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Treatment for Facial Wasting

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[Editors note: Additional information about the treatment for facial wasting

follows the text of the message]

Dear Forum,

Greetings from LLS (Consortium of MSM with HIV)

I am on HAART since year 2002 till date continuing and similarly, I

have many peers who are also on this therapy.

Some of them including me developed Lipoatropy- lost fat from face, (Facial

Wasting) arms, legs and buttocks and it's a psychological challenge before us

and in society.

We MSM here initially faced discrimination because of our sexual

orientation, secondly because of HIV infection and now the easily

available ARV drug i.e. Stavudine made our life more miserable due to

side effects of Stavudine.

Due to financial problem and ignorant about the side effect, many of

us had continued taking Stavudine for many years. Which lead to the condition

called " Facial Wasting " .

We would like to know the details of treatment for facial wasting, particluerly

about Poly-Alkyl-Imide (Bio-Alcamid)

How it Works: Synthetic material is injected into the face, then

molded and pressed into precise shape; a thin collagen capsule forms

around it.

Pros: A single procedure can inject large volume; can be removed;

extremely stable.

Cons: Not easily accessible; little data on efficacy and safety.

Accessibility: Bio-Alcamid can be injected in one session and is

permanent -- yet is generally not easily accessible.

We request e-forum members to provide us more information on the Bio-

Alcamid, specialists who administered this medicine in India and the

cost of this medicine in India.

Francis De Melo

President

Love Life Society

e-mail: <lovelifesociety@...>

___________________________

Polyalkylimide gel safe and effective for treatment of facial lipoatrophy

comment: Thaczuk, Tuesday, May 22, 2007

A small, open-label study has found that injections of polyalkylimide gel

(Bio-Alcamid) safely and effectively reduced the visible symptoms of facial

lipoatrophy in HIV-positive patients, and improved self-reported anxiety,

depression and overall quality of life. The study, performed at a clinic in

Toronto, was reported in the May 31st edition of AIDS.

Facial lipoatrophy (FL), the loss of subcutaneous facial fat, is not uncommon in

individuals (particularly men) on antiretroviral therapy. FL is a distressing

and stigmatising condition which affects self-esteem and may deter people from

going onto antiretroviral treatment. Medical treatments for FL are very limited;

the most effective treatments are forms of plastic surgery involving filling

agents which replace the lost volume under the skin.

Polyalkylimide gel (PAIG, Bio-Alcamid) has become one of the most promising and

widely-used facial fillers used in treating facial lipoatrophy. Multicentre

studies have found PAIG to be extremely safe and effective at improving FL in

some 2000 patients so far worldwide. As few or no randomised trials have been

done to date, researchers at the Maple Leaf Medical clinic in Toronto, Canada

conducted a small, randomised comparison of immediate vs. deferred PAIG

treatment.

Participants

Thirty-one participants were enrolled in the trial between April and July 2005.

All but one were male; nearly all were white gay men. The median age was 48

years; all were currently on antiretroviral therapy and quite highly

treatment-experienced, diagnosed a median of 16 years and on antiretrovirals of

some kind a median of twelve years. Participants were evaluated using

Carruther’s facial lipoatrophy severity score (FLSS), as gauged by three

observing physicians and participant self-report. The FLSS ranges from 0 (for no

lipoatrophy), 1 (for mild) to 4 (severe). At baseline, 23 participants (74%) had

moderate to severe FL, with a median score of 2 (none had a zero score at

baseline).

Participants were randomised to either receive PAIG injections immediately (at

weeks 0 and 6: n=16) or at a later time point (weeks 12 and 18: n=15), and were

followed for 48 weeks. Most participants (58%) required either one or two

injections; the remainder received a total of three or four. The median volume

of PAIG injected over the course of the study was 16.0 ml.

Week twelve: comparative results

No infections, nodules, necrosis or other serious events were seen: adverse

events were limited to mild swelling, redness, bruising and pain, and lasted a

median of three days.

FLSS and quality of life scores were compared at week twelve, when the immediate

group had received treatment but the deferred group had not. The treated group

improved by a median of 2 scale points on the FLSS, compared to no improvement

in the deferred group (p < 0.0001). Mental quality of life (measured by MOS-HIV)

was significantly better in the treated group (improved by 72 vs. 3 on a

700-point scale, p = 0.02), as was self-reported anxiety, measured by HADS

(improved by 3 vs. 1 on a 21-point scale, p = 0.02). HADS depression and

physical QOL scores tended to be better in the treated group but were not

significant.

Week 48: final results

By week 48, benefits were seen in all participants, such that “no significant

difference between groups was evident in any endpoint.” Overall mean FLSS scores

were 0 (as physician-rated) and 1 (patient-rated) for the entire cohort.

Improvements were seen in all MOS-HIV scores; the change in mental health was

statistically significant (values not cited). Significant improvements were seen

for all participants in rated depression (3 out of 21 points, p = 0.01) and

anxiety (3 out of 21 points, p = 0.001).

The researchers acknowledge limitations in the nearly exclusively male cohort,

the lack of objective skin-thickness measurements and the lack of follow-up past

48 weeks. (Cost of treatment outside the clinical trial setting is also

acknowledged as a serious practical challenge.) However, treatment resulted in

measurable improvements in quality of life, anxiety and depression compared to

those who did not receive the treatment. The authors state that polyalkylimide

gel “is a safe and effective corrective option for the correction of

HIV-associated facial lipoatrophy, resulting in clinically important

improvements in patient appearance, QoL, anxiety and depression.”

Reference

Loutfy M et al. Immediate versus delayed polyalkylimide gel injections to

correct facial lipoatrophy in HIV-positive patients. AIDS 21: 1147-1155, 2007.

http://www.aidsmap.com/en/news/80227380-8415-4C05-93C6-4492ABD4A841.asp

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