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Efficacy and safety of switching to abacavir/lamivudine (ABC/3TC) plus rilpivirine (RPV) in virologically suppressed HIV-infected patients on HAART

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Abstract

We analysed the efficacy and safety of switching from a regimen based on nonnucleoside reverse transcriptase inhibitors (NNRTI) or integrase inhibitors (INI) to ABC/3TC + RPV in virologically suppressed HIV-infected patients. This multicentre, retrospective study comprised asymptomatic HIV-infected patients who switched from 2 NRTI + NNRTI or 2 NRTI + INI to ABC/3TC + RPV between February 2013 and December 2013; all had undetectable HIV viral load prior to switching. Efficacy and safety, and changes in lipids and cardiovascular risk (CVR) were analysed at 48 weeks. Of 85 patients (74.1 % men, mean age 49.5 years), 83 (97.6 %) switched from a regimen based on NNRTI (EFV 74, RPV 5, ETV 2, NVP 2), and 45 (53 %) switched from TDF/FTC to ABC/3TC. The main reasons for switching were toxicity (58.8 %) and convenience (29.4 %). At 48 weeks, 78 (91.8 %) patients continued taking the same regimen; efficacy was 88 % by intention to treat, and 96 % by per protocol. Two patients were lost to follow-up and five ceased the new regimen (4 due to adverse effects and 1 virologic failure). Mean CD4 cell counts increased (744 vs. 885 cells/μL; p = 0.0001), and there were mean decreases in fasting total cholesterol (–15.9 mg/dL; p < 0.0001) and LDL-cholesterol (–11.0 mg/dL; p < 0.004), with no changes in HDL-cholesterol, triglycerides, total cholesterol:HDL-cholesterol ratio, and CVR. ABC/3TC + RPV is effective and safe in virologically-suppressed patients on antiretroviral therapy (ART). Forty-eight weeks after switching the lipid profile improved with decreases in total and LDL cholesterol.

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Acknowledgments

The authors would like to thank the study participants as well as the investigators. The authors also thank Ian Johnstone for help with the English language version of the text and the Sociedad Andaluza de Enfermedades Infecciosas for its support.

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Authors and Affiliations

  1. Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

    R. Palacios, I. A. Pérez-Hernández, C. M. González-Domenech & J. Santos

  2. UGC Enfermedades Infecciosas, Hospital Clínico Universitario Virgen de la Victoria, 29010, Málaga, Spain

    R. Palacios, I. A. Pérez-Hernández & J. Santos

  3. Hospital Universitario de San Cecilio de Granada, Granada, Spain

    M. A. Martínez & J. Hernández-Quero

  4. Hospital Regional Universitario Carlos Haya, Málaga, Spain

    M. L. Mayorga

  5. Hospital Universitario Ciudad de Jaén, Jaén, Spain

    M. Omar

  6. Hospital Costa del Sol, Marbella, Spain

    J. Olalla

  7. Hospital Universitario de Puerto Real, Cádiz, Spain

    A. Romero

  8. Hospital Torrecárdenas, Almería, Spain

    J. M. Romero

  9. Hospital de Poniente, Almería, Spain

    I. Pérez-Camacho

Authors
  1. R. Palacios
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  2. I. A. Pérez-Hernández
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  3. M. A. Martínez
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  4. M. L. Mayorga
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  5. C. M. González-Domenech
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  6. M. Omar
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  7. J. Olalla
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  8. A. Romero
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  9. J. M. Romero
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  10. I. Pérez-Camacho
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  11. J. Hernández-Quero
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  12. J. Santos
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Corresponding author

Correspondence to R. Palacios.

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Funding

This study has been supported in part by the RD12/0017/0017 project (Plan Nacional R + D + I) and cofinanced by Instituto de Salud Carlos III-Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional and a grant from by Janssen Cilag.

Conflict of interest

R.P., M.O., J.O., J.H.Q. and J.S. are on the scientific advisory board and speakers’ bureau for Janssen Cilag and have received grants and travel expenses for conferences from Janssen Cilag.

I.A.P.H., M.A.M., M.L.M., C.M.G.D., A.R., J.M.R. and I.P.C. have no personal disclosures.

Ethical approval

Institutional review board/ethics committee approval was obtained for the study protocol for the analysis of anonymous routine clinical data of patients.

Informed consent

Patients were informed about the nature of the study and accepted to be included.

Members of the SAEI 00/0067 study group

R. Palacios, I.A. Pérez-Hernández, C.M. González-Doménech, J. Ruiz, E. Nuño, M. Márquez, J. Santos (Hospital Clínico Universitario Vírgen de la Victoria, Málaga), M.I. Mayorga, M. Castaño (Hospital Regional Universitario Carlos Haya, Málaga), M.A. Martínez, D. Vinuesa, J. Hernández-Quero (Hospital Universitario San Cecilio, Granada), M. Omar (Hospital Universitario Ciudad de Jaén, Jaén), A. Romero (Hospital Universitario de Puerto Real, Cádiz), J.A. Romero, M.C. Gálvez (Hospital de Torrecárdenas, Almería) I. Pérez-Camacho (Hospital de Poniente, Almería), A. del Arco, J. de la Torre, J. Olalla, J.L. Prada (Hospital Costa del Sol, Marbella).

This study was partially presented at the HIV Drug Therapy Congress, Glasgow 2014.

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Palacios, R., Pérez-Hernández, I.A., Martínez, M.A. et al. Efficacy and safety of switching to abacavir/lamivudine (ABC/3TC) plus rilpivirine (RPV) in virologically suppressed HIV-infected patients on HAART. Eur J Clin Microbiol Infect Dis 35, 815–819 (2016). https://doi.org/10.1007/s10096-016-2602-3

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  • DOI: https://doi.org/10.1007/s10096-016-2602-3

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