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Peptide

Enfuvirtide

Injectable peptide that prevents HIV-1 from fusing with lymphocytes. Reserved for people with HIV who have resistance to other antiretrovirals.
Regulatory status
Approved (FDA / EMA)
Family
HIV fusion inhibitor (antiretroviral peptide)
Scientific evidence
High
Number of findings
1
Where it acts
Immunity and defense
Also known as
enfuvirtide, Fuzeon, T-20, pentafuside

Regulatory status

FDA (US): Approved (2003, Fuzeon) in combination with other antiretrovirals for HIV-1 in treatment-experienced patients with persistent replication

EMA (EU): Approved (2003, Fuzeon) in combination for HIV-1 in adults and children aged 6 years or older after failure of or intolerance to other treatments

Dose

90 mg subcutaneously twice a day in adults; in children aged 6 to 16 years, 2 mg/kg twice a day (maximum 90 mg per dose) (FDA/EMA label).

Safety

Injection-site reactions in almost all patients (pain, lumps, redness). More cases of bacterial pneumonia in trials. Rare severe allergic reactions. Rarely used today because oral options exist. Only under the supervision of an HIV unit.

Interactions

No relevant pharmacokinetic interactions known with other antiretrovirals.

Effect by goal · level of evidence

HIV-1 resistant to multiple treatments

improves High RCT (AA) in people
−1.7 vs −0.8 log10 viral load

TORO 1 trial with 501 heavily treated patients. At 24 weeks, adding enfuvirtide to an optimized regimen lowered viral load by 1.7 log10 vs 0.76 log10 without it. CD4 counts rose by 76 vs 32 cells/mm³. 98% had injection-site reactions.

View the study (RCT) →

In depth

Where it acts

Immunity and defense

Defenses and infections

How it works

It mimics part of the gp41 protein of the virus envelope. By binding to it, it prevents the change in shape that HIV needs to fuse its membrane with that of the T cell. This way the virus cannot enter the cell. It acts outside the cell, so it does not share resistance with other drug families.

What the evidence says

In people

  • HIV-1 resistant to multiple treatments. TORO 1 trial with 501 heavily treated patients. At 24 weeks, adding enfuvirtide to an optimized regimen lowered viral load by 1.7 log10 versus 0.76 log10 without it. CD4 counts rose by 76 versus 32 cells/mm³. Injection-site reactions occurred in 98%. PubMed 12637625

References

  1. PubMed 12637625

Information, not medical advice. Prescription or unapproved peptides should only be used under medical supervision.

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