Happy about my membership in the DHHS HIV Adult and Adolescent Guidelines Panel

Gang

I am very happy about having been selected to be a community member to this respected panel. This is my second try in the past 4 years and I finally made it through. This is one of the most important (if not the most important) medical guidelines panel in HIV treatment. I will be lucky to be working with great researchers and clinicians, and will make sure that the concerns from the patients in the field are brought to their attention. Jules Levin has already reminded not to forget bone density issues, aging related issues, some women-specific issues and toxicities as areas to bring up as data and signals in the field become available. I am glad I have good mentors like Jules, Bob Munk. Marty Delaney and Lynda Dee that have been there before me !

Wish me luck!

Nelson


Issue No. 52 | December 12, 2008

AIDSinfo.nih.gov is pleased to provide you with a weekly update of highlights about what has happened in the world of HIV/AIDS treatment, prevention, and research. We hope you find this encapsulated view of HIV/AIDS news useful.


Adult and Adolescent Guidelines Panel Announces New Members

The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (a working group of the Office of AIDS Research Council) is pleased to welcome the following new members to the Panel. The new members will begin a 4-year term beginning February 2009.

New Scientific Members:
Robert Dodge, Ph.D., R.N., A.N.P. (University of North Carolina)
Christopher Gordon, Ph.D. (National Institute of Mental Health, NIH)
Michael Hughes, Ph.D. (Harvard University)
William Kapogiannis, M.D. (National Institute of Child Health & Human Development, NIH)
Daniel Kuritzkes, M.D. (Harvard University)
Mark Sulkowski, M.D. (Johns Hopkins University)


New Community Member:
Nelson Vergel (Houston, Texas)


The following members will be concluding their services to the Panel in February 2009. The Panel thanks them for their contributions over the years.
A. Cornelius Baker (National Black Gay Men's Advocacy Coalition)
Charles Carpenter, M.D. (Brown Medical School)
Suzanne Willard, Ph.D., C.R.N.P. (Elizabeth Glaser Pediatric AIDS Foundation)

Should I take Vitamin D if I am taking Viread or Truvada?

Vitamin D and Viread. Should I be concerned?
Dec 1, 2008

Dear Nelson:

Thanks for what you do for us

I just read an email that said that a study showed that people on Viread had low vitamin D and may have problems with bone. Should I take Vitamin D with Viread?

I do not want to have broken bones as I age

Tony



Response from Mr. Vergel

Dear Tony

Researchers at Mount Sinai School of Medicine recently presented a very interesting paper at the ICAAC 2008 conference on this issue. As you well know, Tenofovir (Viread) is probably the best nucleoside analog out there with the least problems with lipoatrophy and other side effects. However, it has been associated with kidney issues in some treatment experienced patients and also with loss of bone density in some studies. It seems that the bone effects are greater in those taking tenofovir with boosted protease inhibitors. Unfortunately, most of us do not know we have low bone density until we get a fracture.

Vitamin D is needed by our bodies to metabolize calcium to build up bone. Most of it is made when our skin in exposed to sunlight. Many people do not get enough sun in winter months.

In this study, most patients on tenofovir had low Vitamin D levels in their blood (measured as 25(OH)D). 39% of those with low Vitamin D levels also had high parathyroid hormone levels (PTH)

PTH is produced in the parathyroid glands which are four pea-sized glands located on the thyroid gland in the neck. Though their names are similar, the thyroid and parathyroid glands are entirely different glands, each producing distinct hormones with specific functions. The parathyroid glands secrete PTH, a substance that helps maintain the correct balance of calcium and phosphorus in the body. PTH regulates the level of calcium in the blood, release of calcium from bone, absorption of calcium in the intestine, and excretion of calcium in the urine.

When the level of calcium in the blood falls too low, the parathyroid glands secrete just enough PTH to restore the blood calcium level. High PTH usually means that there may be some bone loss problems. Low Vitamin D is known to cause hyperparathyrodism (high PTH).

The study investigators hypothesize that Viread's effect on bone may be related to this low Vit D/high PTH effect. More studies are needed with a larger number of patients

You may want to ask your doctor to measure 25 (OH) D levels. I am also an activist who is trying to get DEXA bone scans to be part of standard of care for people with HIV. It would be great to get a DEXA bone scan before someone starts HAART and then repeated it every two to three years to see how your bones are doing on therapy.

By the way, HIV infection by itself has also been associated with loss of bone density. But some medications may also add to this problem.

Bone density research in HIV is progressing. I tell people to work out with weights and machines, to get at least 30 minutes of sun a day, and to make sure their thyroid hormones and testosterone are in normal range to prevent bone loss. Some people would also benefit from taking Calcium/Vitamin D supplements and/or precription drugs approved to increase bone density.

Talk to your doctor since this is very new data.

Nelson

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies
Posted on 15:42 December 1st, 2008 by Millard Baker

http://www.mesomorphosis.com/blog/2008/12/01/world-aids-day-adverse-impact-of-steroid-law-for-hiv/

In recognition of World AIDS Day, we urge Congressional leaders in the United States to carefully consider the significant harm that morally-guided U.S. steroid policy has had for the life-saving therapeutic applications offered by anabolic-androgenic steroids. The criminalization of anabolic steroids and steroid hysteria perpetuated by Congressional steroid hearings has had an adverse impact on medical research and medical therapies involving anabolic steroids, particularly in the prevention and treatment of HIV+ associated wasting disease.

Anabolic steroids are one of the safest and most effective treatments for HIV associated wasting and have been invaluable in helping HIV+ patients retain, preserve and restore lean body weight and stay alive. Given that wasting is one of the most common symptoms of HIV and that HIV+ patients with wasting symptoms have significantly higher mortality rates, anabolic steroids have been an invaluable medical treatment.

Michael Mooney, of Medibolics, and Nelson Vergel, of the Program for Wellness Restoration, have spearheaded educational efforts and have extensively documented the benefits of anabolic steroid therapy for AID/HIV wasting in “Built to Survive“. Mooney and Vergel have discussed the negative consequences arising from the demonization of steroids by the Anabolic Steroid Control Act of 1990 (”Anabolic Steroid Legality and the Physician,” January 28).

The Anabolic Steroid Act of 1990 created grave misunderstandings about the legal status of “steroids as medicines” to the public and to the physicians trying to help their patients. This law states only that anabolic steroids can not be prescribed for cosmetic or athletic purposes, but the impression it created was that steroids were off limits to everyone, and that they are basically illegal for any use. This is not the case. To compound this climate of fear, it seems that when this law was passed in 1990 several of the more conservative regional governing medical organizations made doctors uneasy, giving them impression that they would become the object of scrutiny if they prescribed steroids at all.

The scheduling of anabolic steroids as controlled substances was a medical catastrophe that pandered to anti-doping crusaders in sports while ignoring the medicinal value of androgens and the life-saving therapeutic potential this category of pharmaceutical drugs offered for HIV+ patients. The regulatory agencies in charge of scheduling of drugs strongly protested the inclusion of anabolic steroids in the Controlled Substances List. Legislators ignored the scientific advisors and experts from the American Medical Association (AMA), the Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS) and the Drug Enforcement Enforcement (DEA) to pass the Anti-Drug Abuse Act of 1988 and the Anabolic Steroid Control Act of 1990.

The legislators were guided by the moral condemnation of athletes that use anabolic steroids and performance enhancing drugs rather than a rational empirical analysis of steroid use and abuse and the effects of such legislation on leigitmate medical research and anabolic therapy.

Unfortunately, the steroid hysteria has continued with the Congressional steroids and baseball hearings initiated by Henry Waxman (and former chief of staff Phil Schiliro) and the passage of more draconian steroid laws in recent years. California resident Mark A. Meier outlined the impact the steroid hearings in a letter to the Nancy Pelosi, Speaker of the House (”Representative Henry Waxman’s Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions,” March 12).

The result, then, of Representative Waxman’s hearings has been an attack on an important, powerful, beneficial and legal therapy solely because professional athletes use it improperly. Patients with legitimate medical needs should not be made to suffer because of the improper actions of a few.

Nelson Vergel of the HIV Blog explains how political pressure and steroid hysteria have restricted the availability of anabolic steroids for HIV+ patients. The moral and political pressure resulted in the discontinuation of Deca Durabolin by Watson Pharmaceutical and the discontinuation of nandrolone decanoate by compounding pharmacies like Applied Pharmacy (”Important information about nandrolone in the U.S.” March 17).

Watson stopped making [nandrolone decanoate] because… Congress and the DEA are treating anabolics like the treat crack-cocaine and are closely watching every prescriber’s and manufacturer’s move. No HIV doc has ever got in trouble since many studies have shown nandrolone’s benefit and can justify its medical use. However, inexperienced HIV doctors who have not been around long enough to know its history shy away from prescribing due to the bad publicity and misconceptions around these medicines. [...]

Applied Pharmacy stopped all production due to DEA pressure. Some compounders are making doctors sign a waiver to say they will not prescribe nandrolone for non medical uses. Some doctors feel this represents extra liability.

The effects of anabolic steroids in treating HIV+ associated wasting syndrome by preserving and increasing lean body weight has been well documented by multiple studies. Unfortunately, Congressional leaders in the United States have based steroid policy on emotional testimony and moral objections to cheating in sports rather than scientifically-guided legislative policy; this has been to the detriment of individuals with AIDS/HIV+ associated wasting syndrome. The morally-guided steroid policy has effectively limited the availability of anabolic steroids for those individuals who use steroids as a matter of medical necessity. We urge Congress to reconsider and re-evaluate the Anabolic Steroid Control Act to address the address the adverse effects of current steroid policy on the advancement of anabolic therapies in medicine.

Happy Thanksgiving to All

To all of you in pozhealth:

I would like to take this opportunity to thank all of you who help each other daily on this list. It amazes me that we have been sharing since 2002 with more than 30,000 emails in 7 years. We now have close to 3000 members!

I am also thankful that new drugs for multidrug resistance were approved this year and that 3 million people are now in treatment around the world, although 7 more million need it to survive. Hopefully we will see treatment spreading faster to help those who need it most and cannot afford them.

The cure of HIV is now part of the research conversation for the first time. I see the word "cure" more frequently now, although it may take years to get there.

Side effects seem to be decreasing with better drugs, and for that I am very thankful.

I am also thankful that Obama won and that hope is slowly being restored in our hearts. I hope that he does not let us down and that we can support him fully while hoping that evil does not attempt to destroy him in his mission.

I am thankful for all the sweet emails I have received from many of you through my hard times this year. Although most of us have not met face-to-face, the love I feel through the electronic lines can certainly reach my heart.

Yes, there is a lot to do and a lot we should have done to save lives in the world. But today, I am thankful that we are here helping each other while we remember our friends and family who are no longer in our presence, but they are in our hearts.

Regards,

Nelson Vergel
powerusa.org

Do we know enough about lipodystrophy?

Do we know enough about lipodystrophy?
Aug 26, 2008
Dear Nelson,

I have a quick question that I feel you can best answer for being an hiv survivor for 25 years. Is the the war on lipo able to be won??? I mean will working out bring muscle back or will my time be wasted??? Also what supplements do you suggest a person take??? I am taking the mv k-pax single strength. Thank You



Response from Nelson

I would asnwer: "yes, partially"

We now know that a lot that we did not know a few years ago.

1- D4T and AZT are two drugs that are linked to fat loss under the skin (lipoatrophy). Tenofovir (Viread) does not cause lipoatrophy in most patients (only 11% had a loss of 20% or more of fat under the skin when used they used tenofovir/3TC with Kaletra or Sustiva in one study)

2- That some protease inhibitors can negatively affect the job of insulin to help store glucose in muscle as glycogen ( insulin resistance) which may increase triglycerides and fat cell size in some patients

3- We know that exercise helps to build lean body mass

4- we know that anabolic steroids like nandrolone and oxandrolone can help those having a difficut at regaining normal weight

5- Statins and fibrates work at reducing lipids in poz people but sometimes not good enough to have them reach normal levels

6- That supplements like Omega 3 fish oils and niacin can help statins and fibrates improve their job at lowering LDL, triglycerides and increasing good cholesterol (HDL)

7- That those who start HAART with low CD4 cells tend to be more prone to having increased belly fat when their CD4 cells increase

8- That there are products like Sculptra, Silikon 1000 and Radiesse in the United States that can help people restore a healthy face

9- That supplements like K PAX and others have some promising but limited data in HIV that requires more studies

10- That growth hormone (Serostim) works at reducing visceral fat but we cannot use it for lipodystrophy because the FDA did not like growth hormone's side effects. Another less effective but lower side effect product may be approved in the future

11- That switching first line patients from Kaletra to Reyataz does not improve their bodies. Other "switch" studies showed the same results.

Unfortunately, we do not data on lower glycemic index diets, good comparison data of what happens to visceral fat when different protease inhibitors or non-nucleosides are used with Truvada in naives with low and higher CD4 at baseline, diet/exercise combinations, and other supplements like carnitine and others. Stay tuned for my upcoming review of studies to be presented at the Lipodystrophy Conference in London on Nov 2008.

You can read more about where we are now here:

http://www.thebody.com/content/art45454.html

I hope this helped

And yes, single strength K PAX is great as a supplement since it includes all minerals and antioxidants you need.

Nelson

How Can I Lower Cholesterol Without Drugs?

Lower cholesterol without drugs
Jun 6, 2008
My cholesterol levels have crept above 200 after three years on Reyataz & Epzicom. I'm in good condition with my aerobic exercise routine, take supplements that should help my cholesterol (like omega-3s and green tea extracts), and have a small glass of red wine most evenings with dinner. I avoid fried and overly-processed foods for the most part. How much can I reasonably expect my eating and exercise habits to be effective in lowering my cholesterol? Is there anything you recommend I add to my supplements to help (e.g. l-carnitine)?



Response from Mr. Vergel

It seems that you are doing everyting you can to lower cholesterol but I have a few suggestions:

Just make sure that you are taking at least 3000-4000 mg a day of Omega 3 capsules, that you sweat while doing cardio for at least 20 min a day, that your sweet consumptions is low, that you are eating oatmeal daily , and that you do not exceed two glasses of wine a day. L-Carnitine at 2000 mg a day can also help bring triglycerides and cholesterol down, specially taken with Omega 3 fatty acids. Niacin has also been shown to be effective decreasing cholesterol. In some studies, niacin at daily doses of 2-3 grams can lower LDL and total cholesterol by approximately 20-30%, lower triglycerides by 35-55%, and increase HDL cholesterol by 20-35%. It can cause "flushing" of the skin in some patients for 20-30 minutes that may make it uncomfortable for them to take it. Slow adjustment of the dosage, administration with food, and giving a baby aspirin before niacin may minimize these reactions. Niacin is available as an over-the-counter supplement and also as a prescription drug called Niaspan.

Some people do all they can to lower cholesterol naturally but are yet to get down to recommended levels. There are genetic factors involved in many cases. For those, taking lipid lowering meds is a good idea.

Keep up with the great work!

Nelson

How do I get my insurance to pay for my facial wasting treatment?

How do I get my insurance to pay for my facial wasting treatment?
Jun 28, 2008
Hello Nelson-

I hope this finds you well. I wanted to check in with you to see if you were aware if there is any insurance coverage for silicone treatments for facial wasting. I have had several sessions, and it works great. It is not cheap, of course. I am in need of a refresher treatment. I should mention that my insurance is Medicare A,B and D. I receive my meds through a Blue Cross-Part D plan, backed up by ADAP.

Neal



Response from Mr. Vergel

Neal,

It is difficult to get reimbursement for Silikon 1000 since it is an off-label use for facial wasting, but you have nothing to lose and a lot to gain if you have your doctor write a medical necessity letter to send to your insurance company.

Here is a letter that Dr. Doug Mest wrote for my web site facialwasting.org for Sculptra. You can have your doctor use this letter as a template and also to use these scientific references. You can also visit the wonderful resource guide that TheBody.com has created for trying to get coverage for facial lipoatrophy reconstruction options from your insurance:

http://www.thebody.com/lipo/insurance.html

References for silicone and facial lipoatrophy:

http://findarticles.com/p/articles/mi_m0PDG/is_2_4/ai_n13559216

SAMPLE LETTER:

Insurance Co Name

Insurance Co Address

Patient Name

Subscriber #

Date

To Whom It May Concern:

This letter is written in regards to the medical necessity of restorative treatment for the facial deformities this patient suffers from secondary to HIV-Associated Lipoatrophy. Facial fat loss is the most devastating aspect of this condition as it can not be disguised by clothing or other means. Although the exact underlying mechanism of HIV-Associated Lipoatrophy is unknown (1), the devastating effects of this condition are known (2,3). Patients suffering from this condition are at an increased risk of depression, socially withdrawn and potentially suicidal. Furthermore, patients have even stopped their life saving HAART therapy without consultation with their physician in an attempt to stop this side effect. The implications for viral mutations, increasing viral load and worsening of patients underlying condition requiring more expensive treatments cannot be stressed enough. Treatment of HIV-Associated Lipoatrophy with Sculptra (Poly-L-Lactic Acid) has been shown to improve anxiety and depression scores (4) as well as improve patient's quality of life as measured by visual analogue scale (5). The use of Sculptra is clearly indicated as a reconstructive procedure; that is, repair of abnormal facial structure caused by HIV or its treatment, in order to create a normal appearance.

The safety and efficacy of Sculptra in restoring the normal facial contours of patients suffering from HIV-Associated Facial Lipoatrophy has been evaluated by the US FDA (6). Based on the available scientific evidence (4,5), the FDA granted approval of Sculptra as a restorative medical device for the specific indication of HIV-Associated Facial Lipoatrophy in August 2004.

For your information. the ICD9 diagnosis code for lipodystrophy is 272.6. HIV-related lipodystrophy syndrome consists of lipo-hypertrophy (fat accumulation in the visceral area and dorsocervical pad) and lipoatrophy (subcutaneous fat loss in the face, extremities and buttocks).

Due to the medical necessity of this treatment and the availability of a safe and effective treatment option, pre-approval is hereby requested for treatment of this patient's HIV-Associated Facial Lipoatrophy with Sculptra.

As this approval is relatively recent, I would be happy to further educate your company on this issue in any way that you might deem helpful. Please feel free to contact me at the above office with any questions you may have.

Sincerely,

References:

1) Montessori, V. CMAJ. 2004;170:229-238.

2) James J, Carruthers, A. Dermatol Surg. 2002;28:979-986.

3) Martinez, E. Drug Saf. 2001;24:157-166.

4) Moyle, GJ. HIV Medicine. 2004;5:82-87.

5) Valantin, M. AIDS. 2003;17:2471-2477.

6) FDA Scientific Advisory Panel 3/25/2004 Washington DC

Are Creatine Supplements Effective to increase muscle?

Creatine Supplement
Jul 29, 2008
I workout six times a week, take a teaspoon of creatine before each workout with some juice. Is there a problem taking this supplement pratically everyday. I noticed that on my recent labs that my creatine number was 1.4H, I've been taking this supplement for about 6 weeks.



Response from Nelson

Creatine is the most popular bodybuilding supplement out there. It has been shown in non HIV studies to increase lean body mass and strength. I have taken it once in a while and definitely feel more pumped and a little stronger. There are concerns about loading up the kidneys, however. Your creatinine blood level is higher than normal, so I would probably be careful if I was you.

We have some pilot data in HIV presented by Dr. Sakkas at the Lipodystrophy Workshop in Dublin in 2005. It was a placebo controlled study of the use of creatine or placebo plus exercise.

Strength did not differ much between the creatine arm and the placebo arm. But men taking creatine had a significant jump in triglycerides, a risk factor for heart disease. I am not sure if the creatine supplement used had sugar in it, which may explain the increase in triglycerides.

Lean body mass index rose in both groups, but significantly more with creatine (2.3 versus 0.9 kg, P = 0.01). Thigh muscle cross-sectional area also increased more with creatine, but not significantly more than with placebo (12.2 versus 9.3 cm2, P = 0.34).

What are your triglycerides? Talk to your doctor since you may have some reduction in kidney function that may not make you a good candidate for this supplement.

You may want to try Juven, another supplement that has arginine, HMB and glutamine that may not have a negative effect on the kidneys.

Reference:

G.K. Sakkas, K. Mulligan, MI. DeSilva, et al. Creatine supplementation fails to augment the benefits derived from resistance exercise training in patients with HIV infection. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. November 13-16, 2005. Dublin. Abstract 6.

Provigil for Fatigue?

Provigil...what is your opinion?
Aug 4, 2008
I suffer from severe fatigue and my doctor wants me to try Provigil. What is your opinion? Thanks guru man



Response from Nelson

PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder (SWSD), or narcolepsy.

It is used in HIV off label to treat fatigue. A pilot study done by Dr Judith G. Rabkin in NYC showed good results in increasing energy levels and mood in people with HIV. There is a larger study now recruiting :

http://clinicaltrials.gov/ct2/show/NCT00118378?intr=%22Modafinil%22&rank=32

I have taken Provigil for three years on and off and absolutely love it. I take a very small dose of 100 mg at morning time when I am too fatigued to work. I have mild sleep apnea and did not enjoy using a CPAP machine. I experience mood elevation also.

Two bad thing: it is expensive and many insurance companies do not wan to pay for it, and it is metabolized in the P450liver enzimatic path, so there may be interactions with HIV medications that use the same path. So far we have no interaction data since many pharmaceutical companies do not include this drug in their "normal" list of drugs to test.

Insurance companies that do not wan to pay for the drug argue that cheaper amphetamine-based products do the same thing. What they ignore is that Provigil is not an amphetamine and it has no habit forming properties. It is not classified as a Class II drug as amphetamines are. It also does not decrease appetite. The company has a patient assistance program (I have not audited it, however). You can have your questions about reimbursement answered by calling the PROVIGIL Reimbursement Assistance Hotline at 1-800-675-8415.

Some people are very sensitive to it and experience nervousness with it. I say if that happens try half a pill and build up from there.

Of course, Provigil is not a substitue for a good night sleep.

I hope this helps!

Nelson

What is better? Testosterone Injections or Gels?

What is better? Testosterone Injections or Gels?
Nov 6, 2008
I am currently on testosterone enanthate, one injection every two weeks. Is there an actual advantage to using testim, the gel? I have all options available to me. Ed



Response:

Dear Ed:

If you are used to the injections, you may not feel the same "lift" by the gels. The injections cost around $80 a month compared to $1100 a month for Testim or Androgel. Some people argue that gels are better to keep your testosterone blood levels more constant and to avoid "peaks and valleys"

Some people love the daily gels. I am an injection guy since I do not want to deal with daily application.

Some people cannot reach adequate testosterone blood levels (0ver 500 nanograms per deciliter of total testosterone) while using Testim or Androgel since these two only contain 1% testosterone. It is unfortunate that most people and their doctors do not know that you can get better and more concentrated (5%) testosterone gels from compounding pharmacies at around $60 a month. Some of the cheapest ones are apsmeds.com and newrx.com

More info on medibolics.com or our book Built to Survive, available at amazon.com

Nelson