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Updated: Aug 14, 2026

Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors
Published on: April 9, 2014
Effect of first line therapy including efavirenz and two nucleoside reverse transcriptase inhibitors in HIV-infected
Markus B Funk1, G Notheis, T Schuster
1Children's Hospital, Johann Wolfgang Goethe University, Frankfurt, Germany. m.funk@em.uni-frankfurt.de
Insights
Efavirenz-based first-line therapy in children with HIV demonstrated significant viral load reduction and increased CD4 counts. This treatment was well-tolerated, showing efficacy comparable to other regimens.
Area of Science:
- Pediatric Infectious Diseases
- Antiretroviral Therapy Research
- HIV/AIDS Clinical Management
Background:
- Human Immunodeficiency Virus (HIV) infection in children requires effective first-line antiretroviral therapy (ART).
- Efavirenz is a key component in many ART regimens, but its efficacy and safety in pediatric populations require ongoing evaluation.
Purpose of the Study:
- To assess the efficacy and tolerability of efavirenz-based first-line therapy in HIV-infected children.
- To evaluate viral load reduction, CD4 cell count changes, and adverse reactions associated with this treatment regimen.
Main Methods:
- An intent-to-treat study involving 10 perinatally HIV-infected children (median age 5.8 years) over 24 months.
- Regular monitoring of viral load and CD4 cell counts every 4-8 weeks.
- Pharmacokinetic evaluation of efavirenz and recording of adverse reactions.
Main Results:
- Significant viral load reduction (>3.5 log10 copies/mL) achieved in 80% of children, with HIV-1 RNA <50 copies/mL.
- Median CD4 cell count increased from 378 cells/µL at baseline to over 1000 cells/µL by 24 months.
- Efavirenz pharmacokinetic levels were within therapeutic ranges; mild skin rash was the most common adverse effect.
Conclusions:
- First-line therapy with efavirenz and two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) is well-tolerated in HIV-1 infected children.
- The viral load reduction achieved is comparable to regimens containing single protease inhibitors.
Objective:
In an intent-to-treat study, reduction of viral load, increase in CD4 cell count, clinical benefit and adverse reactions were examined in HIV-infected children receiving first line therapy including efavirenz.
Methods:
The data of 10 perinatally infected children (median age: 5.8 years) were evaluated during a treatment period of 24 months. Viral load and CD4 cell count were measured every 4 - 8 weeks. Pharmacokinetic evaluations of efavirenz were performed in all patients at study onset. Adverse reactions were reported after obtaining interval history and examination.
Results:
At base line, median CD4 cell count was 378 cells/microl (21%) and median viral load was 350,000 copies/ml (5.5 log10 copies/ml). After 24 months of treatment, the median viral load reduction was > 3.5 log10 copies/ ml and HIV-1 RNA < 50 copies/ml was found in 8/10 children (80%). Median CD4 cell count increased to 721 cells/microl (24%) after 3 months and was maintained at a level of >1000 cells/microl (> 25%) after 24 months of treatment. Regarding efavirenz levels, C min. values ranged from 845 to 3550 ng/ml (median: 1845 ng/ml) and C max. values from 2380 to 24 200 ng/ ml (median: 3670 ng/ml). The most common adverse effect was a mild skin rash (4/10 children). CNS symptoms were recorded in one patient and no hyperlipidaemia was seen.
Conclusion:
First line therapy with efavirenz and two NRTIs was well tolerated by HIV-1 infected children and the reduction of viral load seems to be similar to single protease inhibitor-containing regimens.
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