Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA)
2008

Comparing Safety of Abacavir and Nevirapine in HIV Treatment

Sample size: 600 publication 10 minutes Evidence: moderate

Author Information

Author(s): P. Munderi, C. Kityo, A. S. Walker, C. Gilks, D. M. Gibb, F. Ssali, A. G. Babiker, A. Reid, D. Bray, J. H. Darbyshire, H. Grosskurth, P. Mugyenyi

Primary Institution: Medical Research Council Clinical Trials Unit

Hypothesis

Is abacavir safer than nevirapine for HIV-infected adults starting antiretroviral therapy?

Conclusion

Abacavir may have a lower rate of serious adverse reactions compared to nevirapine in Ugandan adults starting antiretroviral therapy.

Supporting Evidence

  • 95% of participants completed the study.
  • Only 2% of abacavir participants experienced a suspected hypersensitivity reaction.
  • 14% of nevirapine participants discontinued due to toxicity.

Takeaway

This study looked at two medicines for HIV and found that one, abacavir, might be safer than the other, nevirapine, for people starting treatment.

Methodology

A 24-week randomized double-blind trial with 600 symptomatic ARV-naive adults comparing abacavir and nevirapine.

Potential Biases

Potential for unblinding due to adverse reactions may have influenced the results.

Limitations

The study was slightly underpowered to determine the significance of the observed differences in toxicity rates.

Participant Demographics

72% women, median age 37 years, 19% had WHO stage 4 disease.

Statistical Information

P-Value

0.06

Confidence Interval

0.16–1.09

Statistical Significance

p=0.06

Digital Object Identifier (DOI)

10.1111/j.1365-3156.2007.01973.x

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