summary i: opportunistic infections hcv/hbv co-infections ... · ampliprep/cobas® taqman® version...
TRANSCRIPT
![Page 1: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/1.jpg)
La Pedrera, BarcelonaMarch 1st 2016
Dr. José M. MiróInfectious Diseases Service Hospital Clinic - IDIBAPS University of Barcelona
Barcelona (Spain)
Summary I: Opportunistic InfectionsHCV/HBV Co-Infections & Tumors
E-mail address: [email protected]
![Page 2: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/2.jpg)
Accepted, 951 (49%)- Oral, 114- Poster, 884 Hepatitis (mainly HCV), 97 Tuberculosis, 31 Other OIs and Cancer, 45
Abstracts - CROI 2016
![Page 3: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/3.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 4: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/4.jpg)
START
Effect of Immediate-initiation ART on risk of severe bacterial infections (SBI) in HIV positive
people with CD4 count > 500/mm3
Jemma O’Connor, Fred Gordin, Andrew Phillips, Brian Angus, David Cooper, Beatriz Grinsztejn, Gustavo Lopardo, Satyajit Das, Aimee Wilkin, Elbushra Herieka, David Jilich, Hartwig Klinker, Pacharee Kantipong, Karin Klingman,
Jens Lundgren for the INSIGHT START study group
CROI 2016 #474
![Page 5: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/5.jpg)
NEJM 2015
![Page 6: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/6.jpg)
START
Results - endpoint summary• 94 people experienced at least one Severe Bacterial
Infection [SBI] (immediate-initiation group n=28, deferred-initiation group n=66) during 13,890 person-years at risk (incidence of 0.68 per 100 person-years of follow-up (PYFU), 95% CI 0.54–0.81).
• Of the 94 people who developed an SBI, 50 experienced a bacterial infectious disease [BID] (immediate-initiation group n=14, deferred-initiation group n=36) and 48developed bacterial pneumonia (immediate-initiation group n=14, deferred-initiation group n=34).
BID = grade 4 severity, requiring unscheduled hospitalisations or causing death
CROI 2016 #474
![Page 7: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/7.jpg)
START
Results - Change in BiomarkersCROI 2016 #474
![Page 8: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/8.jpg)
START
Results SBI - Cox model CROI 2016 #474
![Page 9: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/9.jpg)
CROI 2016 #160
![Page 10: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/10.jpg)
CROI 2016 #160
![Page 11: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/11.jpg)
CROI 2016 #160
![Page 12: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/12.jpg)
CROI 2016 #160
![Page 13: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/13.jpg)
CROI 2016 #160
![Page 14: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/14.jpg)
CROI 2016 #160
![Page 15: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/15.jpg)
CROI 2016 #160
![Page 16: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/16.jpg)
CROI 2016 #160
![Page 17: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/17.jpg)
#708
Hospitalizations with AIDS and Chronic End‐Organ Conditions in the HIV Outpatient Study (HOPS)
![Page 18: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/18.jpg)
#708
Hospitalizations with AIDS and Chronic End‐Organ Conditions in the HIV Outpatient Study (HOPS)
![Page 19: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/19.jpg)
#708
Hospitalizations with AIDS and Chronic End‐Organ Conditions in the HIV Outpatient Study (HOPS)
Hospitalizations occurred increasingly among patients who were older, had higher CD4 cell counts and lower HIV viral loads.
![Page 20: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/20.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 21: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/21.jpg)
#155
![Page 22: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/22.jpg)
#155RCT designed for nurses in rural primary care clinicsObjectives: Rapid diagnosis and Rx to TB in HIV and early ART in order to reduce mortality.
![Page 23: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/23.jpg)
#155
‐ 83% culture positive TB started TB treatment within 7 days‐ The TB Fast Track algorithm enable nurses to identify people at highest risk of TB and increased % starting TB treatmentSupports existing WHO policy on empirical TB treatment!
![Page 24: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/24.jpg)
#155
![Page 25: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/25.jpg)
#155
The TB Fast Track algorithm did not reduce mortality
![Page 26: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/26.jpg)
#155
The TB Fast Track algorithm did not reduce time to start ART
![Page 27: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/27.jpg)
Treatment Outcomes for HIV/MDR‐TB Co‐infection in the Era of ART in Botswana
#755
![Page 28: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/28.jpg)
Treatment Outcomes for HIV/MDR‐TB Co‐infection in the Era of ART in Botswana
#755
![Page 29: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/29.jpg)
TB Outcomes with ATV/r and Rifabutin‐containing TB Regimen in HIV/TB Co‐Infected Patients in South India
#753
ATV/r‐ART NNRTI‐ART
![Page 30: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/30.jpg)
#158LB
![Page 31: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/31.jpg)
#158LB *High intrinsic resistance against MTB BlaC
*
![Page 32: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/32.jpg)
#158LB
MeropenemAmx‐Clv
FaropenemAmx‐Clv HRZE
![Page 33: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/33.jpg)
751
Association of Tuberculosis With CD4 Recovery and HIV RNA Decline on ART in Europe
![Page 34: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/34.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 35: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/35.jpg)
Pre-ART Cryptococcal Antigen Titer Associated with Preemptive
Fluconazole FailureBozena M Morawski 1, David R Boulware 1, Elizabeth
Nalintya 2, Agnes Kiragga 2, Francis Kakooza 2, Radha Rajasingham 1, Benjamin J Park 3, Yukari
Manabe 2,4, Jonathan E Kaplan 3, David B Meya 1,2
1 University of Minnesota; 2 Infectious Diseases Institute, Uganda; 3 U.S. Centers for Disease Control and Prevention; 4 Johns Hopkins University
#159
![Page 36: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/36.jpg)
CrAg Prevalence
#159
![Page 37: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/37.jpg)
Protocol for CrAg+ Persons• Enrolled shortly after CD4 draw & CrAg result• Initiated preemptive fluconazole at enrollment
– 800mg/day for 2 weeks, then 400mg/day for 8 weeks
– No secondary prophylaxis• Fluconazole intervention exclusion criteria:
Suspected meningitis, history of cryptococcalmeningitis, known cirrhosis or jaundice, allergy or pregnancy
• ART initiated ~2 weeks after fluconazole• Participants followed for 6 months
#159
![Page 38: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/38.jpg)
Population Characteristics
CharacteristicTiters <1:160n=92 (61%)
Titers ≥1:160n=59 (39%) P-value
Age, years 32 [28, 39] 34 [26, 40] 0.69BMI, kgs/m2 19.3 [17.4, 21.1] 19.3 [17.3, 21.2] 0.70Women, percent 39 (42.4%) 29 (49.2%) 0.42Time to enrollment 8 [3.5, 13.5] 8 [3, 13] 0.86Receiving rifampicin 15 (16.3%) 5 (8.5%) 0.17WHO stage III or IV 54 (58.7%) 39 (66.1%) 0.36
#159
![Page 39: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/39.jpg)
Risk of Cryptococcal Meningitis
10-week risk 6-month riskCrAg Titer Cutoff
Hazard Ratio (95%CI)
P-value Hazard Ratio (95%CI)
P-value
>1:160 4.55 (0.97, 21.32) 0.06 9.20 (2.14, 39.58) <0.01
>1:320 5.25 (1.10, 24.95) 0.04 6.33 (1.76, 22.82) <0.01
>1:640 10.07 (2.25, 45.0) <0.01 12.10 (3.38, 43.37) <0.001
*Competing risks regression. Results present the sub-Hazard Ratio adjusted for CD4 cells/L and participant age
#159
![Page 40: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/40.jpg)
Mortality Risk among CrAg+#159
≈10%
≈30%
![Page 41: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/41.jpg)
CrAg+ Risk of Meningitis or Death #159
≈15%
≈40%
![Page 42: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/42.jpg)
Immunologic Discrimination of CryptococcalIRIS from Culture‐positive Relapse
• Prospective cryptococcal meningitis cohorts in Uganda, 2006-2012
• Profiled CD4, viral loads, and CSF cytokines between paradoxical IRIS (n=62) vs. culture-positive relapse (n=12)
• CD4 Change on ART, neither necessary nor predictive:– paradoxical-IRIS events did not consistently have substantial
reconstitution of CD4+ cells (61% increased by >25 cells/L) – In culture positive relapse 50% increased >25 cells/µL.
• Viral Loads– All IRIS events had appropriate virologic responses– 50% of culture-positive relapses had virologic failure. #762
![Page 43: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/43.jpg)
CSF Profiles
Y-axis ValuesWBC in cells/LProtein in mg/dLCytokines in pg/mL
Th2Th1
#762
![Page 44: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/44.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 45: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/45.jpg)
824
Safety of stopping primary T. gondii prophylaxis with suppressed viremia and CD4>100/mm3
#765
Viral loadCD4
Prophylaxis
![Page 46: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/46.jpg)
N Engl J Med 2016;374:636‐46.
![Page 47: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/47.jpg)
![Page 48: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/48.jpg)
N Engl J Med 2016;374:636‐46.
Survival = 81.5% (22/27)
![Page 49: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/49.jpg)
#77LB
![Page 50: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/50.jpg)
#77LB
![Page 51: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/51.jpg)
#77LB
‐ RCT 1:1 to receive either: 3 infusions of 50 mg/kg ZMappTM 3 days apart plus oSOC (combination arm) or oSOC alone (control arm).‐ Early closure of the RCT due to the extinction of the Ebola outbreak in 2016.
![Page 52: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/52.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 53: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/53.jpg)
HCV Cure in HCV/HIV coinfected patients: Are we there?
LTAcute
Hepatitis
![Page 54: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/54.jpg)
Ledipasvir/Sofosbuvir FDC
FDC, fixed‐dose combination. 54
• Ledipasvir– Once‐daily, oral, 90‐mg
NS5A inhibitor
• Sofosbuvir‒ Once‐daily, oral, 400‐mg
NS5B inhibitor
• Ledipasvir/Sofosbuvir FDC–Once‐daily, oral, fixed‐dose (90/400 mg) combination tablet
–Single‐tablet regimen for hepatitis C
SOF nucleotide
polymerase inhibitor
LDVNS5A
inhibitor
SOF nucleotide
polymerase inhibitor
SOF nucleotide
polymerase inhibitor
LDVNS5A inhibitor
SOF nucleotide polymerase inhibitor
LDVNS5A inhibitor
SOF nucleotide polymerase inhibitor
![Page 55: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/55.jpg)
55
Ledipasvir/Sofosbuvir for 6 Weeks in HIV-Infected Patients with Acute HCV Infection
Patients with chronic HIV and acute HCV infection – HCV GT 1 or 4– ART consistent with LDV/SOF co-administration with HIV <200 copies/mL
or not receiving ART with no plans to start
Acute HCV infection with detectable HCV RNA (Roche COBAS® AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for <24 weeks, defined by
– HCV RNA-positive and negative anti-HCV antibody/HCV RNA test within last 6 months or
– Elevated ALT/AST >2.5 x ULN in past 6 months with normal LFTs in past year, and other causes excluded
5 sites in Germany and UKART, antiretroviral therapy
Week 0 6 18
LDV/SOF FDCN=26SVR12
#154LB
![Page 56: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/56.jpg)
56
Results: SVR4 and SVR12 (ITT)
*3 patients relapsed, 1 was reinfected (GT 1a at baseline, 4d in post-treatment).Error bars represent 95% confidence intervals.
85% 77%
0
20
40
60
80
100
Pat
ient
s, %
20/2622/26
SVR4
4 Virologicfailures*
4 Virologic failures*2 Lost to follow-up
SVR12
#154LB
![Page 57: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/57.jpg)
57
Results: Baseline HCV RNA and Treatment Outcome (SVR)
0
1
2
3
4
5
6
7
8
SVR12 RelapseSVR4H
CV
RN
A (lo
g 10
IU/m
L)Reinfection
The 3 relapses had BL VL >7 log10 IU/mL: GT 1a (2) and 4 (1). No new NS5A or NS5B RAVs were observed #154LB
![Page 58: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/58.jpg)
LT
HCV Cure in HCV/HIV coinfected patients: Are we there?
IFN-free DAA Regimens
![Page 59: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/59.jpg)
A New Predictive Index Predicts Outcomes in Compensated Cirrhosis in HCV/HIV
#529
LS≥21 predicts variceal bleeding (#530)
![Page 60: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/60.jpg)
#582
Response to DAA‐based regimens in HIV‐HCV co‐infected patients in real‐life, France
Sofosbuvir‐based regimens: with daclatasvir, ledipasvir or simeprevirwith/without ribavirin for HCV GT 1 (61%), GT 3 (14%) and GT 4 (21%)
≈90%
![Page 61: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/61.jpg)
#584
Response to DAA‐based regimens in HIV‐HCV co‐infected patients in real‐life, Germany
![Page 62: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/62.jpg)
#584
Response to SOF‐LDV for 8 weeks in HIV‐HCV co‐infected patients in real‐life, Germany
![Page 63: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/63.jpg)
#538 LB
High Efficacy of HCV Treatment by Primary Care Providers: The ASCEND Study
Specialists = SVR 92%‐ Primary care = SVR 97%‐ Nurses = SVR 95%
![Page 64: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/64.jpg)
HBVLT
HBV Cure in HBV/HIV coinfected patients: Are we there?
![Page 65: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/65.jpg)
Liver transplantation in HIV/HBV coinfected patients: a cohort study
Five-year patient survival Five-year graft survival
#571
![Page 66: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/66.jpg)
OIs, HCV Coinfection & Tumors
Introduction Tuberculosis Cryptococcal meningitis Other infections Hepatitis – DAA Rx - LT Cancer
![Page 67: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/67.jpg)
#630
Risk Factors for Hodgkin (HL) and Non‐Hodgkin Lymphoma (NHL) in Europe
![Page 68: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/68.jpg)
#617
Global Burden of Cervical Cancer in HIV‐Positive Women on Antiretroviral Therapy
![Page 69: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/69.jpg)
#162
Is Intensive Cervical Cancer ScreeningJustified in Immunosuppressed Women?
![Page 70: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/70.jpg)
#161
![Page 71: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/71.jpg)
#161
![Page 72: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/72.jpg)
#161
![Page 73: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/73.jpg)
#161
![Page 74: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/74.jpg)
#161No influence on persistent oral HPV, or single detection at last visit (HR [95%CI] 0.68 [0.26, 1.80])
![Page 75: Summary I: Opportunistic Infections HCV/HBV Co-Infections ... · AmpliPrep/COBAS® TaqMan® version 2.0, LLOQ=15 IU/mL) for](https://reader030.vdocuments.site/reader030/viewer/2022041013/5ec4155cb8ff57173b34034e/html5/thumbnails/75.jpg)
A.H. BorgesD.R. BoulwareK. Buchacz R.T. DaveyA.H. DiaconA. PhillipsH. FurrerA. GrantJ. D. Jenks
Acknowledgements
http://www.croiconference.org
J. LundgrenC. ManzardoS. MaussA. MocroftJ.A. PinedaJ.K. RockstrohI. WakedL. WittkopT. Wilkin