Does Enfuvirtide work?
Yes, in large controlled trials; one covered 501 people.
Approval rested on two randomized open-label phase 3 trials, TORO 1 (n=501, cited here) and TORO 2, in heavily treatment-experienced patients, both showing a larger drop in viral load when enfuvirtide was added to an optimized regimen. That is an A for salvage HIV therapy; the drug has no other use. 12
TORO 1 enrolled 501 patients in North America and Brazil. They had taken an average of a dozen antiretrovirals and had resistance to all three oral classes. Researchers randomized them 2:1 to an individually optimized background regimen with or without enfuvirtide. At 24 weeks, viral load fell by 1.70 log10 copies per milliliter with enfuvirtide versus 0.76 without. HIV RNA was below 400 copies in 37% of the enfuvirtide group, compared with 16% of controls. CD4 counts rose more with enfuvirtide. TORO 2, run in Europe and Australia, found the same. 1
The effect depended on the rest of the regimen. Patients who had at least two other active drugs in their background therapy did far better than those who had none. This is the general rule in salvage HIV treatment. 1
Evidence checklist
- Randomised controlled trial TORO 1 and 2, randomized open-label
- Human study over 100 people TORO 1 enrolled 501
- More than one research group Trials run by sponsors Roche and Trimeris
- Clinical outcomes, not surrogate markers Viral load, a surrogate marker
- Human safety data beyond case reports Trial safety data, near-universal site reactions
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Reference information only, not medical advice. Drawn from the Enfuvirtide article, fact-checked against the cited sources. No dosing anywhere on this site.