Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Kobicistat

Klassificering: B

Preparat: EVOTAZ, Genvoya, REZOLSTA, Stribild, Symtuza

ATC kod: J05AR09, J05AR14, J05AR15, J05AR18, J05AR22

Substanser: kobicistat

Sammanfattning

Inga studier med relevant analys av könsskillnader i effekt eller säkerhet av kobicistat har hittats. Både män och kvinnor har inkluderats i de kliniska studierna men framförallt i de randomiserade studierna har andelen kvinnor varit låg.
 

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 does not recommend any difference in dosing between men and women [1].

Effects

Both men and women have been included in the pivotal studies although the number of women was low (17%) [1]. No studies with a clinically relevant sex analysis regarding effects of cobicistat have been found.

Adverse effects

Safety and tolerability were evaluated in a European HIV cohort with antiretroviral treatment (958 men, 336 women). Women had a higher risk of treatment discontinuation than men but no increased risk of virological failure. Compared to men, women had less diarrhoea and severe dyslipidaemia but more lipodystrophy [2]. No other studies with a clinically relevant sex analysis regarding adverse effects of cobicistat have been found.

Reproductive health issues

Plasma concentrations of ethinyloestradiol have been shown to decrease following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat but it is not known how cobicistat interacts with other contraceptive agents [1]. Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner).

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

Other information

In a post-hoc analysis of data from a randomized phase-III trial in HIV patients treated with atazanavir boosted with either cobicistat or ritonavir in combination with emtricitabine/tenofovir disoproxil fumarate (574 men, 118 women) found more discontinuations due to withdrawal of consent and pregnancies in women receiving atazanavir+ritonavir compared to atazanavir+cobicistat [3]. In a Spanish retrospective observational study of dolutegravir and elvitegravir/cobicistat treatment in HIV patients (414 men, 128 women), women in both treatment groups were more prone to discontinuation due to adverse events than men [4].

Försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande kombination av kobicistat och darunavir (ATC-kod J05AR14) på recept i Sverige år 2017, totalt 143 män och 125 kvinnor [5].

Fler män än kvinnor hämtade ut läkemedel innehållande kombination av kobicistat, emtricitabin, tenofoviralafenamid och elvitegravir (ATC-kod J05AR18) på recept i Sverige år 2017, totalt 218 män och 96 kvinnor [5].

Fler män än kvinnor hämtade ut läkemedel innehållande kombination av kobicistat, emtricitabin, tenofovirdisoproxil och elvitegravir (ATC-kod J05AR09) på recept i Sverige år 2017, totalt 26 män och 9 kvinnor [5].

Fler män än kvinnor hämtade ut läkemedel innehållande kombination av kobicistat, emtricitabin, tenofoviralafenamid och darunavir (ATC-kod J05AR22) på recept i Sverige år 2017, totalt 17 män och 9 kvinnor [5].

Något fler män än kvinnor hämtade ut läkemedel innehållande kombination av kobicistat och atazanavir (ATC-kod J05AR15) på recept i Sverige år 2017, totalt 11 män och 8 kvinnor [5].

Uppdaterat: 2018-12-19

Litteratursökningsdatum: 2018-07-18

Referenser

  1. Tybost (cobicistat). Summary of Product Characteristics. European Medicines Agency (EMA); 2018.
  2. Svedhem-Johansson V, Pugliese P, Brockmeyer NH, Thalme A, Michalik C, Esser S et al. Long-term gender-based outcomes for atazanavir/ritonavir (ATV/r)- containing regimens in treatment-experienced patients with HIV. Curr HIV Res. 2013;11(4):333-41. PubMed
  3. Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP et al. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.] länk

Författare: Mia von Euler, Linnéa Karlsson Lind

Faktagranskat av: Karin Schenck-Gustafsson

Godkänt av: Karin Schenck-Gustafsson