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Matthew Coldiron, Epicentre

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1 Matthew Coldiron, Epicentre
Pegylated liposomal doxorubicin for the treatment of Kaposi’s sarcoma in Maputo, Mozambique: First results of a prospective study Matthew Coldiron, Epicentre

2 Kaposi’s sarcoma (KS) HIV-associated malignancy (KS-associated herpesvirus/HHV8) High incidence in sub-Saharan Africa *All photos in this presentation taken during study follow-up and with written consent of study participants

3 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
KS treatment Antiretroviral therapy Chemotherapy Sub-Saharan Africa: triple therapy with conventional doxorubicin, bleomycin and vincristine (ABV) High-income countries: monotherapy with pegylated liposomal doxorubicin (PLD) Coldiron, Epicentre/MSF, PLD for KS in Mozambique

4 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
MSF program in Maputo 1803 KS patients treated since 2010 40% have complete/partial remission 57% needed >10 doses of ABV 36% lost to follow-up, 7% death Ideal setting to introduce PLD Need good documentation of its use Push for changes in protocols and price/availability of PLD Coldiron, Epicentre/MSF, PLD for KS in Mozambique

5 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Methods Observational study among chemotherapy-naïve on ARV PLD given in 3-week cycles until: Complete remission or Partial remission with symptomatic improvement Serum chemistry and blood counts before each infusion Scheduled study visits at 3, 6, 9, 12, 18 and 24 months Regular psychosocial evaluations Approval by MSF-ERB and Mozambican National ERB Coldiron, Epicentre/MSF, PLD for KS in Mozambique

6 Screening and enrolment
Enrolments began on 1 March 2016 168 screened, 130 eligible (77%) Main reasons for ineligibility: previous chemotherapy; plans to leave during 2 year follow-up period 116 enrolled (8 declined, 6 no-shows) Coldiron, Epicentre/MSF, PLD for KS in Mozambique

7 Baseline characteristics (N=116)
Male sex, n (%) 72 (63) Age in years, median (IQR) 36 (30-42) CD4, cells/µl, median (IQR) 218 (73-406) Months since HIV diagnosis, median (IQR) 6 (1-26) Currently on NNRTI-based ARV, n (%) 110 (95) Currently on PI-based ARV, n (%) 6 (5) Currently on treatment for TB, n (%) 18 (16) Past history of TB, n (%) 21 (18) Coldiron, Epicentre/MSF, PLD for KS in Mozambique

8 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Outcomes at 6 months 91 participants with 6 months follow-up 55% with complete or partial remission 19% died or lost to follow-up Coldiron, Epicentre/MSF, PLD for KS in Mozambique

9 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Doses of PLD received Coldiron, Epicentre/MSF, PLD for KS in Mozambique

10

11 Coldiron, Epicentre/MSF, PLD for KS in Mozambique

12 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Deaths No deaths directly related to PLD 5 advanced HIV and KS + social problems 3 opportunistic infections + social problems 1 opportunistic infection 1 lymphoma 1 probable stroke Coldiron, Epicentre/MSF, PLD for KS in Mozambique

13 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Adverse events 3 non-fatal serious adverse events: 1 immediate infusion reaction 2 non-KS, non-PLD related hospitalisations 43 adverse events definitely/probably linked to PLD Mostly haematologic (35 cases of anaemia +/- neutropenia) 2 hand-foot syndrome Others: acute kidney injury, transaminitis, rash Coldiron, Epicentre/MSF, PLD for KS in Mozambique

14 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Conclusions Limitations: observational design, ongoing follow-up PLD shows good clinical results, satisfactory safety profile Next steps: Continued follow-up Analysis of psychosocial data Expanded use of PLD (better pricing/access) Coldiron, Epicentre/MSF, PLD for KS in Mozambique

15 Coldiron, Epicentre/MSF, PLD for KS in Mozambique
Acknowledgements MSF Mozambique Lucas Molfino Ana Gabriela Gutierrez Zamudio Loide Cossa Puri Gonzalez Vini Fardhdiani Natercia Madeira Doctors, clinical officers and nurses of the CRAM Study scientific committee Laurence Toutous Trellu Alain Makinson Nilesh Bhatt Sandrine Grüningen Elisabeth Poulet MSF Geneva Iza Ciglenecki Barbara Rusch MOH Mozambique Gilda Luciano Rolanda Manuel Epicentre Geneva Mathieu Bastard Coldiron, Epicentre/MSF, PLD for KS in Mozambique

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