TY - JOUR
T1 - Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial
AU - Hansen, Ann-Brit Eg
AU - Gerstoft, Jan
AU - Kirk, Ole
AU - Mathiesen, Lars
AU - Pedersen, Court
AU - Nielsen, Henrik
AU - Jensen-Fangel, Søren
AU - Sørensen, Henrik Toft
AU - Obel, Niels
N1 - Multicenterundersøgelse
PY - 2007
Y1 - 2007
N2 - OBJECTIVE: To compare the outcome of highly active antiretroviral therapy (HAART) in HIV-infected patients initiating equivalent regimens within and outside a randomized controlled trial (RCT). STUDY DESIGN AND SETTING: The Danish Protease Inhibitor Study (DAPIS) was a national multicenter RCT comparing initial treatment with indinavir, ritonavir, or saquinavir/ritonavir during 96 weeks. From the Danish HIV Cohort Study we identified all patients initiating one of these protease-inhibitor-based HAART regimens: 425 patients within DAPIS and 677 outside the trial. We compared viral load, CD4 count response, and mortality. RESULTS: At weeks 96 and 240, trial participants were more likely than nonparticipants to have undetectable viral load (adjusted odds ratio [adOR] 1.28 [95% CI=0.94-1.74] and 1.70 [95% CI=1.16-2.50]) and a CD4 increase > or =100 cells/microl (adOR 1.37 [95% CI=1.03-1.82] and 1.53 [95% CI=1.04-2.25]). For antiretroviral-experienced, but not for antiretroviral-naïve patients, trial participants had a lower risk of death (mortality rate ratio [MRR]=0.46 [95% CI=0.27-0.77]) than nonparticipants. This effect was moderated in adjusted analyses (MRR=0.60 [0.33-1.07]). CONCLUSIONS: Compared to nontrial patients, trial participants had better response to HAART. The differences were small defying the notion that results obtained in RCTs are unachievable in routine clinical practice.
AB - OBJECTIVE: To compare the outcome of highly active antiretroviral therapy (HAART) in HIV-infected patients initiating equivalent regimens within and outside a randomized controlled trial (RCT). STUDY DESIGN AND SETTING: The Danish Protease Inhibitor Study (DAPIS) was a national multicenter RCT comparing initial treatment with indinavir, ritonavir, or saquinavir/ritonavir during 96 weeks. From the Danish HIV Cohort Study we identified all patients initiating one of these protease-inhibitor-based HAART regimens: 425 patients within DAPIS and 677 outside the trial. We compared viral load, CD4 count response, and mortality. RESULTS: At weeks 96 and 240, trial participants were more likely than nonparticipants to have undetectable viral load (adjusted odds ratio [adOR] 1.28 [95% CI=0.94-1.74] and 1.70 [95% CI=1.16-2.50]) and a CD4 increase > or =100 cells/microl (adOR 1.37 [95% CI=1.03-1.82] and 1.53 [95% CI=1.04-2.25]). For antiretroviral-experienced, but not for antiretroviral-naïve patients, trial participants had a lower risk of death (mortality rate ratio [MRR]=0.46 [95% CI=0.27-0.77]) than nonparticipants. This effect was moderated in adjusted analyses (MRR=0.60 [0.33-1.07]). CONCLUSIONS: Compared to nontrial patients, trial participants had better response to HAART. The differences were small defying the notion that results obtained in RCTs are unachievable in routine clinical practice.
KW - Adult
KW - Antiretroviral Therapy, Highly Active
KW - CD4 Lymphocyte Count
KW - Confounding Factors (Epidemiology)
KW - Epidemiologic Methods
KW - Female
KW - HIV Infections
KW - HIV Protease Inhibitors
KW - Humans
KW - Male
KW - Middle Aged
KW - Randomized Controlled Trials as Topic
KW - Treatment Outcome
KW - Viral Load
U2 - 10.1016/j.jclinepi.2007.04.001
DO - 10.1016/j.jclinepi.2007.04.001
M3 - Journal article
C2 - 18083465
SN - 0895-4356
VL - 61
SP - 87
EP - 94
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 1
ER -