Regímenes STR: Análisis Crítico · 2018-10-04 · Raltegravir Aluminium and magnesium containing...
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Regímenes STR:Análisis Crítico
XXI Curso VIH
SOCHINF
Agosto 2018
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Conflictos de interés
Speaker/ Congresos
• MSD
• Pfizer
• Abbott
• Novartis
Actividad laboral
• Fundación Arturo López Pérez
• Consulta privada pacientes VIH
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Regímenes de tableta única disponibles (STR)
Agent Type Yr of FDA
Approval
Efavirenz/tenofovir DF/emtricitabine
(EFV/TDF/FTC)
NNRTI + dual NRTI 2006
Rilpivirine/tenofovir DF/emtricitabine
(RPV/TDF/FTC)
NNRTI + dual NRTI 2011
Elvitegravir/cobicistat/tenofovir DF/emtricitabine
(EVG/COBI/TDF/FTC)*
INSTI + booster + dual NRTI 2012
Dolutegravir/abacavir/lamivudine
(DTG/ABC/3TC)*
INSTI + dual NRTI 2014
Elvitegravir/cobicistat/tenofovir alafenamide/emtricitabine
(EVG/COBI/TAF/FTC)*
INSTI + booster + dual NRTI 2015
Rilpivirine/tenofovir alafenamide/emtricitabine
(RPV/TAF/FTC)
NNRTI + dual NRTI 2016
Bictegravir /tenofovir alafenamide/emtricitabine * INSTI + dual NRTI 2018 (BIC/ FTC /TAF)
*DHHS recommended regimen for initial ART.
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Class DHHS[1] IAS-USA[2]
INSTI BIC/TAF/FTC DTG/ABC/3TC DTG + (TAF or TDF)/FTC EVG/COBI/(TAF or
TDF)/FTC RAL + (TAF or TDF)/FTC
BIC/TAF/FTC DTG/ABC/3TC DTG + TAF/FTC
DHHS, IAS-USA Guidelines: Recommended Regimens for First-line ART
• Recommendations may differ based on baseline HIV-1 RNA, CD4+ cell count, CrCl, eGFR, HLA-B*5701 status, HBsAg status, osteoporosis status, and pregnancy status
• Data are lacking for women of child-bearing age not using contraception
• IAS-USA now lists EVG/COBI/TAF/FTC and RAL + TAF/FTC as alternative regimens owing to their lower resistance barriers and, respectively, more drug interactions and higher pill burden[2]
1. DHHS Guidelines. May 2018. 2. Saag MS, et al. JAMA. 2018;320:379-396.
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Potenciales Ventajas y desventajas de Regímenesde tableta única (STR)
VENTAJAS DESVENTAJAS
Simplicity
Conveniencia
Reduce la no adherencia
selectiva a componentes del
regimen terapeútico
Imposibilidad de ajuste de
dosis de sus componentes
individuales si se requiere:
-interacciones
medicamentosas , tolerancia ,
insuficiencia renal
No disponible para todos los
regímenes de TARV.
No disponible para todos los
backbone de NRTI.
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ATHENA and Swiss HIV Cohort Studies: Polifarmacia enPacientes Among VIH + en terapia antiretroviral
5.2% of pts 50-64 yrs of age and 14.2% of pts ≥ 65 yrs of age received ≥ 4 meds other than ART comedications
• Predicts that 20% of pts will be receiving ≥ 3 meds other than ART in 2030
1. Smit M, et al. Lancet Infect Dis. 2015;15:810-818. 2. Hasse B, et al. Clin Infect Dis.
2011:53;1130-1139.
ATHENA Modeling Study[1]
16,0
0014,0
0012,0
0010,0
00800
600
0400
0200
00P
eop
le (
n)
+ comedications2 comedications1 comedicationNo comedication
201
0
201
5
2020 202
5
203
0
Swiss HIV Cohort
Study (N = 8444)[2]
Prospective Observational
Study
< 50 Yrs 50-64 Yrs ≥ 65 Yrs
10
0
80
60
40
20
0
Part
icip
ants
(%
)
n5761 2233 450
No
comedication
1 comedication
2 comedication
3 comedications
4+
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Una variedad de interaccionesfarmacocinéticas afectan absorción de drogas
El grado de absorción oral de antiretrovirales pueden ser afectados por :• Ambiente Gástrico• Agentes que disminuyen la producción de ácido (ej. PPIs,
antagonistas H2, antiácidos) pueden reducir la absorción de ARVs que requieren acidez gástrica (ej. ATV -RPV)
• Cationes Polivalentes en algunos productos (ej. Al3+-, Ca2+-, Mg2+ en antiácidos/suplementos/ productos con fierro) pueden unirse a inhibidores de integrasa y reducir suabsorción.
• Drogas que inducen/inhiben enzima CYP3A4 o la glicoproteína P intestinal (efflux transporter) puedereducir/promover la absorción de otras drogas.
DHHS guidelines. Updated October 2017. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf
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Antiácidos disminuyen concentraciones plasmáticasde Elvitegravir
Ramanathan S, et al. J Acquir Immune Defic Syndr 2013;64:45–50
0 6 12 18 24
1000
100
EVG/r alone
EVG/r + antacid (Al/Mg)
Mea
n (
SD)
pla
sma
con
cen
trat
ion
(n
g/m
L)
Time (hours)
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Patel et al 2011
Dolutegravir Quelación de Inhibidores de Integrasa por cationes
polivalentes
0 10 20 30 40 50 8060 70
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
Mea
n D
TG c
on
cen
trat
ion
(µ
g/m
L)
Time (h)
DTG + antacid 2 hours later
DTG alone
DTG + antacid
Mg2+
Mg2+
InSTI
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Inhibidores de Integrasa y Antiácidos que contienenCationes : Recommendaciones
Inhibidores de Integrasa
Recomendación
RaltegravirAluminium and magnesium containing antacids reduce RAL plasma levels. Co- or staggered administration of RAL with these antacids is NOT recommended.RAL 600 and Ca++ (altas dosis) - NOT recommendedRAL 400 with Ca++ no dose adjustment
DolutegravirMagnesium/ aluminium-containing antacid should be taken well separated in time from the administration of DTG (minimum 2 hours after or 6 hours before). Applies also to Ca++ and Fe++ supplements.
Elvitegravir/cobicistat
It is recommended to separate Stribild and antacid administration by at least 4 hours.No specific recommendation for Ca++ and Fe++.
Tivicay SPC; Isentress SPC; Stribild SPC
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*Recommended TDF/FTC dose in pts with CrCl 30-49 mL/min: 1 tablet q48h. †Caution needed in INSTI-experienced pts (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with severe renal impairment.
ARVFDA Approved for Pts
With CrCl, mL/min
EVG/COBI/FTC/TDF[1] ≥ 70
DRV/COBI[2] + FTC/TDF*[3] ≥ 70
EFV/FTC/TDF[4] ≥ 50
RPV/FTC/TDF[5] ≥ 50
DTG/ABC/3TC[6] ≥ 50
DRV/RTV, DTG,† or RAL + FTC/TDF*[3] ≥ 50
EVG/COBI/FTC/TAF[7] ≥ 30
RPV/FTC/TAF[8] ≥ 30
DRV/COBI, DRV/RTV, DTG†, or RAL +
FTC/TAF[9]
≥ 30
Consideraciones para Pacientes con InsuficienciaRenal
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Potenciales Interaciones para Cobicistat y Ritonavir
• Ambos inhiben CYP3A y gp-P; RTV es un inductor de CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, y UGT1A1
Marzolini C, et al. J Antimicrob Chemother. 2016;71:1755-1758.
COBI [package insert]. RTV [package insert].
Agents That Have Interactions With RTV and/or COBI
Analgesics Contraceptives
Antiarrhythmics Digoxin
Anticancer agents Glucocorticoids
Anticoagulants Methamphetamine
Anticonvulsants PDE5 inhibitors
Antidepressants Rifabutin
Beta-blockers Sedatives/hypnotics
Clarithromycin Statins
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Selección de Inhibidor de Integrasa
Agent Advantages Disadvantages
RAL Longest experience
Fewer DDIs vs EVG, DTG
No coformulation
Relatively low barrier to resistance
EVG STR with TAF
Once-daily dosing
EVG/COBI/FTC/TAF STR
approved for use in pts with CrCl
> 30 mL/min
Requires COBI boosting with
associated DDIs
Relatively low barrier to resistance
DTG Only non-tenofovir–containing
STR
Once-daily dosing
Higher barrier to resistance
Few DDIs
Active against some RAL- and
EVG-resistant virus
Only coformulated with ABC/3TC
Increases metformin levels
DTG/ABC/3TC STR not
recommended for pts with CrCl < 50
mL/min
EVG/COBI/FTC/TAF [package insert]. DTG/ABC/3TC [package insert]. RAL
[package insert].
Clutter DS, et al. Infect Genet Evol. 2016
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Tsepamo: Defectos Tubo Neural y Exposición a Dolutegravir
• At latest analysis on July 15, 2018[2]
– NTD prevalence with DTG exposure at conception: 4/596(0.67%; 95% CI: 0.26% to 1.7%)
– NTD prevalence with DTG started during pregnancy: 1/3104(0.03%; 95% CI: 0.01% to 0.18%)
• Next formal analysis to occur after March 31, 2019, which will include 72% of national births
Zash R, et al. N Engl J Med. 2018;[Epub ahead of print]. 2. Zash R, et al. AIDS 2018. Session TUSY15.
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Estudios Clínicos STR
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STARTMARK 156 semanas RAL vs EFV
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Boosted EVG-Based Regimens Noninferior in Treatment-Naive Pts at Wk 48
1. Sax PE, et al. Lancet. 2012;379:2439-2448.
2. DeJesus E, et al. Lancet. 2012;379:2429-2438.
3. Sax PE, et al. Lancet. 2015;385:2606-2615.
Study Regimens Wk 48 HIV-1 RNA
< 50 c/mL, %
Adjusted
Treatment
Difference, %
(95% CI)
GS-102[1]
EVG/COBI/FTC/TDF
(n = 348)
EFV/FTC/TDF (n =
352)
87.6
84.13.6 (-1.6 to 8.8)
GS-103[2]
EVG/COBI/FTC/TDF
(n = 353)
ATV/RTV + FTC/TDF
(n =355)
89.5
86.83.0 (-1.9 to 7.8)
GS-
104/111[3]
EVG/COBI/FTC/TAF
(n = 866)
EVG/COBI/FTC/TDF
(n = 867)
92.4
90.42.0 (-0.7 to 4.7)
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Estudio SINGLE
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Resultado virológico semana 48-96-144
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Fracaso virológico
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Estudio SPRING 2
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Resultado virológico semana 96
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Fracaso virológico
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Eventos adversos
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Bictegravir
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CROI 2018
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DRV/COBI/FTC/TAF: Primer STR basadoen Inhibidores de la Proteasa
• Once-daily single-tablet regimen approved by FDA in July 2018
DRV/COBI/FTC/TAF [package insert]. July 2018.
Key US Label Information
Indications For treatment-naive patients For patients with virologic suppression (ie, HIV-1 RNA < 50 copies/mL)
for ≥ 6 mos with no known resistance to DRV or tenofovir
Administration requirements
Take with food
Key DDIs
Contraindicated with: alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine (if renal/hepatic impairment), rifampin, lurasidone, pimozide, ergot derivatives, cisapride, St John’s wort, elbasvir/grazoprevir, lovastatin, simvastatin, sildenafil (when used for pulmonary arterial hypertension), oral midazolam, oral triazolam
Dose adjustments
None for mild/moderate renal or hepatic impairment; not recommended if CrCl < 30 mL/min or Child-Pugh C
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Encuesta de TARV
• 48 pacientes con TARV no STR
• 46 hombres 2 mujeres
• 4 (8,3%) responden que mantendrían su actual TARV.
• 44 (91,7 %) cambiarían a STR.
• 35 (73%) cambiarían a antiretrovirales de depósito inyectables cada 8 semanas.
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Conclusiones
• Terapias STR se consideran como de primera Línea en Guías Clínicas nacionales e internacionales.
• Considerar y monitorizar sus diversas interacciones medicamentosas.
• No olvidar seguimiento de función renal.
• Se necesita más evidencia de eficacia en pacientes que debutan con enfermedad avanzada.