Important note: Information in this article was accurate in June 2002. The state of the art may have changed since the publication date.The following is a summary of highlights from the 9th Conference on Retroviruses and Opportunistic Infections (CROI), which took place February 24-28, 2002 in Seattle.
The conference brought together nearly 3,500 of the world's scientists, researchers, clinicians, AIDS advocates, and the press. In addition to sharing relevant medical information from the conference, this article is also an attempt to shed a little light for the Women Alive Newsletter readers on what takes place at a scientific conference such as Retrovirus.
Most of the material presented comes from clinical studies conducted in the developed world (primarily the US and parts of Europe). There were however, many interesting studies presented from resource-poor continents, as well (like Africa, Asia, and Central/South America). Many countries are struggling to find ways to deal with the devastation that AIDS has caused, often without any government or financial support, and no means of activism which has been so successful here in the United States in terms of demanding that the government do the right thing which resulted in, among other major advancements, the receiving of financial aid such as the Ryan White Care Act Funding.
Before we look at what the scientists had to say, I thought it would be helpful to give a little background into the realm of AIDS research.
When working a jigsaw puzzle, usually you assemble the border first, and then you can build inward toward the middle. Imagine that you and your friends are trying to put together a giant puzzle with thousands of "teenie weenie little pieces"; each one of you working on a different section at different times and in different locations. It is a difficult and slow process, but when you use the picture on the box as a guide, you can eventually begin to group the segments together and form the completed picture. This is kind of what the Retrovirus conference looks like -- lots of tiny little pieces to the big puzzle.
The problem with AIDS research is: There are no "pictures on the box" to follow, and needless to say, it is a very slow process.
What happens when one of these researchers finds a few pieces that fit together?
So now that you have had your briefing, I hope that the information from this year's Retrovirus conference will be helpful to you in your own search for knowledge. I encourage all people infected with HIV (especially women) to learn as much as they can in order to take charge of this disease in their own lives. It's not always easy to learn this stuff, especially if you're like me. And in most cases, most infected women are like me. We come from various backgrounds, but most often have experienced some other hardship such as drug addiction, homelessness, or oppression of some sort prior to us becoming HIV infected.
After reading the following conference summary, if you would like to look at any of the data in more detail or to watch some of the plenary sessions on video, I encourage those who have access to log-on to the conference Web site at www.retroconference.org.
One study that is of particular interest to women with HIV was one that looked at the connection between PI use and decreased bone mineral density in women over the age of 35 (abstract 717-T, J.H. Arnsten). In this study, they looked at 40 women with an average age of 48. They had 19 HIV-positive women and 21 HIV-negative participants. In the study they analyzed the impact of protease inhibitor use on bone mineral density and found that PI use is independently associated with decreased bone density in older HIV-positive women. Note: There are several studies that have shown a correlation between HAART and bone loss in people with HIV, it is especially important to monitor this problem in HIV-positive women. A DXA (pronounced dexa) screening is a good test to detect decreased bone mineral density. Ask your doctor if you are concerned about this issue.
Another study that brought out an important issue for women was an oral abstract presentation on human papillomavirus (HPV) levels in the female genital tract. The study (abstract 119, L.J. Conley) took an issue that is already well known. The fact that HIV-positive women are at increased risk for cervical cancer related to co-infection with HPV, and looked at it a little further. They wanted to know if HAART therapy (meaning a combination of at least 3 HIV meds) has any effect on the HPV levels in the vaginal secretions of women. After performing a series of tests, they concluded that HAART did not affect the HPV levels, and therefore their findings stated that even women who are fully suppressed on medications, (meaning with undetectable viral loads) are still at high risk of getting cervical cancer, and should be screened just as frequently and thoroughly as women who are not on HAART.
There were a few studies that attempted to look at gender differences. One interesting presentation (abstract 777-W) was a retrospective study (meaning that they went back and looked at patients' charts over a period of time) done by Columbia University. They wanted to know if men and women who had similar T-cell counts when they started on meds got the same virologic response. They found these interesting points: first, women usually start meds with about the same T-cell count as men, but spend more time "just being observed" at the clinic before beginning therapy than men do. Once the women start meds, they have a better chance at becoming undetectable than the men in the study did. Once they were on stable therapy, they both maintained about the same T-cell and viral load responses.
Another study (abstract 775-W) did a retrospective review looking for gender differences in viral loads. Through a review of published data from the past seven to ten years, they found that women consistently had lower viral loads than men at similar stages of disease, in fact up to two- to six-fold lower viral loads than men, particularly early in HIV infection following seroconversion. These findings clearly push for more research and, perhaps our treatment guidelines for when to start therapy should be adjusted according to gender.
In another study (409-W, J. Eron et al.) scientists looked at different dosing schedules of Kaletra (lopinavir/ritonavir) comparing an 800/200 mg once-a-day dose to the standard 400/100 mg twice-daily regimen. The study was conducted on people who have never taken antiretrovirals before. The study found that there is a high concentration of Kaletra maintained in the blood over a period of time (due to the small amount of ritonavir that is included in the formulation to boost its potency). This can make it possible for people to take Kaletra once daily instead of two times a day. The safety and efficacy data were similar for the two regimens through 48 weeks, and side effects did not seem to be increased in the people taking the once daily dose. Ritonavir has been shown to increase drug levels in Kaletra (and has been studied recently for use in combination with many PIs). Another study which took place in Spain (abstract 441-W, Lopez-Cortez et al.) looked at whether or not a "nuke-sparing" regimen could be put together using 600 mg of Sustiva (Effavirenz) plus Saquinavir 1,200 mg, and adding a dose of 100 mg ritonavir (Norvir). During the past couple of years, the focus has been on finding "PI-sparing" regimens to hopefully prevent some complications such as lipodystrophy.
Now, as people have fewer options, researchers wanted to see if they could find a workable regimen for people who may already have high resistance to the nukes (nukes meaning: AZT, 3TC, etc.). Normally, saquinavir and Sustiva would not be used together because Sustiva causes the saquinavir to be metabolized very quickly by the body, thereby decreasing levels in the blood and increasing the chance of developing resistance. It was thought that perhaps by adding a little ritonavir to the saquinavir, this might reverse the problem with the Sustiva. The study evaluated the pharmacokinetics (which is what happens to the drug once you take it), safety, and efficacy. At the end of a year, the data showed that their idea was correct, and people generally did well. Those that entered the study with a viral load of less than 50 remained undetectable, and of those persons who had a high viral load to begin with, 13 out of 20 became undetectable. (This is a possible option for people who may need it).
Another drug that is already approved for once-daily dosing and is the newest HIV medication on the market (in a new class called NtRTIs) is tenofovir (Viread). Data (abstracts 413-W through 416-W) showed that tenofovir is very effective in reducing viral load for persons with lots of prior treatment experience, and also in people who have never been on meds. Side effects are minimal for tenofovir as compared to people who only took a placebo (or fake pill) in the study.
A new medication that is not yet approved but is looking good is atazanavir (TAZ for short). This is a new once a day Protease Inhibitor currently in clinical trials by Bristol Myers Squibb. Data presented at Retrovirus (abstract 42, D. Haas) showed that when used in combination with Saquinavir in patients who have failed a prior regimen, atazanavir was well tolerated, effective in reducing VL, and did not seem to have the same cholesterol and triglyceride increases that are seen with some of the other PIs.
Currently there are several exciting compounds being developed. The first is T-20 (which many people have heard about for years but have yet to see). This medication is in a class called "entry" inhibitors and so far is in injectable form. T-20, (which attempts to prevent HIV from fusing itself into our T-cells) is still in phase III trials and so far shows good success at lowering the viral load in people with a lot of treatment experience. One abstract (418-W, J. Lalezari et al.) showed that T-20 is effective in people who have already been on a PI and have developed some resistance, but are just starting an NNRTI for the first time. Another study showed that doubling the dose of the drug would allow patients to cut the number of injections to one every 12 hours and have the same effectiveness.
Another interesting candidate is SCH-C, (abstract 1, J. Reynes) This is also in the class of drugs called "entry inhibitors," but this one is in a sub-group called co-receptor antagonists. It interacts with one of the receptors (CCR5) that HIV uses to attach itself to our T-cell and get in. In a very small and short study, data showed that the drug has been successful in reducing viral load among the 12 patients currently enrolled, and proves the CCR5 receptor to be a viable target for antiretroviral therapy.
There are also five additional drugs described as co-receptor antagonists in development. One of these is AMD-3100 (oral abstract 2, D. Schols). It works as a CXCR4 (the other co-receptor that HIV uses) antagonist. In a phase II study conducted in 40 HIV-positive patients with VL more than 5,000 copies, the drug was administered intravenously for 11 days. The antiviral efficacy and safety of AMD-3100 was evaluated and the results were good, however more research needs to be done. As more information becomes available about AMD-3100 and other new compounds, Women Alive will keep our readers updated on these developments.
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