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What's New in Treatment Information?

from the Information Department of Project Inform

August 2002

Expanded Access Confusion

According to the Access Project, the only HIV drug that is in expanded access currently is atazanavir (Zrivada). T-20 is in open label trials (a type of drug trial in which researchers and participants know who is taking the experimental drug or treatment being given), which can be easily confused with expanded access programs (programs designed to make experimental drugs available on a wide basis to people who do not qualify for the drug trials or who live too far from a trial site). According to our IA department, T-20 should be coming out in expanded access sometime after mid-July.

For more information on the atazanavir expanded access program, check out the Access Project website at www.atdn.org/access/index.html and click on the Expanded/ Early Access Programs link.


Valganciclovir Added to the ADAP Formulary

The drug valganciclovir which is used to treat the symptoms of cytomegalovirus (CMV) retinitis -- an infection in the eyes associated with HIV -- has been successfully added to the ADAP Formulary!!

Although valganciclovir will not cure CMV, it may help to keep the symptoms such as floaters (small spots in the vision), decreased visual activity loss of peripheral vision, blurred vision and blind spots from becoming worse. Please note that many people with CMV retinitis have no symptoms.

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There are some side effects such as black, tarry stools; blood in urine or stools; chills; cough; fever; hoarseness; lower back or side pain; painful or difficult urination; pale skin; pinpoint red spots on skin; sore throat; seeing flashes or sparks of light; seeing floating spots before the eyes; troubled breathing; ulcers, sores, or white spots in the mouth; unusual bleeding or bruising; unusual tiredness or weakness; veil or curtain appearing across part of vision and less common such as changes in facial skin color; fast or irregular breathing; hives, itching, and skin rash; large, hive-like swellings on eyelids, face, lips, mouth, and/or tongue; puffiness or swelling of the eyelids or around the eyes; runny or stuffy nose; shortness of breath; tightness in chest and/or wheezing. These side effects may arise for a person taking valganciclovir so as always encourage the caller to talk to their doctor about any and all changes or difficulties.


Company Halts Production of Deca-Durabolin (Nandrolone)

Organon, the company that makes the anabolic steroid deca-durabolin (Nandrolone), halted the manufacturing of the product in early June. The Food and Drug Administration approved the decision. People using deca-durabolin can expect difficulty getting it, if they have not already experienced it. When pharmacies run out, no replacement is expected. Also, generic products are not available to serve public programs, like ADAPs.

Organon sites extensive off label use of deca-durabolin as the reason for stopping the manufacturing. Off label use is when a therapy is being used for conditions for which it has not been FDA-approved. For example, this therapy is not approved for treating HIV-related weight loss, but many people with HIV use deca-durabolin off label for treating the condition.

A number of therapies are approved for treating HIV-related weight loss. They include:

  • Megesterol acetate (Megace): This female sex hormone is shown to be effective in promoting weight gain in people with HIV-related wasting syndrome. Studies suggest that the weight gain associated with its use is primarily fat gain, as opposed to lean body mass, like muscle. People with HIV-related wasting syndrome often experience a decrease in both fat and lean body mass. While fat weight gain is important, experts propose that lean body mass gain is likely more important. Therefore, megesterol may be a less desirable option. Also, its side effects include developing secondary female sex characteristics (like development of breasts in men), making it a less desirable option for many.
  • Human Growth Hormone (Serostim): This anabolic agent is associated with increases in lean body mass and is approved for treating HIV-related wasting syndrome. Studies show that growth hormone preferentially promotes developing lean body mass and seems to result in further loss of body fat. This therapy is also being tested for its usefulness for treating some manifestations of lipodystrophy (central obesity or protease paunch and dorsal fat pad or buffalo hump). Growth hormone is very expensive and not without side effects. Because of its expense, many hospital and reimbursement plans require people to try less expensive products (like deca-durabolin) before being allowed to try growth hormone.
  • Dronabinol (Marinol): This synthetic pill is a form of THC, the psycho-active ingredient in marijuana. It is approved for treating loss of appetite (anorexia) in people with HIV. Essentially it works by giving people the "munchies." Some studies suggest that the primary form of weight gain from using this product is fat gain. However, not everyone with HIV who experiences unwanted weight loss also experiences a loss of appetite. For this reason, the drug is not useful for many people.
  • PPN or TPN: This form of giving nutrients intravenously is called partial or total parenteral nutrition. This treatment is very expensive and invasive, and it's often reserved for more severe cases of wasting syndrome.

Because of the drawbacks of other strategies for treating wasting syndrome, testosterone-like therapies have become popular. Hospital and HMO administrators readily approve and encourage physicians and patients to explore the off label use of products like deca-durabolin, because they save costs. Many living with HIV prefer to use testosterone and similar products because they have somewhat fewer side effects and perhaps more desirable or workable side effects than megesterol and growth hormone. Other products are available, such as testosterone creams and patches and other anabolic drugs.

Deca-durabolin is a testosterone-like product, but it's not testosterone. It is a preferred treatment for women, as it doesn't have the degree of virilizing effects as other products, which means the degree to which it promotes developing secondary male sex characteristics. It does, however, in both men and women, interfere with the body's ability to naturally produce testosterone.

There is rumor that a compounding pharmacy has secured a minimal generic supply of deca-durabolin. It is unclear how long their supplies will last. They can be reached at www.gulfsouthrx.com/HIV.htm or 877-729-1015.

Clearly this is not the most desirable means for long-term access. Activists are working on this issue, and undoubtedly more information will be available as the story unfolds. For more information on HIV-related weight loss and developing a weight maintenance strategy, contact Project Inform's hotline.


Nandrolone (Deca-Durabolin) Shortage: The Saga Continues

For John James' AIDS Treatment News article on the supply problem with the anabolic agent, nandrolone, click here.





  
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This article was provided by Project Inform. It is a part of the publication What's New. Visit Project Inform's website to find out more about their activities, publications and services.
 

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