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News Briefs

November/December 2001

New HIV Drug

A new HIV drug should be in the pharmacy by the time you read this. Viread (generic name tenofovir) is a one 300-mg tablet taken once a day. It's from a new HIV drug class called nucleotide (not nucleoside) reverse transcriptase inhibitors. It does not get processed by the body's CYP450 system, which breaks down drugs in the liver, so it should not add to the liver burden of other HIV meds. Doctors and patients report that it's extremely well-tolerated (with exceptions, of course). It also has activity against hepatitis B, but no studies for this use have been reported. Bone toxicity was seen in animal studies. Viread should be taken with food, so unfortunately, it cannot be taken at the same time as the only nucleoside analogue on the market that can be taken once-a-day, Videx (the nukes are included in the vast majority of HIV drug combinations). Although no serious kidney toxicities were reported with Viread (as was seen with an earlier drug from the same company), it was not allowed to be taken with nephrototoxic drugs during the manufacturer's small compassionate access program. These drugs include Crixivan, Viracept, Ziagen, hydroxyurea, Zovirax, Cytovene and Mepron. For more information, see the HIV Drug Guide at www.tpan.com or call 1-800-GILEAD5 (445-3235). Also visit www.gilead.com.

40 Percent Drug Resistance?

University of California researchers estimate that in four years, 42% of people with HIV in San Francisco will have some antiviral drug resistance. HIV medications start losing their power against the virus when the pills aren't taken correctly. Therapy options then begin to decrease, although new meds on the horizon may help take up the slack. The HIV drug combinations on the market to date are notoriously unforgiving of lapses in correct dosing. The researchers published their report in the September issue of Nature Medicine. They also estimated that a "low" 16% of newly infected people will have HIV with pre-existing resistance to meds. That's one out of six folks with troubled drug options from the get-go.

HIV "Superbug"?

Meanwhile, well-known HIV researcher Julio Montaner of Vancouver reported finding two newly-infected patients with HIV that had resistance to all three HIV drug classes on the market. (Resistance to at least one of the drug classes is somewhat common among newly infected people.) Of the few documented people with resistance to all three classes, most had an HIV that had been weakened during its successful fight to develop resistance to the meds. These two people, however, went from having no symptoms to very weakened immune systems within months, Montaner reported. Montaner and Dr. John Mellors of the U.S. co-authored an editorial in the New England Journal of Medicine discussing this problem. They urged pharmaceutical companies to be flexible in allowing HIV patients to use experimental drugs. Currently, most trials will only allow one experimental drug to be part of a study combination in order to show whether that drug has an effect. The benefit would be harder to prove if two or more experimental drugs are being used.

Women's Body Changes

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Italian researchers reported finding more body changes in women than men on HIV therapy. In fact, when looking at various factors such as time on therapy, age, and viral load, the greatest risk for developing body changes was being a woman. Women were twice as likely as men to have changes. HIV medications have been associated with bodily changes lumped under the term "lipodystrophy" (which means abnormal redistribution of fat). These changes include increased triglyceride and cholesterol levels, as well as body changes such as loss of facial fat leading to a gaunt look, increased breast size in both men and women and abnormally large abdomens. The researchers reported on 2,258 people with HIV, about a third of them women. In all, body changes were found in 30% of the total group. The findings were reported at the first Conference on HIV Pathogenesis and Treatment, held by the International AIDS Society in Buenos Aires in July.

HIV Drug Price in Brazil

HIV Drug Price in Brazil

Brazil succeeded in dropping the price of the HIV protease inhibitor Viracept (nelfinavir) by 40%. The country's law ("compulsory license") allows Brazil to produce generic versions of HIV medications if price negotiations are not successful with the companies holding patents to the drugs. Brazilian officials estimated that the country would have saved 40% on the cost of providing the drug to its people had it produced a generic version. The pharmaceutical company Roche holds the patent for Viracept in Brazil, although Agouron Pharmaceuticals does in the United States. Agouron is now part of the pharmaceutical giant Pfizer. See http://ww2.aegis.org/news/ap/2001/AP010901.html.

Side Effects Management

The HIV Treatment Bulletin in London has an excellent guide to the side effects of HIV treatment, and how to deal with them. Visit www.i-base.org.uk/publications/side/con.html. However, notice that the British sometimes have different names for their medicines. Check with your healthcare providers.

Activists Sue South Africa

The South African activist group Treatment Action Campaign has sued the country's health minister and nine provincial health ministers in an effort to force them to provide Viramune (nevirapine) for the prevention of HIV infection from mothers to infants. Three doses used at the time of labor and birth has been proven to effectively and safely prevent transmission, for very little cost. The studies making this determination included a large clinical trial reported on by a Johannesburg pediatrician at the International AIDS Conference held in South Africa last year, but the government continues to raise concerns over possible toxicity and the development of resistance to Viramune during three perinatal doses. HIV specialists around the world have overwhelmingly dismissed both of these concerns. TAC was joined in its lawsuit by the Children's Rights Centre and a pediatrician from the South African hospital that participated in the trial presented at the world conference.

Magic Johnson Shines . . .

. . . in a cover story in the August 20 issue of Sports Illustrated, 10 years after his public announcement that he has HIV. The magazine reported that Johnson has an undetectable viral load and normal T-cell count. Ten years ago, Johnson told the magazine that he "was going to beat the disease." This year, he was quoted as saying, "I got turned on when people said, 'It's all over for Magic.' I wanted to show them I wasn't going away." And yes, he still gets in a lot of exercise.

Condoms Are Good

In light of a recent report on condoms that caused confusion about their effectiveness against sexually transmitted diseases (STDs), UNAIDS did an outstanding job of rushing to press with clarifications on issues raised in the report. The analysis of condom studies was put together by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention in the U.S., along with the World Health Organization. They found that condoms are effective against transmission of HIV for both men and women, and gonorrhea in men, but perhaps not as effective against other STIs, such as human papilloma virus (HPV), which can cause cancer.

According to a press release issued by UNAIDS, "In news items following the [report], there appear to have been misunderstandings about the difference between 'lack of evidence of effectiveness' and a 'lack of effectiveness.' Many reasons exist for the current lack of evidence: studies to establish reliably the effectiveness of condoms against specific STIs can be very difficult to conduct in a scientifically valid and ethical manner. Nonetheless, additional studies are already under way and more are planned. Until these or other studies providing additional reliable evidence can be completed, the effectiveness of condoms against some specific STIs will remain a matter of debate."

UNAIDS went on to stress that, "The report underscores the effectiveness of condoms against HIV and nothing in it challenges WHO and the UNAIDS Secretariat's conviction about the importance of condoms in HIV prevention programmes. On the contrary, unclear presentation of the report's conclusions by some commentators may distract from the vital effort to reduce risk of HIV infection through the use of condoms. It is imperative to continue promoting condoms for HIV prevention while undertaking further studies on their effectiveness for prevention of other STIs." In California, state legislators dropped efforts to pass a law that would put a warning statement on condom packages stating that the product may not protect against HPV, listening to critics who explained that such a statement could make it difficult for people to be clear that condoms do protect against HIV. To read the entire UNAIDS statement, visit www.unaids.org/whatsnew/press/eng/pressarc01/NOTEcondoms_160801.htm. To see the condom report, visit www.niaid.nih.gov/dmid/stds/condomreport.pdf (PDF).

Lubes May Help Prevent Transmission

Researchers looking at whether over-the-counter products could help protect against HIV found three lubricants that significantly and quickly lowered the reproduction of the virus from infected cells (by more than 1,000 times): Astroglide, Silken Secret, and Vagisil. Moreover, these products did not irritate mucosal membranes, a process that may increase the risk of infection by creating breaks in flesh. Only clinical studies will show whether all of this can actually lead to a decreased risk of transmission -- and that would take years. But in the meantime, would throwing some Astroglide into sexual encounters hurt? Probably not. The University of Texas Medical Branch at Galveston (UTMB) researchers published their report in the July 20 issue of AIDS Research and Human Retroviruses.

Oral Sex Safe?

University of California at San Francisco Center for AIDS Prevention Studies researchers reported that the risk of getting HIV from giving a blowjob is just about zero. A report last year found that the risk of transmission through oral sex between men was 8%, an astoundingly high number given the widespread belief of a near 100% safety from HIV through oral sex. (Other diseases may be transmitted, and are especially problematic to people with HIV.) The findings, based on 198 people, were presented at the Second National HIV Prevention Conference, held by the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta in August. The researchers reminded people that there is still a risk, especially as the individual's number of oral contacts increases. Visit http://hivinsite.ucsf.edu.

HIV Undetected

Also at the prevention conference, researchers from Kaiser Permanente reported that an amazing 40% of people they surveyed had already progressed to AIDS by the time their HIV infection was discovered. This was despite the fact that they had risk factors or symptoms associated with HIV. The results came from 19,000 people in 12 states. In a press release, Leo Hurley, one of the authors of the study, says, "What this tells us is that patients and doctors need to be more aware of the possibility of HIV infection and to test more routinely for it. We all need to assess our level of risk on an ongoing basis and seek testing to be sure of our status. Early detection can make better treatment outcomes possible and can reduce the spread of the virus."

Another Kaiser report found that a pilot program offering test results and counseling over the telephone improved the rate of people following up on the results of their HIV test, another big problem in detecting infection. Testing programs report that many people fail to return in person for HIV test results -- one of the barriers to detecting HIV that was documented by the Kaiser organization in yet another report at the conference.

Fighting Infection

Fighting Infection

Also at the conference, New York City officials reported that syringe exchange programs for drug users was "key" to dramatically slowing the rate of infection for that population. They reported a drop from 50% in 1990 to 20% in 2000. And the CDC itself noted that numbers of AIDS cases and AIDS-related deaths are stabilizing -- which signals an end to dramatic drops seen since the mid-1990s. The CDC also released a study showing that a third of the young gay or bisexual men they surveyed said they had unprotected anal sex with a man within the previous three months, and nearly one in five surveyed also had sex with a woman. The CDC surveyed 2,600 young men ages 15 to 25 in 13 cities across the country.

AIDS and Depression

The HIV Cost and Services Utilization Study reports that half of the nearly 3,000 people with AIDS whom they surveyed have psychiatric symptoms such as depression and anxiety. The study noted that this was four to eight times higher than seen in the general population. Depression has been shown to decrease survival in people living with HIV (see "Medicine Chest" in this issue). Also, one out of four people (25%) reported using an illicit drug other than marijuana, and 12% said they had an addiction. The findings were reported in the August 14 Archives of General Psychiatry.

FDA HIV E-Mail

From the FDA: "An e-mail list has been established by the Division of Antiviral Drug Products (Center for Drug Evaluation and Research) and the Office of Special Health Issues (Office of the Commissioner) of the Food and Drug Administration (FDA) to provide updates on safety and regulatory issues related to HIV/AIDS products. The purpose of this e-mail list is to give patients, industry, academia, other government agencies and other interested parties one source for FDA HIV/AIDS related information. Information such as product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment will be distributed through this e-mail list. To join the e-mail list, please go to http://list.nih.gov/archives/fda-hiv-aids.html."

New Treatment Group

HIV treatment advocates from around the country have formed a new group to improve AIDS research, treatment access, and empowerment of new activists in communities most affected by the epidemic. For now, contact is only through the Internet. Visit www.atac-usa.org.

Stopping Therapy

U.S. treatment guidelines for HIV were recently updated in August to include more information on viral load before starting therapy and on stopping therapy. Unpublished data from the Multicenter AIDS Cohort Study (MACS) clarify that while therapy "should be offered" to people with less than 350 T-cells across all viral load levels, those people with less than 20,000 viral load still have a lesser risk of disease progression. (However, the MACS study is only in men and the number of people being reported on are small.)

For stopping therapy, the guidelines -- which are produced by the U.S. Department of Health and Human Services -- state the following:

"If a decision is made to interrupt therapy the patient should be closely monitored including clinical and laboratory evaluations. Prophylaxis [medicine to prevent certain diseases] should be initiated as needed based on the CD4+ T cell count. There has been interest in what is commonly called structured or supervised treatment interruptions (STI). The concepts underlying STI vary depending on patient populations and encompass at least three major strategies: 1) STI as part of salvage therapy, 2) STI for "auto-immunization" and better immune control of HIV, and 3) STI for the sole purpose of allowing less total time on antiretroviral therapy. As a consequence of limited data, currently, none of these approaches can be recommended.

"Salvage STI is directed at patients whose virus has developed significant antiretroviral drug resistance and who have persistent plasma viremia and relatively low CD4+ T cell counts despite receiving therapy. The theoretical goal of STI in this patient population is to allow for the re-emergence of HIV that is susceptible to antiretroviral therapy. Although HIV that was sensitive to antiretroviral agents was detected in the plasma of many individuals following several weeks to months of interrupting treatment, the emergence of drug-sensitive HIV was associated with a significant decline in CD4+ T cells and a significant increase in plasma viremia, suggesting improved replicative fitness and pathogenicity of wild type virus. In addition, drug resistant HIV persisted in CD4+ T cells. The observed decrease in CD4+ T cells is of particular concern in this patient population, and STI cannot currently be recommended for this group of patients.

"Auto-immunization STI and STI for the reduction of total time on drugs are directed at individuals who have maintained suppression of plasma viremia below the limit of detection for prolonged periods of time and who have relatively high CD4+ T cell counts. The theoretical goal of auto-immunization STI is to allow several short bursts of viral replication to augment HIV-specific immune responses. This strategy is being studied in individuals who began HAART during either the very early or chronic stages of HIV infection. STI for the purpose of less time on therapy utilizes predetermined periods of long or short cycle intermittent antiretroviral therapy. The numbers of patients and duration of follow-up are not sufficient for adequate evaluation of these approaches at this time. Potential risks include a decline in CD4+ T cell counts, an increase in transmission and the development of drug resistance.

"Due to insufficient data in the situations discussed, STI cannot be recommended for use in general clinical practice at this time. Further research is necessary in each of these areas."


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This article was provided by Positively Aware. It is a part of the publication Positively Aware. Visit Positively Aware's website to find out more about the publication.
 
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