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HIV and Hepatitis.com Coverage of the
48th Annual ICAAC & 46th Annual IDSA Meeting
October 25 - 28, 2008, Washington, DC

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.



The material posted on HIV and Hepatitis.com about ICAAC 2008 and IDSA 2008 is not approved by nor is it a part of ICAAC 2008 or IDSA 2008.

 

 

 

 

 

 

 

 

 

 

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