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Working Groups of
Consensus Conference

Working group 1 - Perioperative Immunosuppression

Working Group Coordinators: Dinesh Jothimani, Prashant Bhangui.

Working Group Coordinators: Dinesh Jothimani, Prashant Bhangui.

Working Group Experts: Ajitabh Srivastava, Amrish Sahney, Anand Khakhar, Anand Vijay, Ashok Choudhury, Ashwin Rammohan, Bhaskar Nandi, Chandan Kumar KN, Gaurav Pandey, Madhumita Premkumar, Mukul Rastogi, Ramdeep Ray, Sachin Palnitkar, Sanjay K Yadav, Sharat Putta, Vinay Kumaran, Vishal Chorasiya.

Vanguard Committee: Hirak Pahari, Shashwat Sarin.

TOPICS


1. Induction immunosuppression Perioperative Period

Standard induction strategy and choice and timing perioperative period
Induction in ABO Compatible Transplant

  • 1.1 Scenarios where induction antibodies are needed?
  • 1.2 Currently available induction antibodies & how to choose?
  • 1.3 Dosing & timing of induction antibodies
  • 1.4 Role of CNIs after induction (including dosing & timing)
  • 1.5 Monitoring, Adverse Effects, and Outcomes

2. Steroids - Peri-operative Period

  • 2.1 What could be the optimal dosing of steroid boluses at the time of reperfusion
  • 2.2 What is the short term and long-term impact of steroid boluses at the time of reperfusion
  • 2.4 Steroid free immunosuppression: Steroid avoidance versus steroid withdrawal and its short term and long-term impact
  • 2.5 HCC and HCV recurrence - Impact of peri-operative steroid dosing

3. Perioperative IMS

Immunosuppression strategies – Double/Triple immunosuppression
Define standard immunosuppression protocol in standard risk adult and managing rejection

  • 3.1 Define safe tacrolimus trough levels
  • 3.2 Trough levels after 12 months
  • 3.3 What is the minimum agreeable trough level when a third agent is available with stable renal function
  • 3.4 Role of cyclosporine

4. Immunosuppression strategies - Optimal CNI minimization strategy

  • 4.1 Should all patients be considered for IMS minimization
  • 4.2 Does reduced CNI exposure compromise graft safety (esp in very low dose CNI protocols)

5. Antimetabolites – MMF vs. Azathioprine

  • 5.1 What is the first line choice and why - Is Mycophenolate better than AZA?
  • 5.2 Should MMF drug level monitoring be done, Should MPA AUC monitoring be routine when TAC level is low for renal protection?
  • 5.3 Is routine evaluation of TPMT/NUDT15 genotype (to reduce myelotoxicity of AZA) indicated in Indian setting?
  • 5.4 Define scenarios where AZA remains acceptable (like, pregnancy, MMF toxicity, Cost)

6. Postoperative steroids (first three 3 months and beyond)

Postoperative steroid strategies

  • 6.1 Rapid vs traditional taper of steroids
  • 6.2 What should be the strategy beyond 3 months - maintenance low dose or complete cessation
  • 6.3  What should be the optimum policy of interaction of steroid and induction antibodies
  • 6.4  How to standardize outcome end points (eg: biopsy proven rejection versus composite graft failure)

7. Sepsis & Immunosuppression

  • 7.1  Should all the immunosuppression be stopped or continued at low dose during the episode of sepsis
  • 7.2 How should immunosuppression be tailored depending on the severity of sepsis
  • 7.3 What should be the immunosuppressive approach if confusion persists with respect to sepsis versus rejection
  • 7.4 What to do if AST and ALT rise in a recipient with sepsis

8. Immunosupression in concomitant infections

  • 8.1 Immunosuppression approach during viral illnesses
  • 8.2 IS during Tuberculosis infection
  • 8.3 IS in invasive fungal infection
  • 8.4 IS in opportunistic infection
  • 8.5 Immunosuppression and biliary sepsis

Working group 2 – Immunosuppression Strategies in Rejections, and Renal dysfunction

Working Group Coordinators: Dharmesh Kapoor, Shaleen

Working Group Experts: Akash Shukla, Ashish Goel, Charles Panackel, Joy Varghese, Mettu Srinivas Reddy, Basant Mahadevappa, Narender Choudhary, Swapnil Dhampalwar, Gomathy Narsimhan, Radhika Venugopal, Mithra Prasad, Giriraj Bora, Chetan Kalal, Rahul Saxena, Mukul Vij, Narender Choudhary, Radhika Venugopal, Rahul Saxena, Rakhi Maiwall.

Vanguard Committee: Dhiraj Agrawal, Gayatri Balachandran, Kalyan Vijay kumar.


TOPICS


9. T-cell Mediated Rejection - Treating early rejection

  • 9.1 Presumptive steroid versus liver biopsy proven rejection management
  • 9.2 What is the optimal dosing of steroid pulse for rejection
  • 9.3 Diagnosis & Management of TCMR
  • 9.4 What is the Standard First-line Approach
  • 9.5 Steroid Dosing and Regimens
  • 9.6 Response Monitoring
  • 9.7 Escalation Pathways
  • 9.8 Maintenance Immunosuppression Adjustment
  • 9.9 What is standard definition and management of steroid resistant TCMR
  • 9.10 Treatment regimen for SR TCMR (Dosing of each regime recommended in Q. 9.9)

10. Late Acute Rejection

  • 10.1 Diagnostic criteria for LAR
  • 10.2 What is the optimal biopsy timing after minor LFT rise for the diagnosis
  • 10.3 What is the optimal pulse dose and duration
  • 10.4 Role of Alternative or Adjunctive Agents

11. Antibody Mediated Rejection

  • 11.1 When to clinically suspect AMR
  • 11.2 Diagnostic criteria for AMR
  • 11.3 How to approach C4d-negative AMR (What is the threshold MFI for DSA positivity)
  • 11.4 What is the role of routine DSA screening in stable recipients
  • 11.5 Recommended treatment of AMR
  • 11.6 What is the optimal response monitoring
  • 11.7 Role of Proteasome inhibitor in refractory AMR

12. Chronic Rejection

  • 12.1 Recommendation on the diagnosis of chronic rejection
  • 12.2 Recommendation on management of Chronic rejection

13. Preoperative Renal dysfunction

  • 13.1 What is the role of Delayed CNI vs induction with IL2-RA
  • 13.2 Role of antimetabolites & mTORs - When & how

14. New onset renal dysfunction after LT

  • 14.1 What is the modified IMS protocol in AKI vis a vis risk of rejection
  • 14.2 Long term management of renal dysfunction after LT - Role of antimetabolites & mTORs
  • 14.3 Complete CNI cessation is safe or if lower tac trough level is preferable
  • 14.4 Role of ATG vs IL-2RA in this population
  • 14.5 What is the role of MMF alone
  • 14.6 Is there a role of mTOR inhibitor, before 30 days of liver transplant

15. IMS in SLKT

  • 15.1 Role of induction antibodies
  • 15.2 IMS protocol - Is it different?

16. Chronic Kidney Disease after LT

  • 16.1 Whether low TC (<3) with MMF can prevent CKD progression without increasing rejection
  • 16.2 What is the role of EVR ± low-dose tacrolimus in patients with CKD > stage 2?
  • 16.3 What should be the immunosuppression strategy in patients awaiting renal transplant but not on haemodialysis?
  • 16.4 What should be the immunosuppression strategy in patients awaiting renal transplant while on haemodialysis?
  • 16.5 What should be the immunosuppression protocol after renal transplant?
  • 16.6 What is the role of Balatacept and induction antibodies in patients with CKD after liver transplant?

17. Long-term kidney protection strategy

  • 17.1 What is the role of antimetabolites & m-TORs
  • 17.2 Is lower tac trough level (2–4 ng/mL) plus MMF enough to cover rejection during AKI without induction?
  • 17.3 What EVR trough best balances renal rescue and metabolic toxicity in CKD stage 3–4?
  • 17.4 Can early (<30 d) EVR conversion prevent AKI from evolving into CKD?

Working group 3 – Special Situations 1 : ABO Incompatible, Metabolic liver disease, ALF/ACLF, AIH & AID, Elderly and Sarcopenic

Working Group Coordinators: Sanjiv Saigal, Sudhindran S

Working Group Experts: Abhishek Mathur, Akash Roy, Amit Rastogi, Anand Kulkarni, Anil Arora, Anurag Shrimal, Dinesh Balakrishnan, Imtiakum Jamir, Kausar Makki, Neerav Goel, Pranjal Modi, Rajesh Ramalingam, Sadhana Shankar, Shalimar, Shekhar S Jadaun, Shweta Mallick, Swapnil Dhampalwar.

Vanguard Committee: Aditya Nanavati, Rohit Mehtani.


TOPICS

Special situations

Standardize immunosuppression in special situations

18. ABO incompatible LT

Strategies for effective immunosuppression in ABOi LT

  • 18.1 Desensitization protocol
  • 18.2 Pre-operative CNI/anti-metabolite or not?
  • 18.3 Protocol biopsies vs on demand
  • 18.4 IMS protocol in ABO incompatible liver Transplant
  • 18.5 IMS protocol in rising LFT after LT
  • 18.6 IMS protocol in rising titre
  • 18.7 ABOi LT in ALF/ACLF (without 2 weeks’ time to prepare)
  • 18.8 Whether B-cell or CD19 monitoring should guide timing of surgery

19 Metabolic syndrome (preoperative and postoperative)

  • 19.1 IMS protocol - is it different from other patients?
  • 19.2 What is the role of antimetabolites and mTOR inhibitors?
  • 19.3 How should metabolic syndrome be managed from an immunosuppression
  • 19.4 perspective (NODAT, obesity, dyslipidemia)?
  • 19.5 How can the long-term metabolic impact of immunosuppression be minimized?

20. Immunosuppression in ALF and ACLF

  • 20.1 Do patients with ALF have different immunosuppression requirements than for other indications?
  • 20.2 What should be the timing of starting CNI pending neurological recovery?
  • 20.3 What is the role of antibody induction in ALF?
  • 20.4 What should be the initial tacrolimus trough levels in ALF?
  • 20.5 Is immunosuppression in AIH-ALF similar to AIH-CLD or different?
  • 20.6 What should be the immunosuppression strategy in ACLF?
  • 20.7 Should immunosuppression be delayed in ACLF or ALF recipients?
  • 20.8 How does immune paralysis affect immunosuppression decisions?
  • 20.9 What is the impact of sarcopenia on immunosuppression strategy?
  • 20.10 How should immunosuppression be managed in an ACLF patient developing cholestasis after LT?
  • 20.11 What is the appropriate immunosuppression strategy while awaiting sepsis resolution in ACLF?

21. Immunosuppression in elderly/Sarcopenic liver transplant patients

  • 21.1 Recommended IMS regimens & evidence in elderly ≥ 65.
  • 21.2 Any changes in IMS for older recipients with baseline CKD or neurologic-risk
  • 21.3 Can steroids be omitted or tapered within ≤ 7 days in all low-immunologic- risk elders without raising rejection?
  • 21.4 Which frailty/sarcopenia metric best predicts over-immunosuppression, and how should it modify drug choices and doses?
  • 21.5 What are the measures to curb drug variability?
  • 21.6 How frequently should skin, PTLD and solid-organ cancer screening be
  • 21.7 performed, and does early Everolimus truly lower cancer incidence enough to justify routine switch?

22. Immunosuppression in Autoimmune hepatitis (AIH) & other AILD

  • 22.1 Can we predict early TCMR vs AIH recurrence in a patient transplanted for AIH (concept of high immunologic risk)
  • 22.2 What is the optimal Tac trough level in the first 6 months & later.
  • 22.3 Is there any role of CNI minimization or CNI monotherapy
  • 22.4 What is the role of antimetabolite
  • 22.5 What is the role of mTOR inhibitor
  • 22.6 Lifelong vs finite steroids.
  • 22.7 What is the optimal way of steroid withdrawal if attempted
  • 22.8 AIH recurrence vs plasma cell rich TCMR
  • 22.9 Optimal immunosuppression regimen for recurrent AIH
  • 22.10 IMS protocol for other non AIH AILD - Is it different?

Working group 4 – Special Situations – Hepatitis B / Hepatitis C / HIV, Retransplant, GVHD, Neurotoxicity, Elderly, AIH, Pregnancy

Working Group Coordinator: Neeraj Saraf, Sonal Asthana

Working Group Experts:Ameet Mandot, Amit Gupte, Arun Valsan, Balachandran Menon, Chirag Desai, ElanKumaran Krishnan, Gaurav Chaubal, Harikumar Nair, Murugan Natarajan, Naimish Mehta, Praveen Sharma, Rajesh Dey, Sanjay Govil, Sunil Taneja, Vinit Shah.

Vanguard Committee: PrithviRaj Nabi, Sasidhar Reddy.


TOPICS


Special circumstances

Standard immunosuppression approach in different clinical settings

23. HBV & HCV treatment and interaction with immunosuppression

  1. Suggest protocols to standardize the dose adjustment for CNIs and mTOR inhibitors.
  2. Highlight the long-term impact on graft survival and fibrosis progression post-SVR in immunosuppressed LT

24. Other Viral infections post LT

  1. How immunosuppression is modified in EBV, CMV, VZV, etc infections/reactivation
  2. What is the Role of vaccination/immunization in patient on IMS

25. HIV and immunosuppression

  1. Impact of HIV±AIDS on IMS management
  2. How immune dysregulation contributes to higher rejection rates and management
  3. Risk of malignancy in HIV/AIDS and IS modifications
  4. Recommended IMS regimen
  5. On optimal renal sparing IS regimens or routine use of mTOR inhibitors.
  6. Double whammy of ART and IS on metabolic syndrome: Clarify role of routine steroid-minimization and alternative IS strategies (e.g., mTOR inhibitors, Balatacept).
  7. Special note on ART-IS interactions

26. Re-transplantation

  1. What is the role of induction therapy
  2. ATG vs Basiliximab in re-LT patients: How to choose and dose effectively?
  3. What should be the Standardized protocols for desensitization pre- and post-re-LT?
  4. Suggest on Renal-sparing regimens, and malignancy/infection prophylaxis
  5. Suggest ways to optimize IMS protocol in re-LT
  6. How should immunosuppression be tailored to reduce malignancy recurrence risk post re-LT
  7. Should routine use of m-TOR inhibitor replace or significantly supplement CNI-based IS in re-LT
  8. What should be the Optimal early-phase Tacrolimus trough levels post re-LT?
  9. Develop Criteria and safety of long-term monotherapy post re-LT?

27. Graft versus host disease after Liver Transplant

  1. Shoulg GVHD post-LT be treated with reduced or intensified immunosuppression?
  2. At what point should agents like Ruxolitinib or Basiliximab be introduced?
  3. Define a stepwise algorithm on
  4. Lessons from HSCT GVHD treatment algorithms

28. IMS strategies in Neurotoxicity

  1. When and how to adjust CNIs in neurotoxicity (dose reduction vs. conversion to mTOR inhibitors vs. temporary cessation)
  2. At what neurotoxicity threshold (clinical severity, imaging finding, drug level) should CNIs be reduced or switched
  • 28.1 Immunosuppression adjustments
  • 28.2 Is switching to mTOR inhibitor (e.g., sirolimus, Everolimus) preferable over just lowering CNI dose in neurologic complications?
  • 28.3 What protocol should guide assessment and management of suspected CNI neurotoxicity
  • 28.4 Once neurotoxicity is settled - Switching back to CNI vs alternative immunosuppressants (e.g., mTOR inhibitors, induction agents)
  • 28.5 Role of induction therapy (if any) to minimize long-term neurotoxicity risk
  • 28.6 How immunosuppression adjustments affect graft survival & neurologic recovery

29. Pregnancy

  • 29.1 What is the prerequisite for allowing liver transplant patients to consider pregnancy
  • 29.2 What are the recommended immunosuppression changes before and during pregnancy
  • 29.3 Immunosuppression during breastfeeding
  • 29.4 Management protocol if rejection develops during the first, second and third trimester of the pregnancy
  • 29.5 What immunosuppression are to be considered if pregnancy related complications develop in each of the trimesters

Working group 5: Immunosuppression in Transplant Oncology, Perioperative Immunosuppression in non-liver surgery/ Immunosuppression in Pediatric recipients

Working Group Coordinators: Naveen Ganjoo, Viniyendra Pamecha

Working Group Experts: Anupam Sibal, Ashish Kumar, CH Madhusudan, Gaurav Sood, Mallikarjun Sakpal, Mathew Jacob, Naresh Shanugam, Neelam Mohan, Pankaj Puri, Pavan Hanchanale, Ravi Bhardwaj, Ravi Mohanka, Ravichand Siddhachari, Seema Alam, Sumana Ramachandra, Uday Sanglodkar, Vikram Kumar, Vivek Vij.

Vanguard Committee: Arti Pawaria, Anish Gupta.


TOPICS


30. Immunosuppression in PTLD

  • 30.1 Risk factors & age distribution
  • 30.2 Can we prevent PTLD by modifying IMS in high-risk recipients (Preventive strategies)
  • 30.3 If PTLD, what should be the immunosuppression protocol
  • 30.4 Does early sirolimus (with or without low-dose CNI) improve PTLD outcomes and renal function without raising rejection?
  • 30.5 What biopsy or biomarker schedule best detects early rejection while PTLD is treated under reduced IS?

31. Immunosuppression in patients transplanted for non-HCC malignancy

  • 31.1 What is the optimal induction strategy
  • 31.2 What is the role of induction agents in those who have received neoadjuvant chemotherapy
  • 31.3 What should be the early CNI exposure and role of TTR and IPV?
  • 31.4 Is the role of mTOR inhibitors similar to their role in HCC?
  • 31.5 What should be the optimal steroid policy
  • 31.6 What is the role of antimetabolites?
  • 31.7 What is the role of checkpoint inhibitors?
  • 31.8 What is the role of surveillance guided tailoring of immunosuppression?

32. Immunosuppression in patients with de novo malignancy

  • 32.1 What are the risk factors and age distribution for de novo malignancy (DNM)?
  • 32.2 Can DNM be prevented by modifying immunosuppression in high-risk recipients, and what preventive strategies are effective?
  • 32.3 If DNM, what should be the immunosuppression protocol?

33. Perioperative immunosuppression in non-liver surgery after LT

  • 33.1 IMS on hold vs low dose peri-operative
  • 33.2 Define tacrolimus/cyclosporine trough targets during surgical stress (minor vs major surgery, early vs late post-LT)
  • 33.3 If patient is on mTOR inhibitors
  • 33.4 Should antimetabolites (MMF/MPA/azathioprine) be continued perioperatively?
  • 33.5 Are stress-dose corticosteroids necessary for LT recipients on chronic low-dose prednisone, and if so, what should the dose be?
  • 33.6 Is there any role for IV or sublingual tacrolimus in patients who are NPO or have ileus?
  • 33.7 Targeted minimization/temporary withdrawal algorithm
  • 33.8 Pharmacology & drug interactions
  • 33.9 What antifungal strategies can be used that avoid CYP3A interactions?
  • 33.10 Anticoagulation/VTE prophylaxis with IS
  • 33.11 Special populations/procedures

34. IMS in patients with HCC recurrence

  • 34.1 Strategy & timing
  • 34.2 Tac minimization (trough 3–5 ng/mL) vs standard
  • 34.3 mTORi + low-dose tac vs mTORi alone
  • 34.4 With cancer therapy
  • 34.5 Monitoring & targets
  • 34.6 Special scenarios
  • 34.7 Peri-procedural
  • 34.8 Safety and pathways

35. Immunosuppression in Pediatric transplant recipients

  • 35.1 How much do pharmacokinetic immunosuppressive agents differ from adults?
  • 35.2 What circumstances and recommendation should one follow when it comes to Tac vs Cyclosporine
  • 35.3 Define immunosuppression protocol for induction, maintenance and treatment of rejection
  • 35.4 Optimal way of administration of immunosuppression
  • 35.5 Weight based IMS or trough level IMS for MMF
  • 35.6 Standard Tac trough levels in pediatric recipients
  • 35.7 Pediatric ABOi liver transplant
  • 35.8 Management of non-adherence
  • 35.9 Immunization while on immunosuppression
  • 35.10 Standard immunization protocol vs modified
  • 35.11 Steroid and linear growth
  • 35.12 CNI induced neurotoxicity
  • 35.13 How long the CMV prophylaxis be continued in Pediatric while on immunosuppression
  • 35.14 What is the optimal immunosuppression in pediatric AIH patients and role of steroid
  • 35.15 Should children (much higher EBV-mismatch risk) follow a different prophylactic strategy?

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