Prezista’s( a new HIV protease inhibitor) approval today- My comments

Prezista (TMC 114, a new protease inhibitor) got approved by the FDA today.

I have a few comments for those wishing to start this drug.

First, avoid virtual monotherapy at all costs, if you can. Virtual monotherapy means adding a new drug to a failing regimen to which your virus has developed resistance. This approach usually renders the new drug ineffective since HIV eventually also develops resistance to the new drug. If you have no “active” drugs in your genotype (resistance) test, you may want to wait until you can start Prezista with Merck’s integrase inhibitor MRK 518 (to come out in expanded access later this year), or Maraviroc (an entry CCR5 inhibitor to be available in expanded access early next year.) The studies that got Prezista approved also showed that those who started Fuzeon at the same time with Prezista had a significantly better response to treatment, so if you have not started Fuzeon you may want to talk to your doctor about this option (they are enrolling in their needle-free device study.) Many of us have nucleoside resistant virus, but these agents may still provide some benefit as background therapy to decrease the capacity of the virus to replicate.

Through my yahoo groups and salvagetherapies.org, I keep getting emails daily from people all over who have joined either the Merck study, the Tibotec Duet study, or who have started Fuzeon with Prezista. Many tell me that they have undetectable viral load for the first time in their lives. Those in studies do not yet know if they are in the placebo arms, however.

Tibotec has had good communications with activists (for the most part) through Prezista’s POWER studies and expanded access. Lew Silbert, their community relations person, has been in constant communication with many of us in the activist world for months. Among the good things that they have done: designed a study combining two experimental drugs (TMC 114 + TMC 125- DUET studies) for the first time in AIDS history, helped make possible the first meeting between US and European treatment activists, agreed to our demands to allow experimental agents in their TMC 114 expanded access (which made it possible for us to take it in the Merck integrase study), agreed to demands to provide emergency IND access of TMC 125 (their non nuke in research now) to patients at high risk of death, and possibly not pricing Prezista higher than the previously approved protease inhibitor (Aptivus) (we will know this soon), which will reverse a nasty trend of price escalation in the US. Among the few bad things so far: not accepting the community’s request to start a compassionate open label study of TMC 125 (plus TMC 114) for patients with no active agents in their background, and consciously allowing people with risk of virtual monotherapy in their DUET studies (with a 50 % chance of placebo TMC 125 with no roll over to treatment arm until week 24.) Prezista is Tibotec (and Johnson & Johnson’s) first HIV product, so we will keep a close eye on how they will now relate to the community after approval and if they will keep their post approval phase IV study commitments recommended by the FDA. They surely can learn from past mistakes of other companies to realize that a win-win can be attained for stock holders and stake holders and that compassion and profits are not mutually exclusive.

The approval of Prezista, the availability of previously approved drugs like Fuzeon for multidrug resistance, the positive data on the integrase class (Merck and Gilead’s), the expectation for upcoming positive data on Maraviroc (CCR5 inhibitor), and expectations for Tanox’s TNX 355 (an IV every 2 weeks) and Panaco’s maturation inhibitor really give me tremendous hope for the first time in a long time for those of us who have been struggling with multidrug resistance. After drugs like these, the horizon is now showing gene therapy and potentially effective therapeutic vaccines. Managing potential toxicities and raising costs will be key, of course.

The new wave is here.

June 5, 2006: AIDS first identified 25 years ago

AIDS first identified 25 years ago

05:52 PM EDT on Monday, June 5, 2006

For Nelson Vergel, remembering the early days of aids is difficult.

“All my friends from the ‘80s are dead, the early ‘90s are dead.”

He was only 25 in 1985 when he found out he was HIV positive.

“Back then we had no drugs, no hope,” he said. “I was told to go home and pray and take care of myself and put things in order.”

And he did. And he kept waiting to die. But he didn’t.

About 10 years later, some powerful AIDS drugs became available and transformed treatment of HIV.

Dr. Michael Gottlieb saw some of the first cases of AIDS and lost many patients. He remembers what a difference the drug “cocktail” made: “People were able to leave hospital beds and live functional somewhat normal lives.”

Today, 22 drugs are available. And even though they must be taken for life, for many patients HIV no longer means certain death. Nelson has tried them all. But the virus can mutate around the drugs

“I’m already resistant to all available HIV medications but my health is stable, I’m just waiting for the next best thing.”

In the meantime, he takes six pills a day to weaken his virus as much as possible and hopefully buy time. And he wants his life to be a warning to keep others from getting infected.

“This is an illness that can hit anybody: gay, straight, black, white, Latino, Asian, anybody. Young and old, it will change your life. There is no cure.”

Flaming Mad- from Genre Magazine

I took the liberty to re-publish this great article written by Lady Bunny, an entertainer, in Genre Magazine( June 2006.) I think she has a point.

“… what we gays can learn from this whole immigration debacle: Organization. No matter what side of the debate you fall on, one thing is clear about those immigrants: When they felt their rights about to be irreversibly trounced upon by our government, they knew how to get together and protest. Spanish-speaking radio disc jockeys from L.A. to Texas mobilized enormous crowds to take to the streets to proclaim their rights. I wonder why that didn’t occur to gays when the Federal Government passed the Defense of Marriage Act (DOMA) or when George W. Bush tried to amend the Constitution—a political act so rare that it should have sparked something—to ensure that gays would never be granted the equal right of marriage. Or, how about when good ol’ Bush actually did remove language from a long-established law, which stated that sexual orientation could not be used as a disqualifying factor in determining someone’s eligibility for a security clearance? Did you even know about that?

Can you even name a gay radio jock or TV personality, who could rouse you to do anything but dance or decorate your apartment? Like immigrants, the rights of gays are under attack—and many of us are full-born United States citizens, not illegal immigrants! Where’s our righteous, defiant spirit in the face of our attackers? Where’s our fire? I realize there are many within our community who devote their entire careers to the movement. But, let’s face it: Most gay men really do have the shallow mentality of 16-year-old schoolgirls. Will historians look back at the gay community of the early 21st century and conclude that we cared more about having a good time than doing away with our status as second-class citizens?

But, activism isn’t only dead for gays. Most wimpy Democrats are guilty as charged, when Republicans accuse them of standing for nothing. And Al Sharpton read the African-American community to filth when Rosa Parks died, claiming that all Ms. Parks had was her voice and she used it—unlike a lot of today’s famous black youth, who are best known for using their voices to insult each other in rhyme. The whole country has been dangerously dumbed down by entertainment propaganda, which masquerades as news—so much so that we aren’t even aware of the real challenges that face us, much less organized enough to combat them. And, pay mind, are our enemies ever super-organized! They meet every Sunday morning at churches, as we lay crashed out, nursing our hangovers.

So, what? Is this just another rant about how fickle the gay community is? Maybe so. But, should we just be content that we now have a gay and lesbian cable TV channel, or that we can legally marry in just 1 of our 50 states? No doubt, these things are indeed big steps in the struggle for gay and lesbian civil rights. By all means, this Gay Pride, go out there and be proud of those accomplishments. But, try to keep in mind the spontaneous strength and community that a massive group of illegal immigrants has shown us this year. And when the confetti and used condoms are swept away from the party floor, why not take some of that Gay Pride, and heat it up until it turns into some good, ol’ fashioned Gay Rage? After all, we’re not called flamers for nothing.

Lady Bunny is an actress, singer, songwriter, comedienne, DJ, ho and an illegal immigrant from the Kingdom of Narnia. Check her out at ladybunny.net”

Update on Current Options in the US for HIV-related Facial Wasting

Gang

Some of you have emailed me to ask me about my opinions lately on the most popular options for facial reconstruction. I have been following this field for almost 7 years now and my opinions have evolved with time.

I have realized that there is place for each of the facial reconstruction products in the HIV facial wasting field. Initially, I was not impressed after seeing how slowly NewFill (Sculptra in the US) works and how some people with grade 3-4 facial wasting never attained complete reconstruction even after 6 sessions. I also used to believe that permanent solutions were the way to go for cost effectiveness and durability.

The first poster presentations on facial reconstruction products for HIV were the one on PMMA (Dr Serra – Brazil) and NewFill (Dr Armard from France). Not one , but two.

Most of the world focused on the French product a lot more. I have no idea why PMMA did not get any attention.

I have met people around the country, received emails, and followed this field closely as part of my work in facialwasting.org. Their feedback gives me a sense of where we are right now in this field:

1- Sculptra’s perceived weakness is its strength. Yes, it is not completely permanent for some (it may need a touch up every 1-2 years), but that may be its main attractiveness. Since some studies show that fat under the skin can return (although very slowly) in patients after they switch from Zerit or AZT to Ziagen or Viread, we may not want something permanent. For instance, I decided to get BioAlcamid in my face 4 years ago and my lipoatrophy has gotten better since that. I consider that I now have too much product in my face and may get some extracted in the future (more of that later). Sculptra is the only option that has FDA approval and patient assistance program. But an at average $400 fee for doctor’s time per session, it would cost someone on patient assistance around $1200 to $2400 of out-of-pocket cost for 3-6 sessions, depending on the severity of facial wasting. No reimbursement for this fee is available through insurance or Medicare/Medicaid, although a few HMOs and VA systems pay for it. Activism is needed to convince third party payers that the facial reconstruction needed to repair a drug-induced side effect is actually not a cosmetic procedure but a clinical one. Women with breast cancer that needed reimbursement for breast implants fought this battle after a few years successfully. Will we do the same in HIV? Not until we start writing letters and having our doctors appeal rejections to reimbursement requests. It will take work.
Also, make sure that the doctor who applies the product in your face has experience and training. For a list of doctors in your zip code and for patient assistance information go to Sculptra.com. Most doctors that inject it also take care of your patient assistance application. I am hearing good things about this process (simple form, one week processing time, and product for 6 sessions is paid for). I have been following this product since 1999.

2- BioAlcamid is permanent but removable in many cases. But it is not approved in the US and you need at least $4500 to pay for it and travel to Mexico, Europe or Canada once or twice. I have hardly seen any decent studies presented in HIV conferences. I like the product since I have my own biases but having selected it 4 years ago. My face feels natural but I have a little more than I think I need (due to my lipoatrophy reversal after being 6 years off Zerit.) The doctor in ClinicEstetica and a doctor in Los Angeles have successfully extracted product from people with “overcompensated” faces. No other product so far has been shown to be extractable. I will inform the group when and if I get some of mine pulled out (I have not had the time for a trip to LA for that purpose). I have been following this product since 2001.

3- PMMA in Brazil has as much history as NewFill (Sculptra) in HIV and has gained a lot of acceptance. It is also the cheapest option but you need to go to Rio at least once. I think the going rate is $700 total for the entire face (someone correct me if I am wrong), plus travel. DR Serra has been injecting HIV faces for longer time than anyone else in the field. Like all other products that I mention here, I have heard about isolated cases of granulomas that have been successfully treated with corticoid steroids. Dr Serra also treats the buttock area for $1000 (I think). This product cannot be removed later. I have been following this product since 1999.
I am hearing that ClinicEstetica has a product similar to this one also and that they are using it more than BioAlcamid now. May be someone can correct if that is a wrong statement.

4- The Silikon 1000 microdroplet procedure has also gained a lot of acceptance in the US even though this product is not used for its approved indication (go to facialwasting.org for more). Last time I checked , its cots was $700-900 a session. Most people need 3-6 sessions and it is a permanent, non-removable option. Many doctors are using it successfully. No patient assistance is available.

There are also products (Radiance®, Radiesse®) that contain synthetic calcium hydroxylapatite, a natural substance found in bones and teeth. It seems that the company selling Radiesse is going for a HIV lipoatrophy indication in the US. More on this later. Cost will be an issue and the fact that it will require 1-2 year touch ups. I hope this company sets a good patient assistance program (I am yet to communicate with them)

This is the best article I have found to give a review on all facial reconstruction options, besides my facialwasting.org
http://www.aidsmeds.com/lessons/Lipoatrophy.htm

Regards,

Nelson Vergel