Virological failure at one year in triple-class experienced patients switching to raltegravir-based regimens is not predicted by baseline factors

Author:

Bucciardini R1,D'ettorre G2,Baroncelli S1,Ceccarelli G2,Parruti G3,Weimer L E1,Fragola V1,Galluzzo C M1,Pirillo M F1,Lucattini S1,Bellagamba R4,Francisci D5,Ladisa N6,Antoni A Degli7,Guaraldi G8,Manconi P E9,Vullo V2,Preziosi R10,Cirioni O11,Verucchi G12,Floridia M1

Affiliation:

1. Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome

2. Department of Infectious Diseases and Public Health, University of Sapienza, Rome

3. Unit of Infectious Diseases, Ospedale Civile Spirito Santo, Pescara

4. National Institute for Infectious Diseases ‘L. Spallanzani’, Rome

5. Clinic of Infectious Diseases, University of Perugia, Perugia

6. Clinic of Infectious Diseases, University of Bari, Bari

7. Department of Infectious Diseases and Hepatology, Azienda Ospedaliera di Parma, Parma

8. Department of Medical Specialties, Infectious Diseases Clinic, University of Modena and Reggio Emilia, Modena

9. Clinic of Infectious Diseases, Department of Medicine and Immunology, University of Cagliari, Cagliari

10. Belcolle Hospital, Viterbo

11. Clinic of Infectious Diseases, Department of Biomedical Sciences, Università Politecnica delle Marche, Ancona

12. Department of Internal Medicine, Geriatrics and Nephrologie Diseases, Section of Infectious Diseases, S. Orsola-Malpighi Hospital, Bologna, Italy

Abstract

We evaluated rates and determinants of virological failure in triple-class experienced patients receiving raltegravir-based regimens from a national observational study over 48 weeks, defined by any one of the following: (1) no HIV-RNA suppression to undetectable levels (<50 copies/mL) during follow-up; (2) detectable viral load after obtaining undetectable levels; and (3) leaving the study before 48 weeks. Among 101 eligible patients, 26 (25.7%; 95% CI 17.2–34.2) had virological failure. No significant differences between patients with and without virological failure were observed for gender, age, route of transmission, baseline CD4/HIV-RNA, CDC group, hepatitis B or C co-infections, resistance (based on the last genotype available), type and number of concomitant drug classes, concomitant use of darunavir, atazanavir, etravirine, enfuvirtide or maraviroc, and health-related quality-of-life measures. A high rate of treatment response was observed. The analyses did not identify any baseline factor associated with failure, including resistance status. Even if we cannot exclude the presence of pre-existing minority resistant variants not captured by genotypic tests, the lack of baseline predictors of failure suggests the need to monitor patients closely during follow up for other factors, such as potential drug interactions and reduced levels of adherence, which may favour virological failure.

Publisher

SAGE Publications

Subject

Infectious Diseases,Pharmacology (medical),Public Health, Environmental and Occupational Health,Dermatology

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