ICAAC: No added benefit from adding AZT to nevirapine to prevent MTCT

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Adding a short course of AZT (zidovudine, Retrovir) to nevirapine (Viramune) therapy does not reduce the rate of mother-to-child transmission of HIV, according to a study conducted in Zimbabwe and presented to the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington DC.

Earlier studies have shown that a short course of nevirapine can reduce the rate of mother-to-child transmission of HIV by 47% compared to a short course of AZT.

Investigators wished to see if providing a short course combination of nevirapine and AZT was more effective at preventing vertical transmission than nevirapine alone.

Glossary

mother-to-child transmission (MTCT)

Transmission of HIV from a mother to her unborn child in the womb or during birth, or to infants via breast milk. Also known as vertical transmission.

placebo

A pill or liquid which looks and tastes exactly like a real drug, but contains no active substance.

vertical transmission

Transmission of an infection from mother-to-baby, during pregnancy, childbirth, or breastfeeding.

 

statistical significance

Statistical tests are used to judge whether the results of a study could be due to chance and would not be confirmed if the study was repeated. If result is probably not due to chance, the results are ‘statistically significant’. 

double-blind

A clinical trial where neither the researchers nor participants know which assigned treatment an individual participant in the trial is taking until after the end of the trial. This reduces the risk of biased results. 

A double-blind, randomised, placebo-controlled trial was designed involving 1172 HIV-positive pregnant women attending the Salvation Army Howard Hospital in rural Zimbabwe. All the women received 200mg nevirapine during labour and all the infants received 2mg/kg nevirapine within 72 hours of birth. The women were randomised into one of two treatment arms. Women in Group A received an initial dose of 600mg of AZT followed by additional 300mg doses of the drug for every three hours of labour. Their infants also received 2mg/kg three times daily for 72 hours. The women and infants in Group B received placebo doses at the same intervals.

The study was terminated on the grounds of futility when an interim analysis was performed at week six. The investigators found that the rate of mother-to-child transmission was 46% in the study patients who received a combination of nevirapine and AZT, and 50% in the group who received nevirapine alone. The difference was not statistically significant.

“Short course AZT did not significantly decrease mother-to-child transmission when added to two doses of nevirapine”, conclude the investigators. They added that further follow-up was ongoing to see if adding AZT reduced the rate of nevirapine resistance.

References

Thistle P et al. A randomised double-blind placebo-controlled trial of combined nevirapine and zidovudine compared to nevirapine alone in prevention of perinatal transmission of HIV. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy, abstract H-416, Washington DC, 2005.