Georgetown University’s Newspaper of Record since 1920

The Hoya

Georgetown University’s Newspaper of Record since 1920

The Hoya

Georgetown University’s Newspaper of Record since 1920

The Hoya

GU Study Proposes New HIV Treatment

By Tracy Zupancis Hoya Staff Writer

A new study from a team of Georgetown University researchers reports that intermittent drug treatment may be more effective than continuous treatment for some HIV-positive patients.

The study was published in the Jan. 22 edition of The Lancet, a European medical journal, and led by Dr. Julianna Lisziewicz and Dr. Franco Lori, adjunct professors of microbiology and immunology. They are also the founders of the nonprofit Research Institute for Genetic and Human Therapy, which has offices at the university and in Pavia, Italy.

Their findings run contrary to current recommendations for HIV-positive patients, which advise the use of highly active antiretroviral therapies to inhibit HIV replication, without stopping treatment. The findings published in The Lancet raise the possibility that patients may be able to take breaks from their often unpleasant, costly and strict regimen of drug cocktails, though treatment cannot be stopped altogether. The scientists hypothesize that structured treatment interruptions allows the body’s immune system to mount a maintainable response to HIV during drug holidays.

Lisziewicz cautions, however, that “at this point we warn every physician not to try this themselves because we don’t yet have a successful recipe, we don’t know which population we can control HIV with in this way. For this reason, we suggest that people continue on highly retroactive therapy.”

The study reports that daily doses of three or more antiviral drugs have been shown to suppress growth of the HIV virus to where it is near undetectable in the bloodstream. Nevertheless, in the majority of cases, the virus returns to high levels when treatment is stopped.

Lisziewicz said that the researchers believe one reason the virus rebounds in such a way is that long periods of virus suppression cause the body to be unprepared to attack the virus. “Eradication proved to be a difficult goal, and now we are trying to go in the direction of finding how to control the immune system to fight HIV,” she said.

The Institute is conducting two major projects both directed to control HIV in the absence of drugs. One is the stop-and-go intermittent therapy, and the other is the development of an HIV vaccine. Lisziewicz said that she hopes that the findings may be extended to treat other diseases as well, such as cancer. “A genetic modification of the body’s most effective immune cells shows a response, and these are the cells that are able to kill HIV,” she explained. “It is very exciting because these same cells are required to obliterate such cells as cancer. We are hoping that it will not only cure, but be preventative.”

The idea of intermittent therapy first arose in 1998 with the case of a German man known as “the Berlin patient.” The man started triple therapy soon after being infected, but had to stop two weeks later when he got another infection. The virus returned when he stopped, but when he resumed antiviral drugs it disappeared. Four months into treatment the man again became sick, and stopped triple therapy. The virus did not come back during the course of the two weeks that he was off of the drugs. A little over a month after this occurred, the Berlin patient decided to stop his therapy altogether. Though he is not cured and HIV can be found in some cells and tissues, the virus has remained undetectable in his bloodstream for more than three years.

Lisziewicz, Lori and their team enrolled three HIV-positive patients and mimicked the Berlin patient’s course of treatment interruptions. None of the three had taken antiviral drugs and were scheduled to be treated for three weeks, with one week’s structured treatment interruption. Then, at intervals of three months, therapy was stopped for a week and not resumed until the level of HIV in the blood reached 5,000 viruses per milliliter. Each had recently been infected, and their immune systems not yet damaged by the virus.

In the first patient, the virus lay below 5,000 for sixth months following the second interruption of treatment. Nevertheless, the virus eventually reached above that level and the patient again began triple therapy. He is slated to again stop therapy in the next few weeks.

The virus level in the second patient quickly increased after treatment was stopped. In the case of the third, known as the “Washington patient,” the rate of rebound decreased from the second to the fifth treatment interruption. He has continued with therapy and has had many drug holidays, allowing him to be drug free for 50 percent of his treatment period.

The team noted that the results suggested that antiviral drug combinations can be interrupted and successfully restarted many times and that no drug resistance occurred after as many as five treatment discontinuations. Additionally, however, they explained that as the second patient did not show control of HIV in the absence of treatment, control of the virus may require several interruptions in some patients, and may not be successful in others.

Recently, explained Lisziewicz, the team began a randomized control study, which will compare normal therapy with the new approach. A group of 60 has been chosen for the study, which the Institute hopes will point to which patients best respond to structured interruption of therapy. “We are developing a diagnostic test which will show who will respond to treatment interruption.” said Lisziewicz.

The structured interruption treatment is also being conducted on monkeys. Therapeutic vaccination, which induces an immune response that fights diseases, has not yet been studied in humans. Lisziewicz noted that the animal studies show promising results and possible new treatment options for people with HIV.

Lisziewicz and Lori recently presented their findings at a retrovirus conference in San Francisco.

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