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Resistance

New Treatment Effective Against Advanced Drug-Resistant HIV

NEW TREATMENT

Ibalizumab is designed to help when other drugs fail.

There is hope for those who are in the advanced stages of drug-resistant HIV. Skipping days of medication can allow the virus to multiply, causing it to mutate and adapt to the medication, rendering drugs useless. Worse, drug-resistant HIV can be passed onto another person before they even get a chance to take medication.

We reported on ibalizumab last year and it was shown to reduced HIV replication and boosted immune cells in people with advanced, drug-resistant HIV. The drug is delivered by injection and could rewrite how people deal with complex HIV-related situations.

A phase 3 study was published on Aug. 16 in the The New England Journal of Medicine. Co-authored by Yale assistant professor of medicine Brinda Emu, M.D., the study furthers the case for the new drug candidate in patients with severe drug-resistant HIV.

"These patients had extremely advanced HIV and resistant virus with limited options,” Emu toldScience Daily. “To see viral suppression in a significant percentage of these patients at six months is heartening. The result represents a much-needed new mechanism of action for patients who have highly resistant HIV."

For the study, 40 adults with multidrug-resistant HIV-1 infection were enrolled into the program. All had a higher-than-acceptable viral load under their current treatment plan. All had endured multiple failed antiretroviral drugs. The patients were given incremental doses of ibalizumab, beginning with 2000 mg. The ibalizumab was combined with their current failing drug for weed one, and combined with optimized treatments for the next six months. By week 25, nearly 50 percent had reached undetectable levels. In total, 83 percent, or 33 of the patients observed, experienced a decrease in viral load over the course of the study. “Significant antiviral activity” in normally struggling health situations was reported. A total of 31 patients completed the study, researchers reported.

Four patients in the study died, reaffirming the significance of taking drug-resistant HIV seriously, in a day and age when the darkest parts of the AIDS epidemic sometimes seem like a thing of the past. One adverse event was also noted. That patient experienced immune reconstitution inflammatory syndrome.

But in most outcomes — ibalizumab was not only a last resort, but a life-saver. Presumably, most of the participants were out of options to pick and choose from.

Drug makers call ibalizumab the first monoclonal antibody approved to treat HIV, a class of antibodies developed in a laboratory. "It's ushering in a whole class of medicine and a new mode of delivery for the treatment of HIV," added Emu. "I look forward to discussions in the community about how such a therapy will fit into the current treatment paradigm for HIV infection."

Patients with that level are relatively rare, as noted in the study, but it’s comforting to know that there are options are being developed to turn to when common medications fail.

Adherence to antiretroviral medications daily or as directed is key to preventing drug resistance. Of course — not all of us have that luxury. Some HIV strains are much more serious than others. Developments in the drug industry are trying to make sure that everyone has a way to control HIV.

 

 

 

 

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Benjamin M. Adams

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