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This Month in HIV: A Podcast of Critical News in HIV
  

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

September 2007

This podcast is a part of the series This Month in HIV. To subscribe to this series, click here.

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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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Copyright © 2007 Body Health Resources Corporation. All rights reserved. Podcast disclaimer.

This podcast is a part of the series This Month in HIV. To subscribe to this series, click here.


  

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