On February 11, Abbott Laboratories, a pharmaceuticals health care company, announced that the U.S. Food and Drug Administration had approved a new version of their anti-HIV medication, Norvir (ritonavir).

Norvir is a drug of the antiretroviral medication class known as protease inhibitors (PI). It is generally used as a “booster” drug to enhance the effects of other antiretroviral medications in order to prevent drug resistance in HIV-positive individuals.

The newly FDA approved formulation of Norvir is a heat-stable version, which means that the tablets do not require refrigeration to be effective. This change makes using Norvir more convenient for patients, especially in developing countries where access to refrigeration is not always available. The original soft-gel formulation of Norvir requires refrigeration; both versions contain 100 mg of Norvir.

Abbott also manufactures Kaletra (lopinavir/ritonavir), which contains both lopinavir and Norvir and is also heat-stable.

Doctors Without Borders, an international medical humanitarian organization, recently issued a press release regarding the FDA approval of heat-stable Norvir as well.

For developing countries where antiretroviral therapy centers on PI medications, the lack of a heat-stable form of Norvir was inconvenient.

Unfortunately, Norvir is the only approved protease inhibitor currently available. Thus, without a heat-stable form of Norvir available for use with other PIs, it was more practical for many developing countries to use the drug Kaletra, which combines a protease inhibitor and Norvir, and is still heat-stable.

Doctors Without Borders is now calling on Abbott Labs to move forward in several ways: to register the heat-stable form of Norvir in developing countries; to reduce the cost of Norvir in developing countries; to develop a special pediatric form of heat-stable Norvir for children who cannot swallow tablets; and to include patients using Norvir in the Patent Pool for HIV Medicines by the UNITAID, which provides patients with more affordable medicines in developing nations.

For more information, please see the Abbott and Doctors Without Borders Web sites.