Drug products: EVOTAZ, Genvoya, REZOLSTA, Stribild, Symtuza
ATC code: J05AR09, J05AR14, J05AR15, J05AR18, J05AR22
No studies with a clinically relevant sex analysis regarding efficacy or adverse effects of cobicistat have been found. Both men and women have been included in the randomized studies although the number of women has been low.
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 .
Both men and women have been included in the pivotal studies although the number of women was low (17%) . No studies with a clinically relevant sex analysis regarding effects of cobicistat have been found.
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 . 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 . 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).
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 . 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 .
Date of litterature search: 2018-07-18
- Tybost (cobicistat). Summary of Product Characteristics. European Medicines Agency (EMA); 2018.
- 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
- 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
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.] länk
Reviewed by: Karin Schenck-Gustafsson
Approved by: Karin Schenck-Gustafsson