Monthly Archives - October 2007

Last HIV Update in Houston this year

WHEN: OCT 24, 6:30 PM



LIMITED SEATING. E-mail or call the Houston Buyers Club at 713/520-5288


1- Review of data on two new drugs in two new class recently approved- Selsentry- CCR5 inhibitor ( and Isentress – integrase inhibitor( )

2- Review of data on Etravirine (TMC 125), a non nuke now available via expanded access

3- Update on Metabolics and Lipodystrophy

4- Resources in Houston: programs to help people go back to work or school while keeping social security and Medicare/Medicaid, lipodystrophy study enrolling at Body Positive, and new clinics in Houston for the uninsured.

The New Wave of HIV Drugs Is Here
by Nelson Vergel

For the first time in 10 years, HIV-postive patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a “second chance” to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 percent of the half a million patients taking HIV medications in the United States are not responding to their medication and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.

No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that “direct” the immune system’s response against invaders. MDR patients need to start at least two to three “active” drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen concurrently.

Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc, trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon (an approved fusion inhibitor), Aptivus and Prezista (approved second generation protease inhibitors), and TMC 125 (a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.

This second wave of HAART (highly active antiretroviral therapy) has the potential to save many lives. I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years. It is imperative to do your homework before jumping into a new regimen with limited data.

Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on Oct. 24 at 6:30 pm at the United Way on 50 Waugh. Patients and clinicians are welcomed. Free parking and food will be provided. Seating is limited. For reservations or more information, e-mail or call the Houston Buyers Club at 713/520-5288. More information on new HIV medications can be found at Nelson’s website

The best HIV drug in history approved today

Merck Gets FDA Approval
For New HIV Treatment

Wall St Jnl
October 12, 2007 5:50 p.m.

WASHINGTON — A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.

The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.

Isentress was approved as part of the FDA’s accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.

Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.

Patients with HIV typically are treated with a “cocktail” of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs.

Merck’s Isentress HIV Medicine Approved by U.S. FDA

By Shannon Pettypiece and Rob Waters

Oct. 12 (Bloomberg) — Merck & Co.’s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.

Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.

Isentress, Merck’s first HIV therapy since 1999, may generate as much as $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard-to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck’s vice president for infectious disease and hospital products.

“This is the first of a class of agents that should show growth for many years,” said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. “We expect this drug to be widely considered in conjunction with other therapies for patients where existing therapies are failing.”

Hazlett said he expects sales of $400 million next year, rising to $950 million in 2010.

Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.

Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so.

$27 a Day

Isentress, taken twice daily, will cost $27 a day, or almost $10,000 a year, similar to AIDS drugs developed in recent years, Merck spokeswoman Amy Rose said in a phone interview.

“We’re pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,” Rose said.

The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.

Pfizer’s Selzentry

This is the second new form of HIV medicine to come on the market this year. Pfizer Inc., the world’s biggest drugmaker, won FDA approval in August for Selzentry, the first drug to block a chemical portal the HIV virus uses to enter cells.

Merck’s studies found that Isentress reduced the virus to less than could be detected after four months in 61 to 62 percent of patients who got the medicine in combination with other anti- HIV drugs. That compares with 33 to 36 percent of those who got a placebo along with their most effective therapies.

Side effects included rashes, diarrhea, nausea and headaches. Although more patients taking Isentress developed cancers, the drug didn’t appear to pose an increased risk, according to regulatory advisers.

Thirty AIDS treatments are approved in the U.S., according to the FDA. AIDS patients take so-called cocktails of anti-HIV drugs each day, typically three or more medicines. The drugs can’t cure HIV, and people with the infections still have the virus in their bodies. Eventually, HIV develops resistance to treatment. Once a drug fails, the combination loses effectiveness.

Further Studies

Merck is also studying the drug in children and patients who haven’t been on any other HIV medicines.

All HIV drugs are designed to interfere with a part of the HIV life cycle of infection and replication. HIV attacks and destroys white blood cells, which the immune system uses to fend off invasions from viruses and bacteria.

GlaxoSmithKline Plc’s Lexiva and Pfizer’s Viracept interfere with the action of the protease enzyme, while drugs such as Gilead Sciences Inc.’s Viread inactivate another viral enzyme, reverse transcriptase.

A third class of medications, called entry inhibitors, works by blocking HIV from entering target white cells. These drugs include Roche Holding AG and Trimeris Inc.’s Fuzeon, which reached the market in 2003.

Merck sold the U.S. rights to its previous AIDS drug, Stocrin, to Bristol-Myers Squibb Co., which markets it under the name Sustiva. Merck continues to market Stocrin outside the U.S. and sells another older AIDS drug, Crixivan.

Merck’s New AIDS Drug Has Promise — if It Isn’t Too Pricey

Merck’s New AIDS Drug Has Promise — if It Isn’t Too Pricey

Wall St Journal
October 11, 2007; Page B1

Merck & Co. could break new ground on the AIDS-fighting front this week with the Food and Drug Administration’s expected approval of Isentress, a new type of drug that could be especially useful for patients who no longer respond to many existing treatments. Yet despite the continuing need and market for HIV treatments, and doctors’ enthusiasm about the drug’s prospects, it’s no sure thing that Isentress will pay off for Merck.

A major factor is pricing, yet to be determined and especially important because of the recent arrival of several other drugs to fight HIV, the virus that causes AIDS. Pfizer Inc.’s Selzentry, which won regulatory approval this summer, costs about $10,600 a year wholesale. Roche Holding AG’s Fuzeon, which came out in 2003, costs about $24,500 a year wholesale, much higher than many other AIDS drugs. And Johnson & Johnson came out with Prezista last year and may win approval of another HIV drug in early 2008.

Merck declines to discuss pricing ahead of an FDA decision. But if the company were to price Isentress at the high end of the range, “there’s no way the system could handle that,” says Lanny Cross, a former director of the New York AIDS Drug Assistance Program and a consultant for the National Alliance of State and Territorial AIDS Directors.

Martin Delaney, a longtime AIDS activist, who has participated in price negotiations with Merck on behalf of a group called the Fair Pricing Coalition, says the company has shown sensitivity to patients’ financial needs in the past. But he says Merck officials have been “arguing they need to get profitability.” He says Merck has indicated it wants to price Isentress in the range of relatively new AIDS drugs such as Prezista and Bristol-Myers Squibb Co.’s Reyataz, both of which cost around $9,500 a year wholesale, according to their makers. He also says Merck has told him it has spent close to $2 billion on HIV research.

Isentress arrives at a time when Merck has just one other HIV drug in clinical trials, at the earliest stage of such testing. And it is just weeks after Merck’s leading experimental AIDS vaccine collapsed in a clinical trial. Isentress represents a chance for Merck to show it is still a major player in this arena despite a years-long gap since it last brought a new drug to counter HIV to the market. Some doctors are excited by Isentress’s potential, in particular because the pill represents a new way to attack a virus that has managed to develop resistance to many other drugs.

An advisory panel of outside medical experts last month said the data support FDA approval of Isentress for patients who have failed treatment with other HIV drugs. The agency isn’t required to follow such panels’ advice, but usually does.

Merck may find it difficult to sell Isentress at the highest price possible when many public-assistance programs that help pay for HIV treatments are experiencing fiscal strain. In the 2006 fiscal year, 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets decrease, according to the Kaiser Family Foundation, a nonprofit health-policy research group in Menlo Park, Calif. Such programs bought drugs for nearly 100,000 HIV patients in 2006 and provided insurance coverage for thousands more, according to Kaiser.

Merck declines to specify how much it spent to develop Isentress or to research other HIV drugs, beyond saying it has spent “hundreds of millions of dollars” on such work. “We believe [HIV research] is the right thing to do,” says Robin Isaacs, the Whitehouse Station, N.J., company’s executive director of infectious-disease clinical research. “We are hopeful that will translate into return on investment for our shareholders.”

While Merck is viewed by many in the AIDS community as one of the major drug makers most committed to HIV research, revenue from such products currently represents a modicum of Merck’s total revenue, which amounted to $22.64 billion last year. The company drew a combined $327 million from sales of Crixivan, an HIV drug from the mid-1990s that is no longer used widely, and Stocrin, which Merck sells overseas.

Isentress could provide a bottom-line boost, though it doesn’t carry the potential of some major Merck products such as asthma-drug Singulair, which had $3.58 billion of sales last year. Credit Suisse drug analyst Catherine Arnold estimates Merck’s annual sales of Isentress could be $500 million world-wide by 2012, and likely more if used in a broad swath of patients. Merck is an investment-banking client of Credit Suisse.

Another factor influencing Isentress’s prospects is whether doctors will prescribe it for patients in early stages of HIV treatment. The FDA advisory panel debated how early in a patient’s treatment to approve Isentress use, given that most patients in Merck’s trials had used a number of drugs already. It will be up to the FDA to make that determination — though doctors would be permitted to prescribe Isentress “off label” at any point in treatment.

About two-dozen HIV drugs are now available, most of which block two enzymes that HIV uses to replicate in the body: protease and reverse transcriptase. Isentress, known generically as raltegravir, would be the first drug on the market to target a third enzyme — integrase — that helps the virus insert its DNA into that of human cells.

Because HIV mutates quickly to outwit drugs, cocktails of three medications are typically used to simultaneously attack the virus in different spots. Patients tend to change drugs as their virus adapts. Isentress would be taken along with other drugs.

Merck’s late-stage studies of Isentress involved patients who had been receiving HIV treatment for a median of 10 years, had virus resistant to at least one drug in each of three major classes of HIV drugs and showed evidence the virus was continuing to replicate in their bodies. In other words, they were already sick or in danger of becoming sick soon.

“Since this drug seems to be very effective and pretty well tolerated, I think [there is] potential for it to move in and take territory” from some older drugs, says Judith Feinberg, a leader of the AIDS clinical-trials unit at the University of Cincinnati College of Medicine who served on the advisory panel.

However, she said some doctors may be uncomfortable prescribing Isentress more broadly until further studies are complete. Merck is currently conducting late-stage Isentress studies in patients who are new to HIV treatment. The company expects to have the results toward the end of 2008. Dr. Feinberg says she had no ties to Merck at the time of the panel hearing but has since agreed to give talks sponsored by the company.

Isentress will be used principally in “patients who have tried a whole raft of drugs,” says Daniel Kuritzkes, director of AIDS research at Brigham and Women’s Hospital in Boston, who consults for Merck and other HIV-drug makers. However, “for patients who have earlier stages of disease, there will be some tendency to hold off because it’s so useful in patients with extensive treatment experience.”

Another potential complication is that Isentress is taken twice a day, while some new patients take a once-a-day pill called Atripla that combines three drugs. That could make it tougher to get patients to take Isentress from the beginning.

While Merck has little else for HIV in clinical trials, research-and-development chief Peter Kim says the company is committed to pursuing HIV treatments, and continues to do research related to the integrase enzyme.

“We really do think that this drug-resistance issue is going to continue to be a significant unmet medical need,” Dr. Kim says.

Lipodystrophy Providers List

Still slow response (60 responders in a list of 2500 people in pozhealth at, but we are starting to see some valuable information

Click on “view” in questions 2, 3 and 4 to see what people have typed in

For those of you who want to share with us, use this link

Letter to Doctors and ADAP directors about changes in weight loss/quality of life medication access

May 8, 2007

Dear ADAP Director:

As you may be aware, your HIV patients will soon face an abrupt change in available treatment options for HIV-related weight loss and AIDS wasting syndrome. In March 2007, Watson Laboratories, the sole manufacturer of the inexpensive HIV anti-wasting agent nandrolone decanoate (also known as Deca-Durabolin), halted production of this agent. Instead, Watson will promote their generic version of Oxandrin (oxandrolone). As patient advocates, we are alarmed that patients now will have to switch to an agent that is over five times the cost, with a greater risk of hepatotoxicity.

Watson had a previous licensing agreement with Savient Pharmaceuticals, the maker of Oxandrin brand oxandrolone. In December 2006, Watson received the go-ahead from Savient to begin marketing oxandrolone as an AB generic.

After acquiring rights to sell generic oxandrolone, in March 2007 Watson stopped production of nandrolone. This left oxandrolone as the only other anabolic steroid treatment on the market that has been studied in trials for AIDS wasting.

BTG Pharmaceuticals, later bought out by Savient Pharmaceuticals, set up a patient assistance program (PAP) for Oxandrin when it was launched in the mid 90’s. But in April, Savient announced the end of the old patient assistance plan. Patients who are most in need and have the fewest resources are plain out of luck.

The projected cost of the generic Oxandrin will be virtually the same as the ‘brand name’ version, with less than a 15% price difference at the time of this letter. A key HIV pharmacy in Los Angeles will be charging $1350.00 for a typical month’s worth (20 mg /day) of branded Oxandrin from Savient, versus $1100.00 for the AB generic from Watson. (This compares with a cost of about $200 per month for 200 mg a week of nandrolone.)

Out of the fifty states, only nine AIDS Drug Assistance Program (ADAP) formularies (Alaska, Arizona, California, Delaware, Florida, Maryland, New Hampshire, and New Jersey) cover Oxandrin and nandrolone, six (Connecticut, DC, Kansas, Michigan, Mississipi, and Oklahoma) cover Oxandrin only, and four (Georgia, Indiana, Nevada, and New York) cover nandrolone only; patients in the remaining states either pay for it out-of-pocket, or obtained it through the now-defunct patient assistance program. Private insurers often do not cover Oxandrin without time-consuming prior authorizations, which will leave your HIV wasting patients without medication for weeks if not months. These burdensome prior authorizations must be repeated every three months.

One stop-gap solution for your patients is to avail themselves of nandrolone composed at compounding pharmacies, whose prices are usually even less than Watson’s version of nandrolone. However, these pharmacies do not process insurance claims or are equipped to supply ADAPs, Medicaids and Medicare Part D vendors. (A list of compounding pharmacies is attached to this letter.)

Still, use of compounding pharmacies is a stop-gap solution. Your patients and third party payment systems need a more permanent solution. It is imperative that Watson hear from credible health care providers such as yourself that their actions have adversely affected your patients’ treatment options, and that Watson should resume nandrolone manufacturing. It would also be important to let Savient hear about how their decision of stopping Oxandrin’s PAP would negatively affect your patients. Watson’s fax number is 951-493-5842 and corporate office is 951-493-5300. Savient’s telephone is 732-418-9300 and fax 732-418-0570

We have enclosed copies of two articles on this subject, a list of compounding pharmacies that supply nandrolone, oxandrolone and testosterone gels, and our non-profit resource post cards. For more information on this matter and future updates, please visit or our main portal If you wish to help us with this patient advocacy issue, there are sample letters in that blog that could be sent to Watson and Savient from your office.

Fortunately, the incidence of involuntary weight loss has decreased in the post-HAART era but there still is a small number of patients that may need help after an opportunistic infection or other illness. According to a study at Tufts University, 29% of people with undetectable viremia still experience involuntary weight loss and have low body mass index. According to over 9 studies performed in men and women with HIV, physician-monitored use of anabolic agents has been shown to help those patients regain body mass and stamina.

Please do not hesitate to let us know if you need any more information and if you can help us to inform the patient community about their treatment options for involuntary weight loss.


Nelson Vergel

Applied Pharmacy Services 3207 International Drive
Mobile, AL 36606 877-729-1015 877-729-1019 $9.50 per ml in a 10 ml multi dose vial or $9.75 per ml for a 4 ml multi dose vial or $10.00 per ml in a 1 ml vial

The Compounding Shop 4000 Park St. N St Petersburg Florida 33709 866-792-6731 727-347-2056 $12.00 per ml in 10 ml multi dose vial

Collage Pharmacy 3505 Austin Bluffs Parkway, Suite 101
Colorado Springs, CO 80918
800-888-9358 (800) 556-5893 or (719) 262-0035 only available as a 10 ml multi dose vial for $94.75 this is for 200 mg/ml, this compounder also offers100 mg/ml

Kronos Compounding Pharmacy Now sold to AnazaoHealth 3675 S. Rainbow Blvd.
Suite #103
Las Vegas, NV 89103-1059 800-723-7455 800-238-8239 $26.50 per ml for a 10 ML vial

Medaus Pharmacy 2637 Valleydale Road
Birmingham, Alabama 35244 800-526-9184
800-526-9184 $44.00 per ml in one ml vials or or 18.60 per ml in 10 ml multi dose vials

B&B Pharmacy 10244 Rosecrans Ave BellFlower, CA 90706 562-866-8363 Unavailable at this time,

Cheap HIV drugs are more important than patents

Tuesday, October 09, 2007

African countries should follow Thailand’s lead in manufacturing their own affordable medication in the face of U.S. pressure.

By Lara Santoro

October 9, 2007 In January, the Thai government gave its domestic drug manufacturers carte blanche to effectively copy the formula for Abbot Laboratories’ AIDS drug, Kaletra, and reproduce it in Thailand at a fraction of the cost.

A storm of protest ensued. The U.S. placed Thailand on a “priority watch list” of badly behaved countries. The European Union followed suit with a sharply worded letter from Trade Commissioner Peter Mandelson lamenting Thailand’s outrageous disregard for Abbot’s intellectual property.

Yet, contrary to common perception, Thailand’s move was, and remains, in perfect observance of international law. The Doha Agreement on Trade-related Aspects of Intellectual Property Rights, signed by all members of the World Trade Organization, stipulates that “every country has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.”

“Compulsory” licenses essentially allow governments to revoke patents when they are deemed to work against the public good, either by stifling competition or unreasonably restricting access to a product. Once a royalty fee is negotiated and a time limit set, governments are free to compel the original patent holder to hand over its intellectual property.

The U.S. government routinely grants compulsory licenses for purely commercial reasons, largely to streamline production of consumer electronics and military hardware. Five such licenses were issued in the last year alone, one of them specifically to Abbott. To no one’s horror or, frankly, interest, Italy recently issued a compulsory license for a drug that treats enlarged prostates.

Thailand’s compulsory license addresses a far starker reality — in a country of 65 million, 650,000 people (one in every 100) is infected by the AIDS virus. With soaring temperatures — and refrigeration the exception rather than the rule — heat-stable drugs such as Kaletra are crucial. Kaletra also has the advantage of low toxicity; for people whose livers have withstood years of harsh antiretroviral treatment, Kaletra is a gentler, but prohibitively priced, passport to life.

Why, then, has the Thai government’s attempt to acquire a lifesaving drug run into a wall of corporate indignation and government censure?

The standard answer is that pharmaceutical advances are based on the respect of intellectual property. Without the protective role of patents, the argument goes, drug makers would fail to recover their research-and-development costs and consequently shy away from pursuing new drugs.

The truth is that more than half of all antiretroviral drugs were researched entirely on U.S. government grants. Both lopinavir and ritonavir, the two antiretroviral agents in Kaletra, were researched with public money. “Heck, we paid for them,” said James Love, director of the Washington-based Consumer Project on Technology.

The pharmaceutical industry lives in fear of a cheap-drug domino effect. Thailand’s compulsory license could inspire the entire continent of Africa — where 70% of the world’s 40 million HIV/AIDS cases are found — to issue licenses for a series of drugs.

Countries such as Kenya and Uganda, not to mention South Africa, have not only the manufacturing base needed to copy and reproduce drugs for a fraction of their cost, they also have the right. So what’s stopping them? “There is a history of trade pressures,” Love said. “Very few countries are willing to face such pressures.”

Despite death on an unimaginable scale, talk of compulsory licensing remains anathema in most of Africa, so millions of lives are left in the hands of a well-meaning yet ineffectual group of international donors, whose solution to the problem has been to purchase and distribute generic AIDS drugs made in India and Brazil. It’s a noble effort, but with pitiful results. Fifteen years after the invention of antiretrovirals, only one in four Africans has access to them.

But it gets worse. For many of those who survived thanks to first-line treatments, the time has come to switch to newer, less-toxic drugs — all of them patented, none of them even remotely available. “We’re starting from zero again,” said Buddhima Lokuge, U.S. manager of Doctors Without Borders’ “campaign for access to essential medicines.” By the time generic competition kicks in for the newer drugs, millions of people will have died unnecessarily.

The AIDS epidemic will constitute the single greatest loss of life in modern history. It is impossible for us in the West to conceive of death on such a scale. Far more difficult to understand, however, is the arbitrary nature of this holocaust: The drugs exist, why can’t people have them?

African countries should find the resolve to follow Thailand’s example and grant compulsory licenses when they see fit. In so doing, they would put an end to a drug monopoly whose human cost brings shame to us all.

Lara Santoro worked as a journalist in Africa from 1997 to 2004.

SOURCE: Los Angeles Times,0,43…