Adverse Drug Reactions to Antiretroviral Therapy: Frequency, Type, and Risk Factors in Children in Mali.

OBJECTIVE: The aim of our study was to evaluate the frequency, type, and risk factors associated with adverse drug reactions (ADRs) in HIV-positive children with adherence to antiretroviral therapy (ART) at the Unit of Care and Accompaniment for People Living With HIV (USAC) of Bamako. METHODS: A cross-sectional study was conducted at USAC of Bamako from May 1, 2014, to July 31, 2015. We included children aged 1 to 14 years with at least 6 months of ARV treatment initiated at USAC, with or without ADRs. Data collection was based on information collected from parents and clinical/biological assessments. RESULTS: Median age of participants was 36 months and female sex was predominant (54.8%). Poor adherence during the study was observed in 15% of cases. Of patients in the study, 52% had a CD4 count less than 350 cells/mm3 at the time of adverse events. In bivariate analysis, we found that participants with adherence to ART tended to be younger than those with non-adherence to ART (36 vs 72 months, p = 0.093). In multivariable analysis, prophylactic treatment was the only factor marginally associated with ART adherence in HIV patients (p = 0.09). No other adverse biological effects or clinical conditions were associated with ART adherence in this study. CONCLUSIONS: In this study we found that ADRs were frequent in HIV-positive patients but less frequent in ART-adherent HIV-positive children. Therefore, it is essential to regularly monitor children receiving ARVs to detect and treat the complications associated with these therapies according to ART adherence.

Precursor B-cell acute lymphoblastic leukaemia-a global view.

As haematologists, we always seek to follow standardised guidelines for practice and apply the best treatment within our means for our patients with blood diseases. However, treatment can never follow an exact recipe. Opinions differ as to the best approach; sometimes more than one treatment approach results in identical outcomes, or treatments differ only by the manner in which they fail. Furthermore, the haematologist is faced with constraints relating to the local economic environment. Patients too are not the same the world over. Early presentation is commoner in the developed world, as is the patient's understanding of the disease process. This in turn has an impact on the way patients are managed, the rigorousness of patient adhesion to the treatment schedule and the outcome. Here we take a look at the precursor B-cell acute lymphoblastic leukaemia in an adolescent in a range of different settings from low- to high income countries with widely differing challenges for diagnosis, therpy and follow-up. For these reasons, given the same starting conditions, patients will be treated differently according to the institute and the country they are in. Experts from around the world have been tasked to describe their management plan and rationale for a specific disease presentation. Here they explore the management of precursor B-cell acute lymphoblastic leukaemia (pre-B ALL) in five different institutions worldwide with a focus on those with more or less strained economies. We end with a conclusion from an expert in the field comparing and contrasting these different management styles and considering their merits and limitations.

Treatment of retinoblastoma in Sub-Saharan Africa: Experience of the paediatric oncology unit at Gabriel Toure Teaching Hospital and the Institute of African Tropical Ophthalmology, Bamako, Mali.

BACKGROUND: Retinoblastoma (Rb) is the most common intraocular primary malignancy in children. In industrialised countries, the cure rate is about 95%. We present the results of a prospective study on the management of Rb in the paediatric oncology unit of Gabriel Touré Teaching Hospital and African Institute of Tropical Ophthalmology, from November 1, 2011 to December 31, 2015. PROCEDURE: The aims of this prospective study were to evaluate the treatment of localised Rb, ocular prosthesis after enucleation, conservative management for bilateral Rb as well as survival rates in all patients. Patients with early stage Rb at diagnosis were included. The treatment was performed according to the retinoblastoma treatment guidelines of the French-African Paediatric Oncology Group. RESULTS: Eighty-eight patients were included in the study. Sex ratio was 1:1 (M = 44, F = 44). Median age at diagnosis was 3 years (range: 2 months-5 years). Unilateral intraocular Rb was predominant (n = 50; 56.8%). Conservative treatments were performed on nine eyes in nine patients. Overall survival and event-free survival of the entire cohort at the end of 4 years were 73% (95% CI 60.8-81.2%) and 59% (95% CI 47.9-69.5%), respectively, with a median follow-up of 3.7 years (0.1-5.6 years). In conclusion, early enucleation in early stage of Rb can improve outcomes in resource-limited countries. Delayed enucleation and refusal of adherence to treatment are still major concerns and remain a barrier to improving overall patient survival.

Neuroblastoma in Africa: A Survey by the Franco-African Pediatric Oncology Group.

PURPOSE: Neuroblastoma is a sympathoadrenal lineage neural crest-derived tumor. It is the third most common childhood malignancy in the Western world. Studies from the United States show that black patients with neuroblastoma have a greater proportion of high-risk neuroblastoma with poorer prognosis compared with white patients. In Africa, there are few published data on the epidemiology and management of neuroblastoma. The primary aim of this study was to assess the diagnostic and therapeutic resources available for the management of neuroblastoma within the Franco-African Pediatric Oncology Group (GFAOP). METHODS: A survey was conducted in the pediatric oncology centers of the GFAOP. Participating GFAOP centers were Abidjan, Algiers, Bamako, Dakar, Lubumbashi, Lomé, Ouagadougou, Rabat, Tananarive Antananarivo, and Tunis. Questionnaires were sent out by e-mail to the principal investigators at each participating GFAOP center in December 2013. RESULTS: Ten (62%) of 16 GFAOP centers responded to the questionnaire. Neuroblastoma represented only 3% to 5% of childhood cancers in the sub-Saharan African centers, with the exception of Antananarivo, where it represented 7.5%. In contrast, in the northern African centers of Tunis, Rabat, and Algiers, neuroblastoma accounted for 30%,10%, and 7% of childhood cancer, respectively. At initial diagnosis, 50% to 80% of patients had metastatic neuroblastoma in eight of 10 centers. CONCLUSION: Based on this survey, neuroblastoma seems to be less common in sub-Saharan Africa. The proportion of patients with metastatic neuroblastoma seems to be higher than reported in Western countries.

[National reference unit of neonatology: state of play]. / Unit6é de néonatologie de référence nationale du Mali: état des lieux.

BACKGROUND: The neonatal mortality rate in Mali is one of the highest in the world. Only one national reference neonatology unit is available in the country. AIM: To describe the time-course of morbidity, mortality, staff and accommodation facilities from 2008 to 2009 in Mali's unique national reference neonatology unit. METHODS: This descriptive and cross-sectional study was conducted in the neonatology unit of Gabriel Touré Teaching Hospital, Bamako. Data concerning staff number of admissions, sex ratio, diseases, patients outcome, capacity and length-of-stay were compiled for the period from 1st January 2008 to 31 December 2012. RESULTS: Medical staff increased from one to three in 2009 and the number of nurses and midwives decreased from 16 to 14 with an average number of beds of 44. The mean number of hospitalizations per year was 3,900 (range: 3667-4585) with 14% of in-born deliveries and a mean length-of-stay of 3.7 days. Prematurity birth asphyxia and infection represented 80.5% of reasons for admission and 79.5% of deaths. The mortality rate varied from 28.5% to 36.8% with an annual mean of 33.2%. The diseases associated with the highest mortality were tetanus (60.8%), prematurity (42.7%), birth asphyxia (29.4%) and infection (25.7%). CONCLUSION: Neonatal mortality remains very high in Mali. Health authorities should take measures to decentralize the care of sick newborns in order to reduce neonatal mortality in Mali.

[Retinoblastoma: inventory in Mali and program to develop early diagnosis, treatments and rehabilitation]. / Le rétinoblastome: état des lieux au Mali et programme d'aide au diagnostic précoce, aux traitements et à la réhabilitation.

Retinoblastoma (RB) is a rare embryonic tumour that represents 1/16,000 births in France. In Mali, a study showed the characteristics of a hospital series of cases seen in Bamako in the Pediatric Oncology Unit of Gabriel Touré Teaching Hospital and in the Tropical Ophthalmology Institute of Africa (IOTA) between January 2005 and June 2007. Median age was 4 years versus 2 years in France for unilateral disease. Near two third of children with RB had extra-ocular extension at diagnosis, which is now exceptional in France. Only 11% were bilateral versus 35% in France. Cure rate was around 50%, but it is estimated only on the cases arriving in Bamako and with at least 20% lost of follow-up. Cure rate is over 95% in France within an exhaustive register. RB appears as an exemplary tumor and rapid improvements could be obtained in low-income countries with relatively limited means. This is why, the Alliance mondiale contre le cancer (AMCC), the Institut Curie in Paris, which is the reference center in France for RB, and teams in Bamako were proposing a program to help the development of early diagnosis, treatments, including eye preservation, and rehabilitation of children with RB in sub-Saharan Africa in collaboration with the Groupe franco-africain d'oncologie pédiatrique (GFAOP). The official launching of this program was held in Bamako November 4, 2011 for Mali and the surrounding regions. After this first experience, this program is now implemented in other countries.

Adverse drug reactions to antiretroviral therapy: prospective study in children in sikasso (mali).

OBJECTIVES: Adverse events during antiretroviral treatment are frequent and various. Their diagnosis incurs some various difficulties according to the geographic context. Our aim was to describe the frequency, nature, and preventability of adverse drug reactions (ADRs) due to antiretroviral treatment in Malian outpatient children. METHODS: The study was a 6-month (June 1 to November 30, 2010) prospective, observational study of 92 children admitted to a pediatric hospital in Sikasso, Mali. The patients were treated with a generic drug and/or drug combinations. Prior to treatment initiation, demographic characteristics, clinical history, and biologic parameters, including CD4 cell counts, were collected for each patient. The World Health Organization's adverse drug reactions classification was used to characterize the side effects. Adverse effects and toxicities were graded 1, 2, and 3. Analysis of data was performed using SPSS Version 17.0 software. RESULTS: Ninety-two human immunodeficiency virus-infected children met the criteria of inclusion. After 24 weeks of treatment, we observed that 14.1% of children had at least one side effect during our study. Side effects were many and varied, with the most frequent being cutaneous rash, nausea, vomiting, and diarrhea (38.5%, 23.1%, 15.4%, and 15.4%, respectively). Side effects were grade 1 in most cases. One case of grade 2 and one case of grade 3 were observed with rash. We observed one case of grade 3 side effects during our study. The treatment regimen was changed in 15.2% of cases, including one case because of side effects. CONCLUSION: ADRs are not rare in Mali, particularly in children. These ADRs have an impact on quality of life for patients. We recommend a pharmacovigilance system for sustainable management of side effects in patients infected with human immunodeficiency virus in Mali.