Prezista’s( a new HIV protease inhibitor) approval today- My comments

Prezista (TMC 114, a new protease inhibitor) got approved by the FDA today.

I have a few comments for those wishing to start this drug.

First, avoid virtual monotherapy at all costs, if you can. Virtual monotherapy means adding a new drug to a failing regimen to which your virus has developed resistance. This approach usually renders the new drug ineffective since HIV eventually also develops resistance to the new drug. If you have no “active” drugs in your genotype (resistance) test, you may want to wait until you can start Prezista with Merck’s integrase inhibitor MRK 518 (to come out in expanded access later this year), or Maraviroc (an entry CCR5 inhibitor to be available in expanded access early next year.) The studies that got Prezista approved also showed that those who started Fuzeon at the same time with Prezista had a significantly better response to treatment, so if you have not started Fuzeon you may want to talk to your doctor about this option (they are enrolling in their needle-free device study.) Many of us have nucleoside resistant virus, but these agents may still provide some benefit as background therapy to decrease the capacity of the virus to replicate.

Through my yahoo groups and, I keep getting emails daily from people all over who have joined either the Merck study, the Tibotec Duet study, or who have started Fuzeon with Prezista. Many tell me that they have undetectable viral load for the first time in their lives. Those in studies do not yet know if they are in the placebo arms, however.

Tibotec has had good communications with activists (for the most part) through Prezista’s POWER studies and expanded access. Lew Silbert, their community relations person, has been in constant communication with many of us in the activist world for months. Among the good things that they have done: designed a study combining two experimental drugs (TMC 114 + TMC 125- DUET studies) for the first time in AIDS history, helped make possible the first meeting between US and European treatment activists, agreed to our demands to allow experimental agents in their TMC 114 expanded access (which made it possible for us to take it in the Merck integrase study), agreed to demands to provide emergency IND access of TMC 125 (their non nuke in research now) to patients at high risk of death, and possibly not pricing Prezista higher than the previously approved protease inhibitor (Aptivus) (we will know this soon), which will reverse a nasty trend of price escalation in the US. Among the few bad things so far: not accepting the community’s request to start a compassionate open label study of TMC 125 (plus TMC 114) for patients with no active agents in their background, and consciously allowing people with risk of virtual monotherapy in their DUET studies (with a 50 % chance of placebo TMC 125 with no roll over to treatment arm until week 24.) Prezista is Tibotec (and Johnson & Johnson’s) first HIV product, so we will keep a close eye on how they will now relate to the community after approval and if they will keep their post approval phase IV study commitments recommended by the FDA. They surely can learn from past mistakes of other companies to realize that a win-win can be attained for stock holders and stake holders and that compassion and profits are not mutually exclusive.

The approval of Prezista, the availability of previously approved drugs like Fuzeon for multidrug resistance, the positive data on the integrase class (Merck and Gilead’s), the expectation for upcoming positive data on Maraviroc (CCR5 inhibitor), and expectations for Tanox’s TNX 355 (an IV every 2 weeks) and Panaco’s maturation inhibitor really give me tremendous hope for the first time in a long time for those of us who have been struggling with multidrug resistance. After drugs like these, the horizon is now showing gene therapy and potentially effective therapeutic vaccines. Managing potential toxicities and raising costs will be key, of course.

The new wave is here.

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