Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey

Hwang, Bella; Shroufi, Amir; Gils, Tinne; Steele, Sarah Jane; Grimsrud, Anna; Boulle, Andrew; Yawa, Anele; Stevenson, Sasha; Jankelowitz, Lauren; Versteeg-Mojanaga, Marije; Govender, Indira; Stephens, John; Hill, Julia; Duncan, Kristal; Cutsem, Gilles van

doi:10.1371/journal.pone.0212405

Cited by 36 publications

(30 citation statements)

References 21 publications

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“…The paediatric antiretroviral market is small and fragmented, and stock-outs in low-level health facilities are frequent. 12 Additionally, children in the lower weight bands would require yet another (dispersible) formulation. 13 , 14 Last, complex regimens with two different tablet doses of the same drug have the potential to cause dosing errors by both health-care workers and caregivers.…”

Section: Introductionmentioning

confidence: 99%

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

Bollen¹,

Moore

Mujuru

et al. 2020

The Lancet HIV

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Summary Background Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV. Methods We did pharmacokinetic and safety substudies within the open-label, multicentre, randomised ODYSSEY trial ( NCT02259127 ) of children with HIV starting treatment in four research centres in Uganda and Zimbabwe. Eligible children were randomised to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg. In children weighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which were approved by the SRAs for the children's weight band; then switched to 50 mg film-coated tablets once daily. Steady-state 24 h dolutegravir plasma concentration-time pharmacokinetic profiling was done in all enrolled children at baseline and 1, 2, 3, 4, 6, and 24 h after observed dolutegravir intake. Target dolutegravir trough concentrations (C trough ) were based on reference adult pharmacokinetic data and safety was evaluated in all children in the corresponding weight bands who consented to pharmacokinetic studies and received the studied doses. Findings Between Sept 22, 2016, and May 31, 2018, we enrolled 62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles). In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough (coefficient of variation) was 0·32 mg/L (94%), which was 61% lower than the GM C trough of 0·83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 kg to less than 30 kg taking 25 mg film-coated tablets, the GM C trough was 0·39 mg/L (48%), which was 54% lower than the GM C trough in fasted adults; and in those 30 kg to less than 40 kg taking 35 mg film-coated tablets the GM C trough was 0·46 mg/L (63%), which was 45% lower than the GM C trough in fasted adults. On 50 mg film-coated tablets or 30 mg dispersible tablets, C trough was close to the adult reference (with similar estimates on the two formulation...

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Section: Introductionmentioning

confidence: 99%

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

Bollen¹,

Moore

Mujuru

et al. 2020

The Lancet HIV

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“… 26 , 32 End-user monitoring of the supply chain by patients and civil society has the potential to increase transparency and complement public sector monitoring systems. 8 …”

Section: Discussionmentioning

confidence: 99%

“…Using the documented existing service delivery gaps, we analysed EPI and HIV programmes as examples of priority essential health services to be maintained by South Africa during this emergency period. 6 , 8 , 18 In addition, solutions to strike a balance between responding to COVID-19 pandemic and maintenance of these essential services are proposed.…”

Section: Approachmentioning

confidence: 99%

“…6 , 7 South Africa has existing antiretroviral (ARV) and vaccine stock-out challenges because of supply chain constraints. 8 , 9 , 10 , 11 In addition, gaps have been identified around low routine immunisation coverage resulting in outbreaks of vaccine preventable diseases, such as measles, in South Africa. 12 Anecdotal reports show that there is a decline in access to ART from March 2020 by those already initiated on ART.…”

Section: Introductionmentioning

confidence: 99%

“…immunisation) and HIV services stand out as the most critical markers and a proxy for the strength of a health system, particularly in the context of South Africa. 6 , 8 , 12 Resilience of a health system is indicated by its ability to offer basic healthcare services to pregnant women, children and people with HIV. These groups are comparatively more vulnerable and contribute to a high burden of morbidity and mortality at a population level.…”

Section: Introductionmentioning

confidence: 99%

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The effects of coronavirus disease 2019 pandemic on the South African health system: A call to maintain essential health services

Nyasulu

Pandya

2020

African Journal of Primary Health Care & Family Medicine

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South Africa had its first coronavirus disease 2019 (COVID-19) case on 06 March 2020 in an individual who travelled overseas. Since then, cases have constantly increased and the pandemic has taken a toll on the health system. This requires extra mobilisation of resources to curb the disease and overcome financial loses whilst providing social protection to the poor. Assessing the effects of COVID-19 on South African health system is critical to identify challenges and act timely to strike a balance between managing the emergency and maintaining essential health services. We applied the World Health Organization (WHO) health systems framework to assess the effects of COVID-19 on South African health system, and proposed solutions to address the gaps, with a focus on human immunodeficiency virus (HIV) and expanded programme on immunisation (EPI) programmes. The emergence of COVID-19 pandemic has direct impact on the health system, negatively affecting its functionality, as depletion of resources to curb the emergency is eminent. Diversion of health workforce, suspension of services, reduced health-seeking behaviour, unavailability of supplies, deterioration in data monitoring and funding crunches are some of the noted challenges. In such emergencies, the ability to deliver essential services is dependent on baseline capacity of health system. Our approach advocates for close collaboration between essential services and COVID-19 teams to identify priorities, restructure essential services to accommodate physical distancing, promote task shifting at primary level, optimise the use of mobile/web-based technologies for service delivery/training/monitoring and involve private sector and non-health departments to increase management capacity. Strategic responses thus planned can assist in mitigating the adverse effects of the pandemic whilst preventing morbidity and mortality from preventable diseases in the population.

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Is “Undetectable = Untransmissible” Good Public Health Messaging?

Tan

Lim

Chan³

2021

AMA Journal of Ethics

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This article considers merits and drawbacks of "undetectable = untransmissible" (U = U) messaging in the global HIV response. First, viral suppression might be achieved with effective treatment, but not everyone living with HIV has access to such intervention and care. Second, although U = U can help individuals living with HIV, this messaging might stigmatize those for whom interventions have not achieved viral suppression. Third, although biomedical advances have attempted to address infectiousness, syndemic drivers that predispose individuals to HIV acquisition are not well accounted for by U = U messaging.To claim one AMA PRA Category 1 Credit TM for the CME activity associated with this article, you must do the following: (1) read this article in its entirety, (2) answer at least 80 percent of the quiz questions correctly, and (3) complete an evaluation. The quiz, evaluation, and form for claiming AMA PRA Category 1 Credit TM are available through the AMA Ed Hub TM .

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Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey

Cited by 36 publications

References 21 publications

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

The effects of coronavirus disease 2019 pandemic on the South African health system: A call to maintain essential health services

Is “Undetectable = Untransmissible” Good Public Health Messaging?

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