as often. Sleep on a silk pillowcase, instead of a cotton one.
  • Drink at least one gallon of water per day to combat fatigue, headaches, muscle and body aches, and nausea. Have a water bottle with you at all times.
  • If you have issues with depression prior to hep C treatment, don't wait till you start treatment to start the antidepressants. They can take up to three weeks to be fully effective. Start the antidepressants one month before the first injection.
  • If you experience depression during your hep C treatment, taking an antidepressant may help you get through the depression side effect.
  • Plan to loaf around the house the day after you take your weekly interferon injection because you'll need a couple of days to recoup. For example, do it on a Friday so you'll have the weekend to recover.
  • Some health care professionals advise people to take two tablets of Tylenol (acetaminophen) or Advil (ibuprofen) 30-60 minutes before injecting to avoid injection site reactions.

The other question I have is specifically for Greg. Have you ever had a liver biopsy done?

Greg: Yes. I have.

Can you talk to me about what that was like? What actually happens? How did it feel? And what kind of information did it give you?

Greg: It's really nothing. Nothing to it. I went in. They did a slight sedation ... not sedation. What's the word I'm thinking of? They anesthetized the area locally and took a gadget, a spring-loaded gadget, and zip, zip. They pressed it up against me. They made a small incision, went in with a little TV camera to make sure they were in the right spot. And then they put the mechanism, the spring-loaded mechanism in there, and snip. And that was all there was to it. I was out the same day. No pain. No problem. I was a little sore. I had to watch my lifting for a couple of days.

Greg, what exactly did the liver biopsy tell you?

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Greg: Dan, could you help me out with that?

Dan: As I remember, that's where we got the indication that you were one stage below cirrhosis.

So it kind of lets the patient know, kind of, what damage, if any damage, there had been.

Dan: Right.

Greg. You mentioned earlier that one of the recommendations was to avoid alcohol. Do you drink at all, or do you completely not have alcohol?

Greg: I drink very, very seldom now, and only on social occasions. I used to drink a great deal. But I do know that my side, and my liver, will hurt if I drink. And during the treatment I did not drink at all. But even if I have a beer now, I notice I can feel it in that area. So it kind of warns me that I need to keep alcohol at bay.

You had mentioned to me in another conversation that you had had hepatitis A and B, at one point?

Greg: Correct.

Can you talk to me a little bit about that? When you were diagnosed and ...?

Greg: Well, I worked for a hospital, and I was in charge of burning all of the isolation trash. I was contaminated a couple of times from the needle sticks and pricks, and had received both hepatitis A and B within a two-year period. I didn't even realize I had it until I had gone in for an annual physical and the doctor checked me over and said I looked jaundiced and did a test and boom, there it was.

Gosh. That was back in the early '70s, I would think.

What year was that?

Greg: I think it was 1978. Maybe later '70s, '78.

What happened after the doctor tested you?

Greg: For hepatitis A, nothing. Because I worked for a hospital I had to take time off till it had gone through my system. Like I said, I didn't realize I even had it. With hepatitis B, I turned jaundiced for about three weeks. I really did not feel miserable at all -- at least, in comparison to the hepatitis C. Hepatitis C has caused me to ... it's very different than A and B. It's caused me to have weeks of fatigue, and months and months and months of depression, feeling like I have the flu all the time. So I would say, having A and B was just a breeze, in comparison.

Let me ask you about hepatitis B, Greg. Did your body just naturally clear that? Or did you ever take any medicine for that?

Greg: No. I didn't take anything for it. And the body naturally just cleared it out.

You mentioned that with hepatitis C, you've experienced depression. Talk to me about that. What did that feel like? And did your doctor maybe put you on an antidepressant, or maybe recommend that you go see a therapist?

Greg: I went to see a therapist and she recommended that I go to a psychiatrist to get medication because I was at the onset of depression. But I was put on medication for it. It affected every facet of my life, from desire for sexual attraction to socializing, to willingness and wanting to do anything, wanting to hide from people, canceling appointments, staying in bed all the time. Even though I felt like getting up, [I was] still staying in bed all the time because I didn't want to face the world. It was very difficult.

What medication did they put you on for your depression?

Greg: Celexa [generic name: citalopram].

Are you still on that medication now?

Greg: Yes, I am.

So, even though you're off the treatment, you still feel better taking the antidepressant?

Greg: Yes, I do. I have to say, after I got off the treatment, I went through a period of depression again -- even on the Celexa. The period lasted about three months, and I think a lot of it might have been situational, with the weather change and season change, and that kind of thing. But I do know that I was really scared there for a while, that I was going to go into an even deeper depression. But I did pull out of it, and I am much better.

Greg, did you ever feel suicidal?

Greg: Very much so.

Dan, can you talk to me about that time when Greg was very depressed? How that felt for you to watch your partner get that depressed? What are some things you did to try to comfort him to get through that period?

Dan: Well, I found it really kind of heart wrenching to see him go through that. When I was much younger, I went through a depressionary period, and I completely understand what he was going through. I felt that, whether he liked it or not, I kind of needed to get a little closer to him, and tried to throw in some laughter to help change the situation a little bit, at least for a couple of minutes. Just basically to help him improve his outlook. I would remind him that this is just temporary. It will pass. And don't give up yet.

Dan, tell me about some of the things that you saw that happened when Greg was depressed? Describe to me some of the things that he did or said that you knew were due to the depression?

Greg: I was actually suicidal.

Dan: Yes. Greg was actually suicidal. He'd talk to me about it and of course I would convince him otherwise. Let's see. I could notice by how critical he might be of everything around him. He became much more vocal. That was kind of a sign for me, also. Then just noticing other than [because of the] fatigue, him laying in bed a lot, spending a lot of time down, even though he may not have needed it.

Dan, did you feel like the depression affected his appetite?

Dan: It might have. But I think the biggest thing that affected his appetite was the nausea that accompanied the hep C treatments.

It would be hard to tease out: Is it depression, or is it just feeling so nauseated? Or maybe a combination of both?

Dan: Right. Right. A combination of both.

Greg: Terri, I'm going to add to what Dan said, there. There were periods when I just wanted ... I wanted the world to go away. Actually, I wanted what I was feeling to go away. Not as far as wanting to end my life. I just wanted the way I was feeling to go away. I will say that Dan was brilliant, in that every time I felt that way, he would always manage to get just a little bit closer to me and he wouldn't go away, even if I wanted him to. He would still find a way to stay with me, and to hold me, and to care for me. Just having his hand on my knee, or sitting in the same room, reading a book -- just to let me know that he was there. I've got to say that that was the biggest help anybody could have done.

I'm noticing that we are about to run out of time, and I wanted to take a minute to ask each of you, separately, to talk about any suggestions or advice that you could give to someone who's living with HIV and hepatitis C coinfection. So, Dan, I want to start with you first. Maybe take this opportunity to give advice to other partners who are helping their partner go through the hepatitis C treatment, just give some tips on how to help their partner get through that treatment process.

Dan: Okay. Well, that's a tough one.

Greg: Laughter helps.

Dan: Yes. Well, first and foremost, for example, people need to realize that no matter what life is like, it's still worth it. That's kind of like number one that I would tell them. The other is, don't give up hope. There's always a chance that it could be reversed -- the situation, or the virus. And the other thing is, don't shut out the rest of the world, and don't let the rest of the world shut you out. And I'll leave it at that.

Greg, I want you to talk from the perspective of a person who has gone through the hepatitis C treatment. Any advice that you can give to someone who is actually considering going through treatment?

Greg: Make a lot of apologies to people and friends ahead of time, about not being able to keep appointments. One of the great distracting things about it was that I would make an appointment to, for example, do an interview like we're doing on a certain time and a certain day. That day, I would feel terrible and would be unable to keep the appointment. The same would go for socializing ... almost everything. So, just make a lot of apologies to people for both your mood and your absence for the next year or so.

Maybe another way of putting it is to ask the people in your personal life to be flexible with you.

Greg: Yes, yes. It's to have the people in your personal life be as flexible as possible.

Let me ask you one more question, both of you. Are there any resources that you guys can recommend for people, whether it be a book or a Web site, that helped you get information about hepatitis and HIV coinfection, and maybe how to deal with that? Or is there a support group that you may be able to refer someone to?

Greg: I would say that the AIDS Project, here in Minnesota, is probably the greatest resource to go through. One of the biggest problems that anybody would be facing that I know of is the mountain and maze of paperwork, trying to get on social services. The local AIDS organizations -- I'm familiar with Oregon and Minnesota -- I highly recommend them. They did a wonderful job in providing information on where to go, who to see, what to do, and social outlets with other people that are infected in one way, or have a disability in one way or another.

Greg, are you saying that they helped you with paperwork? Was that to cover the treatment financially?

Greg: Well, to connect myself with everything that I would have been eligible for in both health care and any other support from local, state, government offices, as well as have one focal point for other people to get information about me, to do studies. Like the University of Minnesota does several studies on people that are coinfected and have HIV. They put me in contact -- both Dan and I in contact -- with them, and that was a wonderful experience. They are a great resource for people. If you're having a problem with housing, if you're having a problem with the government, if you're having a problem with even medical or life situations, I found them to be a very, very good resource to go through.

Let me ask you two closing questions. You were in a clinical trial for coinfected people, Greg?

Greg: It was for HIV. Both Dan and I were in separate clinical trials. I'm part of one that is a three-year trial where they actually take a biopsy of a lymph node, and see how much damage HIV has done to it over the years.

Is the clinical trial looking at your coinfection, or is it just looking at the HIV?

Greg: Just at the HIV.

My final question is: I know that the hepatitis C treatment can be rather costly. How was your hepatitis C treatment paid for?

Greg: By the government.

When you say that, do you mean Medicaid?

Greg: Medicaid.

Okay. Because that is a question that I have asked several people when I've been talking with them about coinfection. How are they having this treatment paid for? And either people have private insurance or Medicaid. But some of the states that I have contacted have their ADAP [AIDS Drug Assistance Program] program as paying for it, or they are in the process of advocating to have their ADAP program eventually cover that hepatitis C treatment. When I talked to Dr. Schwebke the other day she said that at this time, Minnesota's ADAP did not cover hepatitis C treatment, but that they were looking towards talking with legislators about having that added.

Dan: If I may interject, Terri. Greg used to be on disability with Social Security, complete disability. He had gotten off disability to help me with my situation. In the process, they offered him something called a 1619(b), which is a special program that will allow him to work and they will keep up the medical part of it, because he would not work if he didn't have the medical part of it. Do you understand what I mean?

So it sounds like it's an incentive for him.

Greg: Right. I can hold down a job, a full-time job, and Medicare would still pay for all of my medical.

Medicaid?

Greg: Medicaid, for all of my medical.

Dan, what did you say the name of the program was?

Dan: It's called the 1619(b). That's at the federal level. Now, it's also connected with the state level, which is called the MA-EPD [Medical Assistance for Employed People with Disabilities] program, which allows him to continue the Medicaid. It's kind of odd. I'm on MA-EPD, myself. It's kind of an odd situation. With his 1619(b) status, it's a little bit different from mine. But he is covered as long as he's working. But if he can't work because he can't get the medical, then he would have to go back on disability.

Right.

Greg: Getting paid for disability.

Right. Greg, your work is to be a personal care attendant to Dan. Is that correct?

Greg: That's correct.

So that helps.

Greg: That was a little rough, during that hepatitis C treatment. That was a little rough.

I would imagine that it would have been a little bit of a role reversal.

Greg: Well ...

Dan: It was a dual struggle.

Greg: It was a dual struggle, yes. We made it through, but it was a dual struggle.

Well, I want to thank you both for taking the time to talk with us today. I look forward to talking to you both in the future to see what comes about with any hepatitis C treatments that are coming down the pipe, and seeing if Greg, you'll be eligible for that.

Greg: 2010; that's what Dr. Schwebke has said.

Okay. Well, we'll give you a call in about three years and see how you guys are doing. So, again, I want to thank you for your time and your input into this very important issue.

Dan: Well, you're very welcome, Terri.

Greg: You're very, very welcome. Bye-bye.

To contact Dan or Greg, click here.

Tracy Swan, Coinfection Project Director, Treatment Action GroupHi. This is Terri Wilder with The Body. Today I am talking with Tracy Swan. She's the coinfection project director at Treatment Action Group. She's been working in HIV since 1990, and has done work in hepatitis since 1998. So, welcome, Tracy.

Thank you, Terri.

I just want to start by having you tell our listeners and our readers exactly what you do at Treatment Action Group.

I work to promote better policy for access to hepatitis C treatment, and better research with the pharmaceutical industry, the government, and most importantly, other community members, and researchers, policymakers, and clinicians.

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What are some of the issues around the medications particularly in hepatitis C, that you are working on around advocacy issues? My guess would be -- and you can correct me if I'm wrong -- maybe trying to find a medication that's not as challenging on the body.

Certainly, the current standard of care, pegylated interferon [brand name: Pegasys, PEG-Intron] and ribavirin [brand name: Copegus, Rebetol], has profound limitations, both in the ability to tolerate it because there are so many side effects, and that it's not nearly as effective as it could be. So, the first issue is: Can people who need to be treated even get access to the current standard of care?

When you say have access, you mean do they have the resources to even pay for it? Or that their clinic or the area they live in may not even be able to get it?

Both. Do they have the resources to pay for it? Do they have access to specialty care, or a doctor that's knowledgeable about hepatitis? And also, will the doctor be willing to treat them? Because even though the United States guidelines now specify that treatment decisions for people who are actively using drugs should be made on a case-by-case basis, between each person and his or her doctor, a lot of doctors simply won't treat people who are using drugs, and they are the largest prevalent population of people living with hepatitis C.

The other part of my question was about reimbursement for this medication. I understand that it's pretty expensive. I also understand that, for example, if you don't have insurance, or Medicaid, or Medicare, things like ADAP [AIDS Drug Assistance Program] don't necessarily always pay for the hepatitis C medication for the person who's living with HIV and hepatitis C. I'm wondering if you could make some comments about that, and if you do think that that is something that is needed, or that people should advocate for.

It's a complicated issue. Definitely, not every state ADAP program covers hepatitis C treatment. But it's not because of an unwillingness on the part of the programs; it's simply that they are really underfunded. The really big picture issue is that ADAP needs to be fully funded, because we still have people on waiting lists who are dying before they gain access to antivirals and that should not be happening. Everybody who needs HIV treatment in this country should be able to gain access to it -- the same thing with hepatitis C treatment.

The problem is, it's not just the HCV [hepatitis C virus] treatment that's quite expensive. White and red blood cell growth factors that are used to manage certain side effects, such as anemia and neutropenia (low white blood cells that fight bacterial infections) are also extremely expensive. [In addition,] a lot of people are not able to take months and months off of work, or to cut back work to part time, so even if they can manage to patch together coverage, it's simply not an option, because they have too many side effects to be able to go to work while they are on treatment. So that's another added cost.

The two companies that make pegylated interferon, Roche and Schering[-Plough], do have patient assistance programs. [For phone numbers, see our resource section.] But that's a really inadequate safety net, instead of having a health care system that takes care of the needs of our citizens.

You mentioned that there are some ADAP programs that do cover the hepatitis C treatment. Do you know offhand what states those reside in?

I can find out for you, because I just did a grid, and it's on TAG [Treatment Action Group]'s Web site.

What is your Web site?

www.treatmentactiongroup.org.

So that would be something that our readers and listeners could actually go to and find out material, as well.

Yes. And also, NASTAD, which is the National Alliance of State and Territorial AIDS Directors, in conjunction with Kaiser Foundation, does a report on the formularies of every state ADAP program each year. That's where I got this information. It's from their project, which is extremely helpful, and I just want to make sure that their work gets recognized.

Talk to me about what you think are maybe the top three kinds of pertinent advocacy issues related to HIV/hepatitis C coinfection. What are the really pressing issues that you really feel people need to pay attention to?

Well, in the biggest picture, there are a lot of new HCV therapies in the pipeline. I think we're at a very interesting time in hepatitis C treatment, where it's not just going to be whether a drug is approved or not, but what is the best, most strategic way to use that drug, so that maybe the course of treatment could be shortened, or treatment could be more effective, or both. It looks that interferon and ribavirin are going to be a mainstay of hepatitis C treatment for years to come. But it might be much easier for people if they knew it was a much shorter course, or that they had a 95 percent chance of clearing the virus after their treatment.

It's like the pre-HAART era in HIV, where we have something that we know can sort of do the job -- not so well for coinfected people, in particular -- but that we just need better therapies for coinfected people, for people with HCV alone, for African Americans -- in whom hepatitis C treatment is less effective -- for transplant candidates and recipients, and people with advanced liver damage. We also need really good structures to deliver the care and treatment.

You mentioned the African-American community. Are you saying that race may play a factor in treatment success?

It definitely does. It's known to be associated with treatment success. For some reason, or reasons, hepatitis C treatment is less effective for African Americans than Caucasians.

There's no explanation as to why that may be?

There are many. It may not just be one simple thing. But the NIH [National Institutes of Health] is currently supporting a study called ViraHep-C to look into this and see if they can determine the cause, and therefore -- hopefully -- learn how to increase treatment effectiveness.

Are there any preliminary ideas as to maybe why that may happen?

I know the one thing that's pretty well established is African Americans are less likely to clear hepatitis C when they are first infected than Caucasians. No one is sure why there may be a difference in immune response. I wish that there was an established body of knowledge so that the problem could be addressed. Because hepatitis C is more prevalent among African Americans than white people, or Caucasians, in this country.

I have another question about a population that's affected, and that's in women. I'm wondering if there's any information about the response to treatment in women that are coinfected with HIV. The reason why I ask this is because it seemed, at least in the HIV community, it took a while to realize that women's bodies are different from men's bodies, as it relates to the antiretroviral medication, or even the progression of the illness in women's bodies. I'm wondering if there is anything like that for women who are coinfected with hepatitis C.

Unfortunately, I don't think enrollment in clinical trials of women has been large enough to sort of break things out and say women are doing better, or not as well. So it's really hard to say what the differences are, which is the classic problem in HIV, also. You can't make a conclusion about something if you don't have enough people in the studies. There are some data in hepatitis C monoinfection to suggest that women don't progress as rapidly, but that's not always true in coinfection.

What would be a women's issue around coinfection? I am thinking about women who may be interested in getting pregnant and having children, and they are coinfected. Are there any special issues around that that maybe our listeners or readers may need to be aware of, if they are thinking about having children?

Definitely. Because with HIV, people can use antiretrovirals to decrease the risk of having an HIV-positive baby. With hepatitis C, ribavirin causes severe birth defects, so it can't be used during pregnancy. So there's no way to continue treatment as a preventive measure. It does seem that treating the HIV may decrease the likelihood that the baby will be born with hepatitis C, as well as HIV. Although it's not currently recommended for women with hepatitis C alone, planned C-section is recommended to reduce the risk of mother-to-infant HIV transmission among coinfected women. What would be really helpful for women is to get screened for hepatitis C as part of prenatal care, so at least a woman can go into it [her pregnancy] with that information. I don't think that this always happens.

The recommendation is that all HIV-positive people should be tested for hepatitis C. But a lot of times, that means people get tested once as part of an intake into care, and even though they may be at ongoing risk, they are not tested annually, or [tested] according to risk or exposure. Or doctors may not be asking people. So it's possible that women might not know their hepatitis C status. Although, if they are HIV positive, it's probably more likely that they would.

I have another question about liver transplant access. I spoke with a woman the other day who is actually on the transplant waiting list. I know, at one point several years ago, there was what seemed like resistance to people who were coinfected being able to even have access to a liver transplant.

That was really an HIV-specific issue, in general. Because the real problem is, there's an organ shortage, and people weren't necessarily aware of how much the prognosis for HIV has changed since the advent of highly active antiretroviral therapy [HAART]. People had concerns about giving HIV-positive patients immunosuppressive drugs after transplants.

But now there is the huge survival benefit of antiretroviral therapy. It has really been characterized. That's no longer a reason to withhold transplantation. So the NIH is sponsoring a study -- the National Institutes of Health -- kidney and liver transplantation in people with HIV. And I think that's really helpful, because it will also answer, or at least define, a lot more important questions, and help to clarify what the standard of care is for a coinfected transplant candidate or recipient.

One of the biggest problems is that the hepatitis C almost always comes back. You may be getting a new liver, but the virus is still in a person's blood. So managing antiretroviral drugs and immunosuppressants, where there can be drug-drug interactions, plus hepatitis C treatment, can be really, really complicated.

You mentioned earlier that there are new drugs in the pipeline. Possibly, we won't be seeing them for a couple of years. But I'm wondering if you could talk about some of the drugs that are in the pipeline that look to be promising.

Sure. I think one thing about HIV that's been very interesting is that people have more of a sense of inevitability about drug development. Meaning that if something enters clinical trials, it will eventually be approved. We have been really lucky with a new drug from a completely novel class for HIV approved just yesterday. But some of these drugs might not make it into the clinic, and they might not make it out of phase 2 or phase 3. So I think it's important to follow them critically and keep an eye on them. But also for people to know that there are other drugs behind them, backup compounds that may be more effective, have less side effects, etc. So if one drug doesn't move forward, not to feel that all is lost. Instead, [it helps to know] that there are other drugs coming along.

That much being said, there are a lot of different types of approaches being studied. It seems like almost every day there is an announcement about some compound. But what I really stay focused on are things that have entered a later phase of development, [these studies are known as] phase 2, phase 3 [studies]. There are drugs in the same classes that are used to treat HIV. So there are protease inhibitors and polymerase inhibitors, and these are both oral drugs.

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These would be drugs that people who are coinfected with HIV and hepatitis C could use to treat both.

Well, this is another issue. I'm very, very glad you asked me that. Because earlier, when you were asking me what was most important, I forgot to say something that is extremely important. In order to study drugs in people who are coinfected, a lot of them will be on antiretrovirals. So it's important to do drug-drug interaction studies, to make sure that there's not going to be a problem with certain ARVs [this is an abbreviation for antiretrovirals, i.e., anti-HIV medications]. So companies absolutely have to do interaction studies before they can give the drugs to coinfected people.

This is a huge research issue, that these studies must be done early, so that we don't hear, "Oh, we can't study this drug in coinfected people because there might be an interaction." And there's no current requirement that hepatitis C drugs be studied in HIV-positive people before they are approved for hepatitis C monoinfection.

The FDA [U.S. Food and Drug Administration] had a meeting about some hepatitis C trial design issues last October, and this very issue came up. The antiviral advisory committee recommended that there should be interaction studies done early, and at least early safety and efficacy data in coinfected people, prior to approving drugs in hepatitis C monoinfection.

I just want to clarify what you're saying. It sounds like the majority, if not all, of the research that's being done around hepatitis C treatment is being done on people who are mono hepatitis C infected.

That's right. I think I just saw an announcement for a compound in development where they are actually going to be looking at it in coinfected people, but that's extremely unusual. What's been characteristic is, studies are not launched in coinfected people until after the drug has already been approved for people with hepatitis C alone. And this is really not acceptable, because coinfected people have more rapid disease progression, and the current standard of care is simply less effective for coinfected people, and the side effects are more severe. Some of the hepatitis C treatment trials in coinfected people have had almost 40 percent discontinuation rates, because the side effects are so bad from the drugs.

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Hepatitis C/HIV coinfected people definitely have an urgent need for better drugs. Drugs should be studied in coinfected people as soon as possible, preferably after a dose has been established at the end of phase 2, and we know what a safe and effective dose is.

What should people do who are interested in advocating for clinical trials to include coinfected people? Who would they contact, or what group could they get involved with so that they could talk about their experience of being a coinfected person, and let people know this is a need -- that their experience is different and needs to be studied.

That's a great question. Right now, there isn't a formal group. The reason why I think about what happened at the FDA is, I was privileged to be on the advisory committee, and to really have an opportunity to push. There's also a movement in Europe with a lot of coinfected people, and advocates. There was a meeting in Sitges, Spain, last March where, at the end of the meeting, the participants listed all their priorities and concerns about hepatitis C drug development. We made a statement and a declaration that Roche and Schering both signed on -- the two companies that have hepatitis C treatment: pegylated interferon and ribavirin. So there's definitely some work to be done. There just isn't a formal structure. But you could feel free to give people my e-mail address.

What is that?

It's Tracy, T-R-A-C-Y, Swan, S-W-A-N, @verizon.net.

Let me go back to what you were talking about, the meeting that you attended where the declaration was signed. What exactly did these pharmaceutical companies sign on to when they signed this declaration?

We actually created the declaration at the meeting, at the end of the meeting, and then circulated it amongst everyone who was at the meeting afterwards to come up with something final and make sure it clearly and accurately recommended people's statements. So I'm actually just going to pull it up on my computer right now.

Is it something that you can hold the pharmaceutical companies to? You know, people sign on to things, and then you find out a year later that it was just ink on paper. I'm wondering if they made a commitment to do something specifically, for this population.

I can send you the statement, first of all, so you have a draft of it. The beginning of the statement says: "Community activists, doctors, researchers, company representatives and members of regulatory agencies concerned about the life expectancy and the quality of life of people living with HIV and HCV hereby declare that collaboration between the community, regulatory agencies, and industry is a crucial part of the HCV drug development process. The community is an important stakeholder and must be given the opportunity to provide input into HCV drug development."

It specifically asks for community participation in the development of regulatory guidance for hepatitis C drug development. The EMEA [European Agency for the Evaluation of Medicinal Products], which is the European FDA, is going to issue regulatory guidelines for hepatitis C drug development. The FDA did hold a meeting. Jules Levin was invited to speak and give a community perspective. I was allowed to sit on the panel. Other people came up and made statements. I'm not sure what the ultimate output of the FDA is going to be. But it's pretty critical that all of us are in touch with regulators about guidance, or, if a study is launched and people are not happy with the study, that they are able to communicate both with the drug companies, and with the regulators.

When you say regulators, who are you referring to?

The FDA and the EMEA.

Is there a specific person that is kind of the key contact for those regulatory agencies, that a person would contact?

I'm not sure who the contact is at EMEA, but at the FDA it's Richard Klein.

What is his role there?

He is the HIV/AIDS Program Director, Office of Special Health Issues, and part of his job is working with the community, to facilitate communication and dialogue and make sure that people are on list serves, get updated information, can access information and know how the FDA is working.

So if people wanted to get in contact with him, would they just go to the FDA Web site, and they could search his name?

I think that's how it works, yes. There's a directory and they can e-mail him. [For information on how to contact Richard Klein, click here.] One example of this is last year. Schering-Plough has a hepatitis C protease inhibitor in development, and they were doing a phase 2 study, looking at safety and effectiveness of different doses in people who had not responded to hepatitis C treatment. This was in combination with pegylated interferon and with or without ribavirin, plus a different dose of their drug. They initially decided to exclude African Americans from the trial.

What was their rationale for that?

I think primarily that because African Americans are less likely to respond to hepatitis C treatment. Since it was a small study and there was no allowance for stratification by race, if you randomly get a group of African Americans in one dosing arm, the result might be skewed because the background therapy is not as effective for African Americans as it is for Caucasians.

Personally, I think this is unacceptable and that the study just should have been made larger to accommodate for this, and that all people should have the opportunity to share the risks and benefits of research, equally. I have two colleagues that co-wrote a letter to the FDA about this, and just said that we didn't think that it was an acceptable situation, nor was it a good scientific precedent.

Did you get a response back from them?

Yes.

What was their response?

We got a letter and also, by that time, Schering had modified the protocol and added another arm, in which they allowed 15 African Americans to enroll.

Fifteen?

Yes.

Out of the entire United States?

I think the arm was 65 people, but I'm not exactly sure. This was not what we think of as an acceptable solution to something, but there was a problem with the amount of teeth regulators actually have in this country. So, they can do some things, but they can't always address everything.

So would you say it was a small victory?

I guess I wouldn't frame it specifically in terms of a victory. What's I think very important is that if pharmaceutical companies want to move [research] studies like that forward, they know that people in the community are paying attention, are not happy, are watching them, and that it's not going to be easy for them to do that in the future.

They now know that people are watching, and that perhaps they won't delay a study by making that same mistake, that they will remember the concerns of the community and include those community concerns from the very beginning.

Exactly. I mean, the company told us that they were doing this, and it was pretty shocking. I think they realized that it was an error in judgment, and reconsidered. Hepatitis C is twice as prevalent among African Americans. So you can't really run a study of a drug and say, well, we don't want to study it in the people who are most likely to have it. You know, a company can argue it's going to wait till later on, when we know what the best dose is, and everything like that. But I just don't think that's acceptable.

I'm wondering if there are any closing thoughts that you have, that you would like to share with the readers or listeners. Or maybe a resource that you want to refer them to.

Well, there's our Web site at TAG, which I think I gave you the address to. Also, Terri, a question for you: Have you talked with Jules Levin from NATAP [National AIDS Treatment Advocacy Project] yet? Because he has a Web site, also, where there's tons of information. And there's a great resource that's a pipeline on the Hepatitis C Advocate. Have you talked with Alan Franciscus?

I have not.

Okay. That's his Web site, and it's really good. He actually would be a good person for you to talk to.

What is his Web site?

It's, I think, www.hcvadvocate.org. They have a coinfection section, really good fact sheets, a great pipeline chart. TAG also does a pipeline report. There are also some really good hepatitis C specific organizations that do really good work, if people are interested in appropriation advocacy.

What I would close with is to tell people, definitely, that hepatitis C treatment is going to be changing in the future. Not next week or next year, but there are definitely some paradigm shifts coming along the way, and that it's important for people to stay hopeful and to get really good medical care and make informed decisions that work for them, to talk to other people who have been on hepatitis C treatment or are considering it, as well as doctors and nurses, just to get information from as many sources as possible. We have a patient information guide out on our Web site. The UK version is also available, and I can give you a Web site for that.

What is that?

The Web site is www.i-base.info/guides/hepc/index.html. [The U.S. version of the hepatitis C/HIV coinfection guide is now also available online as a PDF. For information on ordering the guide, click here.]

And to stay hopeful and savvy.

Tracy, thank you so much for your time and your information. It sounds like lots of things are going to be changing in the next several years; hopefully we can catch back up with you and get updates.

I'd be happy to. And thank you.

To contact Tracy, click here.




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