Integrase inhibitors and their effectiveness and safety in women

Over the past several years leading HIV treatment guidelines in high-income countries have positioned a class of anti-HIV drugs called integrase inhibitors as the preferred option for use in combination anti-HIV therapy (ART) when initiating treatment. This is because integrase-inhibitor-containing ART is potent; in general, such combinations quickly reduce viral load. Overall, integrase inhibitors are generally well tolerated and as a class tend to have fewer drug interactions than other classes such as protease inhibitors and non-nukes.

Several integrase inhibitors are licensed in high-income countries with at least two more on the way over the next several years. Unfortunately, in the rush to licensure, some pharmaceutical companies did not recruit sufficient HIV-positive women in the initial clinical trials of integrase inhibitors, and so doctors and their female patients could not be certain about the safety of some integrase inhibitors in women. That has now been changed with the release of two important studies: Waves and Aria.

In Waves, researchers tested the integrase inhibitor elvitegravir, which is co-formulated with several other anti-HIV drugs and sold as a complete treatment under the brand names Genvoya and Stribild. Waves used the combination of drugs found in Stribild (elvitegravir + cobicistat + tenofovir DF + FTC).

In Aria, researchers tested a competing integrase inhibitor called dolutegravir (Tivicay), which is co-formulated with two other drugs (abacavir + 3TC) to form a complete regimen in one pill that is sold as Triumeq.

The results from both Waves and Aria show that not only does integrase inhibitor–based ART work well in women but that, in general, both regimens are safe and better tolerated than the regimen based on the protease inhibitor atazanavir (Reyataz).

In this issue of TreatmentUpdate we have results from those clinical trials and other research with HIV-positive women.

—Sean R. Hosein


  1. Squires K, Kityo C, Hodder S, Johnson M, et al. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-20.
  2. Orrell C, Hagins D, Belonosova E, et al. Superior efficacy of dolutegravir/abacavir/lamivudine FDC compared with ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate/emtricitabine FDC in treatment-naïve women with HIV-1 infection: Aria study. In: Program and abstracts of the 21st International AIDS Conference, 18-22 July 2016, Durban, South Africa. Abstract THAB0205LB.