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Clinical Trial
. 2023 Jun 1;37(7):1057-1064.
doi: 10.1097/QAD.0000000000003513. Epub 2023 Mar 3.

Bictegravir/emtricitabine/tenofovir alafenamide plus doravirine in highly treatment-experienced men with multidrug-resistant HIV

Felicia L Sterman  1   2 , Jacob P Lalezari  2 , Ula M Kowalczyk  2 , David W Main  3 , Edward M Grant  3 , Luzelena Caro  4 , Cassie M Manning  5 , Rochelle L Burke  5
Affiliations
Clinical Trial

Bictegravir/emtricitabine/tenofovir alafenamide plus doravirine in highly treatment-experienced men with multidrug-resistant HIV

Felicia L Sterman et al. AIDS. .

Abstract

Objective: To evaluate the safety and efficacy of switching highly treatment-experienced people with HIV (HTE PWH) from rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) plus dolutegravir (DTG) to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) plus doravirine (DOR). A pharmacokinetic (PK) analysis was conducted to assess the potential interaction between BIC and DOR.

Design and methods: This open-label switch trial enrolled HTE PWH from a primary care private practice in the United States. Eligible participants were male, aged ≥45 years, with documented viral resistance to protease inhibitors, nucleoside reverse transcriptase inhibitors, and/or nonnucleoside reverse transcriptase inhibitors but no resistance to RPV or DOR, and no K65R or T69 insertion mutations. Virologic suppression (≤50 copies/ml) while on RPV/FTC/TAF plus DTG for ≥6 months was required prior to enrollment. The primary endpoint of the study was virologic suppression (<50 and <200 copies/ml) at 48 weeks. Secondary endpoints included safety, tolerability, changes in body mass index (BMI), and identification of PK parameters of BIC and DOR.

Results: Twenty males [median age: 65 years (range, 46-74), median time since HIV diagnosis: 37 years (range, 12-42)] completed the study. BIC/FTC/TAF plus DOR was well tolerated with no serious or treatment-related adverse events reported and no appreciable changes in BMI from baseline to Week 48. At Week 48, 100% of participants had <50 viral copies/ml. PK parameters for BIC and DOR ( n = 10) were consistent with published data.

Conclusions: Switching from RPV/FTC/TAF plus DTG to BIC/FTC/TAF plus DOR was well tolerated and efficacious in HTE men aged ≥45 years with HIV.

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References

    1. Antiretroviral Drug Discovery and Development. National Institute of Allergy and Infectious Diseases. 2018. Available at: https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-develo... [Accessed 3 March 2022].
    1. FDA-Approved HIV Medicines. National Institute of Health. Available at: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/fda-approved-hiv-m... [Accessed 3 March 2022].
    1. FDA Approval of HIV Medicines. National Institute of Health. Available at: https://hivinfo.nih.gov/understanding-hiv/infographics/fda-approval-hiv-... [Accessed 3 March 2022].
    1. Krentz HB, John Gill M. Long-term HIV/AIDS survivors: patients living with HIV infection retained in care for over 20 years. What have we learned? . Int J STD AIDS 2018; 29:1098–1105.
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. 2022. Available at: https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/what... [Accessed 3 March 2022].

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