Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; darunavir/cobicistat 800 mg/150 mg) |
| Drug Class | Human immunodeficiency virus (HIV-1) protease inhibitors and CYP3A inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HIV-1 infection in treatment-nave and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
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Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- In adults with primary human immunodeficiency virus type 1 (HIV-1) infection, both dolutegravir/tenofovir/emtricitabine and darunavir/cobicistat/tenofovir/emtricitabine regimens led to reductions in HIV-1 DNA levels in peripheral blood mononuclear cells (PBMCs) by Week 48, with no significant difference between groups (median decrease: -1.48 vs. -1.39 log10 copies/million PBMCs; P = 0.52).
- Dolutegravir-based regimens achieved faster viral suppression in HIV-1 RNA levels, with a higher proportion of patients reaching <50 copies/mL at Weeks 4, 8, and 12 compared to darunavir/cobicistat. By Week 48, suppression rates were comparable between the dolutegravir and darunavir/cobicistat groups (94% vs. 90%).
- No notable differences in effectiveness were observed among different population types or subgroups, with consistent outcomes across the study sample.
- During pregnancy, darunavir and cobicistat exposure levels are significantly reduced, with darunavir AUC0-24 decreased by 53% in the second trimester and 56% in the third trimester, and cobicistat AUC0-24 decreased by 50% and 56% in the second and third trimesters, respectively, compared to postpartum levels. This reduction in drug exposure may increase risks of virologic failure and perinatal transmission, indicating a potential need for dose adjustments.
- Limited placental transfer of darunavir and cobicistat was observed, which may influence maternal and fetal drug levels and necessitates careful monitoring in pregnant patients to maintain efficacy.
- The reviewed studies highlight the relevance of rapid viral suppression in adults with primary HIV-1 infection, predominantly male and with a median age of 36 years, noting the critical need for early viral control to reduce transmission risk. For pregnant women with HIV, reduced drug exposure to darunavir and cobicistat during the second and third trimesters suggests a need for potential dose adjustments to mitigate risks of virologic failure and perinatal transmission.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prezcobix (darunavir and cobicistat) Prescribing Information. | 2023 | Janssen Products, LP., Titusville, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Once-daily dolutegravir versus darunavir plus cobicistat in adults at the time of primary HIV-1 infection: the OPTIPRIM2-ANRS 169 randomized, open-label, Phase 3 trial | 101Subjects F: 7% M: 93% | 2022 | The Journal of Antimicrobial Chemotherapy |
| Pharmacokinetics of darunavir and cobicistat in pregnant and postpartum women with HIV | 1,113Subjects F: 100% M: 0% | 2021 | Aids (london, England) |
Sex Distribution:
F:7%
M:93%
101Subjects
Year:
2022
Source:The Journal of Antimicrobial Chemotherapy
Document Title
Sex Distribution:
F:100%
M:0%
1113Subjects
Year:
2021
Source:Aids (london, England)
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institute of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institute of Health |
| European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |