FDA Approves New AIDS Drug

The FDA has approved a new drug in the fight against HIV and AIDS. Viread (tenofovir) is the first drug in the class of HIV drugs known as nucleotide analogue reverse transcriptase inhibitors. The drug acts by blocking reverse transcriptase, an enzyme involved in HIV replication. But Viread differs from other reverse transcriptase inhibitors in that the drug is a nucleotide as opposed to a nucleoside. Being a nucleotide, tenofovir remains in the cell longer, allowing for once a day dosing.

Excitement surrounds the approval of Viread because of its predicted benefit for even the most difficult-to-treat patients. Viread offers patients

• Once a day dosing with one tablet of tenofovir will improve medication adherence and therefore therapy effectiveness.
• Proven effectiveness when used in combination with other HIV drugs even in patients with resistant virus. This provides another chance for those patients who have exhausted all other therapy combinations.
• Resistance that develops slowly which prolongs Viread's effectiveness.
• Well tolerated in studies of almost 1000 patients who have taken Viread in clinical trials.

Like all other HIV drugs, Viread has its share of side effects. They include:

• Mild to moderate nausea, diarrhea, vomiting and flatulence.
• Lactic acidosis and hepatomegaly (enlarged liver) have been seen in other nucleoside drugs alone or in combination with other HIV drugs.
• Bone toxicity has been seen in very high doses in animal studies however this has not been seen in human trials and doses.

Gilead, the makers of Viread will begin shipping their new drug next week. While the new drug will cost about $350 per month ($4135 per year), Gilead is confident that most of that cost will be picked up by the patient's medical insurance.