| Should 
Antiretroviral Therapy Be Guided By Therapeutic Drug Monitoring? By 
Liz Highleyman
 
  Inadequate 
levels of antiretroviral drugs 
in the body can lead to virological treatment failure, while excessive levels 
can cause severe side effects. 
Some experts advocate routine use of therapeutic 
drug monitoring (TDM) to guide treatment decisions, but the benefits of measuring 
plasma drug concentrations remain subject to controversy.
 At 
the at the 48th International Conference on Antimicrobial 
Agents and Chemotherapy (ICAAC 2008) last month in Washington, DC, Italian 
researchers presented results from a meta-analysis of studies looking at TDM to 
assist treatment decision-making.  |  |  | TDM 
Laboratory  | 
 The 
meta-analysis included randomized clinical trials comparing treatment guided by 
TDM versus standard-of-care therapy without TDM. The outcomes of interest were 
proportions of patients who received recommendations to change drug exposure levels, 
proportions with undetectable HIV RNA, and proportions reaching target drug concentrations. 
 Results  
     Data were included from 7 randomized trials, 
with a total of 1046 patients, comparing TDM versus standard of care. 
  
     Fewer patients had their treatment changed 
in TDM arms compared with standard of cafe (RR 0.64).
 
  
     Compared with standard of care control 
subjects, the likelihood of having a viral load below 200-500 copies/mL increased 
over time in the TDM arms:
 
  
     RR 0.91 at week 12; 
     RR 1.1 at week 24;
  
     RR 1.38 at weeks 48-52.
  
     When studies used a viral load cut-off 
of 50 copies/mL, however, proportions of patients with undetectable viral load 
were similar in the TDM and standard of care control arms both at week 24 (RR 
1.13) and at weeks 48-52 (RR 1.05). 
  
     Likewise, proportions of patients achieving 
target drug concentrations did not differ significantly in the TDM and control 
groups (RR 1.04 at weeks 4-12; RR 2.29 at > 24 weeks).
 Based 
on these findings, the researchers concluded that, "Evidence for benefit 
of TDM in randomized trials is limited to a reduction of rates of patients who 
had recommendations to change drug exposure, and to long-term moderate improvement 
of virological response." Ctr. 
of Preventive Med., Verona, Italy; Dept. of Histology, Microbiology, and Med. 
Biotechnology, Padua, Italy.
 11/11/08
 
 Reference
 M 
Crucian, S Parisi, G Serpelloni, and others. Should Antiretroviral Therapy Be 
Guided By Therapeutic Drug Monitoring? A Meta-Analysis. 48th International Conference 
on Antimicrobial Agents and Chemotherapy (ICAAC 2008). Washington, DC. October 
25-28, 2008. Abstract H-4058.
 |