Writer, wit, policy maker and activist Jim Pickett (see Pickett Fences), was among the AIDS Marathon runners who helped raise more than $1.2 million for the AIDS Foundation of Chicago during the October Chicago Marathon. He came in with a time of 4:15:11, placing 14,320 out of 33,000 runners. Pickett wrote, “The male winner, Evans Rutto, came in at 2:06:16, so I got my work cut out for me next year. And hold on to your tiaras, there will be a next year. It was an amazing, tingly experience, the day was stunning, gorgeous, perfect, Chicago never looked better, and seeing many of you out there on the course (including my beautiful partner—Omar—who came in from Dallas to be Head Cheerleader, and later Human Crutch) made it that way.” Congratulations, my dear Pickles. And thank you again for all your efforts on behalf of the HIV community.

The U.S. Food and Drug Administration (FDA) in December approved a 500 mg film-coated tablet formula of Invirase (saquinavir mesylate). Like the other formulas of Invirase, it must be taken with a small dose of Norvir (ritonavir) and food. Both drugs are protease inhibitors. The new tablets reduce the Invirase dose from five pills to two, twice daily.

Nelson Vergel, an outstanding activist for the HIV community, presented this report on the facial filling product approved by the U.S. Food and Drug Administration late last year. “ Sculptra is the new name for what used to be called New Fill (polylactic acid). We had a meeting with Dermik. They presented some of the details of the Sculptra Patient Assistance Program (go to www.Sculptra.com and www.facialwasting.org for more information on the product, and for a sample letter for payers). All doctors and patients wanting to participate in the program should call 1–888–SCULPTRA. For someone with no dependents, the product will be provided for free if income is $40,000 or below. A sliding scale will be applied up to $80,000 (with no dependents) . After $80,000 (no dependents) the full cost of the product is $960 per kit (two vials, which is what most need for one session). Every case is different and will be handled by people answering the number. I think they, or your doctor, have to try to get through your third party payer first and get denied for you to qualify.

“I am trying to come up with a way to get doctors listed in facialwasting.org who have been trained and are charging reasonable labor rates (under $450 per session). Remember that there will be assistance only for product cost, not labor. You will still have to pay a doctor about $300–$500 a session for labor. Most people need 4–8 sessions of Sculptra, depending on the severity of their facial wasting. I hope one day we can get third party reimbursement for not only product but also labor cost (this will require lots of activism). With the help of others, I will generate a list of questions that all patients should ask the doctor applying this product to see if that doctor has received proper training. It will be no easy task to determine who is best qualified to apply this product besides number of prior patients and time using it.” To learn about people’s experiences with Sculptra and other facial restoration products, join a free Internet discussion group by sending a blank e-mail to Pozhealth-subscribe@yahoogroups.com.

U.S. HIV treatment guidelines for both adults and children were updated late last year. Pediatric guidelines now include two supplements, on managing both complications of HIV infection as well as adverse drug effects. There is also information added about Reyataz, Crixivan and Fuzeon.

For adult (and adolescent) guidelines, there were many more changes. People with more than 350 T-cells can wait to start treatment when their viral load is 100,000. The figure from previous guidelines was 55,000. The guidelines state that, “This is based on more recent data supporting HIV RNA level of greater than 100,000 copies/mL being a stronger predictor for disease progression than [above] 55,000, though even at these CD4 and viral load levels, the risk of disease progression is still relatively low. Most experienced clinicians will defer therapy with quarterly clinical and laboratory evaluation.” (Remember that recommendations change with circumstances; for example, therapy is recommended for anyone with an AIDS-defining illness or severe symptoms of infection, no matter what their T-cell count is.)

For initial therapy, Zerit has been moved from the “preferred” to the “ alternative” list because of “increasing reports of [Zerit]-associated toxicities.” Added to the preferred list is the combination of Viread with either Epivir or Emtriva as the backbone of a drug regimen. (Viread and Emtriva are also available in a new combination pill, called Truvada. However, the new combination pill of Epivir with Ziagen, called Emtriva, was not added, probably because of potential toxicity with Ziagen.) Emtriva by itself was also added to initial therapy, on both the preferred and alternative lists.

Treatment considerations for special populations (adolescents, injection drug users, or people with either hepatitis or tuberculosis), were also added.

See guidelines for the complete list of changes. For a free copy, write to AIDSinfo, P.O. Box 6303, Rockville, MD 0849–6303 or call 1–800–HIV–0440 (1–800–448–0440). Visit www.aidsinfo.nih.gov.

As a result of new data, Crixivan (indinavir) is not recommended for HIV-positive pregnant women. The package insert for the protease inhibitor has been updated to include information from a Pediatric AIDS Clinical Trials Group study, PACTG 358, showing substantially reduced Crixivan blood concentrations in women at weeks 30–32 weeks gestation.

The prescribing label for Viramune (nevirapine) has been updated. The label now states that, “Based on serious and life-threatening hepatotoxicity [liver toxicity] observed in controlled and uncontrolled studies, Viramune should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk (see Warnings).” Patients should also now be receiving a medication guide with every refill. The potential for liver problems with Viramune are well known, and new patients especially should be monitored carefully.

The warnings section of the label goes on to state that, ”The patients at greatest risk of hepatic [liver] events, including potentially fatal events, are women with high CD4 counts. In general, during the first 6 weeks of treatment, women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8% versus 2.2%), and patients with higher CD4 counts at initiation of Viramune therapy are at higher risk for symptomatic hepatic events with Viramune. In a retrospective review, women with CD4 counts greater than 250 cells/mm3 had a 12-fold higher risk of symptomatic hepatic adverse events compared to women with CD4 counts <250 cells/mm3 (11.0% versus 0.9%). An increased risk was observed in men with CD4 counts >400 cells/mm3 (6.3% versus 1.2% for men with CD4 counts <400 cells/mm3). However, all patients, regardless of gender, CD4 count, or antiretroviral treatment history, should be monitored for hepatotoxicity since symptomatic hepatic adverse events have been reported at all CD4 counts. Co-infection with hepatitis B or C and/or increased liver function tests at the start of therapy with Viramune are associated with a greater risk of later symptomatic events (6 weeks or more after starting Viramune) and asymptomatic increases in AST or ALT.”

Visit www.viramune.com, or ask your pharmacist for a copy of the package insert (also called “prescribing information”).

A true story, from a member of the Test Positive Aware Network staff, for others who may be experiencing the same problem. “My friend Dan was having vision problems, even though his eyesight had always been good. His mother mentioned to him that it looked like he had Droopy Eyelids. Long story short, he went to his doctor, then an ophthalmologist, who sent him to a plastic surgeon specializing in eyes only. The surgeon said that he has worked on a number of HIV-positive patients who had premature Droopy Eyelids. This means that the muscle holding the eyelid open becomes unattached and the lids sag, covering the eye and blocking vision. Plastic surgery can fix the problem and do a cosmetic eye lift too at the same time.

“Many of us have never heard of this, but apparently it happens to older folks and now to HIV-positive folks with lipoatrophy. I had thought this might be a good thing to feature as many poz people like Dan may be walking around with poor vision and not having any idea what is happening to them. This could keep them informed and learn about how to solve the problem.”

The U.S. Food and Drug Administration (FDA) last summer approved Alinia (nitazoxanide tablets) for treatment of diarrhea caused by the parasite Giardia lamblia in patients 12 years of age and older. The suspension formula had previously been approved for treatment of Giardia and cryptosporidum parvum (crypto for short, another parasitic infection) in children ages 1 to 11.