title: [Clinical efficacy and tolerance of enfuvirtide (Fuzeon), new antiretroviral inhibitors of intracellular penetration of human immunodeficiency virus (HIV) type 1].
abstract: The TORO 1 and TORO 2 clinical trials compared the efficacy and safety of enfuvirtide in combination with an optimized background antiretroviral regimen and optimized background regimen alone in HIV-1 infected patients. The patients had had previous treatment with each of the three classes of antiretroviral drugs and had a plasma level of HIV-1 RNA above 5000 copies/ml at baseline. They were randomly assigned in a 2:1 ratio to receive either enfuvirtide (90 mg subcutaneously twice daily) plus a background regimen optimized with the aid of resistance testing, or an optimized antiretroviral regimen alone (control group). Six hundred and sixty-one patients were enrolled in the enfuvirtide arm and 334 in the control group. The median baseline plasma HIV-1 RNA level was 5.2 log10 copies/ml in the enfuvirtide group and 5.1 log10 copies/ml in the control group. Patients had a median of 7 years of previous antiretroviral treatment. The optimized background regimen comprised a mean of 4 antiretroviral drugs in both groups. At week 48, the mean reduction in viral load was -1.48 log10 copies/ml in the enfuvirtide group, and -0.63 log10 copies/ml in the control group (difference = 0.846 log10 copies/ml, IC95%: -1.066; -0.626. p < 0.0001). The mean increase in the CD4+ cell count was significantly greater in the enfuvirtide group (91 cells/mm3) than in the control group (45 cells/mm3). Injection site reactions were the main reported adverse event which occurred in 98% of the enfuvirtide patients. Most had mild to moderate pain or discomfort not requiring analgesic or limiting usual activities.
authors.affiliation: Service des maladies infectieuses et tropicales, Hôtel-Dieu CHU, place Alexis-Ricordeau, 44093 Nantes cedex 1, France. francois.raffi@chu-nantes.fr
authors.forename: François
authors.initials: F
authors.lastname: Raffi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002986:Clinical Trials as Topic; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000472:pathogenicity; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide