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Tenofovir alafenamide plus dolutegravir as a switch strategy in HIV-infected patients: a pilot randomized controlled trial

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Currently, two-drug antiretroviral regimens are emerging fields in life-long treatment in people living with HIV.


This randomized non-inferiority open-label controlled trial was designed to compare the 48-week efficacy and safety of tenofovir alafenamide plus dolutegravir versus the standard triple therapy in virologically suppressed people living with HIV. To the best of our knowledge this combination has not been studied before.


This open-label randomized controlled trial was conducted in treatment-experienced people with HIV who had HIV-RNA < 47 copies/mL for at least two years. Patients received either tenofovir alafenamide plus dolutegravir combination (26 patients) or a standard three-drug regimen (29 patients). The primary outcome was the proportion of patients maintaining HIV-RNA < 47 copies/mL during 48 weeks, and the secondary outcomes were CD4 cell count changes, the adherence rate, and adverse drug reactions, all over 48 weeks of study.


HIV viral load remained undetectable (HIV-RNA < 47 copies/mL) during the 48 weeks of the study in both arms. The absolute CD4 cell count change was not significant between the two groups. The overall proportion of adverse effects in each group was comparable. The rate of adherence to treatment was acceptable in both groups, and no significant difference was observed.


Treatment simplification with tenofovir alafenamide plus dolutegravir regimen as maintenance therapy was non-inferior in terms of efficacy and safety compared to the standard triple therapy.

Graphical abstract

Comparing efficacy of antiretroviral therapy

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Data availability

The datasets used and analyzed during the current study are available from the corresponding author upon request.


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We are grateful to Dr Kasra Kolahdouzan MD, Dr Hossein Daliry MD, and all personnel of the Voluntary Counseling and Testing Center for their kind help and cooperation. The authors acknowledge with the support of Tadbir Kalaye Jam (Tekaje) Company for providing a part of tenofovir alafenamide.


This study was supported by Tehran University of Medical Sciences (IR.TUMS.TIPS.REC.1398.103).

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Authors and Affiliations



LA, HK, GA—conceptualized and implemented the study, GA wrote the first draft; SASA conducted statistical analyses, GA, MFA, SADM, MH—collected data; LA, SASA, HK—reviewed and provided intellectual and editorial content. All authors have read and approved the final manuscript.

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Correspondence to Ladan Abbasian.

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Ethics approval and consent to participate

The study was approved by the Ethics Committees of Tehran University of Medical Sciences (IR.TUMS.TIPS.REC.1398.087).

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The authors have no conflict of interest.

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Alavian, G., Abbasian, L., Khalili, H. et al. Tenofovir alafenamide plus dolutegravir as a switch strategy in HIV-infected patients: a pilot randomized controlled trial. DARU J Pharm Sci 31, 145–153 (2023).

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