tetano
Editor, Senior Moderator
Iran J Pharm Res
. Fall 2021;20(4):278-288.
doi: 10.22037/ijpr.2021.115157.15243.
Comparison of the Efficacy and Safety of Atazanavir/Ritonavir Plus Hydroxychloroquine with Lopinavir/Ritonavir Plus Hydroxychloroquine in Patients with Moderate COVID-19, A Randomized, Double-blind Clinical Trial
Zahra Nekoukar[SUP] 1 [/SUP], Shahram Ala[SUP] 1 [/SUP], Siavash Moradi[SUP] 2 [/SUP], Andrew Hill[SUP] 3 [/SUP], Ali Reza Davoudi Badabi[SUP] 4 [/SUP], Ahmad Alikhani[SUP] 4 [/SUP], Shahriar Alian[SUP] 4 [/SUP], Minoo Moghimi[SUP] 1 [/SUP], Amir Mohammad Shabani[SUP] 1 [/SUP], Hamideh Abbaspour Kasgari[SUP] 1 [/SUP]
Affiliations
Abstract
This was a randomized, double-blind clinical trial to compare the efficacy and safety of Atazanavir/Ritonavir (ATZ/RTV) with Lopinavir/Ritonavir (LPV/RTV) in moderate Coronavirus disease 2019 (COVID-19). Participants were randomly assigned to receive a single dose of hydroxychloroquine (HCQ) plus ATZ/RTV or LPV/RTV for a minimum of 5 to a maximum of 10 days. The primary outcomes were the reduced length of hospital stay and clinical recovery within 10 days from starting the intervention. The rate of intensive care unit (ICU) admission, intubation, and mortality, the lengths of ICU stay and being intubated, recovery within 14 days, and the frequency of adverse reactions were considered as secondary outcomes. Among 132 enrolled patients, 62 cases in each arm were analyzed at the end of the intervention. Fifty-one (82.3%) cases in the ATZ/RTV arm versus 41 (66.1%) in the LPV/RTV arm were discharged within 10 days (P = 0.06). The median number of the intervention days was 6 (IQR: 5-8) in ATZ/RTV arm versus 7 (IQR: 6-9) in LPV/RTV arm (P = 0.01). The rate and length of ICU admission and intubation (P ≥ 0.99), rate of mortality (P = 0.49), and recovery within 14 days (P = 0.09) were not statistically different between groups. The most reported adverse reactions were nausea and vomiting that all cases were in the LPV/RTV arm (P = 0.006). ATZ/RTV is better tolerated in comparison with LPV/RTV; however, it did not show more efficacy than LPV/RTV in clinical outcomes of COVID-19 in this study.
Keywords: Atazanavir; COVID-19; Hospital stay; Lopinavir; Mortality; Safety.
. Fall 2021;20(4):278-288.
doi: 10.22037/ijpr.2021.115157.15243.
Comparison of the Efficacy and Safety of Atazanavir/Ritonavir Plus Hydroxychloroquine with Lopinavir/Ritonavir Plus Hydroxychloroquine in Patients with Moderate COVID-19, A Randomized, Double-blind Clinical Trial
Zahra Nekoukar[SUP] 1 [/SUP], Shahram Ala[SUP] 1 [/SUP], Siavash Moradi[SUP] 2 [/SUP], Andrew Hill[SUP] 3 [/SUP], Ali Reza Davoudi Badabi[SUP] 4 [/SUP], Ahmad Alikhani[SUP] 4 [/SUP], Shahriar Alian[SUP] 4 [/SUP], Minoo Moghimi[SUP] 1 [/SUP], Amir Mohammad Shabani[SUP] 1 [/SUP], Hamideh Abbaspour Kasgari[SUP] 1 [/SUP]
Affiliations
- PMID: 35194446
- PMCID: PMC8842611
- DOI: 10.22037/ijpr.2021.115157.15243
Abstract
This was a randomized, double-blind clinical trial to compare the efficacy and safety of Atazanavir/Ritonavir (ATZ/RTV) with Lopinavir/Ritonavir (LPV/RTV) in moderate Coronavirus disease 2019 (COVID-19). Participants were randomly assigned to receive a single dose of hydroxychloroquine (HCQ) plus ATZ/RTV or LPV/RTV for a minimum of 5 to a maximum of 10 days. The primary outcomes were the reduced length of hospital stay and clinical recovery within 10 days from starting the intervention. The rate of intensive care unit (ICU) admission, intubation, and mortality, the lengths of ICU stay and being intubated, recovery within 14 days, and the frequency of adverse reactions were considered as secondary outcomes. Among 132 enrolled patients, 62 cases in each arm were analyzed at the end of the intervention. Fifty-one (82.3%) cases in the ATZ/RTV arm versus 41 (66.1%) in the LPV/RTV arm were discharged within 10 days (P = 0.06). The median number of the intervention days was 6 (IQR: 5-8) in ATZ/RTV arm versus 7 (IQR: 6-9) in LPV/RTV arm (P = 0.01). The rate and length of ICU admission and intubation (P ≥ 0.99), rate of mortality (P = 0.49), and recovery within 14 days (P = 0.09) were not statistically different between groups. The most reported adverse reactions were nausea and vomiting that all cases were in the LPV/RTV arm (P = 0.006). ATZ/RTV is better tolerated in comparison with LPV/RTV; however, it did not show more efficacy than LPV/RTV in clinical outcomes of COVID-19 in this study.
Keywords: Atazanavir; COVID-19; Hospital stay; Lopinavir; Mortality; Safety.