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2004 dead for hiv drug approval/Norvir price hike
Jun 3, 2004

Dr. Gerald,

After 2003 was so productive for record hiv approvals, why is 2004 so dead for hiv approvals?

Ben

Response from Dr. Pierone

It is hard to know why drug approval seems to occur in cycles. There are very promising agents in the pipeline for HIV treatment, but dark clouds are on the horizon.

Tipranavir is eagerly awaited for use in salvage therapy. This protease inhibitor must be boosted with Norvir (ritonavir) and has good activity against multi-drug resistant virus. The requirement for boosting with Norvir in relatively high dose (2 capsules twice daily) has raised some anxiety about the potential price of this drug when it is approved. Norvir recently experienced an astonishing price hike (from $205 to $1028 for a 120 pill bottle). This translates into $12,000 per year just for the cost of Novir to boost Tipranavir. So we are looking at a price of boosted Tipranavir that will certainly come in over $20,000 when it is ultimately approved. Given all the restrictions in access to Fuzeon (T20) because of its high price I suspect gaining access to Tipranavir may be equally challenging. Perhaps more so, since many HIV treating doctors are saving Fuzeon for use with Tipranavir when it becomes available. If you do the math it is clear that salvage therapy for HIV infection is about to become extraordinarily expensive.

Several governmental agencies are actively investigating the Abbott price hike for Norvir. In the meanwhile, HIV clinicians are still hoping that the leadership at Abbott will rediscover their ethical compass and rescind this unprecedented price increase for this life-saving medication. Here is a link to the some of the recent articles and governmental hearings on this matter.



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