Effects of cobicistat on tenofovir exposure and its long-term tolerability: is it time to rethink at TAF trials?
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1 Effects of cobicistat on tenofovir exposure and its long-term tolerability: is it time to rethink at TAF trials? Sara Baldelli 1, Andrea Giacomelli 2, Davide Minisci 2, Cristina Mazzali 3, Laura Milazzo 2, Paola Meraviglia 2, Giuliano Rizzardini 2, Emilio Clementi 1, Massimo Galli 2, Dario Cattaneo 1 and Cristina Gervasoni 2 1 Department of Infectious Disease and 2 Unit of Clinical Pharmacology, L. Sacco University Hospital, Milan, Italy; 3 Department of Management, Economics and Industrial Engineering (DIG), Politecnico di Milano
2 Tenofovir disoproxil fumarate (TDF) is given at 300 mg daily according to a one dose fits all approach
3 Tenofovir disoproxil fumarate (TDF) is given at 300 mg daily according to a one dose fits all approach It has been demonstrated that there is a large inter-individual variability in the exposure to the drug Box-plot of Tenofovir (TDF) plasma trough concentrations measured in 100 HIV-infected patients. Gervasoni at al, PLoS One. 2013
4 Rodriguez-Novoa at al, AIDS. 2010
5 AIDS, 2014
6
7 Aims: 1. To identify demographic, hematochemical and clinical covariates potentially associated with TFV plasma trough concentrations
8 Aims: 1. To identify demographic, hematochemical and clinical covariates potentially associated with TFV plasma trough concentrations 2. To investigate the potential role of boosting agents (ritonavir or cobicistat) on TDF tolerability
9 Materials and methods Patients: Patients included in the study: Patients receiving TDF-containing antiretroviral therapies for at least three months Patients with at least one request of TDM of TFV plasma trough concentrations
10 Materials and methods Patients: Patients included in the study: Patients receiving TDF-containing antiretroviral therapies for at least three months Patients with at least one request of TDM of TFV plasma trough concentrations Patients excluded from the study: Paediatric subjects Patients with severe hepatic impairment (defined as Child-Pugh Class B or C) Patients with history of kidney or bone disease Patients with Cl Cr <80 ml/min before starting TFV
11 Materials and methods Statistical analysis: Uni- and multivariate regression analyses TFV concentration = dependent variable Clinical characteristics recorded at the time of TDM = independent covariates Data were grouped in 4 main drug classes: protease inhibitors/ritonavir (atazanavir, darunavir, lopinavir, fosamprenavir) non nucleoside reverse transcriptase inhibitors (efavirenz, rilpivirine, nevirapine) integrase inhibitors (dolutegravir, raltegravir) elvitegravir/cobicistat co-fomulation
12 Materials and methods Statistical analysis: The composite outcome of TDF toxicity included: patients who discontinued TDF for drug-related toxicity (established by the attending physicians) patients that remained on TDF but experienced a clinical worsening in the renal (defined by a >30% increment in serum creatinine concentration from the baseline to the last available) or bone (development of osteopenia or osteoporosis ) function
13 Results 1: Total Patients: 510 PIs/r (n=207, 41.6%) NNRTIs (n=178, 34.5%) INIs (n=49, 9.0%) ELV/COBI (n=76, 14.9%) PIs/r NNRTIs INIs ELV/COBI Males (%) 63% 77% 67% 85% Age (years) 47±10 48± 10 48± 9 44±9 Body weight (Kg) 68±16 70±14 69±13 71±12 Tenofovir therapy (days) 1642± ± ± ±680 Serum creatinine (mg/dl) 0.9± ± ± ±0.2 Co-infections (%) 43% 23% 49% 23% Viral load >37 copies/ml (%) 21% 5% 14% 23% CD4 cell count <250 cells/ml (%) 12% 5% 17% 16%
14 conc. TFV (ng/ml) Results 1: Distribution of TFV trough concentrations
15 conc. TFV (ng/ml) TDF, ng/ml Results 1: Distribution of TFV trough concentrations TFV concentrations clustered according to the companion antiretroviral classes ** ** PIs/ ritonavir NNRTIs INIs Elvitegravir/ COBI Box and Whiskers plots represent the 5th, 25th, 50th, 75th and 95th percentiles, respectively **p<0.01 vs NNRTIS and INIs
16 Results 1: Uni- and multi-variate regression analyses using TFV plasma trough concentrations as the dependent variable and clinical covariates as independent variables Univariate analysis Multivariate analysis beta SD p-value beta SD p-value Concomitant ART < < ELV/COBI vs. PIs INIs vs. PIs NNRTIs vs. PIs Gender (females vs. males) Co-infections (NO vs YES) CD4 cell count (cells/ml) [0-250] vs. [ ] [ ] vs. [ >500] Viral load (>37 vs <37 copies/ml) Duration of TDF therapy <1 yr vs. >6 yrs (1 yr-3 yrs] vs. > 6yrs (3 yr-6 yrs] vs. > 6yrs ,628 Patients age < Body weight Serum creatinine < <0.0001
17 Results 2: Total cases of TDF toxicity: 149 PIs/r (n=75/207, 36,2%) NNRTIs (n=41/178, 23,0%) INIs (n=13/49, 26,5%) ELV/COBI (n=20/76, 26,3%)
18 Probability of free TDF-associated toxicity/discontinuation Results 2: Product-Limit Survival Estimates + + Censored Kaplan-Meier estimates of risk to develop TDF toxicity clustered according to companion antiretroviral classes Product-Limit Survival Estimates Censored Survival Probability Log-Rank p= tempo_a_ev gruppi gruppi terapia terapia COBI COBI INI INI NNRTI NNRTI PI PI Days tempo_a_ev from starting TDF gruppi terapia COBI INI NNRTI PI
19 Probability of free TDF-associated toxicity/discontinuation Results 2: Survival Probability Product-Limit Survival Estimates + + Censored Kaplan-Meier estimates of risk to develop TDF toxicity clustered according to companion antiretroviral classes Product-Limit Survival Estimates Log-Rank p= The + Censored probability to develop a toxic event in the first year is: x COBI x INI x NNRTI x PI tempo_a_ev gruppi gruppi terapia terapia COBI COBI INI INI NNRTI NNRTI PI PI Days tempo_a_ev from starting TDF gruppi terapia COBI INI NNRTI PI
20 Results 2: Cox proportional hazards model to investigate the role of clinical and pharmacological covariates on TDF tolerability (estimated both as development of TDF toxicity or TDF discontinuation) Parameter Stratification Overall Type 3 Probability >Chi-Square Hazard Ratio HR-CI Antiretroviral therapy ELV/COBI INIs NNRTIs Serum creatinine Body weight Gender 2 females Patients age CD4 cell count [ ] [>500] Duration of TDF therapy [1yr-3yrs] [3yrs-6yrs] [>6yrs] Tenofovir concentrations* ,021* PIs as the reference; 2 males as the reference; 3 CD4 [0-250] as the reference; 4 <1 yr as the reference. per 10 ng/ml increment of TFV concentrations
21 Conclusions We confirmed the importance of clinical covariates in predicting TDF overexposure. Indeed, in agreement with previous findings we demonstrated that female gender, aging and low patients body weight were all significantly and independently associated with high tenofovir plasma trough concentrations
22 Conclusions We confirmed the importance of clinical covariates in predicting TDF overexposure. Indeed, in agreement with previous findings we demonstrated that female gender, aging and low patients body weight were all significantly and independently associated with high tenofovir plasma trough concentrations Why despite these evidences all HIV-infected adult patients are still treated with the same TDF dose, irrespectively of their characteristics?
23 Conclusions Co-administration with cobicistat given co-formulated with elvitegravir resulted in significantly higher TDF plasma trough concentrations compared with all other ART regimens, including also ritonavir-boosted PIs
24 Conclusions Co-administration with cobicistat given co-formulated with elvitegravir resulted in significantly higher TDF plasma trough concentrations compared with all other ART regimens, including also ritonavir-boosted PIs Why HIV- infected adult patients are treated with the same TDF dose, irrespectively of boosted/not boosted ART co-regimen?
25 Conclusions TAF: is used at 25 mg in absence of P-gp inhibitor is used at 10 mg in presence of P-gp inhibitor The possibility that the lack of proper dose adjustment for TDF when given with COBI (or with RTV) could have introduced a bias in the comparison of safety between TAF and TDF during registrative trials, cannot be ruled out
26
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