Content about Antiretroviral drug

January 15, 2013

While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.

January 2, 2013

The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

September 5, 2012

The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.

July 9, 2012

After it was first identified as the cause of AIDS in 1983, being diagnosed with an HIV infection was a literal death sentence, and it remains that way for many people in poor countries who lack access to the life-saving medications that have transformed HIV from a sure ticket to death into a chronic illness.

WHAT IT MEANS AND WHY IT'S IMPORTANT — After it was first identified as the cause of AIDS in 1983, being diagnosed with an HIV infection was a literal death sentence, and it remains that way for many people in poor countries who lack access to the life-saving medications that have transformed HIV from a sure ticket to death into a chronic illness.

May 9, 2012

The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

February 14, 2012

The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

May 24, 2011

Several states are cutting funding to programs that provide HIV medications to people who can’t afford them in an effort to reduce spending, according to a published report.

NEW YORK — Several states are cutting funding to programs that provide HIV medications to people who can’t afford them in an effort to reduce spending, according to a published report.

The Washington Post reported that more than 8,300 people are on waiting lists to obtain antiretrovirals and other drugs that treat HIV, AIDS and related conditions. The Post article highlighted particularly large program cuts in Illinois and Georgia, as well as one proposed for Florida.

May 12, 2011

Patients with HIV who immediately started antiretroviral therapy significantly reduced the risk of spreading the virus to an uninfected partner, compared with those who delayed therapy, according to results of a multinational study. The study also found that antiretroviral therapy reduced the risk of transmission by 96%.

WASHINGTON — Patients with HIV who immediately started antiretroviral therapy significantly reduced the risk of spreading the virus to an uninfected partner, compared with those who delayed therapy, according to results of a multinational study. The study also found that antiretroviral therapy reduced the risk of transmission by 96%.

January 27, 2011

A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

January 5, 2010

Increased adherence of HIV therapy may be cost-effective, according to a new study....