Bay Windows - National News, February 17, 2000
Beth Berlo, Bay Windows staff

Researchers presented their findings at the seventh Conference on Retroviruses and Opportunistic Infections in San Francisco.

Though several groups have previously reported successful treatment interruptions with newly infected patients, the majority of people infected with HIV have been taking medications for years.

According to an Agence France Presse news report, a team from the Research Institute for Genetic and Human Therapy (RIGHT) showed that they were able to stop treatment for a patient in Berlin who had taken the medication since becoming infected, and that treatment could be interrupted successfully among those with long-term infection.

The results of the study included control groups of patients who were taking hydroxyurea and ddl. When taken off the drugs for eight weeks, they were able to maintain low levels of virus.

While the development has encouraged many, others remain skeptical. According to a UPI report, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that, though he has begun enrolling patients in a structured interruption trial, he predicts that only the patients who are newly-infected and still retain an immunological response to HIV will be able to succeed with the therapy. In FauciÆs study, patients will spend two months taking medications and then will go off drugs for one month.

Most important to remember, said Dr. Stephen Boswell, executive director of the Fenway Community Health Center (FCHC), is that, ôThis should not be done outside of a very controlled setting.ö The FCHC has been participating in a study of treatment interruption therapy in conjunction with Massachusetts General Hospital and he said, ôWe check peopleÆs viral loads on a weekly basis.ö

Dr. Eric Rosenberg, instructor of medicine at Harvard Medical School and an MGH physician working with the Fenway, said they are looking at a very unique group of people who were diagnosed prior to HIV seroconversion.

ôOur belief is that if you can find people in the earliest stages and treat them with highly active anti-retroviral therapy, you may have the opportunity to preserve critical immune responses that the body may need to control HIV,ö Rosenberg said.

What are the risks of taking someone off therapy? ôYouÆre allowing the virus to come back, and youÆre creating an environment for drug resistance to occur,ö said Rosenberg. ôBut we havenÆt seen any of that. But these are patients that have only been on one regimen their entire time of taking any medication. That might be very different from chronically infected patients.ö

Several years ago, it used to be thought that if someone took the medications long enough, the virus could be eradicated in oneÆs body. But, said Rosenberg, ôIt doesnÆt now seem possible that weÆll ever be able to do that.ö

The MGH/Fenway study maintains a strict criteria of requirements before the physicians will allow patients to come off therapy. First, the patient needs to be diagnosed and treated prior to the time of seroconversion, said Rosenberg: They need to have viral loads below the limits of detection for at least eight months on therapy, have demonstrated no evidence of drug resistance, and have certain immune responses present against HIV. Currently, nine men are in the study.

Why would people subject themselves to the risk? ôFor one major reason,ö said Rosenberg. ôMost patients really dislike being on these medications. ItÆs a major impairment in their quality of life.ö

Cal Cohen, research director of Community Research Initiative, said there are currently two categories of treatment interruption under discussion. ôThe first is for people who are doing well with anti-virals and using it like a vaccination to stimulate the immune systemÆs response against HIV,ö he said. Several studies have suggested hints of potential immune control with this type of interruption therapy. ôA lot more research is going to follow up these hints,ö Cohen said. However, there are potential adverse reactions to the interruption. ôA whole burst of HIV can cause illness,ö Cohen said. ôThatÆs where the therapeutic vaccination also plays a role.ö

The other category is a study of people who are about to start their first anti-viral combination Cohen said, where half of them will receive a therapeutic vaccine. The earlier studies, he said, suggested this vaccine, when given to people just starting therapy, might help the immune system control HIV even more than when people rely on their anti-virals only. ôThis is an international study trying to learn once and for all if this approach is ultimately successful,ö said Cohen.

The vaccine is called Remune. ôItÆs HIV but itÆs been killed and stripped of the outer envelope,ö Cohen said. It was developed over a decade ago by Dr. Jonas Salk, who developed the polio vaccine. Remune builds on the observation that the immune system can sometimes help control HIV.

ôThe question is, it seems that only happened to 5 percent of people,ö Cohen said. ôThatÆs the problem. ThatÆs where we hope that the vaccine might boost the cells that could ultimately control HIV even without anti-virals someday. ItÆs the dawn of a potential new era.ö The first era was finding medications that worked which peaked five years ago with triple drug therapies.

ôThe good news,ö says Cohen, is, ôthat there isnÆt much risk. Outside of the sore arm (from the shot), there doesnÆt seem to be much of a downside to it. It may be that the worse thing that happens to you is that you are on anti-virals and the vaccine does little to help, but at least youÆre still on effective anti-virals.ö

People are welcome to volunteer for this study, Cohen said. The only criteria are that a person has to have a CD4 above 200 and have had no prior use of anti-virals. If interested, call CRI at (617) 566-4004 x213.

Other news that came from the conference included a new class of anti-HIV drugs that show promise by blocking entrance of the virus into the cells. A drug called T-20 has controlled viral replication for nearly 36 weeks in the some of its first patients. It is injected twice a day, and reportedly has doctors very optimistic. One doctor predicted it would launch a feeding frenzy of development by pharmaceutical companies to find small molecules that can be given orally to do the same thing, according to a Los Angeles Times report.

New classes of drugs are critical to the future of therapy, researchers say, because the 14 current HIV medications fail so many. While earlier reports suggested an emergence of new drug-resistant strains of the virus was the cause for the medications to fail, researchers now believe failure was related more to low adherence or low anti-retroviral therapy. In fact, said Boswell, 95 percent or more (of treatment failures) are stemmed from non-adherence. This could in part be due to severe adverse side-affects some suffer from the medications.
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