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NEAT001 finds an alternative combination of drugs for first-line treatment of HIV

19 Aug 2014

The results of the NEAT001/ANRS143 trial, published today in The Lancet, show that a new combination of antiretroviral drugs could be an alternative to the standard approach recommended in guidelines. This new combination may be helpful for people who have problems with the side effects of the current standard treatment.

Treating HIV usually involves a combination of several drugs from different classes, which target different stages of the virus’ life cycle. The standard treatment for people starting HIV treatment for the first time is a combination of two drugs from the NRTI class and one drug from a different class. Treatment based on a ‘backbone’ of two NRTI drugs is very effective at suppressing the virus, and restoring peoples’ immune system. But commonly used NRTI drugs can have side-effects, particularly bone and kidney problems.

NEAT001 investigated whether a combination of drugs not including NRTIs was as effective as the standard treatment of two NRTI drugs plus one from a different class. Participants starting HIV treatment for the first time were allocated at random to receive either:

  • Raltegravir (a drug from the INSTI class) plus darunavir boosted with ritonavir (from the PI class), or
  • Darunavir boosted with ritonavir plus two NRTI drugs (tenofovir and emtricitabine), which is the standard treatment.

The trial was carried out in 15 European countries, and included 805 participants. Participants were followed up for at least 96 weeks, with regular checks to see how much virus they had in their blood, how their immune systems were responding, and whether they were experiencing any side-effects.

Both treatments had good results. There was a 4% higher treatment failure rate in those receiving the new treatment than the standard treatment, but this difference was not significant and within the pre-specified non-inferiority margin. This means that in the view of the doctors and statisticians who designed the trial, the new treatment is not worse than the standard treatment. The levels of side-effects were similar for both treatments.

The new treatment did seem to be significantly worse than the standard treatment for those participants who started the trial with very weak immune systems. For those with healthier immune systems there seemed to be no difference.

While the results do not suggest that the standard treatment should be changed, the NEAT001 trial has identified an alternative approach that could be useful for people with heart or kidney problems, or those who have hypersensitivity reactions to NRTI drugs.

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