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Drexel, Dr Jacobson brink game changing new therapy

link for complete article:

http://exelmagazine.org/article/going-viral/

Fantastic article, here's snippet ...

Jeffrey Jacobson was among the first physicians to take on HIV/AIDS, and over the past 30 years, he had made defeating the disease his life’s work. As his most recent work has shown, he and his colleagues worldwide are getting very close to achieving precisely that.

One of Jacobson’s NIH studies is a Phase II-b clinical trial to optimize the dosing regimen of a novel monoclonal antibody called Pro140. Three initial clinical studies led by Jacobson showed it to be as antiviral as the best oral agents currently in use. Because it’s a molecule produced by the body itself, it’s also less toxic. The most innovative feature of Pro140, Jacobson says, is that it’s longer lasting than drugs currently on the market. One dose of Pro140 was shown to decrease viral loads for at least one to two weeks.

For HIV-infected patients who struggle to take the daily regimen of antiretroviral pills, Pro140 could be a game changer, Jacobson says. The Centers for Disease Control and Prevention estimated that less than 30 percent of the 1.2 million HIV-positive Americans have been diagnosed and treated successfully to the point where their viral loads are undetectable. The main challenge to achieving this clinical result is patient adherence to taking the medication daily as prescribed.

There can be many reasons for non-adherence. In his experience treating HIV patients, Jacobson says, most are young and they struggle to think of themselves as having a chronic disease. Taking a cocktail of pills every day is a reminder that they are different from others. Within the HIV population are subgroups that have particular difficulties, including intravenous drug users and those abused as children.

“It’s hard for anyone to take all their medications all the time but these are people who live disorganized lives to begin with, and that’s how they got infected in first place. They are not necessarily motivated to take care of themselves,” he says.

Stopping the Spread of HIV

Easing the burden of treatment is critical to controlling the spread of HIV because those who engage in high-risk behaviors are at especially high risk of transmitting the virus to others, says Richard Trauger, a former chief scientific officer at CytoDyn, which is hoping to bring Pro140 to market.

“If we can keep people on the therapy, even if they drift off and don’t take their pills, we’ve still got coverage and we’re managing this disease better from an epidemiological perspective,” he says. “Pills have really penetrated the market. We’ve seen what they can do and they’ve saved lots of lives and they’ve been really phenomenal at turning the epidemic around. But they’re just not enough. You can’t give them another pill to solve the [adherence] problem.”

Additional research on Pro140 will explore whether it potentially could be used to block new infections in people for short periods of time, a concept called protective immunity, Trauger says. The earlier clinical studies led by Jacobson show P140 antibodies can remain on cells targeted by HIV for up to 45 days.

During Jacobson’s other NIH Phase II clinical trial, 76 HIV-infected patients who abuse substances and have not been successfully treated with oral drugs will receive a standard drug regimen plus a dose of P140 or a placebo to determine if P140 improves the antiviral response. Researchers will monitor the patients for six months to see if their viral loads reach non-detectable levels.

“Now there’s even more interest in going for a so-called cure,” Jacobson says. “I think the most realistic approach is to go for a functional cure where you don’t fully eradicate the virus, because that’s going to be a tall order.”