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On to the next one, number five.

Number five is something completely different. It looks at an issue that's incredibly important to a lot of people in our clinics, and that issue is whether they can have a baby even though they are HIV positive.

This is a really important and interesting study that was able to quantify some of the experiences that individual providers have been able to offer us. The bottom line is that we know that among women who are HIV infected and who get medications, we can reduce their risk of transmitting the virus to their babies by almost 99 percent. Maybe 95 percent of children born to HIV-positive women will be uninfected, with the proper interventions -- HIV medicines -- to mom and baby.²¹

What's a little bit less clear is what to do about HIV-infected men who are in a discordant relationship -- meaning they're in a relationship with a woman who is HIV negative. Can they produce a child? We shouldn't underestimate the drive of our species to reproduce, and how much joy people get from that. It's hard to deny people with HIV that, and this has become an ethical issue as well as a scientific issue and a medical issue.

This study addressed the biological issue.²² The researchers looked at sperm washing, which is a technique where the sperm, which are not infected with HIV, are separated from the semen and surrounding cells that are infected with HIV. That sperm is used to artificially inseminate the woman, either directly or in vitro, to create a baby. This is a technique that is offered at clinics across the world, and the idea here in this study was to report on that experience.

What the researchers found was that among the over 1,000 couples who underwent the procedure, pregnancy was the result in 51 percent of these cases. There were 410 deliveries. Things looked great, and six months after the procedure, almost 1,000 women had negative HIV antibody tests. There was no known female seroconversion after this procedure.

I think that is really important information that doesn't say that it's impossible or that this is 100 percent completely safe. It says that the HIV risk is extremely low for an HIV-negative woman when this procedure is used. This is good news and this is something people are very interested in.

Unfortunately, the price really precludes a lot of people from using this procedure. But at least it's an option and it's something people can have a little more faith in if it's something they want to pursue.

It's interesting that this was a European study. Why aren't these studies done in the United States?

I think you're right. This could have been done in the United States if the different clinics that perform this procedure were able to pool their data. I think sometimes the Europeans do a great job of creating networks across countries, as we saw with the D:A:D study. One thing I'd like to mention, though, is that with any assisted reproductive technique that involves trying to increase fertility or the insemination of more than one embryo, there is a risk of twins. That was something that was seen here among the women who had that type of procedure. You may get more than you bargained for.

Dr. Wohl, wasn't the risk of twins due to the fact that these women were also receiving fertility drugs after their partners underwent the sperm washing procedure?

That's right.

It seems that in Europe they are very friendly towards HIV-positive people who want to have children. There's not a lot of encouragement here, in the United States. There isn't a lot of fertility treatment available for people who are living with HIV.

Yes, I think that's right. That may have something to do with the epidemiology of the epidemic here, versus in Europe. Also remember, this is a study of a procedure wherein we're talking about HIV-negative women. It's the guys who are the positive ones.

I think you're right that for HIV-infected women, there has been this view that their having babies carries a risk, and there is the question of whether it is really a good idea or not. I do think that's evolving and moving in a direction of being more supportive of HIV-positive women giving birth, because the intervention is so good.

In this case, we're looking at men who are positive, and their discordant relationships. I think this is interesting and novel. What most of us can understand, now that HIV-positive people are living for so long, is how one of the things that separates HIV-positive people from people who are uninfected is the ability to have a child. Now we're finding that that probably doesn't have to be the case any longer.

On to number six!

Number six involves a drug we've previously talked about indirectly, and that's Ziagen. I think one of the positive aspects about Ziagen over the last year has been our ability to neutralize one of the biggest obstacles to using this drug.

Ziagen is a drug that's in the nucleoside class; it's one of those nukes like Retrovir, Viread and Videx. The problem with this drug is that about 5 to 10 percent of people who use it will develop what's called a hypersensitivity reaction.²³

Anyone who's ever been prescribed this drug knows all about this because, when they go to the pharmacy, there's a big warning that they're given, that when they take this drug, they can get this hypersensitivity reaction, which is almost like an allergic reaction. If they experience this reaction, they're to stop the drug and not retake it.

Years ago there were instances where people developed this reaction, stopped taking the drug, and then started again against medical advice, and died. The possibility of death being associated with an HIV drug is really horrible, so there was a lot of concern about this medication and counseling that had to go with it.

A significant contribution to science in general has come from a couple of different studies that have looked at trying to understand who develops this hypersensitivity reaction and who doesn't.^24,25

Work that has been done by a couple of different groups has linked the risk of this reaction to the type of genes a person has. Not the virus's genetics, but individual people and their genetics. There is a genetic predisposition towards this reaction in some people. The gene that's associated with this reaction is much more common in white people than it is in African Americans; and it's even rarer in many Asian groups.

People have thought hard about how to use this information. There was a very nice presentation,²⁴ which is now published,²⁶ looking at using this as a strategy to screen people for this gene. Those who have the gene were not given Ziagen.

The bottom line is that that strategy works really well, such that there's been almost no case of anyone developing a hypersensitivity reaction who does not have this offending gene. Screening for this gene has become clinically adopted already. It's called HLA-B*5701. We call it 5701 for short. What we're doing in clinics is screening people who we're thinking of giving Ziagen; if they have the gene, we don't give Ziagen to them. For people who don't have the gene, we feel much safer about giving them the drug.

That opens up a whole new opportunity to use this medication, whereas before we might have been reluctant to do so. So I think that's good news for this medication.

Is this test expensive?

Initially it was, and I think it varies from lab to lab, but most clinics now are able to get this test done for about $50 to $150. You can think about in the scheme of things how expensive that is. It's good because it's a one-time test; there's nothing that changes. Your genes don't change.

Are genetic tests commonly used before prescribing medication in the United States?

No, and that's one of the things that really excites me about this research. For years, we've been talking about this wonderful science of using a patient's genes to tailor their medical therapy, but it's all been talk. We really haven't been able to use genetic analysis to help craft medical therapy for an individual.

This is one of those examples where HIV is a leader in the medical field. In a short period of time, we've identified the gene and made it clinically relevant such that right now, as we speak, a clinician is ordering this test to determine whether or not they should give Ziagen to someone. That's just fantastic! I think that's great.

So this is a real first for medicine in general?

That's right.

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