Ebola Virus Disease

Kourtis, Athena P.; Appelgren, Kristie E.; Chevalier, Michelle; McElroy, Anita K.

doi:10.1097/inf.0000000000000707

Cited by 33 publications

(18 citation statements)

References 33 publications

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“…Previous clinical data on favipiravir for the treatment of influenza have been collected exclusively in adults. However, given the high EVD mortality rate and the good tolerance profile of the drug, we considered it unethical to restrict access to the drug to parents while their children would receive standard care only [ 23 ]. Therefore, we asked pediatricians to assess potential safety issues in children.…”

Section: Methodsmentioning

confidence: 99%

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Sissoko¹,

Laouénan²,

Folkesson³

et al. 2016

PLoS Med

415

366

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BackgroundEbola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care.Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.Methods and FindingsInclusion criteria were positive Ebola virus reverse transcription PCR (RT-PCR) test, age ≥ 1 y, weight ≥ 10 kg, ability to take oral drugs, and informed consent. All participants received oral favipiravir (day 0: 6,000 mg; day 1 to day 9: 2,400 mg/d). Semi-quantitative Ebola virus RT-PCR (results expressed in “cycle threshold” [Ct]) and biochemistry tests were performed at day 0, day 2, day 4, end of symptoms, day 14, and day 30. Frozen samples were shipped to a reference biosafety level 4 laboratory for RNA viral load measurement using a quantitative reference technique (genome copies/milliliter). Outcomes were mortality, viral load evolution, and adverse events. The analysis was stratified by age and Ct value. A “target value” of mortality was defined a priori for each stratum, to guide the interpretation of interim and final analysis.Between 17 December 2014 and 8 April 2015, 126 patients were included, of whom 111 were analyzed (adults and adolescents, ≥13 y, n = 99; young children, ≤6 y, n = 12). Here we present the results obtained in the 99 adults and adolescents. Of these, 55 had a baseline Ct value ≥ 20 (Group A Ct ≥ 20), and 44 had a baseline Ct value < 20 (Group A Ct < 20). Ct values and RNA viral loads were well correlated, with Ct = 20 corresponding to RNA viral load = 7.7 log10 genome copies/ml. Mortality was 20% (95% CI 11.6%–32.4%) in Group A Ct ≥ 20 and 91% (95% CI 78.8%–91.1%) in Group A Ct < 20. Both mortality 95% CIs i...

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Section: Methodsmentioning

confidence: 99%

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Sissoko¹,

Laouénan²,

Folkesson³

et al. 2016

PLoS Med

415

366

View full text Add to dashboard Cite

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“…Women may be more at risk from caring for the sick and men from carrying sick persons to the hospital. Children may be deliberately kept away from sick persons and funeral rites, and lower incidence among children has been attributed to these factors ( 1 , 11 ). However, preventing exposure of young children in Ebola-affected households is difficult.…”

mentioning

confidence: 99%

Exposure-Specific and Age-Specific Attack Rates for Ebola Virus Disease in Ebola-Affected Households, Sierra Leone

Bower¹,

Johnson²,

Bangura³

et al. 2016

Emerg. Infect. Dis.

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“…He survived despite his high viral load at admission [3]. However, age as a poor prognostic factor is controversial [4,5]. The case fatality rate seems very high in children under 5 years of age, but school children and adolescents seem to survive more.…”

Section: Case Discussionmentioning

confidence: 99%

A 6-Year-Old Child with Severe Ebola Virus Disease: Laboratory-Guided Clinical Care in an Ebola Treatment Center in Guinea

et al. 2016

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Ebola Virus Disease

Cited by 33 publications

References 33 publications

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Exposure-Specific and Age-Specific Attack Rates for Ebola Virus Disease in Ebola-Affected Households, Sierra Leone

A 6-Year-Old Child with Severe Ebola Virus Disease: Laboratory-Guided Clinical Care in an Ebola Treatment Center in Guinea

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