NEWS AND ANNOUNCEMENTS
SAVE THE DATE: FDA Webinar
Please save the date for September 6, 2018 from 8:30-9:30 EST as RESIST-TB invites you to join an exciting webinar on Adequate and Well-Controlled Studies in TB Regimen Development: An FDA Perspective.
This webinar will be presented by Karen Higgins of the Food and Drug Administration.
More information regarding the presentation and connection details to follow.
WHO RAPID COMMUNICATION: KEY CHANGES TO TREATMENT OF MDR/RR-TB
The World Health Organization (WHO) released a rapid communication ahead of updated, more detailed guidelines on treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) later in 2018. These improved guidelines are expected to lead to major improvements in treatment and quality of life of MDR-TB patients. The rapid communication announces a priority ranking for medicines available for treatment. This aims to improve access to more effective drugs in countries that currently have low treatment success rates. WHO also announced the forthcoming establishment of a multi-stakeholder Task Force to support national TB programs through the transition of the improved 2018 guidelines.
Click here to read the full communication.
1. Outcomes of patients with drug-resistant-tuberculosis treated with bedaquiline-containing regimens and undergoing adjunctive surgery.
J Infect. 2018 Aug 7. pii: S0163-4453(18)30246-9. doi: 10.1016/j.jinf.2018.08.003. [Epub ahead of print]
Borisov SE(1), D’Ambrosio L(2), Centis R(3), Tiberi S(4), Dheda K(5), Alffenaar JW(6), Amale R(7), Belilowski E(1), Bruchfeld J(8), Canneto B(9), Denholm J(10), Duarte R(11), Esmail A(5), Filippov A(1), Forsman LD(8), Gaga M(12), Ganatra S(7), Igorevna GA(13), Mastrapa BL(14), Manfrin V(15), Manga S(16), Maryandyshev A(13), Massard G(17), Montaner PG(18), Mullerpattan J(7), Palmero DJ(18), Pontarelli A(19), Papavasileiou A(20), Pontali E(21), Leyet RR(22), Spanevello A(23), Udwadia ZF(7), Viggiani P(19), Visca D(3), Sotgiu G(24), Migliori GB(25).
OBJECTIVES: No study evaluated the contribution of adjunctive surgery in bedaquiline-treated patients. This study describes treatment outcomes and complications in a cohort of drug-resistant pulmonary tuberculosis (TB) cases treated with bedaquiline-containing regimens undergoing surgery.
METHODS: This retrospective observational study recruited patients treated for TB in 12 centres in 9 countries between January 2007 and March 2015. Patients who had surgical indications in a bedaquiline-treated programme-based cohort were selected and surgery-related information was collected. Patient characteristics and surgical indications were described together with type of operation, surgical complications, bacteriological conversion rates, and treatment outcomes. Treatment outcomes were evaluated according to the time of surgery.
RESULTS: 57 bedaquiline-exposed cases resistant to a median of 7 drugs had indication for surgery (52 retreatments; 50 extensively drug-resistant (XDR) or pre XDR-TB). Sixty percent of cases initiated bedaquiline treatment following surgery, while 36.4% underwent the bedaquiline regimen before surgery and completed it after the operation. At treatment completion 90% culture-converted with 69.1% achieving treatment success; 21.8% had unfavourable outcomes (20.0% treatment failure, 1.8% lost to follow-up), and 9.1% were still undergoing treatment.
CONCLUSIONS: The study results suggest that bedaquiline and surgery can be safely and effectively combined in selected cases with a specific indication.
2. ‘I didn’t know so many people cared about me’: support for patients who interrupt drug-resistant TB treatment.
Int J Tuberc Lung Dis. 2018 Sep 1;22(9):1023-1030. doi: 10.5588/ijtld.17.0826.
Snyman L(1), Venables E(2), Trivino Duran L(1), Mohr E(1), Azevedo VD(3), Harmans X(1), Isaakidis P(4).
SETTING: Early interventions for patients who interrupt their treatment for drug-resistant tuberculosis (DR-TB) are rarely reported and assessed. A novel, patient-centred intervention for patients at risk of loss to follow-up (LTFU) from DR-TB treatment was implemented in Khayelitsha, South Africa, in September 2013.
OBJECTIVE: To explore the experiences and perceptions of patients, key support persons, health care workers (HCWs) and programme managers of a patient-centred model.
DESIGN: This was a qualitative study consisting of 18 in-depth interviews with patients, key support persons, HCWs, key informants and one focus group discussion with HCWs, between July and September 2017. Data were coded and thematically analysed.
RESULTS: The model was well perceived and viewed positively by patients, care providers and programme managers. ‘Normalisation’ and tolerance of occasional treatment interruptions, tracing, tailored management plans and peer support were perceived to be beneficial for retaining patients in care. Although the model was resource-demanding, health workers were convinced that it ‘needs to be sustained,’ and proposed solutions for its standardisation.
CONCLUSION: An intervention based on early tracing of patients who interrupt treatment, peer-delivered counselling and individualised management plans by a multidisciplinary team was considered a beneficial and acceptable model to support patients at risk of LTFU from DR-TB treatment.
3. Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003).
Int J Tuberc Lung Dis. 2018 Sep 1;22(9):1016-1022. doi: 10.5588/ijtld.18.0163.
Swindells S(1), Gupta A(2), Kim S(3), Hughes MD(4), Sanchez J(5), Mave V(6), Dawson R(7), Kumarasamy N(8), Comins K(9), Smith B(10), Rustomjee R(10), Naini L(11), Shah NS(12), Hesseling A(13), Churchyard G(14).
BACKGROUND: Current guidelines recommend evaluation of the household contacts (HHCs) of individuals with multidrug-resistant tuberculosis (MDR-TB); however, implementation of this policy is challenging.
OBJECTIVE: To describe the resource utilization and operational challenges encountered when identifying and characterizing adult MDR-TB index cases and their HHCs.
DESIGN: Cross-sectional study of adult MDR-TB index cases and HHCs at 16 clinical research sites in eight countries. Site-level resource utilization was assessed with surveys.
RESULTS: Between October 2015 and April 2016, 308 index cases and 1018 HHCs were enrolled. Of 280 index cases with sputum collected, 94 were smear-positive (34%, 95%CI 28-39), and of 201 with chest X-rays, 87 had cavitary disease (43%, 95%CI 37-50) after a mean duration of treatment of 8 weeks. Staff required 512 attempts to evaluate the 308 households, with a median time per attempt of 4 h; 77% (95%CI 73-80) of HHCs were at increased risk for TB: 13% were aged <5 years, 8% were infected with the human immunodeficiency virus, and 79% were positive on the tuberculin skin test/interferon-gamma release assay. One hundred and twenty-one previously undiagnosed TB cases were identified. Issues identified by site staff
included the complexity of personnel and participant transportation, infection control, personnel safety and management of stigma.
CONCLUSION: HHC investigations can be high yield, but are labor-intensive.
4. Bedaquiline versus injectable containing drug-resistant tuberculosis regimens: a cost effectiveness analysis.
Expert Rev Pharmacoecon Outcomes Res. 2018 Aug 3. doi: 10.1080/14737167.2018.1507821. [Epub ahead of print]
Ionescu AM(1), Mpobela Agnarson A(1), Kambili C(2), Metz L(3), Kfoury J(4), Wang S(5), Williams A(6), Singh V(7), Thomas A(1).
OBJECTIVES: Drug-resistant tuberculosis (DR-TB) continues to be a major public health challenge with suboptimal treatment outcomes including well documented treatment-related toxicities. We compared the cost effectiveness of bedaquiline containing regimens with injectable containing regimens (short course SCR and long course LCR) in India, Russia, and South Africa.
METHODS: The analysis evaluated direct costs of DR-TB treatment which included drugs, hospitalization, injectable-related adverse event costs and other costs. Scenarios altered regimen costs and choice, SCR/LCR ratio and whether the regimen contains bedaquiline or injectables.
RESULTS: Bedaquiline containing regimens are more cost effective based on cost per treatment success compared with injectable containing regimens, reducing these in SCR by 18-20% and in LCR by 49-54%. Average cost effectiveness ratios (ACERs) of bedaquiline containing regimens are lower. The incremental cost effectiveness ratio (ICER) is negative. Exclusive use of bedaquiline containing regimens results in approximately 61,000 more patients treated successfully over five years.
CONCLUSIONS: Across all countries, bedaquiline containing regimens are dominant compared to injectable containing regimens, entailing lower treatment costs to achieve better clinical outcomes. This analysis can provide insight and support to both local and global decision makers and public health organizations to allocate efficiently resources to improve patient and public health outcomes.