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Good Outcomes in Children Using Adult Fixed-dose Anti-HIV Therapy

Many children in the developing world are infected with HIV, but to date, there are only two generic fixed-dose combinations intended for pediatric use (Ranbaxy's Triviro LNS Kid and Triviro LNS Kid DS, containing 3TC, d4T, and nevirapine).

As reported in the October 3, 2006 issue of AIDS, Researchers with Medecins Sans Frontieres/Doctors Without Borders (MSF) conducted a study to determine early treatment outcomes and to assess safety in children in resource-limited settings treated with adult fixed-dose combination antiretroviral tablets.

Data were gathered from June 2001 to March 2005 for 1184 children treated at 16 HIV programs in 8 countries. The median age was 7 years (range 4.6-9.3 years) and 52% were male. When starting therapy, 9% had CDC stage N disease, 14% had stage A, 38% had stage B, and 39% had stage C.

Results

Children were followed for a median period of 6 months (IQR 2-12 months).

At 12 months, the median CD4 percentage gain in children aged 18-59 months was 15% (IQR 6-18%).

The percentage with CD4 gain less than 15% was reduced from 85% at baseline to 11%.

In children aged 60-156 months, the median CD4 cell count increase was 275 cells/mm3 (IQR 84-518 cells/mm3).

The percentage with CD4 counts below 200 cells/mm3 fell from 51% at baseline to 11%.

Treatment outcomes included:
- 1012 alive and on antiretroviral therapy (85%);
- 36 deaths (3%);
- 15 stopped antiretroviral therapy (1%);
- 89 lost to follow-up (8%);
- 31 unknown outcomes (3%).

The overall probability of survival at 12 months was 87% (0.84-0.89).

Side effects led to a change of antiretroviral drugs in 26 children (2%).

There were no deaths due to drug-related adverse events.


Conclusion


"Very satisfactory early outcomes can be achieved in children in resource-limited settings using generic adult fixed-dose combination antiretroviral tablets," the authors wrote. "These findings strongly favor their use as an 'interim solution' for scaling-up antiretroviral therapy in children; however, more appropriate pediatric antiretroviral drugs remain urgently needed."
10/10/06

Reference
D P O'Brien, D Sauvageot, R Zachariah, and others (for Medecins Sans Frontieres). In resource-limited settings good early outcomes can be achieved in children using adult fixed-dose combination antiretroviral therapy. AIDS 20(15): 1955-1960. October 3, 2006.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA-Approved
HIV and AIDS Treatments

Protease Inhibitors
Agenerase (amprenavir)
Aptivus (tipranavir)
Crixivan (indinavir)
Fortovase (saquinavir soft gel)
Invirase (saquinavir hard gel)
Kaletra (lopinavir/ritronavir)
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Nucleoside / Nucleotide Reverse Transcriptase Inhibitors

Combivir (AZT+ 3TC)
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Retrovir (zidovudine; AZT)
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Truvada  (Tenofovir / Emtricitabine)
Videx (didanosine; ddI)
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Zerit (stavudine; d4T)
Ziagen (abacavir)


non Nucleoside Reverse Transcriptase Inhibitors
Rescriptor (delavirdine)

Sustiva (efavirenz)
Viramune (nevirapine)

Entry Inhibitors
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Fixed-dose Combinations
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Combivir
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(tenofovir + emtricitabine)