Dr Shannon Scharder and Nelson Vergel talk about multidrug resistance, Prezista, Fuzeon, Integrase

http://www.prnewswire.com/broadcast/24683/consumer.shtml

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

Fort Lauderdale and Miami Lectures in June

JUNE 6

6:00 PM

Free Dinner

Artserve Auditorium located at 1350 EAST SUNRISE BLVD. Fort Lauderdale (Broward County Library Building right next to the auto dealers & Holiday Park)

Topics:

How to qualify for a free wellness program in Ft Lauderdale,
Upcoming new HIV medications and Clinical Trials,
Exercise, body composition and HIV,
The effects of Alcohol and party drugs on HIV Meds
Latest on HIV Prevention


RSVP by emailing djjimmyp@aol.com

*********************************************
JUNE 8

6 PM

Free dinner
Bellissimo Italian Restaurant. 1672 E Oakland Park Blvd. Ft.Lauderdale, Fl 33334 954-565-1042

TOPICS:

Emerging Drugs and Issues in HIV. How to best manage side effects. Latest lipodystrophy data.

RSVP by emailing jihme@careresource.org
****************************************************
JUNE 7

MIAMI

6:00 p.m.
TEXAS de Brazil Restaurant
11401 NW 12 th St
Suite 514
Miami , Florida
RSVP to Raul Medina at (305) 585-5256.


Nelson Vergel will be the speaker for all lectures.

WallStreet Journal's article on Salvage Therapy

As AIDS Drugs Fail Thousands, 'Salvage' Is Key

By MARILYN CHASE
May 3, 2006; Page B1
http://online.wsj.com/article/SB114660908687541895.html


Steve Kovacev, a sinewy 52-year-old from Truro, Mass., has run the Boston Marathon and sailed in the Transpacific Yacht Race from Los Angeles to Honolulu. Neither event comes close to his current competition: a race for his life.

Mr. Kovacev has AIDS. He has used all the drugs available to fight HIV, the virus that causes the disease, but now almost all regimens have lost strength, and his virus is on the upswing. His plight places him in an unenviable class: the estimated 40,000 U.S. AIDS patients whose illness isn't responding to treatment. As a last-ditch effort, some of these people -- Mr. Kovacev included -- are turning to a regimen known among AIDS patients and doctors as salvage therapy.


In general, salvage therapy refers to any treatment devised by a doctor to save a patient when all other options have failed. There isn't a single recipe for salvage. Some AIDS physicians return to older drugs to wring out a last drop of efficacy, while others bid for access to experimental agents in a desperate attempt to bring the spiraling virus under control.

Today there are about one million people living with HIV in the U.S., with about 40,000 new infections a year. In 2004, the most recent year for which statistics are available, 15,798 people died from AIDS, down sharply, thanks to new AIDS drugs, from 51,000 in 1995. Hepatitis and drug toxicity contribute to deaths among HIV patients. Because of salvage therapy, most patients with drug-resistant virus are, for now, hanging on.

Even with optimal treatment, Daniel Kuritzkes, associate professor of medicine at Harvard Medical School, says, "we've only changed the slope of the disease progression, not halted it altogether, and eventually they do run out of options."

Nearly two dozen AIDS treatments are currently on the market. But as the epidemic turns 25, many long-term patients have been driven by the mutating virus to keep switching regimens until all have failed. Of the 40,000 patients who aren't responding to even the latest high-power medication, "20,000 are in dire need," says Houston AIDS-treatment activist (and AIDS patient) Nelson Vergel. "I call them the invisibles, because they are too tired and too sick to fight for their rights."

Mr. Kovacev believes he contracted HIV in the early 1980s from his partner, who died in 1990. In 1996, illness forced him to begin antiviral cocktail treatment for AIDS. He "got very sick last fall and went on a new regimen -- one of the last available," combining the injectable drug Fuzeon with two antiviral pills, says his doctor, Stephen Boswell of the Fenway Community Health Clinic in Boston.

Over the years, Mr. Kovacev has survived bouts of an intestinal parasite that left him wasted, a virus that nearly blinded him, and painful neuropathy that required morphine. But he rallied to run the 2006 Boston Marathon last month as an unregistered disabled runner. He finished the race -- his 13th marathon -- in six hours and 41 minutes.

Dr. Boswell cites Mr. Kovacev's "voracious will to live" and athleticism for his survival. Mr. Kovacev swears by nutrition and Dr. Boswell's vigilance in tailoring 10 successive AIDS cocktails.

Mr. Kovacev hates the term "salvage therapy." "Salvage sounds like you're dredging a shipwreck," he says.

Mr. Vergel seems resigned to the term. "Salvage isn't a science. Salvage is an art," says the Houston activist, who has taken all 22 approved AIDS drug products.

Many patients now in salvage have, like Messrs. Kovacev and Vergel, lived with HIV for over two decades. Some like Mr. Vergel took the first antiviral, AZT, approved in 1987, and swapped in each new product until protease inhibitors in 1996 heralded the era of modern drug cocktails.


AIDS patient Steve Kovacev as he competed in the 1997 Boston Marathon.
At San Francisco General Hospital, physician Steven Deeks is studying 300 salvage patients, many of whom started on AIDS drugs in the early 1990s. Many considered aggressive switching as the best practice at the time, and the patients quickly switched to each new product like DDI and 3TC.

By the 1996 debut of protease-inhibitor drugs, which are now anchors of modern cocktail therapy, such patients "already had high-level resistance," Dr. Deeks says. It now appears that rapid switching of single drugs had fueled the development of resistant virus.

Dr. Deeks, an associate professor of medicine at the University of California at San Francisco, warns that people on cocktails who still swap in the latest new drug one at a time are perpetuating the problem. "We need to stop switching so aggressively," he says. "We need to hold still until we have a number of new families of drugs."

Salvage therapy is "a huge issue," says Harvard Medical School Professor Jerome Groopman. "You've got these patients who did well and you're excited for them. Then you get back with them and they have 12 mutations. You're desperately searching. They're hanging on by a thread."

Dr. Deeks urges resurrecting old drugs like AZT or 3TC as stopgaps to stabilize patients until two or three novel drugs can be combined in an all-new cocktail.

Once doctors get access to two or three novel drugs, they can concoct the first all-new cocktail many patients have had in several years. Raining multiple blows on HIV gives a chance even patients with multidrug-resistant virus can lower the level of HIV in the blood to the limits of detection, Harvard's Dr. Kuritzkes says.

Experimental drugs furthest along in the new product pipeline include: the new protease inhibitor TMC114 from Johnson & Johnson's Tibotec unit; new integrate inhibitors from Merck & Co. and Gilead Sciences Inc.; new entry inhibitor drugs that block the CCR5 co-receptor from Pfizer Inc. and Schering-Plough Corp.; and Tan ox Inc.'s IV monoclonal antibody to block the virus's entry through the CD4 receptor on human immune cells.

"I'm excited," Mr. Vergel says. But he adds, "I want people to wait. Don't blow your options by adding [one drug] to a failing regimen."

For those who can wait, Mr. Vergel says the new drug pipeline may yield products this summer and next spring. "I am just concerned that so many patients who need help now may not see the good days coming ahead," he says.

Appeals Court Rules that Terminally Ill Patients Have 'Fundamental Right' to Experimental Drugs

ugs
From a Washington Legal Foundation (WLF) press release:

Appeals Court Rules that Terminally Ill Patients Have 'Fundamental Right' to Experimental Drugs



(Abigail Alliance v. Eschenbach)

WASHINGTON, May 2, 2006-In a major victory for the Washington Legal Foundation (WLF), the U.S. Court of Appeals for the District of Columbia Circuit ruled today that terminally ill patients have a “fundamental right” – protected by the U.S. Constitution – to access to experimental drugs that have not yet been fully approved by the Food and Drug Administration (FDA). The decision caps a three-year WLF effort to establish such a right. Because of FDA’s refusal to recognize such a right, WLF filed suit in 2003 on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group.

The appeals court held 2-1 that once FDA has determined, after Phase I trials, that a potentially life-saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient. The court held that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment. The court said that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are “narrowly tailored” to serve a compelling governmental interest. Commenting on the Court’s decision, WLF Chief Counsel Richard Samp said:

Under FDA regulations, the vast majority of patients with life-threatening illnesses do not have access to promising new medications during the years of clinical testing and review required by FDA. The drugs remain unavailable even though there is evidence that they are safe and effective and even though patients have no alternative to the drugs other than to wait for their own deaths. We are hopeful that today’s decision will reverse that policy.

Unless FDA appeals, the case now returns to the district court, where FDA will have an opportunity to demonstrate that it has a “compelling interest” in restricting the constitutional rights of terminally ill patients. WLF is hopeful that it can work with FDA to develop a new policy that takes into account FDA’s legitimate concerns while also respecting the rights of those in need of access to potentially life-saving medications.

Richard A. Samp, counsel for WLF in the Abigail Alliance case, is available for comment at (202) 588-0302. A copy of WLF’s brief is available at its website, www.wlf.org.

Are salvage patients beyond help?

I just found out about the death of Gary Bischop, one of the first patients that I was able to help in the past two months to convince his doctor to advocate for his access of TMC 114 and TMC 125. Gary wrote me a nice testimonial in salvagetherapies.org about his ordeal and how full of hope he was. In it he said: "Thankfully, I don’t have to face the dim prospect of monotherapy again. Nelson informed me and the ATAC discussion group about a process called Emergency Investigational New Drug (EIND) access. So I approached my doctor with this idea. He was hesitant at first, but finally he did apply for the EIND in the beginning of March 2006 and within a week and a half we had permission from Tibotec, the FDA, and my medical Center’s Internal Review Board to proceed with the EIND. That means I will receive my TWO new drugs by the end of this month, March 2006. There is hope after all. Thank you Nelson and Barry for all of your help".
He died a few days after he finally got the combination of investigational agents. I cried just thinking about this terrible loss. Could it have been prevented if he had got the drugs sooner? Could he still be with us? Why has hardly any activist out there help me spread the word about single patient treatment IND access for desperate patients? My mind is full of questions and it is a painful mistery that I hope to have an answer to eventually.

I have so far only been able to help fewer than 10 patients to get this combination of drugs outside a protocol setting. They all found out about this possibility after reading a press release that I wrote that only thebody.com was kind enough to publish (see http://salvagetherapies.org/announcements.htm). TheBody.com and ACRIA.org were the only groups kind enough to post information about this salvage access program. No other AIDS service organization that I contacted supported spreading the word about this potentially life saving program. This is a mistery that I still do not understand.

I have been afraid to write these words. But I have already been isolated and demonized by many of my fellow activists for being too aggressive about the way we should work on salvage access, specially now that there are so many possibilities to help people with drugs in phase III and expanded access.

Many activists think that all salvage patients are dead or beyond help. I wonder what world they live in.

Salvage patients are too tired and too busy trying to stay alive to have any time to get involved with activism, so their voices are never heard. They are silent, invisible, and a great inconvenience for AIDS groups and researchers. Next time you write a check for an AIDS organization, ask them what they are doing to help those who are in dire need for new drug access.

I donot believe in hell and heaven. But right now I am fantasizing with the idea of Gary sitting somewhere, looking down, and getting ready to wake some people up to help this cause. He was a true fighter and one who will be with me in my heart until not a single patient dies after running out of options for HIV. Too bad we coud not help him sooner. I am sorry Gary, and I hope that wherever you are now, you have no pain and no sorrow, but light and hope for the world you left behind.

Hope for those with no options

For those of you trying to get on two active drugs....

You can get TMC 114 in expanded access. It is taking about 3 weeks to get it if the doctor knows the process. No T cell limit but your doctor has to prove that you have multi drug resistance. Three hours of paper work. Your doctor does not get paid for that time. Many doctors refused to be part of this system. To see who is listed in your area, email info@veritasmedicine.com and read
http://clinicaltrials.gov/ct/show/NCT00245739?order=1

Remember: TMC 114 will probably be approved in a month or so. TMC 114 is a second generation protease, and not a replacement to Fuzeon. Some people may be thinking about taking this drug with Merck's integrase (info below) to get off Fuzeon. We really do not know much about how to compare a Fuzeon containing regimen with this one.

Never start a new agent on top of a failing regimen. This is called virtual monotherapy and only works for a little while. Read more here
http://salvagetherapies.org/announcements.htm


If you have multidrug resistance and very low T cells...like under 10, you can qualify for a single patient access program that requires a lot of work from your doctor. Most doctors do not know how to do it. Read the last link about that.


The Merck integrase study is now enrolling fast in phase III. This is a very promising drug (MRK518). They allow the use of TMC 114 in expanded access. Bad news: you have a 33% chance of placebo but they will give you the real thing in 16 weeks if your viral load is not undetectable then.

You can find out more about this here
http://benchmrk.com/secure/investigator_sites/sites.html

This product MAY be in expanded access by the end of the year if Merck enrolls the study fully by then.

Pfizer's oral entry inhibitor Maraviroc: we are waiting to hear from the company to see if this product is a go or no go for treatment experienced patients. We will not know until they unblind their study in August.

Email me if you have any questions since this can be very confusing.

You can read some people's testimonials at
http://salvagetherapies.org/testimonials.html