Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice
Martina Ranzenigo,1,2 Nicola Gianotti,2 Laura Galli,2 Andrea Poli,2 Andrea Mastrangelo,1,2 Elena Bruzzesi,1,2 Matteo Chiurlo,1,2 Silvia Nozza,2 Simona Bossolasco,2 Vincenzo Spagnuolo,2 Daniela Mancusi,3 Roberta Termini,3 Elisabetta Carini,2 Adriano Lazzarin,2 Antonella Castagna1,2 1Vita-Salute San R...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-06-01
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| Series: | Drug Design, Development and Therapy |
| Subjects: | |
| Online Access: | https://www.dovepress.com/switching-from-a-non-protease-inhibitor-based-regimen-to-the-fixed-dos-peer-reviewed-fulltext-article-DDDT |
| _version_ | 1818549354394288128 |
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| author | Ranzenigo M Gianotti N Galli L Poli A Mastrangelo A Bruzzesi E Chiurlo M Nozza S Bossolasco S Spagnuolo V Mancusi D Termini R Carini E Lazzarin A Castagna A |
| author_facet | Ranzenigo M Gianotti N Galli L Poli A Mastrangelo A Bruzzesi E Chiurlo M Nozza S Bossolasco S Spagnuolo V Mancusi D Termini R Carini E Lazzarin A Castagna A |
| author_sort | Ranzenigo M |
| collection | DOAJ |
| description | Martina Ranzenigo,1,2 Nicola Gianotti,2 Laura Galli,2 Andrea Poli,2 Andrea Mastrangelo,1,2 Elena Bruzzesi,1,2 Matteo Chiurlo,1,2 Silvia Nozza,2 Simona Bossolasco,2 Vincenzo Spagnuolo,2 Daniela Mancusi,3 Roberta Termini,3 Elisabetta Carini,2 Adriano Lazzarin,2 Antonella Castagna1,2 1Vita-Salute San Raffaele University, Milan, Italy; 2Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy; 3Medical Affairs Department, Infectious Disease and Vaccines & PAH, Janssen-Cilag SpA, Cologno Monzese, ItalyCorrespondence: Daniela Mancusi, Medical Affairs Department, Infectious Disease and Vaccines & PAH, Janssen-Cilag SpA, Via Buonarroti 23, Cologno Monzese (MI), 20093, Italy, Tel +0039-345 9581944, Email dmancusi@its.jnj.comBackground: The primary objective of this study was to estimate the proportion of people living with HIV (PLWH) who switched from a non-protease inhibitor (PI)-based regimen [integrase strand transfer inhibitor (InSTI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen] to darunavir, cobicistat, emtricitabine, tenofovir alafenamide (D/C/F/TAF).Methods: This was a retrospective study on PLWH treated with a non-PI regimen in January 2017, who switched to D/C/F/TAF or to another antiretroviral therapy (ART) within November 2019. Follow-up was from the start date of D/C/F/TAF until the last available visit or discontinuation for any reason of this regimen. Virological failure (VF) was defined as 2 consecutive HIV-RNA values > 50 copies/mL. Characteristics were reported as median (interquartile range) or frequency (%). A univariate Poisson regression model was used to measure the incidence rate of switch to D/C/F/TAF. Changes in laboratory parameters during D/C/F/TAF were assessed by univariate mixed linear models.Results: Overall, 3076 PLWH were included; 83% were male, median age at ART switch was 50 (42– 56) years and median time on ART was 5.2 (0.3– 13.0) years. PLWH had a median follow-up of 4.76 (3.70– 6.38) years; during 17,099 person-years of follow-up (PYFU), 423/3076 (14%) participants discontinued the non-PI-based regimen and 106/423 (25%) switched to D/C/F/TAF, with an overall incidence rate of switch to D/C/F/TAF of 6.2 per 1000-PYFU (95% CI: 5.0– 7.4). Among PLWH who switched to D/C/F/TAF, the ongoing regimen was based on NNRTIs in 37 (35%) and on InSTIs in 69 (65%). Main reasons leading to switch to D/C/F/TAF included neuropsychiatric adverse events (37%), VF (26%) and Kaposi sarcoma progression (5%).Conclusion: In the last years, a non-negligible proportion of patients on an NNRTI- or an InSTI-based regimen switched to D/C/F/TAF.Keywords: treatment switching, anti-retroviral agents, HIV protease inhibitors, adverse drug events, sustained virologic response |
| first_indexed | 2024-12-12T08:32:16Z |
| format | Article |
| id | doaj.art-5b17757785184543814fbef451ace17e |
| institution | Directory Open Access Journal |
| issn | 1177-8881 |
| language | English |
| last_indexed | 2024-12-12T08:32:16Z |
| publishDate | 2022-06-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Drug Design, Development and Therapy |
| spelling | doaj.art-5b17757785184543814fbef451ace17e2022-12-22T00:31:03ZengDove Medical PressDrug Design, Development and Therapy1177-88812022-06-01Volume 161975198276189Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical PracticeRanzenigo MGianotti NGalli LPoli AMastrangelo ABruzzesi EChiurlo MNozza SBossolasco SSpagnuolo VMancusi DTermini RCarini ELazzarin ACastagna AMartina Ranzenigo,1,2 Nicola Gianotti,2 Laura Galli,2 Andrea Poli,2 Andrea Mastrangelo,1,2 Elena Bruzzesi,1,2 Matteo Chiurlo,1,2 Silvia Nozza,2 Simona Bossolasco,2 Vincenzo Spagnuolo,2 Daniela Mancusi,3 Roberta Termini,3 Elisabetta Carini,2 Adriano Lazzarin,2 Antonella Castagna1,2 1Vita-Salute San Raffaele University, Milan, Italy; 2Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy; 3Medical Affairs Department, Infectious Disease and Vaccines & PAH, Janssen-Cilag SpA, Cologno Monzese, ItalyCorrespondence: Daniela Mancusi, Medical Affairs Department, Infectious Disease and Vaccines & PAH, Janssen-Cilag SpA, Via Buonarroti 23, Cologno Monzese (MI), 20093, Italy, Tel +0039-345 9581944, Email dmancusi@its.jnj.comBackground: The primary objective of this study was to estimate the proportion of people living with HIV (PLWH) who switched from a non-protease inhibitor (PI)-based regimen [integrase strand transfer inhibitor (InSTI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen] to darunavir, cobicistat, emtricitabine, tenofovir alafenamide (D/C/F/TAF).Methods: This was a retrospective study on PLWH treated with a non-PI regimen in January 2017, who switched to D/C/F/TAF or to another antiretroviral therapy (ART) within November 2019. Follow-up was from the start date of D/C/F/TAF until the last available visit or discontinuation for any reason of this regimen. Virological failure (VF) was defined as 2 consecutive HIV-RNA values > 50 copies/mL. Characteristics were reported as median (interquartile range) or frequency (%). A univariate Poisson regression model was used to measure the incidence rate of switch to D/C/F/TAF. Changes in laboratory parameters during D/C/F/TAF were assessed by univariate mixed linear models.Results: Overall, 3076 PLWH were included; 83% were male, median age at ART switch was 50 (42– 56) years and median time on ART was 5.2 (0.3– 13.0) years. PLWH had a median follow-up of 4.76 (3.70– 6.38) years; during 17,099 person-years of follow-up (PYFU), 423/3076 (14%) participants discontinued the non-PI-based regimen and 106/423 (25%) switched to D/C/F/TAF, with an overall incidence rate of switch to D/C/F/TAF of 6.2 per 1000-PYFU (95% CI: 5.0– 7.4). Among PLWH who switched to D/C/F/TAF, the ongoing regimen was based on NNRTIs in 37 (35%) and on InSTIs in 69 (65%). Main reasons leading to switch to D/C/F/TAF included neuropsychiatric adverse events (37%), VF (26%) and Kaposi sarcoma progression (5%).Conclusion: In the last years, a non-negligible proportion of patients on an NNRTI- or an InSTI-based regimen switched to D/C/F/TAF.Keywords: treatment switching, anti-retroviral agents, HIV protease inhibitors, adverse drug events, sustained virologic responsehttps://www.dovepress.com/switching-from-a-non-protease-inhibitor-based-regimen-to-the-fixed-dos-peer-reviewed-fulltext-article-DDDTtreatment switchinganti-retroviral agentshiv protease inhibitorsadverse drug eventssustained virologic response |
| spellingShingle | Ranzenigo M Gianotti N Galli L Poli A Mastrangelo A Bruzzesi E Chiurlo M Nozza S Bossolasco S Spagnuolo V Mancusi D Termini R Carini E Lazzarin A Castagna A Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice Drug Design, Development and Therapy treatment switching anti-retroviral agents hiv protease inhibitors adverse drug events sustained virologic response |
| title | Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice |
| title_full | Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice |
| title_fullStr | Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice |
| title_full_unstemmed | Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice |
| title_short | Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice |
| title_sort | switching from a non protease inhibitor based regimen to the fixed dose combination of darunavir cobicistat emtricitabine tenofovir alafenamide in clinical practice |
| topic | treatment switching anti-retroviral agents hiv protease inhibitors adverse drug events sustained virologic response |
| url | https://www.dovepress.com/switching-from-a-non-protease-inhibitor-based-regimen-to-the-fixed-dos-peer-reviewed-fulltext-article-DDDT |
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