Benefit of treatment interruption in HIV-infected patients with multiple therapeutic failures: a randomized controlled trial (ANRS 097).
BACKGROUND
Both highly potent antiretroviral drug rescue therapy and treatment interruption have been suggested to be effective in patients with multiple treatment failure.


OBJECTIVE
To assess both the benefits and risks of an 8-week treatment interruption associated with a six to nine-drug rescue regimen in patients with multiple treatment failures.


METHODS
A randomized comparative controlled trial in 19 university hospitals in France.


METHODS
Sixty-eight HIV-infected patients with multiple previous treatment failures and CD4 cell counts less than 200 x 10(6) cells/l and plasma HIV-1-RNA levels of 50,000 copies/ml or greater.


METHODS
The primary efficacy outcome was the proportion of patients with at least a 1 log10 decrease (copies/ml) in the plasma HIV-1-RNA level after 12 weeks of therapy.


RESULTS
Treatment interruption followed by multidrug salvage therapy led to a greater proportion of patients achieving virological success (i.e. 1 log10 decrease) at 12 weeks compared with patients receiving multidrug therapy alone (62 versus 26%, intent-to-treat analysis; P = 0.007). The median decrease in the HIV-1-RNA level was -1.91 and -0.37 log10 copies/ml (P = 0.008), respectively. Treatment interruption led to an increase in the number of sensitive drugs of the multidrug regimen (71 versus 35% of regimen with at least two sensitive drugs; P = 0.004). Factors associated with virological success were treatment interruption, the reversion of at least one mutation to wild type, adequate plasma drug concentration, and the use of lopinavir.


CONCLUSIONS
Treatment interruption was beneficial for treatment-experienced HIV-infected patients with advanced HIV disease and multidrug-resistant virus.
Katlama
Christine
C
Département des Maladies Infectieuses et Tropicales/INSERM E 0214, Hôpital Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France. christine.katlama@psl.ap-hop-paris.fr
Dominguez
Stéphanie
S
Gourlain
Karine
K
Duvivier
Claudine
C
Delaugerre
Constance
C
Legrand
Mayeule
M
Tubiana
Roland
R
Reynes
Jacques
J
Molina
Jean-Michel
JM
Peytavin
Gilles
G
Calvez
Vincent
V
Costagliola
Dominique
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000097:blood; D023241:Antiretroviral Therapy, Highly Active; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy; D017211:Treatment Failure
D044966:Anti-Retroviral Agents