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. AIDS Cocktail Could Be Soon Down To Just One Pill

The candy jar could be about to get a whole lot smaller.
by Ed Susman
New York (UPI) Apr 28, 2006
In a unique collaboration, two pharmaceutical companies have developed a one-a-day, single-pill anti-retroviral cocktail taken to treat the virus that causes AIDS. The drug cocktail merged into one yet-to-be-named pill represents the Holy Grail for treatment of human immunodeficiency virus.

The pill contains emtricitabine (Emtriva) and tenofovir (Viread), developed by Gilead Sciences, and efavirenz (Sustiva), developed by Bristol-Myers Squibb.

"It is amazing that we are going to have one pill a day for the treatment of HIV when you consider that it was like 10 years ago when patients were taking handfuls of drugs all day long," Cal Cohen, research director for CRI New England and Harvard Vanguard Medical Associates, told United Press International.

"But not only is this going to be more convenient, the pill also represents the best drugs we have on the market for treating HIV," he said. "These drugs have potency to suppress HIV and yet they have a very safe side-effect profile."

Doctors have long suggested that by reducing the pill burden, there is a greater likelihood patients will adhere to their regimens. Ten years ago when researchers discovered that anti-retroviral drug cocktails suppressed HIV replication -- dramatically changing the course of AIDS -- patients were faced with dizzying regimens that included taking dozens of pills a day.

"This combination pill will become the most used drug by HIV-infected patients," predicted Keith Folger, director of community mobilization for the New York-based National Association of People With AIDS.

"The idea of being able to take one pill, once a day is unbelievable," Folger told UPI. "Ten years ago I was taking 36 pills a day. My life was ruled by my pill schedule. I had to take pills every eight hours; some I had to take an hour before a meal; others I had to take two hours after a meal; some I couldn't eat with fatty foods; etc."

Folger said that the combination already is the most prescribed regimen for patients newly diagnosed with HIV and who do not have a virus that is resistant to the drugs in the cocktail. Putting the drugs into one pill, he said, is bound to improve patient adherence.

He said studies showed that taking this pill with all the ingredients mashed together has the same bioequivalence as taking the pills separately. He said that he would not expect the combination product would have many issues in getting Food and Drug Administration approval, suggesting it might be available within a year.

About 18 months ago Gilead and Bristol-Myers Squibb agreed to jointly develop the one-pill, once-a-day regimen. The companies announced Thursday they had filed a New Drug Application for the drug with the FDA.

"The partnership between Bristol-Myers Squibb and Gilead was founded on the companies' shared commitment to addressing the needs of people living with HIV," John Martin, president of Gilead Sciences, Foster City, Calif., said in a statement. "Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients."

Anthony Hooper, president of U.S. Pharmaceuticals, Bristol-Myers Squibb, said in a statement, "The collaboration between the companies is an important milestone for patients living with HIV. Working together, Bristol-Myers Squibb and Gilead Sciences are ushering in a new era of collaboration driven by the need to deliver HIV therapies to patients in need."

Cohen said the partnership "seems to be a win/win situation for both companies."

The proposed once-daily single-tablet regimen contains 600 mg of efavirenz, from the class of drugs known as non-nucleoside reverse transcriptase inhibitors; 200 mg of emtricitabine, a nucleoside reverse transcriptase inhibitor, and 300 mg of tenofovir disoproxil fumarate, a nucleotide reserve transcriptase inhibitor.

All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication. As with all HIV drugs, the new tablet does not cure HIV or prevent HIV from being transmitted to others.

The drugs, however, severely limit the ability of HIV to replicate and destroy the host immune system, allowing opportunistic infections to emerge. These are diseases caused by infectious agents that a healthy immune system keeps in check. The unchecked infections result in AIDS.

Source: United Press International

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