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Rilpivirine

Classification: A

Drug products: EDURANT, Eviplera, Juluca, Odefsey

ATC code: J05AG05, J05AR08, J05AR19, J05AR21

Substances: rilpivirine, rilpivirine hydrochloride

Summary

No differences between men and women have been reported in efficacy of treatment including rilpivirine. Nausea has been reported to be more common as an adverse event in women while nightmares were found more often in men.
 
In our opinion, the present evidence does not motivate differentiation in dosing or treatment between men and women.

Additional information

Antiretrovirals for treatment of HIV are always given as a combination of at least three medicines. Cobicistat is used to boost the effect of other antiretroviral drugs. As studies on HIV patients always include patients receiving combination therapy it is difficult to know which of the studied medicines that cause changes in effect and/or adverse events.

Pharmacokinetics and dosing

The manufacturer reports no clinically relevant differences between men and women in the pharmacokinetics of rilpivirine and suggests no differences in dosing [1].

Effects

Both men and women have been included in the randomized trials [1]. In a randomized study in HIV infected adults (1040 men, 328 women) treated with rilpivirine or efavirenz plus tenofovir/emtricitabine, zidovudine/lamivudine or abacavir/lamivudine, no difference between men and women was found in achieving virological suppression response [2].

Adverse effects

In a randomized study in HIV infected adults (1040 men, 328 women) treated with rilpivirine or efavirenz plus tenofovir/emtricitabine or, zidovudine/lamivudine or abacavir/lamivudine nausea was more common in women in both treatment groups while abnormal dreams/nightmares were more frequent in men [2].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2018-07-18

References

  1. EDURANT (rilpivirine). Summary of Product Characteristics. European Medicines Agency (EMA); 2018.
  2. Hodder S, Arasteh K, De Wet J, Gathe J, Gold J, Kumar P et al. Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. HIV Med. 2012;13(7):406-15. PubMed
  3. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.] länk

Authors: Mia von Euler, Linnéa Karlsson Lind

Reviewed by: Karin Schenck-Gustafsson

Approved by: Karin Schenck-Gustafsson