IJTLD OPEN 1(7):314–319 ORIGINAL ARTICLE

© 2024 The Authors http://dx.doi.org/10.5588/ijtldopen.24.0213

Savings from the introduction of BPaL and BPaLM regimens at

the country level
C. Auer,1,2 A. Gupta,3 C. Malbacius,4 A. Ghafoor,5 Y. Kock,6 O. Medvedieva,7 P. Hanlon,1,2
P. Steinmann,1,2 S. Juneja3
1
Swiss Tropical and Public Health Institute, Allschwil, Switzerland; 2University of Basel, Basel, Switzerland; 3TB Alliance, New York, NY,
USA; 4Disease Prevention and Control Bureau, Department of Health, Manila, The Philippines; 5National Tuberculosis Program,
Islamabad, Pakistan; 6National Department of Health, Pretoria, South Africa; 7Public Health Center, Ministry of Health, Kyiv, Ukraine
SUMMARY

BACKGROUND: In 2022, the WHO recommended the and longer regimens are replaced with BPaL/BPaLM,
6-month regimens BPaL (bedaquiline þ pretomanid þ the savings per patient treated in Pakistan, the
linezolid) and BPaLM (BPaL þ moxifloxacin) as Philippines, South Africa, and Ukraine are $746, $478,
treatment options for most forms of drug-resistant TB. $757, and $2,636, respectively. An increased number
SLASH-TB estimates the cost-saving and cost- of patients would be successfully treated with
effectiveness for the healthcare system and patients BPaL/BPaLM regimens, with 411, 1,025, 1,371 and
when a country switches from current standard-of-care 829 lives saved and 20,179, 27,443, 33,384 and
treatment regimens to BPaL/BPaLM. 21,924 DALYs averted annually in the four countries,
M E T H O D O L O G Y : Country data from national TB respectively.
programmes (NTP) are used to calculate the costs for all C O N C L U S I O N : Through BPaL/BPaLM regimens, drug-
regimens and treatment outcomes. Where BPaL/BPaLM resistant TB treatment has become more effective,
is not currently used, clinical trial outcomes data are used shorter, less burdensome for patients, cheaper for both
to estimate cost-effectiveness. DALYs are calculated us- health systems and patients, and saves more lives.
ing the Global Burden of Disease (GBD) database. K E Y W O R D S : drug-resistant TB treatment; six-month
R E S U L T S : We present the results of four countries that regimens; cost savings; bedaquiline; pretomanid; eco-
have used the tool and shared their data. When shorter nomic evaluation; cost analysis

Globally, there were an estimated 410,000 incident (Savings from Leveraging & Adopting Shorter & Highly
cases of drug-resistant TB (DR-TB) in 2022. An es- Effective TB Treatments3) that calculates the value added
timated 57% of patients were not enrolled in adequate from transitioning the current standard of care to the
treatment for DR-TB.1 Apart from case finding, the BPaL/BPaLM regimens at the country level. The tool
cost of treatment of DR-TB patients is a key healthcare calculates the costs and cost-effectiveness when a country
challenge for most low- and middle-income countries. continues with the standard regimens compared with
Cost-saving and cost-effective DR-TB treatment op- when the country’s DR-TB patients are treated with
tions are critically needed to reduce the economic BPaL/BPaLM. The tool was applied to data from four
pressure on the currently strained healthcare system. countries: Pakistan, the Philippines, South Africa, and
Until recently, the WHO recommended treatments Ukraine. This paper describes the tool and presents re-
for DR-TB were a 9–11-month standard short oral sults from these countries.
regimen (SSOR) and .18-month standard long oral
regimen (SLOR). In 2022, the WHO updated its
guidelines to recommend 6-month all-oral BPaL METHODOLOGY
(bedaquiline þ pretomanid þ linezolid) and BPaLM SLASH-TB and its structure
(BPaL þ moxifloxacin) regimens (BPaL/BPaLM) for
SLASH-TB compares current shorter or longer regi-
most forms of DR-TB.2
mens with BPaLM for MDR-TB (multidrug-resistant
Wide use of BPaL/BPaLM has the potential to
TB) and BPaL for pre-extensively drug-resistant TB
substantially improve the DR-TB treatment landscape
(pre-XDR-TB; MDR-TB with additional resistance to
by reducing treatment costs, alleviating the burden on
fluoroquinolones). The tool also allows for the com-
health systems, and saving patient-incurred costs. The
parison of individualised treatment regimens. The tool
Swiss Tropical and Public Health Institute and TB
output shows what a country could expect regarding
Alliance have developed a tool called SLASH-TB
cost savings, cost-effectiveness, and budget impact
over 5–10 years. As this was a retrospective study
using data obtained from records and estimates, and
CA and AG contributed equally.

Correspondence to: Aastha Gupta, TB Alliance, New York, NY, USA. email: [email protected]
Article submitted 23 April 2024. Final version accepted 4 June 2024.
 Cost-effectiveness of BPaL/BPaLM 315

no patients were interviewed, no institutional ap- implementing BPaL under operational research
proval was required. achieved similar outcomes as those in clinical trials.
SLASH-TB is MS Excel-based (Microsoft, Red- Treatment success is defined as the sum of patients
mond, WA, USA) for ease of application by countries cured and treatment completed.8 Patients experiencing
where data can be provided by the National Tuber- unfavourable outcomes during post-treatment follow-
culosis Programme and/or other stakeholders. It up in clinical trials were not included in the assessment.
consists of 1) guidance on how to fill the data sheets, 2)
two data sheets in which the user is required to fill in Outputs of SLASH-TB
country data, 3) calculation sheets, which include TB- The outputs are presented in a table format for ease of
related data extracted from the GBD databank4 and 4) use by countries. Table 1 presents the total costs for
the output dashboard. service providers and patients under each regimen and
Of the two worksheets that need to be filled, the first the average per-patient cost for each regimen. The table
one, called ‘TB data’, requires data on DR-TB treatment also presents the annual and per-patient savings for
and outcomes, such as regimens used in the previous year patients and providers resulting from the switch from
latest available treatment outcomes of DR-TB cohorts, current regimens to BPaL/BPaLM.
and the projected number of patients in the country over Table 2 presents the incremental benefit for three
the next 10 years to be treated with different regimens periods: the year before the analysis and the 5- and
(BPaL, BPaLM, SSOR, SLOR). Patient-related data re- 10-year horizons using BPaL/BPaLM. The following
quired for each regimen are as follows: the average were calculated: successful treatment outcomes;
number of patient visits to health facilities during lives saved; treatment failures averted; patients lost
treatment, the proportion of patients hospitalised and to follow-up averted; months of treatment saved;
average duration of hospitalisation, daily hospitalisation disability-adjusted life-years (DALYs) averted; years
costs for the health system and the patient, and other of life lost (YLL) due to premature mortality averted;
costs to calculate direct patient costs, namely minimal and years lived with a disability (YLDs) averted.
daily wage and average local travel costs to hospital/ A scenario analysis was conducted to explore the
clinic. impact of different treatment outcomes on incremental
The second worksheet captures the following costs effectiveness (Table 3). The Philippines is already using
for each regimen used in the country: 1) TB medicines, BPaL, and SLASH-TB uses the actual treatment out-
2) ancillary medicines, and 3) tests for baseline and comes for BPaL and TB-PRACTECAL results for
treatment monitoring (such as sputum examinations, BPaLM5 to calculate the effectiveness - captured as
blood tests, etc); 4) hospitalisation costs; and 5) patient Scenario A. For Scenario B, we used the Zenix trial
costs. For the first four categories, an estimate of the results for BPaL4 and interim published results for
proportion of patients who need them (e.g. 100% need BPaLM in TB-PRACTECAL,9 both showing a lower
bedaquiline under BPaL regimen, while a much lower treatment success rate.
percentage of patients may be using delamanid under Table 4 presents a budget impact analysis showing
the longer regimen) and the number of units needed for cost savings for service providers and patients resulting
the treatment must be estimated. Patient costs include from switching to the new regimens over 5 and 10 years.
an average estimate for travel costs to the clinic/
hospital, lost productive time (assuming minimum
RESULTS
wages), daily hospitalisation costs borne by the pa-
tient, and other costs where available, such as child- We present the results of the four countries that have
care or caregiver costs. provided their data in 2023 to use SLASH-TB fully.
When desired by a country and if data are available,
other costs can be added, such as social support (cash Service provider and patient costs
or food baskets), capital costs, and others. SLASH-TB Table 1 presents the computed costs for each country for
has the flexibility to include additional costs for both SSOR and SLOR, as per the reported use of these reg-
patients and service providers where such data are imens in 2022, stratified by total costs and costs per
available. patient. The costs for the countries per patient ranged
from $1,256 to $3,394 for SSOR and $2,602 to
The treatment outcomes of SLASH-TB $6,920 for SLOR. It should be noted that the costs were
For the cost-effectiveness analysis, treatment outcomes the highest in Ukraine, where all patients are hospitalised
are crucial; hence, the latest available data are for a certain period according to national treatment
requested by regimen from each country. It is noted guidelines. If these patients were to use BPaL/BPaLM
that if the country does not yet have treatment out- instead of SSOR or SLOR, the cost would be between
come data for BPaL, the treatment outcomes presented $996 and $2,573 per patient, indicating savings in each
in the relevant trial (ZeNix for BPaL5 and TB- country. These costs and savings are disaggregated by
PRACTECAL for BPaLM6) are used. Data presented service provider costs and patient costs and detailed in
at The Union Conference in 20237 show that countries Supplementary Data 1.
316 IJTLD OPEN

Table 1. Cost comparison for SSOR, SLOR, BPaL and BPaLM.

Savings when using
BPaL/M instead of
SSOR and SLOR
SSOR SLOR BPaL BPaLM Per
Regimen outcome (USD) (USD) (USD) (USD) Annual patient
Pakistan
Estimated number of patients on treatment in 2,839 982 1,201 2,620
2022, n
Total cost 3,598,662 3,142,085 1,195,782 2,694,750 2,850,215 746
Per patient cost 1,268 3,200 996 1,029 42%
Cost per successful treatment with SSOR/SLOR vs 2,271 1,112
BPaL/BPaLM
Philippines
Estimated number of patients on treatment in 5,154 2,501 161 7,494
2022, n
Total cost 9,115,023 6,507,564 246,336 11,714,494 3,661,758 478
Per patient cost 1,769 2,602 1,530 1,563 23%
Cost per successful treatment with SSOR/SLOR vs 2,698 1,685
BPaL/BPaLM
South Africa
Estimated number of patients on treatment in 4,965 2,820 730 6,665
2022, n
Total cost 6,237,855 9,449,067 950,968 8,839,013 5,896,940 757
Per patient cost 1,256 3,351 1,303 1,328 38%
Cost per successful treatment with SSOR/SLOR vs 3,268 1,437
BPaL/BPaLM
Ukraine
Estimated number of patients on treatment in 2,581 2,709 1,642 3,648
2022, n
Total cost 8,760,303 18,747,194 4,178,530 9,386,269 13,942,698 2,636
Per patient cost 3,394 6,920 2,545 2,573 51%
Cost per successful treatment with SSOR/SLOR vs 7,969 2,739
BPaL/BPaLM
SSOR ¼ standard short oral regimen; SLOR ¼ standard long oral regimen; BPaL ¼ bedaquiline þ pretomanid þ linezolid; BPaLM ¼BPaL þ moxifloxacin.

Incremental effectiveness BPaLM have ~90% success in clinical trials and

In the four analysed countries, the treatment success operational research in countries. Supplementary
rates for SSOR ranged between 67–81%; for SLOR, Data 2 provides detailed treatment outcome data
it was between 53% and 73%. In comparison, BPaL/ from the four countries.

Table 2. Incremental effectiveness of BPaL/BPaLM versus SSOR and SLOR.

Pakistan Philippines South Africa Ukraine
Incremental Annual 5-year Annual 5-year Annual 5-year Annual 5-year
effectiveness Units (2022) (2023–2027) (2022) (2023–2027) (2022) (2023–2027) (2022) (2023–2027)
Successful Patients 530 3,187 1,307 9,187 2,015 11,330 1,501 6,546
treatments
Lives saved Patients 411 2,454 1,025 7,007 1,371 7,010 829 3,617
Treatment Patients 107 685 227 1,762 227 1,189 234 1,035
failures
averted
Patient lost to Patients 320 2,176 609 4,717 1,379 7,153 708 3,082
follow-up
averted
Months of Months 21,447 118,650 47,771 314,184 53,471 289,143 41,838 183,948
treatment
saved
DALYs averted Years 20,179 133,565 27,443 214,585 33,384 164,038 21,942 93,609
YLLs averted Years 19,250 127,411 25,829 201,965 31,258 153,993 20,874 89,052
(years of life
lost due to
premature
mortality)
YLDs averted Years 930 6,153 1,614 12,620 2,126 10,045 1,068 4,558
(years lived
with
disability)
BPaL ¼ bedaquiline þ pretomanid þ linezolid; BPaLM ¼BPaL þ moxifloxacin; SSOR ¼ standard short oral regimen; SLOR ¼ standard long oral regimen; DALY ¼
disability-adjusted life-years; YLL ¼ years of life lost.
 Cost-effectiveness of BPaL/BPaLM 317

Table 3. Scenario analysis: Incremental effectiveness for 2022, The Philippines.

Incremental effectiveness
Successful Failures Loss to follow-up
BPaL BPaLM treatments Lives saved averted averted
% % n n n n
Scenario A (actual data)
Treatment success 98.6 92.6 1,307
rate
Died 1.4 0.0 1,025
Failure 0.0 0.0 227
Lost to follow-up 0.0 0.0 609
Scenario B (trial data)
Treatment success 89.3 88.7 1,001
rate
Died 0.0 0.0 1,028
Failure 0.6 0.0 226
Lost to follow-up 0.6 3.2 367
BPaL ¼ bedaquiline þ pretomanid þ linezolid; BPaLM ¼BPaL þ moxifloxacin.

Table 2 shows that using BPaL/BPaLM, instead a lower success rate, as reported in ZeNix4 and interim
of SSOR and SLOR not only results in considerable cost TB-PRACTECAL trial results,8 the number of additional
savings but also leads to an increased number of patients successful treatments using BPaL/BPaLM in the
annually with successful treatment outcomes (530; Philippines remains high at 1,001 compared with
1,307; 2,015; 1,501), lives saved (411; 1,025; 1,371; 1,307. Although the lives saved and failures averted
829), failures averted (107; 227; 227; 234), and loss to remain similar due to the similarity in outcomes from
follow-up averted (320; 609; 1,379; 708) for the four various studies, the number of patients lost to follow-
countries. Aggregate estimates for the four countries up increases but remains 367 fewer than when using
show that 3,636 lives would have been saved if these current regimens (Table 3).
countries had been using BPaL/BPaLM in 2022, and
20,089 lives would have been saved from 2023 to 2027. Budget impact analysis
The potential number of disability-adjusted life-years Over five years, depending on each country’s DR-TB
(DALYs) that could have been averted was consider- burden and the speed of switch from current to
able (20,179; 27,443; 33,384; 21,942) for the year new regimens, the savings are $14 million (44%),
2022 and even more so for the next 5-year period $23.2 million (15%), $34.4 million (36%), and
(133,565; 214,585; 164,038; 93,609). $61.6 million (60%), respectively (Table 4).

Scenario analysis: Incremental effectiveness under

different treatment outcome scenarios DISCUSSION
Scenario A is the actual treatment outcomes in the One of the main challenges with the tool is the col-
Philippines for BPaL (Supplementary Data 2) and those of lection of data that countries may not routinely gather.
TB-PRACTECAL5 for BPaLM. Scenario B uses less However, with the ongoing efforts to use WHO
favourable treatment outcomes and shows that with guidelines directly and digitise data, including

Table 4. Budget impact analysis: savings when switching from SSOR and SLOR to BPaL/BPaLM.
Pakistan Philippines South Africa Ukraine
10-year 10-year 10-year 10-year
5-year span span 5-year span span 5-year span span 5-year span span
Number of 32,812 81,481 74,946 154,216 48,069 97,119 30,551 71,512
people
treated
Total savings 14,002,655 37,678,985 23,153,108 53,301,425 34,430,535 69,563,734 61,606,894 152,921,201
Provider cost 13,457,879 36,211,235 19,408,472 44,797,456 30,152,151 60,919,652 46,114,424 114,373,593
saving
Patient cost 544,776 1,467,751 3,744,636 8,503,969 4,278,384 8,644,082 15,492,470 38,547,608
saving
Savings per 427 462 309 346 716 716 2,017 2,138
patient
Total savings, 44 48 15 17 36 40 60 65%
%
SSOR ¼ standard short oral regimen; SLOR ¼ standard long oral regimen; BPaL ¼ bedaquiline þ pretomanid þ linezolid; BPaLM ¼ BPaL þ moxifloxacin.
318 IJTLD OPEN

the guide on ‘Electronic recording and reporting for governmental health budget, in addition to better
tuberculosis care and control’,10 such information is treatment outcomes resulting in more people suc-
becoming more readily available. cessfully completing treatment, fewer cases of treat-
While SLASH-TB has the flexibility to include addi- ment failure, and more lives saved due to the positive
tional costs for both patients and service providers where impact on patient cohorts. Other studies in multiple
such data are available, the flexibility also extends to countries have also demonstrated cost savings
unavailable data. For example, among the analysed from implementing these regimens. 14–16 Operational
countries, South Africa and Ukraine failed to procure research in the Philippines shows a higher treatment
data on ancillary medicines. In these cases, we removed success than the clinical trials on which SLASH-TB is
the cost of ancillary medicines from the analysis for based. However, the scenario analysis indicates that
current regimens and BPaL/BPaLM. even when the worst outcomes from all trials are
SLASH-TB uses GBD country data based on TB considered, the use of BPaL/BPaLM would still result
disease and is not disaggregated for DR-TB. This likely in substantially more lives saved and fewer failures or
leads to an underestimation of the burden of DR-TB losses to follow-ups than when continuing the SSOR
disease and, hence, an underestimation of the number and SLOR; thus, these interventions would remain
of lives saved through the new regimens. highly cost-effective. Therefore, there is a strong
The outcome ‘years lived with disability’ was economic and treatment outcome-based case for the
adjusted by the number of patient treatment months rapid implementation of BPaL/BPaLM regimens. The
saved when using the shorter BPaL/BPaLM regimens. expected monetary savings could be used to improve
In reality, the issue of disability is far more complex diagnostic access and treatment support. This
—TB, especially DR-TB, often results in post-TB will contribute to closing the enormous gap that
sequelae and disabilities,11,12 and this is not cap- exists between the incidence cases of DR-TB and those
tured adequately in SLASH-TB. enrolled in adequate treatment: only approximately
Regarding the cost borne by the patients, SLASH- 43% of the estimated number of people who devel-
TB considers the average costs of transportation, oped DR-TB in 2022 were enrolled in treatment.1
hospitalisation expenses and days of lost income due
to trips to a clinic in the frame of DR-TB treatment.
For lost income, the country’s minimum wage was CONCLUSION
used, likely resulting in an underestimation of lost By implementing the BPaL/BPaLM regimens, DR-TB
income. Out-of-pocket expenditures are also likely treatment has become more effective, shorter, less
underestimated for a certain proportion of patients. burdensome for patients, and cheaper for both health
On the other hand, it was assumed that all patients systems and patients. SLASH-TB expresses this in
were wage earners. numbers; therefore, it is helpful for country planning,
SLASH-TB also does not consider the indirect advocacy, and budgeting. Countries will benefit from
benefits of reduced duration of treatment and a lower using SLASH-TB for planning purposes and advocacy
pill burden. Long-term treatment and a high pill by presenting concrete figures that show the benefit of
burden can have a strong negative impact on the the newly recommended BPaL/BPaLM regimens. The
patient’s quality of life. Also not considered are the results from SLASH-TB support the case for rapid
potentially substantial positive effects of lower failure implementation of BPaL/BPaLM made in published
and relapse rates (such as the positive effects of advocacy documents, such as the Call to Action of
less transmission, lower re-treatment rates, and lower WHO and partners17 and the Global Fund’s advocacy
re-hospitalisation rates) through the use of BPaL/ guide on six-month treatments for DR-TB.18
BPaLM. The main challenge now is to scale up the use of
The evidence to support better outcomes for DR-TB BPaL/BPaLM regimens rapidly. There is an epidemi-
when using BPaL/BPaLM regimens is impressive but ological, economic, and moral imperative to ade-
not extensive. More studies on the real-world treat- quately support countries in these scaling-up efforts.
ment outcomes of BPaL and BPaLM are currently SLASH-TB provides countries with an accessible tool
being conducted, and additional data are expected to to rapidly conduct cost-effectiveness and budget im-
be published soon. Data informing SLASH-TB out- pact analyses to support policy decisions, at no to
comes can be adjusted if warranted, and countries will minimal cost. TB Alliance intends to disseminate in-
be able to use the programmatic outcomes data when formation on the tool widely so that countries
they start implementing BPaL/BPaLM. worldwide can benefit from it.
Clinical trials and emerging data from program-
matic implementation6,13 prove that the shorter BPaL/ Acknowledgments
BPaLM regimens are more effective and more easily
The authors thank the following colleagues and partners for their
implementable for DR-TB. SLASH-TB calculates that assistance with data collection: M Diachenko, D Evans, AMC
implementing these treatments would lead to signifi- Garfin, D Goldberg, MT Gler, N Khan, N Muzaffar, DR Omanito,
cant cost savings with a long-term impact on the MIJ Quelapio, MC Salido, and I Terleieva.
 Cost-effectiveness of BPaL/BPaLM 319

This research was supported by TB Alliance (Global Alliance for 8 World Health Organization. Meeting report of the WHO expert
TB Drug Development; New York, NY, USA) with funding from consultation on drug-resistant tuberculosis treatment outcome
Australia’s Department of Foreign Affairs and Trade; the Bill & definitions, 17–19 November 2020. GenevaSwitzerland: WHO,
Melinda Gates Foundation (Seattle, WA, USA; Grant Number: INV- 2021.
042457; the UK Foreign, Commonwealth and Development Office; 9 Nyang’wa BT, et al. A 24-week, all-oral regimen for rifampin-
Germany’s Federal Ministry of Education and Research through resistant tuberculosis. N Engl J Med. 2022;387(25):2331–2343.
KfW; Irish Aid (Dublin, Ireland); and the United States Agency for 10 World Health Organization. Electronic recording and reporting
International Development (Washington DC, USA). The funders for tuberculosis care and control. Geneva, Switzerland: WHO,
2012.
played no role in the study design, data collection and analysis,
11 Igbokwe V, et al. Post-tuberculosis sequelae in children and
decision to publish, or preparation of the manuscript.
adolescents: a systematic review. Lancet Infect Dis. 2023 Apr;
23(4):e150.
12 Loveday M, et al. "This is not my body": Therapeutic experiences
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RÉSUMÉ

CONTEXTE: En 2022, l'OMS a préconisé l'utilisation des RÉSULTATS: Nous présentons les résultats de quatre
schémas thérapeutiques (bedaquiline + pretomanid + line- pays qui ont utilisé l'outil et partagé leurs données.
zolid) et BPaLM (BPaL + moxifloxacin), d'une durée de Lorsque les schémas plus courts et plus longs sont
6 mois, comme alternatives pour traiter la plupart des formes remplacés par BPaL/BPaLM, les économies par patient
de TB résistante aux médicaments. SLASH-TB a réalisé une traité au Pakistan, aux Philippines, en Afrique du Sud et
estimation des économies et de la rentabilité pour le système en Ukraine sont respectivement de 746, 478, 757 et
de santé et les patients lorsqu'un pays décide de passer des 2 636 dollars. L'utilisation des schémas BPaL/BPaLM
schémas thérapeutiques standards actuels au BPaL/BPaLM. permettrait de traiter un plus grand nombre de patients
M É T H O D O L O G I E : Les programmes nationaux de lutte avec succès, ce qui sauverait respectivement 411, 1 025,
contre la TB (NTP) utilisent les données nationales pour 1 371 et 829 vies et éviterait 20 179, 27 443, 33 384 et
évaluer les coûts des différents schémas thérapeutiques et 21 924 DALYs par an dans les quatre pays.
des résultats des traitements. Si le BPaL/BPaLM n'est pas C O N C L U S I O N : Les schémas BPaL/BPaLM ont révolu-
utilisé actuellement, les données des essais cliniques sont tionné le traitement de la tuberculose pharmacorésistante
utilisées pour estimer le rapport coût-efficacité. Les années en le rendant plus efficace, plus rapide, moins contra-
de vie ajustées sur l'incapacité (DALYs, pour l’anglais « ignant pour les patients, plus économique pour les sys-
disability-adjusted life-years ») sont calculées à l'aide de la tèmes de santé et les patients, et en sauvant un plus grand
base de données Global Burden of Disease (GBD). nombre de vies.

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