[Use of darunavir in HIV-infected women during pregnancy]

The use of antiretroviral drugs (ARVDs) in a mother and a child can reduce the risk of vertical transmission of human immunodeficiency virus (HIV) to less than 1%; therefore, highly active antiretroviral therapy is used in all pregnant women regardless of indications for HIV-infection treatment. The major requirements for choosing an ARVD to prevent mother-to-child HIV transmission are its high safety for a pregnant woman, a fetus, and a baby and its high therapeutic efficacy. Clinical trials of darunavir (DRV) in adults and children have shown a high virologic response, good tolerance, and safety. Trials and observations have demonstrated the high efficacy and safety of a DRV when used in pregnant women. Pharmacokinetic studies in pregnant women have indicated the effective and well-tolerated concentration of a DRV when it is co-administered with low-dose ritonavir, which permits the use of a DRV for both the prevention of mother-to-child HIV transmission and the treatment of pregnant women who require antiretroviral therapy. The Russian clinical protocol "Use of ARVDs in the package of measures for the prevention of mother-to-child HIV transmission" approved by the National Scientific Society of Infectiologists in 2013 recommends DRV as an alternative drug in antiretroviral therapy regimens for pregnant women to prevent mother-to-child HIV transmission and to treat maternal HIV infection.