HIV Health News

Two New Combination Drugs Approved

On August 2, 2004, the Food and Drug Administration (FDA) approved two once-daily combination pills: Epzicom, made by GlaxoSmithKline, and Truvada, produced by Gilead. Both drugs consist of two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). Epzicom is a combination of Glaxo's 3TC (lamivudine, Epivir) and abacavir (Ziagen), while Truvada contains Gilead's tenofovir DF (Viread) and FTC (emtricitabine, Emtriva). The new drugs are designed to help people simplify their anti-HIV regimens. However, the two-drug formulations must be used with at least one other antiretroviral. Some generic anti-HIV drugs produced outside the U.S. combine three drugs of more than one class, and can be taken alone as a complete regimen.

Norvir Price Hike Here to Stay?

On August 4, 2004, the National Institutes of Health (NIH) refused to allow Essential Innovations, a small nonprofit company, to make cheaper, generic copies of Norvir. Norvir is the patented form of Abbott Laboratories' protease inhibitor (PI) ritonavir, a drug rarely taken at full strength but widely used in small doses to boost other PIs in anti-HIV drug regimens.

Abbott raised the price of Norvir by over 400% this past December. Essential Innovations then asked the federal government to override Abbott's Norvir patent, arguing that the medicine was developed in part with taxpayer money and was now unreasonably priced. The NIH said that the issue should be decided by Congress, but action at the Congressional level is unlikely.

Abbott insists the price hike was needed to fund their research programs. AIDS advocates counter that Abbott aimed to make their other anti- HIV drug, Kaletra, the least expensive PI on the market, as Kaletra already has ritonavir built in to its formulation. Many advocates worry about the effect of the price hike on government health insurance programs and future development of anti-HIV drugs. Physicians, Congressional legislators, and the attorneys general of Illinois and New York have decried Abbott's unprecedented price increase. Yet despite a vigorous public campaign against Abbott, the federal government appears unwilling to intervene. Abbott's patent on Norvir does not expires until 2014.