Saturday, January 27, 2007


Lipodystrophy Treatments

by Nelson Vergel

September 2006

Some HIV+ people experience unwanted body shape changes and metabolic problems. These problems are often grouped together and referred to as lipodystrophy. However, when talking about treatments for lipodystrophy, it is better to look at these problems individually.
The body changes that have been seen in HIV+ people can include:
Fat gain (lipohypertrophy) in the stomach, breasts, or back of the neck (“buffalo hump”); women are more likely to experience fat gain in the breasts
Fat loss (lipoatrophy) in the arms, legs, butt, or face (sunken cheeks)
The metabolic problems that have been seen in HIV+ people can include:
An inability to handle sugar properly (insulin resistance or diabetes)
High levels of fat (lipids), like cholesterol and triglycerides, in the blood
Some treatments can help with certain aspects of lipodystrophy, but nothing has been proven to resolve all the problems.

Treatments for Fat Gain

No one is really sure what causes lipohypertrophy or fat gain. Sometimes fat gain happens when a person puts on weight because of lack of exercise or getting older. However, fat gain may also be linked to the use of HIV drugs including protease inhibitors or other HIV treatments.

Human Growth Hormone
One treatment that is currently being looked at in research studies for HIV-related fat gain is human growth hormone (hGH).This hormone is naturally produced in the human body. hGH is not approved for lipodystrophy-related fat gain at this time and will not be covered by insurance for this use.
In HIV studies, hGH has been shown to reduce belly fat at doses of two to three milligrams (mg) a day, injected under the skin. It is expensive, costing up to $3,000 a month. Bodybuilders report that it works better if used in combination with exercise, testosterone, or anabolic steroids, but HIV-related combination studies are lacking.
The main side effects are joint aches, water retention, diabetes, and pancreatic enzyme increases. It may also increase the chances of tumor growth and decrease fat under the skin (which can increase lipoatrophy in other parts of the body). Right now, there is a research study using Serostim (a brand of hGH) with Avandia (a diabetes drug) to see if this combination can prevent diabetes and lipoatrophy problems.

Exercise
Several small studies have shown the effectiveness of cardiovascular (aerobic) exercise and resistance (weight) training in reducing belly fat.
Cardiovascular exercise is any activity that increases your heart rate to the level required for increased metabolism. It decreases body fat, improves insulin sensitivity, decreases blood pressure, and improves aerobic capacity. Twenty to 40 minutes a day should be enough, as long as you sweat. Some studies show that wearing a pedometer and aiming at 10,000 steps a day (around three miles) can provide enough exercise to decrease lipids and fat.
Examples of cardiovascular exercise include walking at a fast pace, jogging, roller blading, dancing, and climbing stairs. If you have access to a gym you can also use treadmills, elliptical machines, and stair climbers.
Resistance training consists of using weights to improve muscle strength and growth. Examples include push-ups, squats, and the use of free weights and machines at the gym. Aim for one hour sessions three to four times a week. The key is consistency. Three sets per body part with a weight that only allows a maximum of ten repetitions per set has been shown in studies to be an effective way to increase muscle growth and strength.
Exercise can be very healthy, but it is a good idea to check with your doctor if you are going to start an exercise program to make sure you don’t over do it.

Fat Burners
These products are not recommended and not proven to be effective in HIV+ people. They usually contain stimulants that decrease appetite and the ability to sleep. They can also increase blood pressure and cardiovascular disease.

Growth Hormone or Testosterone Precursors
These products are not proven to increase hormone levels.

Testosterone
Studies evaluating the use of testosterone to decrease waist size in HIV+ men have shown conflicting results. A study recently published showed that testosterone gel at 10 mg a day is effective in increasing energy and decreasing waist size in HIV+ men. Another unpublished study showed no benefit. Testosterone may decreases fat in both the belly and under the skin. It has the potential of worsening lipoatrophy in some patients.
Testosterone replacement in men is given by injections every two weeks (200 mg is a common dose). Testosterone gels (Androgel, Testim) or compounded gels and patches (Androderm) are also available. Women require lower doses and are usually prescribed customized gels made in compounding pharmacies.

Liposuction
Ultrasound-assisted liposuction of the buffalo hump has been successfully used to remove fat accumulation in the back of the neck. Hump liposuction has had a good track record of reimbursement by third party payers when doctors justify it due to pain or sleep disorders. In some cases, however, the hump may return after a few months. Liposuction of fat deep in the belly is a more difficult and risky procedure.

Treatments for Fat Loss
Some HIV drugs may cause fat loss under the skin (lipoatrophy), including Zerit (stavudine or d4T) and Retrovir (zidovudine or AZT/ZDV). To lower the risk of fat loss, consider using other drugs in the same class if possible, such as Viread (tenofovir), Ziagen (abacavir), Emtriva (emtricitabine or FTC), and Epivir (lamivudine or 3TC).
Studies show that those who switch from Zerit or Retrovir to Viread or Ziagen tend to regain some fat under the skin. However, this process may take a long time or it may not be evident for those who have more severe cases of lipoatrophy.
While lipoatrophy can occur in the arms, legs, and butt, fat loss in the face is probably most difficult for HIV+ people. This can make you look older and sicker than you are and cause embarrassment and low self esteem. There are some treatments available for facial wasting.

Sculptra
This is the first facial reconstruction product approved in the U.S. for HIV-related lipoatrophy. The product is injected under the skin by a trained professional, usually a dermatologist or plastic surgeon. It requires three to six sessions with 21 days between each session and a touch-up every year. The product costs $980 per session plus the doctor fee ($250-$500 per session). Dermik, the manufacturer, has a good patient assistance program. For more information, go to www.sculptra.com .

Radiesse
This product received FDA approval for use in the correction of facial lipoatrophy in HIV+ people. Radiesse contains man-made calcium hydroxylapatite, a substance found in bones and teeth. It is currently approved in the U.S. for various uses, including reconstructive surgery and dentistry, and has a good safety record. Radiesse is considered to be a temporary filler, meaning that its cosmetic benefits decrease over time, usually within a few years of receiving the injections. It can be very expensive at up to $3,000 per office visit. The company will offer patient assistance but details are unknown at the present.

Bioalcamid
This product is not approved in the U.S., but is available in Europe, Mexico, Canada, and other countries. Patients have been going to Mexico and Canada to get it. It is a permanent filler and usually requires one or two sessions at a total cost of $4,500. No patient assistance program is available in the U.S.

Silikon 1000
This product is not approved for lipoatrophy, but is commonly used by doctors ”off label” for this purpose. Unlike the way silicone was used in the past, this product is injected in very small quantities (micro droplets) which require anywhere from three to six sessions depending on the severity of the facial wasting. The average cost per session is around $700.

PMMA
This product is not approved in the U.S. Patients have been traveling to Rio de Janeiro and Mexico to obtain it. It is a permanent solution that usually requires two sessions. Total cost in Rio can range from $1,000 to 2,000. (PMMA has also been used in Rio to treat lipoatrophy of the butt.)
The long-term effects of these treatments are unknown. Some treatments are not permanent and results can vary. They can also be costly, and many insurance companies will not provide coverage. If you are planning on using a treatment, and especially if you plan to go outside of the U.S. for treatment, check with the product’s manufacturer to make sure your provider has been properly trained to perform the procedure.

Treatments for Metabolic Problems

High lipids (cholesterol and triglycerides) can increase your chances of having heart problems. Switching HIV medications may help, however some people have elevated lipids without being on these medications. Moderately elevated lipid levels can be addressed by decreasing your intake of fats, exercising regularly, and losing weight if you are overweight.
If the triglyceride or bad cholesterol levels (LDL) are not reduced with diet and exercise, or if they are too high to start with, your doctor may prescribe lipid-lowering drugs called statins and/or fibrates. Some cholesterol medications interact with HIV drugs, so have your doctor review all your medications before prescribing anything.
Many people who take HIV medications also have high levels of blood sugar. This might be caused by insulin resistance, which in some cases may lead to diabetes. If you have been told you are insulin resistant, or have family members who are diabetic, discuss your risk factors with your doctor.
You can reduce your risk of developing diabetes by maintaining an appropriate body weight, exercising, and eating foods that are low in saturated fat – but not too low in overall fat. Serious cases of insulin resistance can be treated with medication. These medications are also being studied to see if they can reduce other aspects of lipodystrophy.
Glucophage (metformin) has been shown to decrease belly fat alone and in combination with exercise. The main side effects include appetite suppression and diarrhea. Glucophage can also worsen lipoatrophy.
Avandia (rosiglitazone) has been shown to increase fat under the skin in those patients that have stopped Zerit or Retrovir in some studies. (It does not improve lipoatrophy in people still taking those drugs.) It can also increase belly fat, cause water retention, and increase triglycerides.
Actos (pioglitazone) seems to have the same effects as Avandia without the increases in triglycerides.

Nutrition
Very few studies have been performed to look at the effect of nutrition on lipodystrophy. One study showed that those patients who ate more soluble fiber tended to have lower incidence of lipodystrophy. Soluble fiber sources include fruits like oranges and apples, several vegetables, and oatmeal. Lowering the amount of sugars and simple carbohydrates has also been shown in some studies to decrease triglycerides.
Proper protein intake is key to sustaining lean body mass in HIV. Most dieticians agree that three to six smaller meals a day that contain vegetables, lean sources of protein, good fats, and soluble fiber are essential for healthy body composition.

Supplements

Omega 3 Oils
Oil derived from salmon has been shown to decrease triglycerides at a capsule dose of 2,000 mg – 3,000 mg a day. It is preferred to find sources that are free of heavy metals. Freezing the capsules tends to minimize burping and the fishy after taste.
Nucleomaxx (Uridine)
Nucleomaxx has been shown to increase subcutaneous fat in small short term studies in those taking Zerit or Retrovir. However, it can also increase belly fat and is expensive. It is not widely available in the U.S., although a study will soon be enrolling at the AIDS Clinical Trials Group (ACTG) sites. More information is available at http://aactg.org or http://www.Nucleomaxx.com.
Carnitine
Small studies show decreases in cholesterol and triglycerides in HIV + patients. Typical doses range from 2,000 mg – 3,000 mg a day. It can be purchased over the counter or by prescription (Carnitor).

Taking Care of Yourself
Some body shape changes and metabolic problems have been linked with heart disease and strokes in HIV+ people. To minimize the risk of heart disease and/or stroke:
Get checked and, if needed, treated for high blood pressure
Eat a healthy diet
Get regular exercise
Give up smoking
Lipodystropy can be a very distressing condition that affects how you feel about yourself. Speak to your doctor if you are experiencing any symptoms. Some of the treatments described above may help. Do not make any changes to your medication regimen without your doctor’s guidance.

1
Chow, D. C, et. al. (2006). Metabolic complications of HIV therapy. HIV InSite Knowledge Base Chapter: Retrieved July 2006 from http://hivinsite.ucsf.edu/InSite?page=kb-03-02-10
©2003-2006 The Well Project, Inc. A Not For Profit Corporation.

Thursday, January 18, 2007

Fundariser-POZ CRUISE


This press release comes from Paul Stalbaum, the organizer:

I am very excited to announce to you our plans for our Annual Poz Cruise Retreat open to all people living with HIV and of course, our friends and family.



This truly unique travel experience combines the perfect blend of socialization and educational aspects. Imagine your self sailing on a luxurious cruise ship over clear blue seas with a horizon that just never seems to end. Visit exotic tropical islands that allow us to relax on white powdery beaches and swim warm crystal clear azure blue waters. Want something more adventurous? Why not see majestic ancient Mayan ruins, rapel in steamy tropical jungles or swim with the dolphins?



This year’s cruise sails from Miami, Florida on October 28 and returns on November 4. We will have the privilege to visit Grand Cayman Island, Belize, Roatan (Honduras), and the golden Mayan Coast of Mexico. Rate begin at an unbelievably low rate of $399.00 per person plus tax for an inside cabins. Balcony cabins are available for just $655.00 per person. These rates are inclusive of all meals, nightly entertainment, private cocktail parties and other social events as well as our informative lectures and panel discussions by HIV specialists.



In years past, we have had many friendships and relationships develop. Several couples are together today because they met on our trips.



A portion of the proceeds collected will be donated to several HIV organizations as a means to raise funds for needy people in the U.S, as well as underdeveloped nations which health care is deplorable



Please do think of joining as we expect a large turn of for the Tenth Annual cruise which just happens to sail over Halloween!!!



Please visit www.positivecruise.com for details and photos or do feel free to call me at the number listed below.

Saturday, January 06, 2007

Comments on current expanded access programs


Comments from N Vergel about using these meds in combination:
1- MK 518 (integrase inhibitor) cannot be used yet with TMC 125 ( a non nucleoside) until Tibotec and Merck finish their interaction studies. Too bad it is taking this long!

2- Maraviroc ( a R5 coreceptor antagonist) can only be used for those who have a purely R5 tropic virus. You will need a test to determine that when applying to the expanded access program. Pfizer will cover the cost for that test. If you have a R5/X4 mixed or dual tropic virus, or a X4 only virus, you will not be allowed into the program. It is impossible to predict wich tropism your virus will have without testing for it, although people with longer term infection tend to have more X4 tropic virus than those in earlier stages.

3- Try to start 3 active meds when you start any new regimen. Ask your doctors to show you your genotype and/or phenotype test and discuss it with her before proceeding. Try to avoid a two active agent combo if you can wait for three. Be on the look out for any baseline resistance to Aptivus or Prezista. Just because you have never taken those two meds, it does not mean that you do not have resistance to them. Message: a new medication may not necessarily mean it is an "active" medication to fight your virus.

4- TMC 125 cannot be used with Aptivus ( a protease inhibitor). Also, you cannot use TMC 125 with Sustiva or Viramune. There is another product coming this year in phase III called TMC 278 (another non nuke) that may be more effective than TMC 125. If you develop resistance to TMC 125 , you may have diminished response to TMC 278. Keep that in mind in deciding when to start or to wait for later if you can.

5- Maraviroc can be used with both MK 518 and TMC 125. The Maraviroc program will start next month (Feb) in many countries

6- Other medications that can be used with either of these meds are: Fuzeon, Prezista, Aptivus, all nucleosides, and non nukes (for non TMC 125 combos)

7- MK 518 blood levels can increase when used with Reyataz. No one knows if this translates to a more durable response in the long term (after 48 weeks). So far, MK 518 seems to have a very good side effect profile


8- Remember that doctors and research nurses do not get reimbursed for their time when helping you get into most expanded access programs. Some doctors chose not to participate because of that. Try to find a doctor who has the manpower needed for all the paperwork required for these programs. It is difficult sometimes to find out who these doctors are since most companies refuse to list them to avoid upsetting non-EAP doctors. Pfizer and Tibotec are now doing a little better when it comes to helping cover manpower costs associated with these pre-approval expanded access programs than Meck is.

This info is from the FDA:

MK-0158, TMC125, and Maraviroc Now Available Through Expanded Access

In the September 15, 2006, At-a-Glance newsletter, AIDSinfo highlighted two anti-HIV medications available through expanded access. The Food and Drug Administration's expanded access programs provide patients with limited treatment options a way to add investigational medications to their treatment regimen. Now, in addition to MK-0158 and TMC125, a third anti-HIV medication has been made available through expanded access: maraviroc.



Maraviroc is a CCR5 antagonist. CCR5 is a protein found on the surface of certain immune cells that the HIV virus uses to enter the cell. CCR5 antagonists inhibit HIV from entering immune cells.



MK-0158, TMC125, and maraviroc are expected to be approved in 2007. Learn more about the Food and Drug Administration's expanded access and expedited approval processes for HIV/AIDS therapies.

FDA Approves Radiesse for Facial Lipoatrophy

In late December, the U.S. Food and Drug Administration (FDA) approved Radiesse, a new injectable therapy for the treatment of facial fat loss (lipoatrophy) in people with HIV; Radiesse was also approved as a cosmetic treatment for moderate-to-severe facial wrinkles and folds.

Radiesse, manufactured by BioForm Medical, contains a synthetic material that stimulates collagen production. Another product, Sculptra (poly-L-acetic acid), is also approved for treating lipoatrophy in HIV positive people.

Radiesse is not a permanent treatment, but is expected to last at least several months, and possibly as long as a few years.

Following is the letter from the FDA announcing the approval:

Radiesse Approved for Facial Lipoatrophy by FDA

On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy [lipoatrophy], or fat loss, in people with human immunodeficiency virus (HIV).

Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency, and to correct certain dental defects.

The safety and effectiveness of Radiesse for the treatment of facial lipoatrophy was evaluated in a prospective, open-label, multi-center study of 100 patients with human immunodeficiency virus and facial lipoatrophy. Study subjects were at least 18 years of age, HIV positive, with a CD4 count >250 cells/mm3 and viral load <5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years, and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic, non-smoking males (94% male) with a mean age of 48 years. Forty-four percent (44%) of patients were Black, Hispanic or Asian. Fifty-six percent (56%) percent were Caucasian.

Patients received an initial treatment (initial injection and an additional injection at 1 month as needed). Six months later, all patients were assessed for the need for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction assessment. Safety was assessed by the recording of adverse events through 12
months.

All treatments were performed with a 25 gauge, 1 and one-half inch needle. Mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4 mL (89% of patients). Four percent (4%) of patients received only one treatment, 18% of patients received a total of two treatments, and 78% of patients received a total of three treatments. No patient received more than three treatments.

Mean left cheek thickness measurements at baseline was 4.7 mm (N=100). At 3 months, the mean thickness was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline, with P-Value = 0.0001. At 6 months the mean thickness was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline, with a P-Value = 0.0001.

Mean cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months, the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline, with a P-Value of 0.0001. At 6 months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline, with a P-Value of 0.0001.

The most common adverse events reported were temporary edema (swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site.

The calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and CT Scans. It is important that patients inform their doctor and other health care professionals that they have had Radiesse injected in the face. In a radiographic study of 58 patients, there was no indication that Radiesse potentially masked abnormal tissues or was interpreted as tumors in CT Scans.


Radiesse is a product of BioForm Medical Inc., of Franksville, WI.

01/05/07

Sources

Food and Drug Administration. Radiesse Approved for Facial Lipoatrophy by FDA. Announcement.

Bioform, Inc. BioForm Announces FDA Approval of Radiesse Facial Filler For Two New Aesthetic Applications. Press Release. December 27, 2006.

www.radiesse.com

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