Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy.
Data from 1330 human immunodeficiency virus type 1 (HIV-1)-infected patients enrolled in seven antiretroviral treatment trials were analyzed to characterize the clinical benefit of treatment-mediated reductions in plasma HIV-1 RNA levels. The risk of a new AIDS-defining event or death was reduced proportionally to the magnitude of the reduction of the HIV-1 RNA level during the first 6 months of therapy. Pretherapy HIV-1 RNA levels were prognostic independently of on-therapy levels. In addition, the reduction in risk associated with any given reduction of the level of HIV-1 RNA did not vary by pretherapy level. Having either a reduction in HIV-1 RNA level or an increase in CD4+ lymphocyte count, or both, was associated with a delay in clinical disease progression. This indicates that patient prognosis should be assessed using both HIV-1 RNA and CD4+ lymphocyte responses to therapy.
Marschner
I C
IC
Center for Biostatistics in AIDS Research and Department of Biostatistics, Harvard School of Public Health, Massachusetts General Hospital, Boston 02115, USA.
Collier
A C
AC
Coombs
R W
RW
D'Aquila
R T
RT
DeGruttola
V
V
Fischl
M A
MA
Hammer
S M
SM
Hughes
M D
MD
Johnson
V A
VA
Katzenstein
D A
DA
Richman
D D
DD
Smeaton
L M
LM
Spector
S A
SA
Saag
M S
MS
D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D010949:Plasma / Q000821:virology; D011379:Prognosis; D012367:RNA, Viral / Q000032:analysis* / Q000097:blood / Q000302:isolation & purification; D012189:Retrospective Studies; D012306:Risk
D019380:Anti-HIV Agents; D000998:Antiviral Agents; D012367:RNA, Viral