Περίληψη:
Background: When a clinical treatment fails or shows suboptimal results,
the question of when to switch to another treatment arises. Treatment
switching strategies are often dynamic because the time of switching
depends on the evolution of an individual’s time-varying covariates.
Dynamic strategies can be directly compared in randomized trials. For
example, HIV-infected individuals receiving antiretroviral therapy could
be randomized to switching therapy within 90 days of HIV-1 RNA crossing
above a threshold of either 400 copies/ml (tight-control strategy) or
1000 copies/ml (loose-control strategy).
Methods: We review an approach to emulate a randomized trial of dynamic
switching strategies using observational data from the Antiretroviral
Therapy Cohort Collaboration, the Centers for AIDS Research Network of
Integrated Clinical Systems and the HIV-CAUSAL Collaboration. We
estimated the comparative effect of tight-control vs. loose-control
strategies on death and AIDS or death via inverse-probability weighting.
Results: Of 43 803 individuals who initiated an eligible antiretroviral
therapy regimen in 2002 or later, 2001 met the baseline inclusion
criteria for the mortality analysis and 1641 for the AIDS or death
analysis. There were 21 deaths and 33 AIDS or death events in the
tight-control group, and 28 deaths and 41 AIDS or death events in the
loose-control group. Compared with tight control, the adjusted hazard
ratios (95% confidence interval) for loose control were 1.10 (0.73,
1.66) for death, and 1.04 (0.86, 1.27) for AIDS or death.
Conclusions: Although our effective sample sizes were small and our
estimates imprecise, the described methodological approach can serve as
an example for future analyses.
Συγγραφείς:
Cain, Lauren E.
Saag, Michael S.
Petersen, Maya
May,
Margaret T.
Ingle, Suzanne M.
Logan, Roger
Robins, James M.
and Abgrall, Sophie
Shepherd, Bryan E.
Deeks, Steven G. and
Gill, M. John
Touloumi, Giota
Vourli, Georgia
Dabis,
Francois
Vandenhende, Marie-Anne
Reiss, Peter
van Sighem,
Ard
Samji, Hasina
Hogg, Robert S.
Rybniker, Jan
Sabin,
Caroline A.
Jose, Sophie
del Amo, Julia
Moreno, Santiago and
Rodriguez, Benigno
Cozzi-Lepri, Alessandro
Boswell, Stephen L.
and Stephan, Christoph
Perez-Hoyos, Santiago
Jarrin, Inma and
Guest, Jodie L.
Monforte, Antonella D'Arminio
Antinori, Andrea
and Moore, Richard
Campbell, Colin N. J.
Casabona, Jordi and
Meyer, Laurence
Seng, Remonie
Phillips, Andrew N.
Bucher,
Heiner C.
Egger, Matthias
Mugavero, Michael J.
Haubrich,
Richard
Geng, Elvin H.
Olson, Ashley
Eron, Joseph J. and
Napravnik, Sonia
Kitahata, Mari M.
Van Rompaey, Stephen E. and
Teira, Ramon
Justice, Amy C.
Tate, Janet P.
Costagliola,
Dominique
Sterne, Jonathan A. C.
Hernan, Miguel A. and
Antiretroviral Therapy Cohort
Ctr Aids Res Network Integra and
HIV-CAUSAL Collaboration
