Rates and risk factors for nephrotoxicity and ototoxicity among tuberculosis patients in Tbilisi, Georgia

Buziashvili, Mariana; Mirtskhulava, Veriko; Kipiani, Maia; Blumberg, Henry M.; Baliashvili, Davit; Magee, Matthew J.; Furin, Jennifer; Tukvadze, Nestani; Kempker, Russell R.

doi:10.5588/ijtld.18.0626

Cited by 14 publications

(7 citation statements)

References 19 publications

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“…WHO now recommends a further modification; the use of a shorter, all oral, bedaquiline-containing regimen for eligible patients: patients without previous exposure to second-line medicines for more than one month, without fluoroquinolone resistance and in the absence of extensive TB disease or severe extra-pulmonary TB [21]. This shift away from regimen containing injectable secondline anti-TB drugs (kanamycin, amikacin or capreomycin) is due to the myriad of challenges associated with their use; logistical and psychological challenges of daily injections as well as adverse drug reactions (ADRs) most notably irreversible ototoxicity and acute renal injury [22][23][24]. Replacing the injectable agent in a shorter treatment regimen with bedaquiline has the added advantage of improving treatment success in patients with fluoroquinolone-susceptible RR/MDR-TB [25,26].…”

Section: Introductionmentioning

confidence: 99%

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

et al. 2020

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Background Globally, drug resistant tuberculosis (DR-TB) continues to be a public health threat. Nigeria, which accounts for a significant proportion of the global burden of rifampicin/multi-drug resistant-TB (RR/MDR-TB) had a funding gap of $168 million dollars for TB treatment in 2018. Since 2010, Nigeria has utilized five different models of care for RR/MDR-TB (Models A-E); Models A, B and C based on a standardized WHO-approved treatment regimen of 20–24 months, were phased out between 2015 and 2019 and replaced by Models D and E. Model D is a fully ambulatory model of 9–12 months during which a shorter treatment regimen including a second-line injectable agent is utilized. Model E is identical to Model D but has patients hospitalized for the first four months of care while Model F which is to be introduced in 2020, is a fully ambulatory, oral bedaquiline-containing shorter treatment regimen of 9–12 months. Treatment models for RR/MDR-TB of 20–24 months duration have had treatment success rates of 52–66% while shorter treatment regimens have reported success rates of 85% and above. In addition, replacing the second-line injectable agent in a shorter treatment regimen with bedaquiline has been found to further improve treatment success in patients with fluoroquinolone-susceptible RR/MDR-TB. Reliable cost data for RR/MDR-TB care are limited, specifically costs of models that utilize shorter treatment regimens and which are vital to guide Nigeria through the provision of RR/MDR-TB care at scale. We therefore conducted a cost analysis of shorter treatment regimens in use and to be used in Nigeria (Models D, E and F) and compared them to three models of longer duration utilized previously in Nigeria (Models A, B and C) to identify any changes in cost from transitioning from Models A-C to Models D-F and opportunities for cost savings. Methods We obtained costs for TB diagnostic and monitoring tests, in-patient and out-patient care from a previous study, inflated these costs to 2019 NGN and then converted to 2020 USD. We obtained other costs from the average of six health facilities and drug costs from the global drug facility. We modeled treatment on strict adherence to two Nigerian National guidelines for programmatic and clinical management of drug-resistant tuberculosis. Results We estimated that the total costs of care from the health sector perspective for Models D, E and F were $4,334, $7,705 and $3,420 respectively. This is significantly lower than the costs of Models A, B and C which were $14,781, $12, 113, $7,572 respectively. Conclusion Replacing Models A–C with Models D and E reduced the costs of RR/MDR-TB care in Nigeria by approximately $5,470 (48%) per patient treated and transitioning from Models D and E to Model F would result in further cost savings of $914 to $4,285 (21 to 56%) for every patient placed on Model F. If the improved outcomes of patients managed using bedaquiline-containing shorter treatment regimens in other countries can be attained in Nigeria, Model F would be the recommended model for the scale up of RR/MDR-TB care in Nigeria.

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Section: Introductionmentioning

confidence: 99%

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

et al. 2020

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“…Higher rates of adverse events occurred among HIV-positive mothers, likely due to the concurrent use of ART (28). Hepatotoxicity and nephrotoxicity were most prevalent ; they have been linked to pyrazinamide, ethionamide, kanamycin and uoroquinolones (29,30) which were the most commonly used drugs to treat our study cohort. Aminoglycosides and ethionamide have since been removed from the new all-oral short and long MDR/RR regimens in South Africa, but given the increasing availability of new drugs such as bedaquiline and linezolid their use among pregnant women should be reconsidered for countries still using the long regimen, (1).…”

Section: Discussionmentioning

confidence: 89%

Treatment and Pregnancy Outcomes of Pregnant Women Exposed to Second-line Anti-tuberculosis Drugs in South Africa

Mokhele

Jinga

Berhanu

et al. 2021

Preprint

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Background:Multi-drug resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) in pregnant women is a cause for concern globally; few data have described the safety of second-line anti-TB medications during pregnancy. We characterize maternal, and pregnancy outcomes for pregnant women receiving second-line anti-tuberculosis treatment for MDR/RR-TB.Methods: We conducted a retrospective record review of pregnant women (≥18 years) who received treatment for MDR/RR-TB between 01/2010–08/2016 at three outpatient treatment sites in Johannesburg, South Africa. Demographic, treatment and pregnancy outcome data were collected from available medical records. Preterm birth (<37 weeks), and miscarriage were categorized as adverse pregnancy outcomes.Results: Out of 720 women of child-bearing age who received MDR/RR-TB treatment at the three study sites, 35 (4.4%) pregnancies were identified. Overall, 68.7% (24/35) were HIV infected, 83.3% were on ART. Most women (88.6%) were pregnant at the time of MDR/RR-TB diagnosis and four women became pregnant during treatment. Pregnancy outcomes were available for 20/35 (57.1%) women, which included 15 live births (11 occurred prior to 37 weeks), 1 neonatal death, 1 miscarriage and 3 pregnancy terminations. Overall, 13/17 (76.5%) had an adverse pregnancy outcome. Of the 28 women with known TB treatment outcomes 17 (60.7%) completed treatment successfully (4 were cured and 13 completed treatment), 3 (10.7%) died and 8 (28.6%) were lost-to-follow-up.Conclusions:Pregnant women with MDR/RR-TB suffer from high rates of adverse pregnancy outcomes and about 60% achieve a successful TB treatment outcome. These vulnerable patients require close monitoring and coordinated obstetric, HIV and TB care.

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“…Higher rates of adverse events occurred among HIV-positive mothers, likely due to the concurrent use of ART [ 31 ]. Hepatotoxicity and nephrotoxicity were most prevalent; they have been linked to pyrazinamide, ethionamide, kanamycin and fluoroquinolones [ 32 , 33 ] which were the most commonly used drugs to treat our study cohort. Aminoglycosides and ethionamide have since been removed from the new all-oral short and long course MDR/RR regimens in South Africa, but given the increasing availability of new drugs such as bedaquiline and linezolid their use among pregnant women should be reconsidered for countries still using the long course regimens for MDR/RR-TB [ 2 ].…”

Section: Discussionmentioning

confidence: 99%

Treatment and pregnancy outcomes of pregnant women exposed to second-line anti-tuberculosis drugs in South Africa

Mokhele

Jinga

Berhanu

et al. 2021

BMC Pregnancy Childbirth

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Background Multi-drug resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) in pregnant women is a cause for concern globally; few data have described the safety of second-line anti-TB medications during pregnancy. We aim to describe TB treatment and pregnancy outcomes among pregnant women receiving second-line anti-tuberculosis treatment for MDR/RR-TB in Johannesburg, South Africa. Methods We conducted a retrospective record review of pregnant women (≥ 18 years) who received treatment for MDR/RR-TB between 01/2010–08/2016 at three outpatient treatment sites in Johannesburg, South Africa. Demographic, treatment and pregnancy outcome data were collected from available medical records. Preterm birth (< 37 weeks), and miscarriage were categorized as adverse pregnancy outcomes. Results Out of 720 women of child-bearing age who received MDR/RR-TB treatment at the three study sites, 35 (4.4%) pregnancies were identified. Overall, 68.7% (24/35) were HIV infected, 83.3% (20/24) were on antiretroviral therapy (ART). Most women, 88.6% (31/35), were pregnant at the time of MDR/RR-TB diagnosis and four women became pregnant during treatment. Pregnancy outcomes were available for 20/35 (57.1%) women, which included 15 live births (11 occurred prior to 37 weeks), 1 neonatal death, 1 miscarriage and 3 pregnancy terminations. Overall, 13/20 (65.0%) women with known pregnancy outcomes had an adverse pregnancy outcome. Of the 28 women with known TB treatment outcomes 17 (60.7%) completed treatment successfully (4 were cured and 13 completed treatment), 3 (10.7%) died and 8 (28.6%) were lost-to-follow-up. Conclusions Pregnant women with MDR/RR-TB suffer from high rates of adverse pregnancy outcomes and about 60% achieve a successful TB treatment outcome. These vulnerable patients require close monitoring and coordinated obstetric, HIV and TB care.

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Rates and risk factors for nephrotoxicity and ototoxicity among tuberculosis patients in Tbilisi, Georgia

Cited by 14 publications

References 19 publications

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

Treatment and Pregnancy Outcomes of Pregnant Women Exposed to Second-line Anti-tuberculosis Drugs in South Africa

Treatment and pregnancy outcomes of pregnant women exposed to second-line anti-tuberculosis drugs in South Africa

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