TABLE 1

Profile and outcome for patients receiving bedaquiline under the compassionate use program at P.D. Hinduja Hospital and Medical Research Center, Mumbai

EntrySexAgeSiteTests at baselineResistance profileSLD Duration# monthsLobes and cavitiesOBR+SurgeryWeight gain kgTime§ monthsOutcome
1Male27PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, Eto
11B/L (3); YLzd, Cfz, PAS, Cs (4)No61Cured
2Female28PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, Eto
36B/L (5); YLzd, Cfz, PAS, Cm, Meropenem, Amox+Clav (6)No105Relapsed (SC+ 16 months after culture conversion)
Reapplying for bedaquiline and also for delamanid
OBR ongoing
3Female40PulSS−/SC−XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, Km, Am, Cm
7U/L (1); YLzd, Cfz, PAS, Cs, Cm, E (6)No7Negative at baselineCured
4Female29Pul+PlSS−/SC−XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, Km, Am, Cm
11B/L (4); YLzd, Cfz, PAS, Clari, Amox+Clav (5)No1Negative at baselineCured
5Female20Pul+PlSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, PAS, Km
16B/L (2); YLzd, Cfz, PAS, Cs, Cm, Eto (6)No6Nonresponder (SS−/SC+, at 6 months of bedaquiline)
Disease progressive
Received delamanid sequentially
Currently SS+/SC+
OBR ongoing
6Male25PulSS−/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, PAS, Km, Am, Cm
2U/L (2); YLzd, Cfz, PAS, Cs, Cm, Mfx (6)No62Cured
7Female23PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, Km, Am, Cm
43U/L (2); YLzd, Cfz, PAS, Cs, Thr (5)No0Nonresponder (SS+/SC+, at 6 months of bedaquiline)
Disease progressive
Currently SS+/SC+
OBR ongoing
8Female31PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, Eto
46B/L (5); YLzd, Cfz, PAS, Cs, Cm, Eto (6)No−1Nonresponder (SS+/SC+, at 6 months of bedaquiline)
Disease progressive
Currently SS+/SC+
OBR ongoing
9Female25PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, Km, Am, Cm
6B/L (3); YLzd, Cfz, PAS, Cs, Cm, Eto, Cm, Meropenem, Amox+Clav (9)Yes (left pneumonectomy)1Nonresponder (SS+/SC+, at 6 months of bedaquiline)
Disease progressive
Currently SS+/SC+
OBR ongoing
10Female22PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, PAS
7B/L (3); NLzd, Cfz, Cs, Km, Eto (5)No83Cured
11Male29PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, Eto
12B/L (3); YLzd, Cfz, PAS, Cs, Cm, Amox+Clav (6)Yes (bilateral upper lobectomy)132Cured
12Male40PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, PAS, Km, Am
12B/L (2); YLzd, Cfz, Cs, Cm, Amox+Clav, Thr, Rifabutin (7)Yes (left pneumonectomy)33Cured
13Male25PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Eto
12B/L (2) YLzd, Cfz, PAS, Cs, Cm, Mfx (6)No43Cured
14Female18PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, PAS, Km, Am, Cm
4B/L (3); YLzd, Cfz, PAS, Cs, Clari, Thr (6)No54Cured
15Male29PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Mfx, Eto, PAS, Km, Am, Cm
12U/L (2); YLzd, Cfz, PAS, Cs, Cm, Mfx (6)No62Cured
16Female29PulSS−/SC−XDR:
H, R, E, Sm, Ofx, Mfx, Eto, PAS, Km, Am, Cm
7B/L (3); YLzd, Cfz, PAS, Cs, Cm, Eto, Mfx, Z (8)No4Negative at baselineCured
17Female32PulSS−/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx
10U/L (1); YLzd, Cfz, Cm, Eto, Meropenem, Amox+Clav (6)No32Sputum and culture conversion (SS−/SC−, 6 months bedaquiline completed)
OBR ongoing
18Female22PulSS+/SC+XDR:
H, R, Z, E, Sm, Ofx, Eto, PAS, Km, Am, Cm
4B/L (3); YLzd, Cfz, PAS, Cm, Lfx (5)Yes (right upper lobectomy)33Sputum and culture conversion (SS−/SC−, 6 months bedaquiline completed)
OBR ongoing
19Female27PulSS+/SC+XDR:
H, R, Z, Sm, Ofx, Km, Am
126B/L (5); YLzd, Cfz, PAS, Cm, Eto, Mfx, Amox+Clav, E (8)No1Nonresponder (SS+/SC+, at 6 months of bedaquiline)
Disease static
Currently SS+/SC+
OBR ongoing
20Female29PulSS+/SC+Pre-XDR (Fq):
H, R, Z, E, Sm, Ofx, Mfx, Eto
74U/L (3); YLzd, Cfz, PAS, Cs, Cm, Lfx (6)No2Nonresponder (SS−/SC+, at 6 months of bedaquiline)
Disease static
Currently SS+/SC+
OBR ongoing
  • OBR: optimised background regimen; XDR: extensively drug-resistant; SLD: second-line drug; Pul: pulmonary; Pl: pleural; SS: sputum smear; SC: sputum culture; H: isoniazid; R: rifampicin; Z: pyrazinamide; E: ethambutol; Sm: streptomycin; Eto: ethionamide; PAS: para-aminosalicylic acid; Fq: fluoroquinolone; Ofx: ofloxacin; Lfx: levofloxacin; Mfx: moxifloxacin; Km: kanamycin; Am: amikacin; Cm: capreomycin; Cs: cycloserine; Cfz: clofazimine; Lzd: linezolid; Amox: amoxicillin; Clav: clavulinic acid; Thr: thioridazine; Clari: clarithromycin; B/L: bilateral; U/L: unilateral; Y: yes for cavitation; N: no for cavitation; #: SLD duration prior to bedaquiline use; : value in parentheses refers to the number of lobes affected; +: value in parentheses is the number of drugs; §: Time to culture conversion.