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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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Abstract

Background

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

Objectives

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.

Methods

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.

Results

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.

Conclusions

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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Acknowledgements

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.

Funding

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

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

    Golbarg Alavian

  2. Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran

    Ladan Abbasian & Seyed Ali Dehghan Manshadi

  3. Department of Infectious & Tropical Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, Iran

    Ladan Abbasian

  4. Department of Clinical Pharmacy (Pharmacotherapy), Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

    Hossein Khalili

  5. Iranian Research Center for HIV/AIDS (IRCHA), Tehran University of Medical Sciences (TUMS), Tehran, Iran

    Seyed Ahmad Seyed Alinaghi

  6. Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran

    Malihe Hasannezhad & Masoumeh Farrokh Ashtiani

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  1. Golbarg Alavian
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Contributions

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.

Corresponding author

Correspondence to Ladan Abbasian.

Ethics declarations

Authors have no any to declare regarding this submission.

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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Not applicable.

Conflict of interest

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). https://doi.org/10.1007/s40199-023-00470-2

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  • DOI: https://doi.org/10.1007/s40199-023-00470-2

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