Around 30 % of people who have extensive Kaletra and protease resistance may have pre-existing resistance to Aptivus (Tipranavir) and/or Prezista (Darunavir).  No one is talking about this and there are a few conference posters on the subject but not discussed by anyone.  Do not fall prey of the hype that is built around new medications, unless they are in a new class that you have never taken before and that show great response.  This is the best chance for many of us to attain undetectable virus and hopefully keep it that way for a long time, if you do it right the first time.


Tales of Salvage
Three men tell their story in a new era of HIV treatment
by Enid Vázquez
photos by Russell McGonagle

A decade ago “Lazarus syndrome” was used to describe people coming back from near death with the use of new HIV drugs.   It was perhaps the most powerful moment in the history of AIDS.

But only in the past year, Chicagoan Dean Triantafillo (pictured) had a Lazarus event of his own, again with new HIV drugs.  More than one powerful new drug is finally here for longterm survivors like Triantafillo who are heavily drug-resistant to mix into an effective combination, and more are soon to come.

Today people with HIV who have never seen an undetectable viral load are reaching that holy grail of therapy.  Somewhat quietly, doctors and advocates are discussing the possibility that the spirit of 1996 has been reborn.

Near zero T-cells

Triantafillo had close to zero T-cells for nine years, but his doctor didn’t want to change his HIV medications.

“He had me on therapy that wasn’t doing shit, saying, ‘Let’s not rock the boat.’  I kept telling him: I’m getting more fatigued each day. I have diarrhea.  I don’t feel well. ” When he ended up bedridden, he finally decided to find a new doctor.  A friend recommended Dr. Frank Palella at Northwestern University hospital.

But there wasn’t much Dr. Palella could do—not right away.

“He kept telling me, ‘Dean, hang in there.  A year from now, some new drugs are going to come out that will be wonderful for you because you’re so [drug] resistant.’  And he turned my life around.  He had Prezista waiting for me at Walgreens the day it was approved.”  That was June 23.  The drug is one of the second-generation protease inhibitors, developed for people whose virus is resistant to the ones that came out 10 years ago and many of the ones since then.

With his new therapy of Prezista (boosted by Norvir) and Truvada, Triantafillo began to improve immediately.  In six months, he went from 105 pounds to 155.  He works out and feels great, with no side effects.  His T-cell count is 255 and his viral load is undetectable.  “My friends and family say it’s a miracle.”

Triantafillo knows he’s been infected since 1981 because that year, his partner came home with shingles, an opportunistic infection seen in people with a weakened immune system.  Triantafillo had been with him for seven years.  At that time, he was a patient at Chicago’s Howard Brown Health Center, a clinic opened in the early 1980s for the gay and lesbian community.  When Triantafillo developed symptoms of illness, a doctor there told him he was surely infected with this new disease.  (An HIV test would not be available for another three years.)

“I was young and naïve.  I had never been with anyone else and I trusted him completely,” Triantafillo says of his partner, an airline pilot.  “But it’s okay.  You learn how to take care of yourself.”

He suffered through the Videx chalky tablets that had to be dispersed in water (“it tasted like cement”) and the kidney stones of Crixivan.   But he says he would have done almost anything for the chance to survive and to maintain some quality of life.

The Experiment

Bill Carter is a personal fitness trainer in Queens who says he can’t list all the drug combinations he’s taken because “there were so many.”   But since learning of his HIV infection 10 years ago, when he was very sick and came down with pneumonia, he’s been continuously on therapy with anywhere from two weeks to two months off between drug regimens.

“I never wanted to stop because I was never undetectable,” he says.  “I figured if I stopped, my viral load would go up again.”

Two years ago in March he entered a clinical study, taking Prezista (with Norvir booster), Fuzeon, and Truvada.  Fuzeon, FDA-approved for advanced patients, is a potent drug that’s generally reserved for that population because of its need for twice-daily injection.

Within three to four weeks he began to feel better.  He could hold down his food and his diarrhea disappeared.  Within six to eight months his viral load went from a very high number in the 400,000 range down to undetectable.  In that time, his weight went up 40 pounds to 185.  The study staff said that his love of cooking helped him regain his health, as he focused on nutritionally sound eating.  He also has had no problem with lipodystrophy—or body shape distortions due to fat problems, either thinning or increasing, as with abdominal distention.  His study nurse said that anecdotally, the clinic staff finds that to be the case in people who have regular cardio workouts the way he does.

He says he loves his job, and takes care of himself, works out every day and “I don’t stress myself out.”

“Don’t do as I did”

Nelson Vergel was one of the treatment advocates who pushed pharmaceutical companies into a bold new era: allowing multiple experimental drugs to be taken together.  This avoids sequential monotherapy, where people add only one effective drug, rather than two as recommended by specialists.  Salvage patients have not had the luxury of adding two new drugs for years now.

As a result of their efforts, Merck & Co.,  maker of the HIV protease inhibitor Crixivan, allowed people enrolling into their study of MK-0518 (from a brand new HIV drug class, integrase inhibitor) to also take the then still experimental Prezista.  And Tibotec put together two experimental HIV drugs in one study, its non-nucleoside TMC-125 and its protease inhibitor TMC-114 (Prezista), and allowed MK-0518 in its trials.

Part of Vergel’s passion for salvage therapy is his own fight for survival. He has been HIV-positive for 23 years and has accumulated resistance to all HIV drugs, including Fuzeon.  And so he entered the MK-0518 study, while also taking Prezista (along with the necessary Norvir booster and Truvada).

But the resistance profile for Prezista had not yet shaken out, and Vergel’s expectation that his virus would be sensitive to the drug—would get knocked out by it—turned out to be wrong.

After reaching the undetectable level for the first time ever, within three weeks of entering the study, he saw his viral load rise again to 800 after 24 weeks and then 20,000 later on.  It’s holding steady, and is still lower than the 60,000 he started with.

His T-cells went from 182 to 420 and as of January was down to 300.  “I’m still healthy,” says the Houston resident, who advocates exercise and nutritional supplements for people with HIV, work that he’s cutting back on to focus on salvage therapy.  “I’ve lived for 23 years without undetectable—hell! I’m getting old!” he says with a laugh.

Vergel says the resistance profile for Prezista was not available for genotype testing until the time of its approval, and running his previous blood sample again found that sure enough, his HIV was already resistant to the drug before he went on it.

“I was really upset because integrase is so good of a class,” says Vergel.  “I’m the only person I know who failed in the study, even though about a third of the patients in the study had treatment failure.  I think the integrase class was the best chance to get to undetectable in a long time.”

Now Vergel wants others to learn from his mistake.

“The summer of 2007 is going to be the best summer since the summer of 1996—if you do it right,” he believes.  That’s when MK-0518 is expected to be approved, as well as maraviroc from Pfizer, which are both now available through expanded access.  (See page 25.) Maraviroc is a new type of HIV entry inhibitor drug.  On their heels are other newbies:  TMC-125 (also available in expanded access) and the Tanox drug TNX-355, which is from another new class, called a monoclonal antibody.

Vergel hears doctors and advocates say that this new era reminds them of 10 years ago.   Vergel agrees, but says it’s “dangerous” to talk about the end of salvage therapy.  He says he hears people say that all the time—that people in need of salvage therapy no longer exist, that the integrase inhibitor from Merck will save them all.

“I say that HAART left a few people behind,“ Vergel says.  “That’s why I tell people, don’t be left behind again.  If you can wait for two or three active drugs, do so.  Don’t be overly aggressive if you can help it.”


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