Please tell us about yourself.
My name is José Sousa. I've been HIV positive since 1985. I work as a waiter, but since '89 I've been involved in HIV treatment information, basically following drugs as they come along. I started therapy in about '94 or '95 [as part of] a placebo-controlled study of Crixivan [indinavir] with AZT [zidovudine, Retrovir], 3TC [lamivudine, Epivir]. Once I found out I was not on the Crixivan, I dropped the study. I've been on and off therapy for most of my 21 years [of being] infected. When I developed the lipoatrophy, I was actually on d4T [stavudine, Zerit] for, probably, a year and a half, two years.
When was that?
I would say about 2000 [is when] I got lipoatrophy, which [affected] mainly [my] face, [though] not very deeply, legs, arms, and the worst was the ass. Basically it was painful to sit, because I take the subway home after work, and it would be very hard to sit on the hard surface. [I also developed a protruding belly.]
Can you describe when you first began noticing the lipoatrophy?
I first noticed it looking in the mirror, by people commenting on how my belly was getting bigger and by sitting down on hard surfaces. It was not really too traumatic for me, because I knew I could stop the drugs, and I knew if I stopped it quickly enough that it would reverse itself. I'm not one of those who just keeps on taking the drugs because [my] lab looks good, so I just stopped taking the drugs for awhile. But I always went on and off drugs anyway.
What do you mean?
Well, I do structured treatment interruptions on a regular basis.
Why is that?
Long-term toxicity of drugs.
How does that work for you?
It works great.
You're able to avoid developing resistance?
Oh, yes. If you do it right, you avoid developing resistance.
Doing it right entails?
Doing it right entails knowing the half-life of the drugs and not stopping all the drugs at the same time. If you're on a drug that has a long half-life, well then you stop that one before -- like the standard now is Sustiva [efavirenz, Stocrin]. You stop it one week before your other drugs, and the nevirapine [Viramune] three days before the other drugs, but my trick is always to use Kaletra [lopinavir/ritonavir], because it's got a high genetic barrier. So if you stop Kaletra, it's not really dangerous. I have some mutations: I have mutations to AZT, but that's from when I was on the study on dual therapy, and I have the [resistance mutation at codon] 181 for NNRTIs [non-nucleoside reverse transcriptase inhibitors]. Actually, I was on a four-drug combo, and I just had a spike, even though I was very adherent. So stopping drugs is not the danger people put it out to be, if you do it right.
That's very interesting. It's a little off-topic, but it's of real concern to people, and I think the question of how people can be on lifelong therapy while minimizing the toxicity and side effects is huge.
Well, this is also when, even if I was more than six months on a drug regimen, I would switch drug regimens [while] staying always undetectable, because different drugs have different toxicities. But I actually like the d4T, because it is a very powerful drug. It's very hard to develop resistance to it, but when it came to the lipoatrophy, I wasn't able to accept that.
Would you say your lipoatrophy was severe?
No, I would say I was a one and a half [on a grading scale of one to four].
Where did the lipoatrophy hit you the hardest?
In my face. My ass was pretty bad. I was basically sitting on my bones.
Over what period of time did you lose the fat?
Well, once it started happening to me, it happened really quickly. I would say within six months there was a very noticeable difference, but it depends on [the person]. Some studies have shown that some people have a genetic predisposition to lipoatrophy. Well, one study, I think, only.
Do you think that had anything to do with it?
No, I don't think that has anything to do with it. It depends on genetic makeup. There was one study that showed that people who had lipoatrophy, 60 percent of them had this specific gene.
Everything [comes] down to genetics. Whether you develop, whatever you develop, I believe that you're just more susceptible because of your genetics, including getting infected with HIV. If you have the CCR5-Delta 32 deletion, then your chances of developing HIV are very unlikely, so everything is down to genetics.
What percentage of people have that?
At what point did you stop the d4T? Was it as soon as you noticed the lipoatrophy, or was it after the six months?
About six months after I noticed it. I was going for an STI [structured treatment interruption] anyway, so I decided to wait as long as I could tolerate it, and then I stopped it. Within six months to a year, it was back to normal.
I thought that there was some disagreement about whether or not lipoatrophy reverses itself. What do you think?
Well, the disagreement is on people who let it go a very long time. If you're on d4T for six years, and your lipoatrophy is really, really severe, [then] no, I don't think you can get it back. Maybe in 10 years you might get it back, but I doubt it. I think you've done permanent damage.
Whereas, if you stop it when it's still a mild case, you have a chance?
I believe if you stop [the offending drugs], change to drugs that don't affect your mitochondria -- like in the TARHEEL study, and there's another study -- you do get it back, but it's just a long time getting it back. The faster you stop, the easier it is to bring [the fat] back. But the thing is, there is actually no need for most people, if you have options, to be on d4T or AZT. That should be left for people with no options.
Right. So, when you began to see the lipoatrophy reverse itself, that was an indicator that you probably wouldn't need to have any kind of facial filler?
So you haven't had to have that?
I work with a group called Le Comité Lipo-Action. Sculptra [poly-L-lactic acid, New-Fill] and Bio-Alcamid [poly-Alkyl-Imide] [are waiting for approval from] Health Canada, but we're going to try to get that reimbursed for people with severe lipoatrophy, but no, I don't think it's my case for now. [Since the date of this interview, Bio-Alcamid, Sculptra and Radiesse have been approved in Canada.]
So, you feel comfortable with the way you look, and you also feel that you really don't have lipoatrophy anymore?
Right now, [yes].
How's your butt doing?
My butt is better. I never had a great butt. At least it doesn't hurt when I sit.
It must have been a great relief to have it come back.
Oh, yes, because it was actually very painful to sit on a hard surface.
Did you try to do anything like exercise?
No. I don't believe exercise will bring back your fat. Exercise just builds your muscle.
I do [take] Carnitor, L-carnitine, which helps in the mitochondria. I was doing about 3,000 milligrams a day.
Do you think that helped?
I think it might have helped a little. I think it does help, but I don't think if [your lipoatrophy is] severe that it will help. [It aids in] the transfer of fatty acids into the mitochondria of cells. There are good studies showing this.
Basically I just ate right. I take a lot of supplements. I take about 80 pills of supplements a day.
How much does that cost?
I pay about $200 a month on supplements.
That's remarkable. That must've taken an enormous amount of research.
Well, you see, I've been in this since 1989. So, I know quite a bit about it. I'm also on a Canadian HIV Trials Network, and we review protocols. I'm the chair of the Community Advisory Committee. I'm also on the Provincial Treatment Committee, on the Canadian Treatment Advocates Council, the Health Canada Expert Advisory Committee on HIV Therapies, so all this research, I sort of do it all the time. That's all I do is research on HIV.
Do you also write about it?
I used to, but the bulletin that I used to write for has become defunct.
What was it called?
ITI. The French language bulletin.
Published out of Montreal?
What did ITI stand for?
Information sur les Traitements de L'Immunodéficience -- Information on the Treatment of Immunodeficiency.
Can you tell me a little bit about the work that you're doing to get facial fillers approved and also to get them covered?
Well, we started the group. It was actually Michael Hendricks who started the group in October 2003. Our first problem was trying to get AIDS groups to help us out. They used to throw out their brochures. They didn't want people to know about lipoatrophy, because they thought, "Oh, people are going to stop their drugs, or people are never going to start drugs, and they're going to die," and all that crap.
Who was throwing these leaflets out?
The directors of the AIDS groups, even drop-in centers. A lot of groups just didn't want to hear about it. They were afraid it was going to stop people from taking their drugs.
But people already knew about it, didn't they?
No, a lot of people don't know, didn't know back then, anyway.
When was this?
This was just 2003. Even [among] doctors. We [put] a lot of pressure on doctors to stop prescribing d4T and to switch patients from d4T. They were telling us, "Oh, no, there's data that shows that AZT is worse than d4T," but that was old data done by GlaxoSmithKline. There's been so much data since then that there's no doubt that d4T is the worst, AZT is the second worst and ddI [didanosine, Videx] is the third worst, and if you mix d4T and ddI, that's even worse. But we [had] to convince the doctors and the groups. Most of them are, basically, all on our side now. They don't really get too involved in it, and they don't support us much, but at least they don't throw away our pamphlets.
What was covered in the pamphlets?
The pamphlets were about lipoatrophy, buffalo hump and the belly.
Protease paunch, yes. Crix-belly was at the beginning, but we know all proteases can cause it, so it's protease paunch, but that kind of scared people. A lot of groups now are led by HIV-negative people who basically want to hold our hand and say, "Don't worry. Everything will be OK. Just take your pills like you're supposed to." And, "Anyway, you're better off with a paunch than you are dead." And yet, there are alternatives.
That's a very condescending point of view.
I find that in a lot of groups.
Even now, but [that might change with the approval of treatments for lipoatrophy. We have asked] the government but they've refused [funding] for Sculptra. They can't give it to us unless it's approved in Canada, [but] we expect approval in May or June.
At this point in time, there's nothing approved of this sort?
In Canada, the only thing we have approved is PMMA [polymethyl-methacrylate], Articol. We actually sent one guy with severe lipoatrophy for a test case to see how much it was going to cost. The doctor was going to charge $12,000, and, actually, our PMMA is an old formulation. It's not like Dr. Márcio Serra's in Rio de Janeiro, which is a much better product.
We also have Restylane [hyaluronic acid, Perlane, Macrolane] and stuff like that, which don't last very long. So [they're] not really beneficial for lipoatrophy.
In your opinion, what are the best facial fillers? What would you want to have the government approve?
The best are the poly-L-lactic acid Sculptra and Bio-Alcamid. I believe there's a role for both of them. Basically poly-L-lactic acid for very light lipoatrophy, because if people stop the drugs, there's a chance that [their fat] will come back. But for someone who is, like, 50 or 60 years old and has severe lipoatrophy, well, then he needs something that's permanent, like Bio-Alcamid.
How does Bio-Alcamid work?
Bio-Alcamid is injected into your face, and your body encapsulates it [in a 2 mm layer of collagen forming what's] called an endoprosthesis. It stays there permanently, but if you ever need to take it out, you can pierce it and squeeze it out, kind of like a pimple. And it's cheaper in the long term than Sculptra.
Because you don't need to have so many treatments?
Right. [With] Sculptra you need to have touch-ups approximately every two years, and there are some reports that people don't get as good a reaction from it the second time out as the first time. [Perhaps] your body stops making the collagen -- I'm not sure why, but I've heard a few people saying that they're not getting the benefits that they got the first time around.
Do you think both Sculptra and Bio-Alcamid will be approved in Canada?
Oh, yes. It's easier to approve facial fillers [in Canada] than in the U.S. You guys had a lot of problems with Sculptra we don't anticipate. [The Canadian government] came back with some questions to the company, but we expect a May, June approval with no problems, and it's going to be not only for HIV lipoatrophy, but [also] general use. You're only supposed to use it for lipoatrophy [in the U.S.], although your doctors are going to use it for [other conditions]. But the indication here is going to be different than the indication in the U.S.
And in terms of getting it covered?
Well, that's [what we're working on] now. We talked to [Dermik, which produces Sculptra,] about a month ago, and the first step is to find out which government department is going to pay for it, because it's not the same government department [as approves drugs or pays for the antiretroviral drugs], and it's different in every province. The company has to make a demand on each province to get it covered. In Quebec, we're not sure which department it's going to be, but the company is working on that.
In the U.S., part of the problem is that the insurance companies claim that it is purely cosmetic, rather than reconstructive or restorational.
Yes. Do they say the same thing about women who have their breasts removed?
No, of course not.
Or about burn victims who have skin grafts done?
Exactly. Is that also an excuse used in Canada?
No, we haven't had that excuse yet, because it's not approved in Canada yet.
But do you anticipate that?
The first step will be for the company to ask the government to pay for it. We expect a no. Then we'll start putting pressure on the government. We've already sent them a report, which is a pretty heavy report about the studies done, the reasons why lipoatrophy is due to medication and examples of diseases like acne that they pay for, which is purely cosmetic, and ours is not. It's reconstructive.
Essentially the difference is that, in terms of reconstruction, you're bringing the body back to baseline or normal?
You're not enhancing it.
That's right, and that's where we're going to have a problem with public image. We always try to get women involved so that it's not, "Oh, this is just the faggots in their mid-thirties who want to look beautiful." It's a delicate situation.
Do you really think that that's part of the public sentiment?
But all you have to do, it seems to me, is show pictures of the effect of lipoatrophy and say, "Imagine walking around looking like this for the rest of your life."
Yes, and we do do that. We have a few pictures, and we've done a few demonstrations. But we need more [than] pictures, but we don't have that many people who are willing to come out with their own faces and show it.
Also the feedback from a part of the [HIV] community is, "Oh, now you're making people identify me as HIV positive, because they didn't know before." Which is crap, because, I'm sorry, you're gay, and you've got no fat in your face -- people are automatically going to assume you've got HIV. It's not an educational thing that people don't know about. It's sort of the controversy that you guys are having. I think it's in the southern U.S., where you're showing the reality of HIV [using] pictures of people with facial lipoatrophy and people sitting on toilets because of diarrhea because of the meds.
Half of the community is saying, "Don't show that." Well, here it's about the same thing. They don't want us to show what lipoatrophy looks like, because then it's going to show that they have AIDS or HIV.
Also, part of the argument has been that you're portraying people with HIV as sick, as ugly, as victimized, rather than as empowered and healthy.
Yes, that's what they say, but we're empowering ourselves by getting ourselves fixed up.
That's a good point.
They don't see that part.
Even though your case of lipoatrophy was mild, did you suffer any psychological effects due to comments from people?
No. People don't tend to comment. People are too polite. They comment behind your back. But I like to have anonymous sex, so I tend to go in darker places when I have lipoatrophy.
But as a waiter did you feel any nervousness about your lipoatrophy?
No, because it wasn't that severe. So people wouldn't notice it to be HIV, but then again, at work, everybody knows I'm HIV positive. They knew the reason [why] my face was like that, and the reason [why] I had the protease paunch, was because of the meds. I mean, I tell everybody.
Also, you're visible in the community.
Yes, most people know me. But we did a survey -- it's in French, though -- of about 200 people, members of the HIV organization here, and there are people who stop drugs, people who are suicidal, people who stop going out completely [due to lipoatrophy]. So there is data, and not only from us. I think Spain has some data on that, too.
I was speaking to someone who had a very severe case of lipoatrophy. Trying to get coverage for it involved a very long process of appealing over and over and over again to his insurance company. He succeeded due to his determination and the extensive documentation he presented. He was in psychotherapy, and his therapist had documented the insidious effect of the lipoatrophy. In her words, he had developed a real complex about it. His life had been severely diminished. He was unable to speak publicly. He felt people were looking at him all the time. He stopped going out.
Oh, yes. People do stop going out. They become hermits in their own house. They feel so deformed that they stop socializing even with friends.
That's hardly a cosmetic issue.
No, it's not cosmetic at all. When you're 40 years old, and you look like someone who has cancer and is in their sixties or seventies, it's not cosmetic. But insurance companies are going to try to use whatever they can not to pay, and they do that in every disease group.
But the more people push for it, the easier it'll become for the next generation of people who will do it. But hopefully we'll be having a lot less [cases of lipoatrophy]. I know patterns of prescription are changing. Even the guidelines have changed to list the dangers of d4T, and it's not a first-line regimen anymore.
So I think this problem is going to be a lot easier for the new generation of people who start therapy in North America. But for poor people in the Third World where everybody's getting d4T and the stigma is way worse, it's going to be a big problem.
They used to call [HIV] the slimming disease in Africa, but now they'll be able to notice it even when the person is physically healthy. Now they'll notice when the person is supposed to be able to work. Before, when you had the slimming disease, [your case was] very advanced and you were going to die very soon, but now these people aren't going to die -- it's going to be horrible for those people there.
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About José Sousa
Home: Quebec, Canada
José had avidly followed the advancements in HIV treatment information for over 10 years, which made it easy for him to notice the signs of lipoatrophy in himself. José says he was able to reverse his case with no side effects by taking a structured treatment interruption and switching HIV meds. A member of several HIV advocacy groups, José is working to get the Canadian health system to cover lipoatrophy reconstruction procedures.
1994: AZT (zidovudine, Retrovir) + 3TC (lamivudine, Epivir)
1994: Gp160 vaccine trial
1995: Part of placebo group in indinavir (Crixivan) trial
1998: Started d4T (stavudine, Zerit)
2000: Enrolled in clinical trial. Trial began with treatment intensification with ddI (didanosine, Videx) and hydroxyurea (Hydrea) for six months. At month three, received GM-CSF (granulocyte-macrophage colony stimulating factor) to purge the macrophages of HIV. At month five, received Remune (HIV-1 immunogen) vaccine every three months. At month six, began a treatment interruption that lasted until his viral load was over 50,000 and one third of his baseline CD4s were lost. Still an active participant in this trial.
Current Regimen: Kaletra (lopinavir/ritonavir) + 3TC + tenofovir (Viread) + hydroxyurea + d4T at a 30 mg dose
José has developed resistance to AZT and delavirdine (Rescriptor). José is an avid user of complementary treatments. Currently he takes about 80 pills of supplements a day and has employed several complementary treatments, including Chinese cucumber enemas (which he tried but saw no evidence that it helped) and urine therapy (which also didn't help).