Monthly Archives - December 2010

Mitochondrial damage in adipose tissue of untreated HIV-infected patients.

Naive patients not on treatment also have some changes in their mitochondria.  So boys and girls, take your carnitine, coenzyme q-10 and B vitamins to protect your tiny energy factories that seem to be affected by the virus and its treatments.  Decrease in mitochondria or its DNA has been linked to aging and other diseases.
We saw a great presentation from Dr Wallace, expert on mitochondria, at the Aging and HIV Conference in Baltimore this past October.  Here is an interview with him

Fw: Press Release – Advancing HCV Drug Development: A Collaborative Approach

——Original Message——
From: Veronica Miller, on behalf of the Forum for Collaborative HIV Research
Sender: Veronica Miller, on behalf of the Forum for Collaborative HIV Research
To: Nelson Vergel powertx
ReplyTo: Veronica Miller, on behalf of the Forum for Collaborative HIV Research
Subject: Press Release – Advancing HCV Drug Development: A Collaborative Approach
Sent: Dec 14, 2010 4:22 PMEmail not displaying correctly? View it in your browser. Contact: Veronica Miller 202-974-6290 veronicam@berkeley.edu   Nancy Glick 202-261-2884 nancy.glick@mslworldwide.com   Hepatitis Experts Create Roadmap for Accelerating the Development of Targeted Therapies for Hepatitis C Virus   WASHINGTON, DC (December 14, 2010) – To improve the care for individuals infected with the hepatitis C virus, a major health problem and a leading cause of chronic liver disease around the world, nearly 200 international hepatitis experts have taken an important step in escalating the introduction of a new class of targeted therapies for HCV — direct-acting antivirals (DAAs).   Meeting December 6 at a major scientific meeting — Advancing HCV Drug Development: A Collaborative Approach — convened by the Forum for Collaborative HIV Research, researchers, hepatitis advocates, members of industry and representatives from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) created the roadmap for accelerating the development of DAAs, agreeing that this new class of drugs targeting specific hepatitis C virus proteins has the same potential to improve treatment outcomes for people with HCV as antiretroviral drugs changed the standard of care in HIV. Currently, two DAA compounds have advanced into phase 3 development in the United State and EU, and many more are in phase 2 trials and likely to advance to the phase 3 research phase in the near future.   "If there was ever a time when we can change the course of HCV, it is now," said Veronica Miller, Ph.D., Director of the Forum. "We are now where we were with HIV more than a decade ago and can apply many of the lessons learned from HIV drug development to significantly accelerate the progress in bringing new and better HCV therapies to market."   DAAs directly attack the ability of the hepatitis C virus to replicate and can increase the cure rate in certain HCV patients to between 60 and 70 percent– a major advance over the 40 percent success rate associated wi

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My Dream Agenda for an Aging Conference in 2011

This would be a great agenda for an aging conference (HIV or non HIV related). I hope someone sees this and picks it up as a possibility!

Advances in Testosterone Replacement for Men and Women
Basic  Home – Based Exercise Prescription for the Aging Population
Preventing and treating bone loss associated with aging
Vitamin D Research Update- Is it all they say it is?
Cardiology Research Update 
Visceral Fat and Inflammation-  Emerging Approaches and Challenges
Therapeutic Approaches to Erectile Dysfunction Refractory to PDE Inhibitors
The Medical Use of Facial Fillers in Aging Associated Facial Tissue Loss.
Preventing Frailty and Disability in Older Men and Women- What works?
The use of compounded products in hormone replacement therapy for men and women- are they safe and effective?
Mitochondrial Function Optimization in Health Maintenance- What does research say about the use of  antioxidants?
The Science Behind Meditation for Stress and Cardiovascular Risk Minimization
More HIV related:
  • effect of donepezil on cognitive function in HIV infected patients with HAND
  • effect of vitamin D supplementation on inflammatory and activation markers in HIV disease
  • effect of vitamin supplementation on blood levels of HIV antiretrovirals
  • assessment of incidence of menopause in HIV infected women under 50 years of age
  • use of leptin on visceral fat and inflammatory markers in HIV infected people
  • effect of armodafinil on fatigue, cognitive function and depression scores in HIV infected patients
  • effect of acyclovir on immune activation and inflammatory markers
  • effect of Coenzyme Q 10/carnitine on mitochondrial DNA/function and fatigue
  • effect of exercise on D-dimer, IL-6 , immune activation , telomeres and frailty scores in HIV infected patients over 50 years of age
  • effect of a Mediterranean diet on inflammatory markers, body composition and lipids in HIV infected patients with BMI> 25
  • effect of testosterone replacement on bone density in HIV infected males with hypogonadism and osteopenia/osteoporosis
  • interaction studies of cardiovascular medications and HIV antiretrovirals

What NOT to do when prescribing testosterone to older men

I covered the results of the study  mentioned below in my book.

It is so strange to me that they did not even mention or monitor hemoglobin and hematocrit in these older men. It is a well known fact that older men have more testosterone to estradiol conversion and more red blood cell increases with the use of testosterone replacement.  Many doctors prescribe low doses of Arimidex to decrease estradiol and edema, and provide phlebotomy (drainage of 2-4 units of blood every 3 months) to older men to have them maximize the benefits of testosterone while minimizing side effects.  A higher than normal estradiol or red blood cell level can produce edema and increased blood viscosity, respectively. Both of these factors can increase cardiovascular risks.
In this study, cardiovascular events included everything from rapid heart beat to light headness, and most of them were not heart attacks or strokes.
Like anything else we take, if side effect management is not present, then the benefits are erased by the side effects.  Sadly, many doctors prescribe testosterone and do not follow their patients properly. Hopefully my book will help!!
Nelson Vergel

On Thu, Dec 9, 2010 at 3:01 PM, Jules Levin <JuLev@aol.com> wrote:

Second Bioplasty Congress in Mexico- PMMA for facial and buttock lipoatrophy

I  attended the second International Congress on Bioplasty in Guadalajara last week. Here is the program in Spanish: http://www.bioplastia.org.mx/es/programa.php
Cosmetic and dermatology physicians from Mexico, Spain, Argentina, Brazil, and Colombia  came to share experiences on the use of PMMA (polymethylacrylate) to treat HIV related facial and buttock lipoatrophy and other non HIV related physical abnormalities.
Bioplasty is a technique of  inyectable implantation  done  under local anesthesia for facial and buttock lipoatrophy and for reshaping other body parts. The product usually used is PMMA (polymethylmethacrylate microspheres) and it is  usually  (but not always) injected using a micro-canula (gun like device that enables faster and smooth dispersion of the product under the skin) .  Two brands used overseas are Metacryl and Newplastic.  In the States, Artefill is the only PMMA based product approved (for cosmetic use, not lipoatrophy). 
It was confusing for me to find out that Bioplasty really is a brand name for the specific use of NewPlastic which was created by Dr Nagul in Brazil (he wrote a book on the procedure and trains doctors in Porto Alegre, Brazil).   But Bioplastic is only one of the several PMMA options available worldwide but it seems to be spreading fast around the world. More on Bioplasty here : http://www.bioplastia.med.br/bioplasty.htm 
I presented  the current status of facial lipoatrophy solutions in the United States and the challenges we still face with access and the lack of an economical permanent solution to facial and buttock lipoatrophy.  I presented the results of the 1500 people survey that people subscribed to my pozhealth yahoo group ( http://health.groups.yahoo.com/group/PozHealth/ ) helped me gather about the impact on lipodystrophy on quality of life.  They were surprised that almost half of the respondents with lipoatrophy have not done anything to treat it and that  25 percent of respondents had  suicidal thoughts in the past due to body changes ( http://bit.ly/fg4ODN )

Dr Luis Casavantes reviewed the different options available for facial and buttock lipoatrophy. Dr Gottfried Lemperle from the US reviewed management techniques for potential complications like granulomas.  Dr Marcio Serra from Brazil reviewed his experiences during the past 12 years of work. He and colleges from Brazil also described their national free assistance program for people with facial lipotrophy. Physicians in Mexico want to use Brazil’s model to provide economical access to patients in Mexico with facial wasting.
The most interesting part of the conference for me was the 3 hours in which all of us got to watch 5 doctors apply PMMA (Metacryl or NewPlastic) to patients in the operating room from a giant screen. Some use a gun-like canula to inject the product and others using insulin syringes.  It was great for me to see the different techniques in person.   It was a true eye opener for me !
I was impressed with the work on Dr Suzana Barreto from  Sao Paulo, Brazil. She does a MRI on patients before she injects them with PMMA and a few months later to see how the implant behaves in people. She showed great slides on MRI results of the face and buttocks. She also compared MRIs done in patients that have had silicone injected to show how silicone migrates and shifts in tissue. I would love for her to present in the United States since I had never seen anyone who has MRI data on patients with any injectable implants.

It amazes me that in the US  we are so far behind  of all of these countries when it comes to dealing with facial and buttock lipoatrophy   in a permanent way. As I said before, the PMMA product in the US is Artefill, which is not approved for HIV lipoatrophy (only for cosmetic purposes- wrinkles, etc)  and was priced horribly high for it to be cost effective for us in HIV. Luckily, its patent expires next year, which will open the door for Brazilians to bring their cheaper option to the US. I had a meeting with a few doctors to discuss how  feasible it would be to do a study  in the United States in 2011 so that we HIV+ patients can have access to a more cost effective permanent correction.  
The two options approved by the FDA (Sculptra and Radiesse) are non permanent and not cost effective for those  with more advanced facial lipoatrophy. They both require yearly touch ups in most patients. Currently, Medicare pays for both but the reimbursement amounts are too low to entice doctors to use it for HIV patients.  Both products have patient assistance programs that are decreasing in scope with time.
The other two products  that can be used in the US for facial lipoatrophy but that are not approved for that use are Silicone 1000 micro droplets and Artefill, and both are permanent. Neither gets reimbursed and there are no patient assistance programs for them. It would be interesting to see an economic analysis of the total cost for each for a facial wasting grade 2-4 in  a 5 year period.  I would not be surprised that permanent solutions will be cheaper in the long run for some patients.  
We have a lot of activist work to do to try to get something permanent approved for lipoatrophy that is not outrageously expensive and that has a good patient assistance program for those with no insurance (ADAP patients).  Most people with facial lipoatrophy still have no access to treatments for that condition.  Let’s see what happens in the long run with Medicare and insurance rates for the two FDA approved options we have now.  Unless something changes with a petition from the community, Medicare approval may actually hurt us more now since both companies are already reducing their patient assistance programs considerably after they assumed that Medicare would pick up a lot of the patients in their programs. If Medicare does not reimburse doctors properly, we will actually lose ground in this field.  Tim Murphy from POZ is writing an article on this problem after he interviewed a few doctors who are having problems with Medicare right now.
I am encouraging companies from other countries that have cheaper PMMA to start studies on facial and buttock lipoatrophy in the US soon to get ready for the time when the patent of the expensive Artefill expires next year.
I will try to post some videos I took of several presentations from the conference. I am still traveling a lot and have not had much time to download and process them.
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Background on PMMA- From www.FacialWasting.org
(collaboration with Al Benson)

The use of PMMA for medical uses dates to 1936 in as a bone cement.  PMMA has presented a good degree of bio-compatibility and as a result it has been extensively used as a soft tissue filler, bone cement, component of denture materials and tooth bond, housing for pacemakers and intra-ocular and contact lenses. The material itself was chemically synthesized in 1904.
Dr. Gottfried Lemperle developed the concept of using PMMA micro-spheres for tissue augmentation in Germany in 1989. PMMA has been available in Germany since as sub-dermal injections used to reduce wrinkles, scars and for certain larger soft tissue deficits.  
PMMA as a tissue filler was first introduced to Europe in 1991 as Arteplast and marketed as a non absorbable injected material. It was composed of microspheres suspended in a gelatin solution. It was observed that the gelatin material was reabsorbed and replaced by native collagen. Not fully recognized at the time was that PMMA itself was stimulating the deposition of new healthy collagen around the individual microspheres without causing fibrotic reactions seen in the implant of foreign materials such as siloxane. Arteplast has since been superseded by newer generations of PMMA of greater consistency in granule size and surface smoothness.  Dr Lemperle said: “because of the extensive fibrous network associated with PMMA related granulomas, intralesional corticosteroid injections are considered the best treatment. We saw an Arteplast® granuloma develop as late as 10 years after injection, which responded well to high doses of local steroids and a pulse light therapy.  After sieving and washing, the second generation Artecoll in Europe caused a significant lower number of foreign body granuloma.” 
There are several PMMA injectable products available. Among the approved and registered PMMA based products are Artecoll and Artesense®, manufactured in Holland and approved in Mexico and Canada since 1998.  Both are formulated with 20% PMMA in a vehicle composed of 79.7% bovine collagen and 0.3% lidocaine. Metracryl and BioPlastic are two other PMMA products widely used in Mexico, Brazil, Argentina and Europe.
Published safety and efficacy studies of PMMA in the United States done for FDA review dealt with PMMA use for the cosmetic correction of nasolabial deficits and concluded that “PMMA is the first soft tissue filler that demonstrates continued improvement and persistence of correction over a 5-year period post-treatment”. PMMA is now manufactured in the United States and was approved by the FDA in October 2006; marketed as ArteFill® (a new formulation of Artecoll), a compound of 20% PMMA in 80% bovine collagen and a small amount of lidocaine.
However, Artefill is extremely expensive for facial or buttock lipoatrophy correction.  ArteFill® costs medical providers $720.00 per ml prepackaged in a box containing 4 syringes of 0.8 ml of product. The professional services of the provider are often sold to the patient for double the cost of the product, thus making it impractical as a corrective for large volume tissue loss. Calculations for the cost-of-treatment climbs astronomically since quite common in the faces or buttocks of people with HIV tissue loss are deficits which can require from 30 ml to 400 ml of filler to correct. A severely atrophied buttock requiring 300 to 400 ml of ArteFill® would cost in the range of $ 200,000 to $ 300,000.
Dr Lemperle has shown that the reported complication appearing in clinical trial results of Arte-Fill has been a small number of tiny palpable nodules. The clinical experience suggests that nodules tend to develop in thin skin areas or when the product is dermally injected in a too superficial manner. These nodules often respond to treatment with Kenalog 40, a cortico-steroid and in many cases also spontaneously remiss.  ArteFill was developed and purified over several generations from the original Arteplast, the appearance of granuloma have decreased dramatically after the micro sphere surface was cleaned up of any imperfections that may have caused macrophages to attack them as foreign objects.
Dr. Luis Casavantes said that based on his experience in the past 5 years of experience with NewPlastic, a PMMA product produced in Brazil and widely used in Mexico and worldwide, does not appear to produce either palpable nodules or true foreign body granuloma, when grafted underneath the muscle fascia.  NewPlastic seems to be a lot cheaper than Artefill.  A moderate to severe facial lipoatrophy correction would cost from 2500 to 3500 depending on the volume needed.  Buttocks require a lot more volume, with costs running from $4000 to $8000 depending on the severity of wasting. Of course, no one knows how much this product would cost in the US if it gets studied and approved here.
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Brief Update from Bioplasty Conference in Guadalajara today

I was invited by Dr Casavantes from Mexico to speak in front of 200 physicians from Mexico and Brazil about the impact of HIV lipoatrophy on patients' quality of life. I also spoke about the role of activists in lipoatrophy in the United States.It has been an amazing day. Doctors from Brazil and Mexico have presented about their products and techniques to correct facial and buttock wasting in HIV positive patients. I will post videos soon from the conference. Nelson
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Fw: World AIDS Day 2010

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From: The Positive Project <contact@thepositiveproject.org>
Date: Wed, 1 Dec 2010 16:31:47 -0500 (EST)
To: <nelsonvergel@yahoo.com>
ReplyTo: contact@thepositiveproject.org
Subject: World AIDS Day 2010
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There is still a lot of work to do.
We sincerely appreciate your support, whether it be financial, emotional, technical
(or all three!).  We could neither have grown this project this far, nor keep going without you.  

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World AIDS Day 2010
As the first decade of the new millennium comes to a close, we reflect on the initial interviews from HIV+ people collected by The Positive Project.
Seven years ago one interviewee named Matt said,I think the general public should know everything there is to know about HIV/AIDS and I am shocked about how little the public does know!

Sadly, this statement is still relevant today. HIV disease is 100% preventable; yet over one million Americans have it, so something clearly is amiss.
Brian

If we can’t even talk about it, we definitely can’t change it.  Talking is the place to start. Therefore, we challenge you to talk about it. Yes you, and yes today, even once, just say it. Not sure how you’d even bring it up?
Try this:
“Today is December 1st, it’s World AIDS Day, and did you know that people are still getting infected with HIV? In fact it’s one new person in this country every 9 ½ minutes.”

The Positive Project has been working for a decade to help the world talk about HIV/AIDS. We use the stories of people infected and affected by HIV/AIDS to raise awareness, reduce stigma, promote prevention, encourage testing, and enhance care.  Over 150 brave people coast to coast, from 9 years old to 70, have added their stories for the greater good. They all recommend that we talk.  They are great at helping us get the conversations going.  Visit the archive of personal video stories and listen for just five minutes, to anyone of your choice.

On behalf of the brave educators here who’ve given their stories to help others, we thank you.
All our best to you in the New Year,
The Staff and Board at The Positive Project

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