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Attention all ADAP Clients Also Enrolled in Medicare Part D
NOTE: This applies ONLY to clients
also enrolled in Medicare Part D

The Florida Department of Health has instituted a statewide change in the AIDS Drug Assistance Program (ADAP) affecting all ADAP medications for clients who are also enrolled in Medicare Part D.

Effective immediately, affected ADAP medications will be dispensed from the Department of Health Central Pharmacy in Tallahassee and not the Broward County Health Department (BCHD) Pharmacy. The Central Pharmacy will fill the prescription and mail it to the BCHD ADAP office in the Fort Lauderdale Health Center (FLHC), 2421 SW 6th Avenue – Fort Lauderdale, 33315. Any concerns with new prescriptions, refills, certifications and recertifications for dually eligible clients will be handled at the ADAP Eligibility Department at FLHC:

• New prescriptions can be dropped off at the FLHC Q-Flow window during regular business hours. Providers (ONLY) can fax new prescriptions to our secured fax line: (954) 467-4861.

• Appointments for certifications and six-month recertifications can be made through the appointment line: (954) 713-3196.

• Refill requests can be called in at (954) 290-2728.

• You will be called when your medication has arrived from the Central Pharmacy. It is important that clients provide staff with the most updated contact phone number(s).

• Times for medication pick-ups: Monday, 8:00am until noon and Thursday,
1:00pm – 5:00pm. Stop at the Q-Flow window and let the receptionist know you
were called for a pick-up.

NOTE: This applies ONLY to clients also enrolled in Medicare Part D

Please don’t wait until you are out of a medication, allow for the extra time to receive the medication from Central Pharmacy.

The BCHD will make every effort to assist you in this process.
Please call (954) 713-3196 with any questions.

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From: Paul A. Moore, MSW
HIV/AIDS Program Director
Broward County Health Department
780 SW 24th Street
Fort Lauderdale, Fl 33315
Tel: 954-467-4700 Ext. 5590
Fax: 954-598-3209

Sent: Thursday, December 16, 2010

Subject: ADAP & Medicare Part D – Good News
Importance: High

It was just announced on a statewide ADAP conference call that current ADAP clients on Medicare Part D can continue on ADAP if they cannot afford the Part D associated costs. Clients should contact ADAP at (954) 467-4700 ext 5630 if they qualify

****************************************************
Our comment:
This is vague information, but good news. “Cannot afford the Part D associated costs” is open to interpretation, but hopefully will be explained soon.

-Steve and Tim

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Human HIV drug trial near

CD4 T-cells are one measurement of the body’s immune system. Another cell that fights infections are called Natural Killer Cells (NK). These are a kind of white blood cell that play a major role in the rejection of tumors and cells infected with viruses.

But they don’t seem to attack cells infected with HIV and that has puzzled scientists for more than two decades. This article explains how HIV produces a protein called Vpu which basically neutralizes the NK cells preventing them from attacking the infected cells.

This new drug, BIT225, targets the Vpu protein of HIV which would then allow the NK cells to do their job. Which means this would be a new class of drugs in the fight against HIV.

“An Australian biomedical research company, Biotron Ltd, already has a drug that specifically targets the Vpu protein of HIV.

The discovery has excited Australian biomedical research company Biotron Ltd which has a drug that specifically targets the Vpu protein of HIV.

The drug has passed through early safety trials, and the company hopes to implement an efficacy trial with HIV-positive patients in the near future.

“This study is really important for Biotron,” said Biotron CEO Dr Michelle Miller.

“We have been working on developing drugs to target the Vpu protein of HIV for several years and, until recently, there has been very little known about exactly how Vpu works, despite good evidence that it is critical to the process of establishing HIV infections in specific cell types.”

From their company web site:

Based on the company info for Biotron, they have an efficacy trial in the works. Looks like there should be a definitive answer in about two years, to how well the treatment might work in humans.

This is a snip from their investor PDF. Looks like their avenue of research is at least promising (not just another ARV). Given the Rush Univ publication, I would think funding will now not be a problem. Because recent studies have shown that if you are adherent to your meds, the chance of resistance is extremely low, investors no longer see new HIV drugs worth the $$$. That’s why this recent news is so important. Otherwise this trial may have come up empty looking for scarce public funding.

• First-in-class new anti-HIV drug
• New mode of action – inhibits budding of virus from infected cells
• Targets HIV in viral reservoirs in vivo
• Reservoirs are last of the holy grail in HIV
• No existing drugs target this source of HIV in the body
• Eradication of reservoirs is essential for “cure” of HIV
• Phase Ib/IIa trial protocols finalised
• 12 – 20 subject trial in HIV+ patients
•Trial designed to demonstrate proof-of-concept i.e. can reduce HIV
loads in HIV-infected reservoir cells in man
• Expected to commence once funding in place

Additional links on related information:

News releases on the drug:

New class of drug in offering

http://www.biospectrumasia.com/content/251110AUS14722.asp

International study supports Biotron’s HIV drug approach

Biotron Presentation to Investors explaining drug’s importance

We will talk about this drug in the second half of the 12-15-2010 Wednesday group meeting.

-Steve

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Truvada slashes HIV Infection Risk in ‘Breakthrough’ Study

This past week a study was released that showed giving HIV-negative men Truvada significantly reduced the percentage of them becoming positive.

About 2,500 trial participants were divided into two groups. One group was given Truvada, the other a look-a-like placebo. Both groups were also given condoms, counseling on safe sex, and tested for HIV and other STD’s once a month. They also returned their pill bottles to see how diligent they were taking the drug. The trial lasted a little longer than a year.

A total of 100 men contracted HIV during the trial, 36 of them were on Truvada and 64 were on the placebo. That translates into a 44% reduction in risk.

Truvada costs between $5,000 and $7,000 a year in the U.S. when purchased through the health care system and more if bought privately.

My Comments: Forgive me for being cynical, BUT we talked about this concept at least two years ago in group with a slightly different slant. The street has been using Truvada to prevent HIV infection for years as part of the Party-n-Play-Cocktail. The PnP-Cocktail consists of 3 drugs; Crystal Meth to get high and remove inhibitions, Vigra to keep an erection (Erectile Dysfunction is a common side effect of Crystal Meth) , and Truvada to prevent HIV infection allowing people to practice unsafe sex totally uninhiiBBited (BB= BareBack). By taking all three drugs, the idea is that you can stay up all weekend having unprotected sex and then go back to work on Monday HIV-negative.

Although the Gilead study is more scientific than the street experiment, I’m not sure a reduction of 44% over just a year is the “end of the AIDS” in the Gay community. Combining that with the cost of Truvada at $5-7,000/year and I also don’t put much faith in the idea that we have the tools “to break the back of the epidemic”.

We don’t know the long-term side-effects of taking Truvada or any anti-HIV medication over a lifetime. HIV is only 30 years old and these HIV medications are still within their patent period.

Even if Truvada became readily available at affordable rates, would Gay men who were using condoms, abandom them for Truvada? These are questions that need to be answered before we jump on the bandwagon that the AIDS epidemic is over.

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If I were to say “God why me?” about the bad things, then I should have said “God why me?” about the good things that happened in my life (Arthur Ashe). With that sentiment, the topic this Wednesday was ‘List Three Things You Have to be Grateful For’. 23 guys showed up for the meeting, including 4 new members. Everyone listed 3 things they were grateful for and put them in a bowl, then we each selected one anonymously, read it and commented. The Three most popular items were #1. Family/Friends, #2. Health, and #3. Job/career. The most unusual was Gucci shoes. We don’t know who that was, but I bet those Gucci shoes are Jungle-red??? It’s very encouraging that in an HIV support group, our health is something so many are thankful for. How far we’ve come since the dark days of this disease. It’s also encouraging that so many people are thankful for their jobs/careers. So many of us are still working regular jobs and have careers. But the most encouraging comment was that the most popular grateful issue was Family/Friends. Having supportive friends and family makes all the difference.

At break, we had some great homemade chocolate squares plus pizza.

After break, we discussed the up coming topics. Next week, we’re having a special Thanksgiving Pot Luck Dinner. We’re requesting that people bring in a healthy dish along with the recipe to discuss what is healthy about the dish. The Holidays can wreck our nutrition, so this is a good time to discuss healthy eating habits.

December 1st is AIDS day and we’re doing a special ‘History of HIV/AIDS’ with a lot of displays, to remember the history we’ve been through. Hope a lot of you come to be part of this special presentation.

On Decemebr 8, 2010, we’re having a guest speaker; Vern Applebee from Dr Gary Richmond’s office who will discuss the newly approved (11-11-2010) drug, Egrifta previously known as TH9507 or Thera. Egrifta is a Human Growth Hormone releasing factor that reduces the abdominal fat that builds around the stomach, liver and other organs caused by the side-effects of some of the medications, like Norvir. This drug does what exercise and diet cannot do for some HIV+ men. I believe this is going to be a highly sought after drug, so this should be an very good meeting.

We then did the ‘Cure Survey’ from Poz Magazine. Of the 19 guys who remained after break; 9 had never heard of the German man who had been ‘cured’ of HIV when doctors did a bone marrow transplant for his leukemia using marrow from a person with the CCR5 Delta-32 mutation. 13 believed that a cure for AIDS will be found, but only 7 believe it will be found in their lifetime. 8 believe that it is ‘somewhat important’ to their well being that scientists are working on a cure, while 4 believe it is very important and 6 believe that it is not important at all. 15 believe that the definition of a cure is total eradication of the virus, while 2 believe a functional cure that eliminates the need for meds is a ‘cure’. Nobody believed that enough money is being spent on finding a cure. And nobody believed that the hope of a cure gave them encouragement to take their meds. 8 believe that pharmaceutical companies are actively trying to prevent a cure being found, while 15 would be willing to participate in research that could lead to a cure.

We discussed the Gay Men’s Chorus of South Florida concert and will be planning to go as a group for the Saturday, December 18th, 8:00 PM concert.

After group, 10 of us went to Peter Pan for eats, laughter and friendship.

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From Tim:

I have been locked in a fierce battle for the Medicare Part D clients with ADAP regarding coverage once they reach Catastrophic. It seems as if I have lost. The answer I keep getting is that coverage for the “Doughnut Hole” is better than no coverage at all and that people with no other serious illness get assistance with their medication costs so they should be grateful they have not been cut entirely. Please get these clients to attend both the Tuesday SFAN meeting and the Wednesday Town Hall meeting as they really need for their voices to be heard. I have also been hit back with the idea that people chose not to vote on Election Day so we have to deal with the consequences. We desperately need Congress to provide additional funding and need to mobilize as a community.

Unless we can get them to change their mind, the rule is as follows for Medicare + ADAP:
1. Client must carefully pick a plan during the open enrollment plan which began today and runs through December 31, 2010 for plan to start on January 1, 2011.

2. They will be required to go to a retail pharmacy for their medications until they reach the Doughnut Hole. This will happen in January or February for most patients. They need to get the pharmacy to give them a print-out showing they have reached the Doughnut Hole and then they can briefly return to ADAP. ADAP will only assist them with HIV meds and Opportunistic Infection Drugs during this phase until the patient emerges from the Doughnut Hole and hits the “Catastrophic Phase.” Catastrophic occurs when the amount of True Out of Pocket Costs from the patient, ADAP and the 50% discount for Brand Name drugs provided by drug manufacturer’s reaches $4550. They are assuming that ADAP will only be assisting these clients for 2 months at most.

3. At this point, they will have to go back to retail pharmacy for remainder of year for ALL DRUGS and pay $2.50 generic, $6.30 brand, or 5% whichever is greater. For HIV drugs in particular it is going to be the 5% and can get really costly.

4. They need to work with their doctors to lower their costs, perhaps switching to low cost generics in any way possible to use the Walmart/Target $4 list, but ultimately their costs are going to increase A LOT. Some might want to join Medicare Advantage plans so they do not have to pay a premium. I have a feeling that Positive Healthcare Partners will be doing a big sell at the Town Hall meeting.

I know this is awful news, but I have fought this battle extremely hard without being able to win. I have given them specific examples yet I can get no one in power to see the harm this can cause. I have also been unsucessful in getting Ryan White Pharmacy to even consider helping those with Medicare Part D. I plan to keep fighting, but we really need to mobilize like we are back in the 1980’s again.

It is strongly encouraged that those who do not have many assets who may be above the 150% Federal Poverty Level ($16,245) apply for Extra Help at http://www.ssa.gov as they sometimes allow people with higher incomes on.

As far as those who are ADAP without Medicare, the change of reducing eligibility from 400% Poverty ($43,320) to 300% Poverty ($32,490) will not happen until February 1, 2011 instead of the December 1, 2010 we were dreading. If anyone in the group falls into this category, they need to meet with a Patient Assistance Program Navigator or their Case Manager to apply for Patient Assistance Programs as soon as possible. I have been told that these affected people “should” all be able to get all of their HIV medications from the Patient Asssistance Programs.

I hope you will post this or at least pass on to the group. If the SFAN meeting and the Town Hall meeting receive poor attendance, the will of Community Advocates will probably decrease.

I will assist any group member in any way that I can. Just ask.

Sincerely,
Tim

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On Wednesday, November 11, 2010, the FDA regulators announced approval of Egrifta, a first-of-its-kind treatment for HIV-associated lipodystrophy. Egrifta is a growth hormone releasing factor, given as a once a day injection, that works to reduce abominal fat in HIV patients. Drugs such as Crixivan, Viracept, Norvir and Invirase commonly experience an increase in fat depostis that can accumulate around the liver, the stomach and abdominal organs. Fat deposits can also form on the back of the neck commonly called Buffalo Hump.

In clinical trials involving more than 800 HIV-positive patients who took Egrifta daily for 26 weeks, patients reported improvements in self-image, as well as a reduction in abdominal fat deposits as shown by a CT scan.

In 2008, Vern Applebee from Dr Gary Richmond’s office came to our group and recruited some of our members for the clinical trials here in Ft Lauderdale. I was one of the recruits. The drug was then called TH9507 or Thera from the company that developed it.

I lost 7″ around my stomach during those 26 weeks and looked Fabulous. After the trials stopped and lost access to the drug, I regained most of the fat, as did other people from our group. The Egrifta people still need to do a maintenance study and there is talk that some of that study might be done in Ft Lauderdale. I will keep you updated on the study.

-Steve

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We set a new record, 42 guys showed up to talk about Facial Wasting. We’re becoming the place to be. Come join us!

We defined facial wasting as the fat loss from the face and one of the components of lipodystrophy. Although it’s not exactly known what causes fat to waste from some area and redistribute in other area, as many as 48% of people taking HIV-drugs may experience it. Most doctors now believe that nucleoside analogues such as Zerit and AZT may be the cause and not Protease Inhibitors.

Reversing facial wasting can partially be accomplished by switching drugs, but this may only partially correct the damage. We discussed a couple medical procedures, Sculptra or New Fill, Radiesse and Silicone.
Silicone is not approved for facial wasting, but some doctors are using it off-label. Radiesse is temporary, but immediate. Sculptra is longer lasting, approximately two years, but takes a month or so to generate the collagen.

We watched a video from Mark S King and ‘My Fabulous Disease’ about a Facial Wasting Procedure he video taped.

We discussed the cost. Sculptra and Radiesse have Patient Assistant Programs that will provide the drug for free for low-income patients, but you would still have to pay the doctor for the procedure. This might be several hundred dollars per visit and you might require 4-6 visits.

In March, 2010, Medicare approved covering the cost of facial filling treatments for HIV patients who are depressed.

Occasionally, some local doctors offer special programs where they cover these procedures for low-income people. The Wellness Center and Project Link has made these offers public a few times. When we hear about these, we will pass the information along in the website.

We also talked about the stigma people with facial wasting feel. Athough, facial wasting itself is not a dangerous health risk, it can have a serious impact on emotional and mental health. Many people with facial wasting may feel stigmatized that the facial wasting is an “HIV tattoo” indicating to the world their HIV status. This could result in a loss of self confidence and self-esteem.

After break, we discussed the Three Thanksgiving dinners coming up. Fusion is having a Pot Luck dinner on Thursday November 18. The Wellness Center is having a Thanksgiving luncheon on Saturday November 20. And Sunshine Cathedral is having a Thanksgiving Day dinner open to all. Information of these activities are in other blogs and on our calendar.

14 or us went to Peter Pan where we continued the conversation.

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South Florida AIDS Network
Community Meeting
Everyone Welcome
HOT TOPICS:
ADAP Update (AIDS Drug Assistance Program)
Part D Plan Changes
&
“Donut Hole De-Mystification”
Opportunity for Questions/Answers
Tuesday, November 16th
5:30 PM Refreshments
6 PM Meeting
Location: Holy Cross Hospital
Sister Innocent Conference Center
Auditorium
Hospital Address: 4725 No. Federal Highway
Ft. Lauderdale, FL 33308
Auditorium is located on the South side of the hospital
map available on website: www.holy-cross.com

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Take the survey on The Cure for HIV from Poz Magazine.

Also, click on the video about “Secretary of Health and Human Services Kathleen Sebelius addresses AIDS Drug Assistance Program protesters at the 2010 United States Conference on AIDS”.

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