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CASE-BASED PANEL DISCUSSION Led by Carl Knud Schewe Infektionsmedizinisches Centrum Hamburg.

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Presentation on theme: "CASE-BASED PANEL DISCUSSION Led by Carl Knud Schewe Infektionsmedizinisches Centrum Hamburg."— Presentation transcript:

1 CASE-BASED PANEL DISCUSSION Led by Carl Knud Schewe Infektionsmedizinisches Centrum Hamburg

2 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM2 Possible Conflict of Interest Statement Within the past 2 years I have received consultancy fees, travel grants and support for scientific projects from the following pharmaceutical companies: AbbVie BMS Boehringer Gilead Hexal Janssen MSD ViiV Healthcare

3 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM3 Disclaimer "The views and opinions expressed in the following presentation are those of the presenter and do not necessarily reflect those of AbbVie Pty Ltd. AbbVie Pty Ltd does not endorse the use of unregistered products or products outside of their registered indications. Please refer to the your country's Product Information for licensed instructions"

4 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 4 Test question: Interactive System On what continent are you currently practicing? 1.Africa 2.Asia 3.Australasia 4.Europe 5.North America 6.South America

5 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 5 Bone Case: General Question for the Audience In your clinic, are you screening for osteopenia/osteoporosis in your HIV-infected patients? 1.No 2.Yes, on a case by case basis, but not systematic 3.Yes, systematic with FRAX® score and if required a DXA scan

6 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 6 Bone Case: Audience and Panel Discussion Is the problem underestimated? Is there a lack of easy to use algorithms and screening tools?

7 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 7 Bone Case 56 years old, retired accountant, MSM HIV diagnosed in 1989: No opportunistic infections ARV treatment since 1996 Comorbid conditions: Chronic hepatitis B, hypertension, hyperlipidemia, polyneuropathy, chronic back pain Previous smoker, 40 pack years, 4–5 beers per week Medication: Aspirin 100 mg, pravastatin, ramipril, amlodipine, HCTZ, diclofenac, metamizole*, omeprazole * Novaminsulfon (metamizole) is not approved in Australia

8 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 8 Bone Case: ARV History DateARTVLCD4+ 7/1996AZT 3TC80,000350failure 2/1998AZT 3TC SQV??failure 6/1998CBV NLF??diarrhea, failure 1/1999EFV d4T DDI??depression 3/1999ABC 3TC d4T??failure 3/2001RTV 400 SQV 400??diarrhea 3/2001EFV d4T ABC15,000530failure 9/2002ARV interruption6 log K103N 2002–2010LPV/r SQV TDF 3TC<50603HBV DNA neg.

9 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 9 Bone Case Physical examination: Height 180 cm, weight 69 kg, BMI 21.3, BP 140/100 mmHg, 56 beats/min, looking older, diminished breath sounds, absent ankle reflexes Laboratory: Cholesterol 190 mg/dL (4.91 mmol/L) Triglycerides 220 mg/dL (2.48 mmol/L) LDL 102 mg/dL (2.63 mmol/L) HDL 32 mg/dL (0.83 mmol/L) Creatinine 1.2 mg/dL (106 µmol/L) Is this patient at increased risk of fragility fracture?

10 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 10 Bone Case: Question 1 Is this patient at increased risk of fragility fracture? 1.Low: <10% 10-year risk of major fracture 2.Moderate: 10 – 20% 10-year risk of major fracture 3.High: >20% 10-year risk of major fracture

11 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 11 Bone Case: Question 1 Panel Discussion How accurate is subjective estimation of fracture risk? How do you screen in your clinic? What is a practical way to detect patients with increased risk of fracture?

12 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 12 Bone Case: FRAX® Score Should HIV be considered a cause of secondary osteoporosis?

13 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 13 Bone Case: FRAX® Score

14 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 14 Bone Case: Do we need a DXA Scan? Assessment threshold – major fracture

15 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 15 Bone Case: We do a DXA Scan!

16 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 16 Bone Case: DXA Scan Tips the Balance Intervention threshold Do we need additional diagnostic tests? Vitamin D? Bone turnover markers?

17 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 17 Bone Case: Question 2 How would you manage this patient in addition to lifestyle interventions? 1.Calcium + Vitamin D 2.Calcium + Vitamin D + Bisphosphonate 3.Calcium + Vitamin D + ARV-switch 4.Calcium + Vitamin D + Bisphosphonate + ARV-switch

18 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 18 Bone Case: Question 2 Panel Discussion Comments of the panel on results of audience response How do you monitor the treatment response? If you opt for an ARV-switch, what would you switch this patient to?

19 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 19 Bone Case: ARV History DateARTVLCD4+ 7/1996AZT 3TC80,000350failure 2/1998AZT 3TC SQV??failure 6/1998CBV NLF??diarrhea, failure 1/1999EFV d4T DDI??depression 3/1999ABC 3TC d4T??failure 3/2001RTV 400 SQV 400??diarrhea 3/2001EFV d4T ABC15,000530failure 9/2002ARV interruption6 log K103N 2002–2010LPV/r SQV TDF 3TC<50603HBV DNA neg.

20 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 20 Bone Case: Follow Up Switch to: Maraviroc 2x150 mg, lopinavir/ritonavir 2x400/100 mg, raltegravir 2x200 mg Entecavir 1 mg (!)

21 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 21 Minimum Prescribing Information: Kaletra Tablets & Oral Solution (LPV/r) Please review full Product Information / Data Sheet before prescribing. Full Product Information / Data Sheet is available on request from AbbVie Pty Ltd, ABN –34 Lord Street, Botany NSW 2019 / AbbVie Ltd. 156–158 Victoria St, Wellington, 6011 New Zealand INDICATIONS For the treatment of HIV-infection in combination with other antiretroviral drugs in adults and children aged 2 years and older. CONTRAINDICATIONS Known hypersensitivity to any of the ingredients in Kaletra, co-administration with medicines highly dependent on CYP3A for clearance: alfuzosin hydrochloride, fusidic acid, astemizole, terfenadine, blonanserin, midazolam, triazolam, ergotamine, dihydroergotamine, ergometrine, methylergometrine, cisapride, St John’s Wort (Hypericum perforatum), lovastatin, simvastatin, salmeterol, pimozide or sildenafil (for the treatment of high blood pressure in the vessels in the lung). Kaletra Oral Solution only: children below 2 years of age, pregnancy, hepatic and renal impairment, patients treated with disulfiram or metronidazole. PRECAUTIONS New onset and exacerbation of diabetes mellitus, hyperglycaemia, use in mild to moderate hepatic impairment, fat redistribution, hyperlipidaemia, increased risk of pancreatitis, immune reconstitution syndrome, autoimmune disorders, PR interval prolongation, Pregnancy: Cat B3. Due to the potential for HIV transmission and serious adverse reactions in nursing infants, mothers should be instructed not to breast feed whilst on Kaletra. ADVERSE EFFECTS Mild to moderate diarrhoea; nausea; lipodystrophy; abdominal pain; asthenia; abnormal stools; headache; dyspepsia; vomiting; rash; abdomen enlarged; hypercholesterolaemia; hyperlipidaemia; increased liver enzymes; hyperglycaemia; hyperuricaemia. See full PI/Data Sheet. INTERACTIONS Co-administration with drugs and herbal products primarily metabolised by CYP3A (dihydropyridine calcium channel blockers, immunosuppressants and erectile dysfunction agents), or are inducers or inhibitors of CYP3A (anticonvulsants, corticosteroids, antifungals and rifamycins). Date of preparation: 30 April 2014, based on PI last updated on 24 April 2014, version 18

22 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 22 Minimum Prescribing Information: Kaletra Tablets & Oral Solution (LPV/r) INTERACTIONS continued Other drugs include fentanyl, antiarrhythmics (digoxin, amiodarone, systemic lignocaine and quinidine), anticancer agents (dasatinib, nilotinib, vincristine, and vinblastine), anticoagulants (warfarin, rivaroxaban), anticonvulsants (phenobarbital, phenytoin, carbamazepine, lamotrigine, valproate), antipsychotics (quetiapine), antidepressants (trazodone and bupropion), antifungals (ketoconazole, itraconazole, voriconazole), HCV protease inhibitor (boceprevir), disulfiram, metronidazole, methadone, colchicine, bosentan, and oral and patch contraceptives. Other anti-HIV medications including other protease inhibitors. DOSAGE AND ADMINISTRATION Kaletra Tablets : Tablets may be taken with or without food and should be swallowed whole and not chewed, broken or crushed. Dosage: 200 mg lopinavir/50 mg ritonavir tablets : Adults and children ≥ 35kg two tablets twice daily. Kaletra tablets may also be administered as four tablets once daily in adult patients with less than three lopinavir associated mutations. Kaletra should not be taken once daily with efavirenz, nevirapine, nelfinavir, amprenavir, carbamazepine, phenobarbital and phenytoin. 100 mg lopinavir/25mg ritonavir tablets: Children < 45 kg dosage is based on body weight. (See full PI/Data Sheet for dosing guidelines). Kaletra Oral Solution (80 mg lopinavir/20 mg ritonavir per mL) Dosage: Adults: 5mL of oral solution (400/100mg) twice daily taken with food. Kaletra oral solution may also be administered as 10mL once daily in adult patients with less than three lopinavir associated mutations. Kaletra should not be taken once daily with efavirenz, nevirapine, nelfinavir, amprenavir, carbamazepine, phenobarbital and phenytoin. Children: 2 years and older: 230/57.5mg/m 2 (or 12/3 mg/kg for children <15 kg or 10/2.5 mg/kg for children ≥15kg) twice daily taken with food, up to a maximum dose of 400/100mg (5mL) twice daily. With concomitant nevirapine or efavirenz, should consider increasing dosage to 300/75 mg/m 2 (or 13/3.25 mg/kg for children <15 kg or 11/2.75 mg/kg for children ≥15 kg) twice daily taken with food. (See full PI/Data Sheet for dosing guidelines). AbbVie Pty Ltd, 32–34 Lord Street, Botany NSW 2019, Australia or AbbVie Ltd, Level 6, 156–158 Victoria Street, Wellington, New Zealand. Date of preparation: 30 April 2014, based on PI last updated on 24 April 2014, version 18

23 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 23 Renal Case 22 year old, fashion designer, MSM Caucasian/African HIV diagnosis 2012, CD4+ nadir 360 cells/mm 3, VL 76,000 c/mL ARV initiated in 2013: FTC/RPV/TDF Serum creatinine 1.2 mg/dL (106 µmol/L), no urinary or other laboratory abnormalities January 2014: Discontinuation of FTC/RPV/TDF, problem with concomitant food intake Switch to EVG/COBI/FTC/TDF April 2014 first presentation at ICH-Hamburg for refill of ARV medication

24 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 24 Renal Case No complaints, tolerates EVG/COBI/FTC/TDF well Moves to Hamburg for new job No time for laboratory testing after switch to EVG/COBI/FTC/TDF Physical exam: Healthy young man BMI 20.5 Blood pressure 115/80 mmHg HR 64 beats/minute No other abnormalities What kind of monitoring would you perform?

25 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 25 Renal Case: Question 1 What tests would you perform to screen for renal abnormalities in this patient? 1.Serum creatinine and urine dipstick 2.Estimated GFR and urine dipstick 3.Estimated GFR, urine dipstick, serum phosphate 4.Estimated GFR, urine dipstick, serum phosphate, renal ultrasound 5.Other

26 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 26 Renal Case: Question 1 Panel Discussion Why is the determination of creatinine not enough? What formula for eGFR calculation would you recommend? When would be the optimal time to look for renal abnormalities? After switch of ARVs in general? After switch to EVG/COBI/FTC/TDF in particular?

27 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 27 Renal Case continued Serum creatinine 1.6 mg/dL (141 µmol/L) eGFR by MDRD 56 mL/min No abnormalities in urine dipstick Question 2: What further workup is necessary?

28 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 28 Renal Case: Question 2 What tests should be done for further workup? 1.Renal ultrasound 2.24 hours urine collection creatinine clearance 3.Albumin/creatinine ratio and protein/creatinine ratio in morning urine 4.Fractional excretion of phosphate 5.All of the above tests

29 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 29 Renal Case: Question 2 Panel Discussion What pathology may we miss when using urine dipstick? (tubular proteins) Is it necessary to further define urinary proteins? If yes, how best to do this? What criteria should be fulfilled to make the diagnosis of renal tubular dysfunction? What is the significance of isolated mild proteinuria in patients on tenofovir? Is isolated tubular proteinuria predictive of future renal failure? Is switching necessary in these patients?

30 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 30 Renal Case continued Normal diet, no creatinine supplements, no abuse of drugs, no over the counter use of NSAIDs, no family history of kidney disease Extended laboratory tests: No inflammatory markers, no markers of autoimmune disease or monoclonal gammopathy Ultrasound: Kidneys of normal size and renal parenchyma, no obstruction Serum creatinine: 1.75 mg/dL (155 µmol/L) 24 hours urine collection: creatinine clearance: 67 mL/min Fractional excretion of phosphate and protein/creatinine ratio normal

31 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM 31 Renal Case continued: Panel Discussion No evidence of underlying kidney disease Did we miss something? Is there an indication for a kidney biopsy? Would you switch the regimen? Discussion of switch options

32 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM32 Acknowledgments Australia Dr Jennifer Hoy Brazil Dr Lauro Pinto Neto Dr Alexandre Naime France Dr Corinne Isnard Bagnis Dr Emmanuelle Plaisier Germany Dr Carl Knud Schewe Dr Ansgar Rieke Oberarzt Dr Markus Bickel Greece Dr Periclis Panagopoulos Hong Kong Dr Lee Man-Po Spain Dr Jose Ramon Arribas Lopez Dr Eugenia Negredo Puigmal Dr Rafael Garcia Rubio Dr Joaquin Portilla Taiwan Dr Chia-Jui Yang Turkey Dr Serhat Unal United Kingdom Dr Barry Peters Dr Frank Post United States of America Dr Mohamed Atta Dr Todd Brown Dr William Powderly Dr Lynda Szczech Dr Michael Yin Italy Dr Marco Borderi Dr Antonio Bellasi Dr Fabio Vescini Dr Paolo Maggi Dr Giovanni Guaraldi Japan Dr Toshio Naito Mexico Dr Jose Antonio Mata-Marin Dr Luis Soto-Ramirez Romania Dr Adrian Streinu-Cercel Dr Sorin Rugina Russia Dr Greg Kaminskiy

33 THANK YOU

34 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM A AbbVie Pty Ltd Lord St, Botany NSW 2019, Australia. July AU-KAL

35 BONE AND RENAL COMORBIDITIES IN HIV: THE OSTEO-RENAL EXCHANGE PROGRAM A AbbVie Pty Ltd Lord St, Botany NSW 2019, Australia. July AU-KAL


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