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Genotypic resistance profiles associated with virological failure to darunavir-containing regimens: a cross-sectional analysis

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Abstract

Introduction

This study aimed at defining protease (PR) resistance mutations associated with darunavir (DRV) failure and PR resistance evolution at DRV failure in a large database of treatment-experienced human immunodeficiency virus (HIV) patients.

Results

Overall, 1,104 patients were included: 118 (10.7%) failed at a median observation time of 16 months. The mean number of PR mutations at baseline was 2.7, but it was higher in patients who subsequently failed DRV. In addition, the number of PR mutations increased at failure. The increase in the mean number of mutations was completely related to mutations considered to be associated with DRV resistance following the indications of the main DRV clinical trials.

Discussion

The higher statistical difference at baseline between failing versus non-failing patients was observed for the V32I and I84V mutations. At DRV failure, the major increase was still observed for V32I; I54L, V11I, T74P and I50V also increased. Despite the increment in the mean number of mutations per patient between baseline and failure, in 21 patients (17.8%) at baseline and 36 (30.5%) at failure, no PR mutation was detected.

Conclusion

The HIV-DB interpretation algorithm identified few patients with full DRV resistance at baseline and few patients developed full resistance at DRV failure, indicating that complete resistance to DRV is uncommon.

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Acknowledgments

We wish to thank all the members of the Antiretroviral Resistance Cohort Analysis (ARCA) Database Study Group for providing the data used in this study.

Conflict of interest

The authors certify that there is no actual or potential conflict of interest in relation to this article.

Author information

Authors and Affiliations

  1. SOD Malattie Infettive, Azienda Ospedaliera Universitaria Careggi, Largo Brambilla 3, 50134, Firenze, Italy

    G. Sterrantino

  2. Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani”, Roma, Italy

    M. Zaccarelli

  3. Laboratorio di Virologia, Azienda Ospedaliera Universitaria Careggi, Firenze, Italy

    G. Colao

  4. Laboratorio di Virologia, Ospedale San Matteo, Pavia, Italy

    F. Baldanti

  5. Divisione Malattie Infettive, Università Cattolica Del Sacro Cuore, Roma, Italy

    S. Di Giambenedetto

  6. Divisione Malattie Infettive, Ospedale di Grosseto, Grosseto, Italy

    T. Carli

  7. Divisione Malattie Infettive, Ospedale di Bergamo, Bergamo, Italy

    F. Maggiolo

  8. Dipartimento di Biologia Molecolare, Università di Siena, Siena, Italy

    M. Zazzi

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  1. G. Sterrantino
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For the ARCA Database Study Group

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Correspondence to G. Sterrantino.

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The ARCA Database Study Group members information is provided in the Appendix.

Appendix

Appendix

Andrea Giacometti (ANCONA-Clinica di Malattie Infettive), Luca Butini (ANCONA-Immunologia Clinica), Romana del Gobbo (ANCONA-Malattie Infettive), Patrizia Bagnarelli (ANCONA-Virologia), Danilo Tacconi (AREZZO-Malattie Infettive), Giovanni Corbelli (ASCOLI PICENO-Malattie Infettive), Stefania Zanussi (AVIANO-Centro di Riferimento Oncologico), Laura Monno (BARI-Clinica Malattie Infettive Università), Grazia Punzi (BARI-Virologia), Franco Maggiolo (BERGAMO-Malattie Infettive), Annapaola Callegaro (BERGAMO-Microbiologia e Virologia), Leonardo Calza (BOLOGNA-Malattie Infettive S. Orsola), Maria Carla Re (BOLOGNA-UO Microbiologia, Lab. Retrovirus), Raffaele Pristerà (BOLZANO-Malattie Infettive), Paola Turconi (BRESCIA-Fleming Labs), Antonella Mandas (CAGLIARI-Centro S.I.D.A., Policlinico Universitario), Sauro Tini (CITTA’ DI CASTELLO-Medicina Generale), Alessia Zoncada (CREMONA-Malattie Infettive), Elisabetta Paolini (CREMONA-Servizio Immunoematologia e Medicina Trasfusionale), Giorgio Amadio (FERMO-Malattie Infettive), Laura Sighinolfi (FERRARA-Malattie Infettive AOU S. Anna), Giuliano Zuccati (FIRENZE-Centro MTS), Massimo Morfini (FIRENZE-Ematologia CAREGGI), Roberto Manetti (FIRENZE-Immunoallergologia CAREGGI), Paola Corsi (FIRENZE-Malattie Infettive CAREGGI), Luisa Galli (FIRENZE-Malattie Infettive Pediatria Meyer), Massimo Di Pietro (FIRENZE-Malattie Infettive SM Annunziata), Filippo Bartalesi (FIRENZE-Malattie Infettive Università), Grazia Colao (FIRENZE-Virologia CAREGGI), Andrea Tosti (FOLIGNO-Malattie Infettive/SERT), Antonio Di Biagio (GENOVA-Clinica Malattie Infettive AOU S. Martino), Maurizio Setti (GENOVA-Clinica Medica Immunologia), Bianca Bruzzone (GENOVA-Laboratorio di Igiene Ospedale S. Martino), Antonio Di Biagio (GENOVA-Malattie Infettive Ospedale S. Martino), Giovanni Penco (GENOVA-Malattie Infettive Ospedali Galliera), Michele Trezzi (GROSSETO-Malattie Infettive), Anna Orani (LECCO-Malattie Infettive), Riccardo Pardelli (LIVORNO-Malattie Infettive), Irene Arcidiacono (LODI-Malattie Infettive), Alberto Degiuli (LODI-Virologia Lodi), Michele De Gennaro (LUCCA-Malattie Infettive), Alessandro Chiodera (MACERATA-Malattie Infettive), Alfredo Scalzini (MANTOVA-Malattie Infettive Ospedale ‘C. Poma’), Loredana Palvarini (MANTOVA-Virologia), Paolo Almi (MASSA-Malattie Infettive), Giovanni Todaro (MESSINA-Malattie Infettive), Paola Cicconi (MILANO-Clinica di Malattie Infettive Ospedale S. Paolo), Stefano Rusconi (MILANO-Dipart. Scienze Cliniche, Sez. Malattie Infettive-Università degli Studi), Maria Rita Gismondo (MILANO-Laboratorio Microbiologia Ospedale L. Sacco [Prima Divisione Malattie Infettive]), Valeria Micheli (MILANO-Laboratorio Microbiologia Ospedale L. Sacco [Seconda Divisione Malattie Infettive]), Maria Luisa Biondi (MILANO-Laboratorio di diagnostica molecolare infettivologica AO S. Paolo), Nicola Gianotti (MILANO-Malattie Infettive San Raffaele), Amedeo Capetti (MILANO-Prima Divisione Malattie Infettive Ospedale L. Sacco), Paola Meraviglia (MILANO-Seconda Divisione Malattie Infettive Ospedale L. Sacco), Enzo Boeri (MILANO-Virologia HSR), Cristina Mussini (MODENA-Clinica Malattie Infettive), Monica Pecorari (MODENA-Virologia), Alessandro Soria (MONZA-Malattie Infettive), Laura Vecchi (MONZA-UO Microbiologia AO S. Gerardo), Maurizio Santirocchi (NARNI-SERT), Diego Brustia (NOVARA-Malattie Infettive AO Maggiore), Paolo Ravanini (NOVARA-Virologia), Federico Dal Bello (PADOVA-Virologia), Nino Romano (PALERMO-Centro Riferimento AIDS Università), Salvatrice Mancuso (PALERMO-Servizio Riferimento Regionale Diagnosi AIDS), Carlo Calzetti (PARMA-Divisione Malattie Infettive ed Epatologia Azienda Ospedaliera), Renato Maserati (PAVIA-Ambulatorio Clinica Malattie Infettive S. Matteo), Gaetano Filice (PAVIA-Clinica Malattie Infettive e Tropicali), Fausto Baldanti (PAVIA-Virologia S. Matteo), Daniela Francisci (PERUGIA-Malattie Infettive), Giustino Parruti (PESCARA-Malattie Infettive), Ennio Polilli (PESCARA-Virologia Pescara), Daria Sacchini (PIACENZA-Malattie Infettive), Chiara Martinelli (PISA-Malattie Infettive), Rita Consolini (PISA-Pediatria I Università), Linda Vatteroni (PISA-Virologia), Angela Vivarelli (PISTOIA-Malattie Infettive), Alessandro Nerli (PRATO-Malattie Infettive), Lucia Lenzi (PRATO-Virologia), Giacomo Magnani (REGGIO EMILIA-Malattie Infettive), Patrizia Ortolani (RIMINI-Malattie Infettive RIMINI), Massimo Andreoni (ROMA-Cattedra Malattie Infettive Tor Vergata), Guido Palamara (ROMA-IRCCS S. Gallicano), Caterina Fimiani (ROMA-Immunologia Clinica Umberto I), Lucia Palmisano (ROMA-Istituto Superiore di Sanità), Simona Di Giambenedetto (ROMA-Istituto di Clinica Malattie Infettive Cattolica), Manuela Colafigli (ROMA-Laboratorio virologia Cattolica), Vincenzo Vullo (ROMA-Malattie Infettive e Tropicali La Sapienza-Umberto I), Ombretta Turriziani (ROMA-Medicina Sperimentale e Patologia-Sezione Virologia-La Sapienza), Marco Montano (ROMA-Virologia per Malattie Infettive Tor Vergata), Andrea Antinori (ROMA, IRCCS Spallanzani), Chiara Dentone (SAN REMO-Malattie Infettive), Angela Gonnelli (SIENA-Malattie Infettive), Andrea De Luca (SIENA-Malattie Infettive 2), Maurizio Zazzi (SIENA-Virologia), Michele Palumbo (TERNI-Malattie Infettive), Valeria Ghisetti (TORINO-Laboratorio di Virologia, Ospedale Amedeo di Savoia), Stefano Bonora (TORINO-Malattie Infettive Amedeo di Savoia), Palma Delle Foglie (TRENTO-Malattie Infettive), Cristina Rossi (TREVISO-Malattie Infettive; VERBANIA-Infettive), Vincenzo Mondino (VERBANIA-Virologia), Marina Malena (VERONA-Centro di Medicina Preventiva), Paolo Grossi (VARESE-Clinica Malattie Infettive e Tropicali), Elena Seminari (VARESE-Virologia), Federica Poletti (VERBANIA-Malattie ULSS 20).

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Sterrantino, G., Zaccarelli, M., Colao, G. et al. Genotypic resistance profiles associated with virological failure to darunavir-containing regimens: a cross-sectional analysis. Infection 40, 311–318 (2012). https://doi.org/10.1007/s15010-011-0237-y

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