News Briefs

by Enid Vázquez

Subjects:

Correction 1
Correction 2
New prison activist group
Guidelines update
There oughta be a law
New-Fill update
Lamictal for peripheral neuropathy
Late Breaker

More Retrovirus Updates:

Treatment interruption in newly-infected people
Newly infected people: resistance lasts a long time
Neuropathy treatment
Bisexual men

The Editor’s Note of March/April incorrectly stated the prices of Reyataz and Lexiva. The correct average wholesale costs for Reyataz is $10,074 and $14,600 for Lexiva. Positively Aware apologizes for the mistake.

Correction 2

The News Briefs of March/April incorrectly stated that the U.S. Food and Drug Administration (FDA) updated the black box warning label for Viramune (nevirapine). Viramune’s manufacturer, Boehringer Ingelheim, updated the warning label on its own. Said one leading HIV researcher, “To their credit, without being prompted by the FDA, they changed their label.” Positively Aware apologizes for the mistake.

New prison activist group

The national AIDS Treatment Activists Coalition (ATAC) in February launched an initiative to help HIV-positive prisoners and their advocates. In a press release the volunteer organization reported that, “HIV/AIDS in prisons is sometimes described as the single most challenging field in domestic AIDS activism.” For more information about the working group, contact Julie Davids at 1-212-966-0466 x 1226 or jdavids@champnetwork.org. Visit www.atac-usa.org.

Guidelines update

The U.S. Department of Health and Human Services (DHHS) in March updated its “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.” The table of treatment for people taking HIV medications for the first time now lists Lexiva and Norvir-boosted Lexiva regimens in the “alternative protease inhibitor-based” treatments (Kaletra is the protease inhibitor of first choice). Information on Lexiva, the newest protease inhibitor on the market, was also added throughout the guidelines. Norvir-boosted Agenerase and Crixivan taken without Norvir were both removed from the table (Agenerase is the older formula of Lexiva). Also added is the recommendation of the combination of Ziagen and Epivir to the alternative dual nucleoside backbones of HIV regimens.

A safety update was added regarding Viramune, noting that there was a higher rate of liver toxicity (11%) in women with more than 250 T-cells and men with more than 400 T-cells. The guidelines state, “Use [Viramune] with caution in these patients, with close clinical and laboratory monitoring, especially during the first 18 weeks of therapy.” Also, “Severe, life-threatening, and in some cases fatal hepatotoxicity [liver toxicity], including fulminant and cholestatic hepatitis, hepatic necrosis, and hepatic failure, has been reported. Patients may present with non-specific prodromes of hepatitis and progress to hepatic failure.” At the same time, the guidelines add the statement that Viramune has “More safety experience in pregnant women with no evidence of increased adverse [liver] events in women who received single dose nevirapine [Viramune] for prevention of mother to child transmission (PMTCT).”

A new table has been added for HIV drug dosing changes in people with kidney or liver insufficiency. To see the guidelines, visit www.AIDSinfo.nih.gov or call 1-800-HIV-0440 (448-0440) to request a free copy.

There oughta be a law

HIV specialists at Northwestern Memorial Hospital in Chicago, IL have teamed up with HIV-positive Illinois State Rep. Larry McKeon, a Democrat from Chicago, to promote a revolutionary idea: allowing people with HIV to become organ donors to other HIV-positive people. McKeon wrote the bill after talking with his HIV specialist Robert Murphy, MD of Northwestern. The bill passed the Illinois House of Representatives in February and the Illinois Senate in March. The governor could sign it into law in May. The U.S. Department of Health and Human Services (DHHS) reports that there are 81,000 people on the list for a transplant in the United States, and someone dies every 90 minutes while waiting for an organ.

New-Fill update

A panel convened by the U.S. Food and Drug Administration (FDA) in March recommended the approval of New-Fill (injectable poly-L-lactic acid) for treatment of facial wasting in people with HIV. If approved, Dermik Laboratories plans to market the product in the U.S. as Sculptra.

Lamictal for peripheral neuropathy

The recent conference report on treatment for peripheral neuropathy (See “More Retrovirus Updates”) brings up another treatment successfully used by a staff member at Test Positive Aware Network. Not to outdo the researchers or study participants, here is his story.

“I suffered (still do to some extent) from neuropathy for years. There were periods that my legs/ankles/feet were in casts and I was on crutches. The pain was unbearable even on heavy painkillers. I tried anti-depressants, anti-seizures, anti-everything. I tried every natural supplement recommended with no response: heat and cold therapy, creams and ointments, magnets, physical therapists, acupuncturists, massage, etc. I went into more than one clinical trial, including one for nerve growth factor that not only gave no help, but was also shut down.

“I began getting The Neuropathy Association newsletter, from a not-for-profit organization, in the mail. Readers always touted different remedies they were trying. People were beginning to mention using a drug that had previously only been used as an anti-spasmodic. It’s called Lamictal.

“I reluctantly tried it, and within three weeks I was noticing a huge difference in the pain. I was able to reduce the recommended dosage and within two months (after six years of excruciating pain) the pain was actually subsiding. I no longer have the sharp, aching, biting, stinging, and burning pain associated with neuropathy. My walk has pretty much stabilized (except for the slight swish). I still have some numbness, especially after walking or standing for lengths of time, but it’s been a great relief. I don’t even take the stuff anymore and it’s not come back.” [Editor’s Note: he does not swish.]

People should know that Lamictal has caused cardiovascular complications in animals, which is not expected in humans unless, possibly, they have liver disease. It can also lower blood levels of folate, which is needed by pregnant women to prevent birth defects. Finally, Lamictal may cause a hypersensitivity reaction that can be serious. Symptoms include rash, fever, and liver abnormalities, and should be reported to a medical provider right away.

Late Breaker

Boehringer Ingelheim announces the expansion of Tipranavir Open Label Safety Study. Tipranavir is an investigational non-peptitic protease inhibitor in Phase III development. All full listing of study locations will be available at www.clinicaltrials.gov.

Treatment interruption in newly-infected people

Dr. Bruce Walker of Harvard University and colleagues years ago reported that early treatment in newly infected people was associated with undetectable viral load when the treatment was stopped after a short period. In this update, the researchers report that control of the virus did not last.

Although 11 out of 14 people (79%) had undetectable virus for at least three months, eventually viral load went up and T-cells went down.

Study participants took antivirals again if their viral load remained above 5,000 for three consecutive weeks or if it went up to more than 50,000 at any point. Two persons were able to stay off antivirals for two years, and most were off meds for six months or one year. The report noted, however, that viral load benefit could not be determined because of the small number of people in the study and the lack of a control group that did not receive treatment.

The researchers found that HIV-specific CD8 cells continued to go up throughout three treatment interruptions. Also, the viral control seen existed despite the lack of protective HLA (human leukocyte antigens) alleles. HLA prevents the immune system from fighting the body’s own cells, which HIV causes it to do. The group reported that, “These data are relevant to current efforts to develop an AIDS vaccine designed to retard disease progression rather than prevent infection, and indicate that durable maintenance of low level viremia may be difficult to achieve.”

Newly infected people: resistance lasts a long time

HIV specialists are planning to change the course of treatment and opt for genotype tests in newly infected people before putting them on therapy.

Dr. Susan Little of the University of California at San Diego and her colleagues followed 11 newly-infected patients not on therapy. They found that in these people infected with drug-resistant virus from day one, the resistance stayed around for a long time. (Normally, people start out with wildtype virus—one that’s not resistant to drugs—and their virus only develops resistance to medications after being on those meds.)

In one of the 11 people, it took three years for a resistant mutation to non-nucleoside drugs (Sustiva or Viramune) to revert back to wildtype virus. In the four people with resistance to protease inhibitors, there was no reversion to wildtype at all, although none of them had passed their first year of infection. Dr. Joseph Eron of the University of North Carolina at Chapel Hill called that “astounding” and said, “This tells me that genotyping may be useful even if infection occurred a year or two ago.” He pointed out, however, that transmission of resistance virus differs from one geographic area to another.

Dr. Kimberly Smith, of Rush-Presbyterian hospital in Chicago, noted that, “If people stop taking their medications, their virus reverts to wildtype faster. This resistant virus sticks around for a long time.” Dr. Smith said that it’s important to do resistance testing, even if patients are not starting therapy. “Take that information and bank it. I think it’s worth it.”

For the record, U.S. guidelines for HIV therapy state that, “Transmission of drug-resistant HIV strains has been documented and has been associated with a suboptimal virologic response to initial antiretroviral therapy. If the decision is made to initiate therapy in a person with acute HIV infection, it is likely that resistance testing at baseline will optimize virologic response, although this strategy has not been tested in prospective clinical trials. Because of its more rapid turnaround time, using a genotyping assay might be preferred in this situation. Since some resistance-associated mutations are known to persist in the absence of drug pressure, it may be reasonable to extend this strategy for 1–2 years post-seroconversion.”

Doctors and patients now have more evidence upon which to base their treatment decisions.

Neuropathy treatment

Peripheral neuropathy (PN) is one of the most common and difficult of side effects associated with HIV and its treatments. This damage to the nerves starts with numbing or tingling of the hands and feet and can progress to permanent and debilitating pain if not treated in time.

Previously, use of a topical (on-the-skin) treatment called capsaicin (pronounced cap-SAY-sin), a derivative of hot chili peppers, produced disappointing results. Several years ago, however, the University of California at San Francisco (UCSF) found good results in 10 people with HIV using high-dose capsaicin cream (5 to 10% concentration; normally the cream comes in a 1% concentration).

In a pilot study presented at CROI, one high-concentration patch of capsaicin effectively reduced PN in patients with HIV. Twelve study participants used a topical anesthetic for one hour followed by high-concentration patches of capsaicin for one hour on the most painful parts of their feet. They experienced pain relief from week one, which remained stable throughout the three months of the study.

The average pain decrease was 40%, with 66% of the participants reporting at least a 30% decrease in pain and the rest reporting at least a 50% decrease. A larger study is being planned.

Both the earlier UCSF trial and this study used pre-treatment topical painkiller to control the burning sensation of capsaicin, which led to great tolerability. Studies with the high-concentration patch in HIV continues in 19 states, and includes the cities of Chicago, New York, Baltimore, Miami and San Francisco. Visit www.ClinicalTrials.gov. (See “Lamictal for peripheral neuropathy.”)

Bisexual men

The New York City Department of Health and Mental Hygiene reported that while the majority of new HIV infections in women are heterosexually acquired, the risk factors for their male partners are unknown. Believing that bisexual men might be a big risk factor for women, the department conducted a study of 363 men in gay bars during 2000 – 2001. Of these men, 85 (23%) identified as bisexual. However, only 41 were “behaviorally bisexual” according to the department’s definition: having had sex with both men and women within the previous year. Nearly a third of these men had high-risk sex (defined as unprotected vaginal or anal sex, or multiple partners) with both men and women. The report concluded that, “HIV prevention messages to men and women should acknowledge the intersection of MSM [men who have sex with men] and heterosexual women. Larger and more diverse samples of bisexual men are needed to explore the extent of the HIV risks for both bisexual men and their female partners.” (MSM is a term developed to better define this group, as opposed to “gay,” which many of the men reject as their identity.)

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