Development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry method for the quantification of the antimalarial drug pyronaridine in human whole blood

Malaria remains a major health concern, aggravated by emerging resistance of the parasite to existing treatments. The World Health Organization recently endorsed the use of artesunate-pyronaridine to treat uncomplicated malaria. However, there is a lack of clinical pharmacokinetic (PK) data of pyronaridine, particularly in special populations such as children and pregnant women. Existing methods for the quantification of pyronaridine in biological matrices to support PK studies exhibit several drawbacks. These include limited sensitivity, a large sample volume required, and extensive analysis time. To overcome these limitations, an ultra-performance reversed-phase liquid chromatography tandem-mass spectrometry method to determine pyronaridine was developed and validated according to international guidelines. The method enabled fast and accurate quantification of pyronaridine in whole blood across a clinically relevant concentration range of 0.500–500 ng/mL (r2 ≥ 0.9963), with a required sample volume of 50 µL. Pyronaridine was extracted from whole blood using liquid-liquid extraction, effectively eliminating the matrix effect and preventing ion enhancement or suppression. The method achieved a satisfactory reproducible sample preparation recovery of 77%, accuracy (as bias) and precision were within ±8.2% and ≤5.3%, respectively. Stability experiments demonstrated that pyronaridine was stable for up to 315 days when stored at −70°C. Adjustments to the chromatographic system substantially reduced carry-over and improved sensitivity compared to prior methods. The method was successfully applied to quantify pyronaridine in whole blood samples from a selection of pregnant malaria patients participating in the PYRAPREG clinical trial (PACTR202011812241529) in the Democratic Republic of the Congo, demonstrating its suitability to support future PK studies. Furthermore, the enhanced sensitivity allows for the determination of pyronaridine up to 42 days post-treatment initiation, enabling assessment of the terminal elimination half-life

Development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry method for the quantification of the antimalarial drug pyronaridine in human whole blood

Malaria remains a major health concern, aggravated by emerging resistance of the parasite to existing treatments. The World Health Organization recently endorsed the use of artesunate-pyronaridine to treat uncomplicated malaria. However, there is a lack of clinical pharmacokinetic (PK) data of pyronaridine, particularly in special populations such as children and pregnant women. Existing methods for the quantification of pyronaridine in biological matrices to support PK studies exhibit several drawbacks. These include limited sensitivity, a large sample volume required, and extensive analysis time. To overcome these limitations, an ultra-performance reversed-phase liquid chromatography tandem-mass spectrometry method to determine pyronaridine was developed and validated according to international guidelines. The method enabled fast and accurate quantification of pyronaridine in whole blood across a clinically relevant concentration range of 0.500–500 ng/mL (r2 ≥ 0.9963), with a required sample volume of 50 µL. Pyronaridine was extracted from whole blood using liquid-liquid extraction, effectively eliminating the matrix effect and preventing ion enhancement or suppression. The method achieved a satisfactory reproducible sample preparation recovery of 77%, accuracy (as bias) and precision were within ±8.2% and ≤5.3%, respectively. Stability experiments demonstrated that pyronaridine was stable for up to 315 days when stored at −70°C. Adjustments to the chromatographic system substantially reduced carry-over and improved sensitivity compared to prior methods. The method was successfully applied to quantify pyronaridine in whole blood samples from a selection of pregnant malaria patients participating in the PYRAPREG clinical trial (PACTR202011812241529) in the Democratic Republic of the Congo, demonstrating its suitability to support future PK studies. Furthermore, the enhanced sensitivity allows for the determination of pyronaridine up to 42 days post-treatment initiation, enabling assessment of the terminal elimination half-life

Adherence to COVID-19 Prevention Measures in the Democratic Republic of the Congo, Results of Two Consecutive Online Surveys

Adherence to preventive measures is essential to reduce the risk of COVID-19 transmission. Two online surveys were conducted in the Democratic Republic of the Congo (DRC) from 23 April to 8 June 2020, and from August 24th to September 8th, respectively. A total of 3268 (round 1) and 4160 (round 2) participants were included. In both surveys, there was a moderate level of adherence to regular handwashing (85% and 77%, respectively), wearing of facemasks (41.4% and 69%, respectively), and respecting physical distancing (58% and 43.4%, respectively). The second survey found that, working in private (OR = 2.31, CI: 1.66–3.22; p < 0.001) and public organizations (OR = 1.61, CI: 1.04–2.49; p = 0.032) and being a healthcare worker (OR = 2.19, CI: 1.57–3.05; p < 0.001) significantly increased the odds for better adherence. However, a unit increase in age (OR = 0.99, CI: 0.98–0.99; p < 0.026), having attained lower education levels (OR = 0.60, CI: 0.46–0.78; p < 0.001), living in a room (OR = 0.36, CI: 0.15–0.89; p = 0.027), living in a studio (OR = 0.26, CI: 0.11–0.61; p = 0.002) and apartment (OR = 0.29, CI: 0.10–0.82; p = 0.019) significantly decreased the odds for better adherence. We recommend a multi-sectorial approach to monitor and respond to the pandemic threat. While physical distancing may be difficult in Africa, it should be possible to increase the use of facemasks

Intimate partners violence against women during a COVID-19 lockdown period : results of an online survey in 7 provinces of the Democratic Republic of Congo

Intimate Partners' Violence (IPV) is a public health problem with long-lasting mental and physical health consequences for victims and their families. As evidence has been increasing that COVID-19 lockdown measures may exacerbate IPV, our study sought to describe the magnitude of IPV in women and identify associated determinants. An online survey was conducted in the Democratic Republic of Congo (DRC) from 24 August to 8 September 2020. Of the 4160 respondents, 2002 eligible women were included in the data analysis. Their mean age was 36.3 (SD: 8.2). Most women (65.8%) were younger than 40 years old. Prevalence of any form of IPV was 11.7%. Being in the 30-39 and >50 years' age groups (OR = 0.66, CI: 0.46-0.95; = 0.026 and OR = 0.23, CI: 0.11-048; < 0.001, respectively), living in urban setting (OR = 0.63, CI: 0.41-0.99; = 0.047), and belonging to the middle socioeconomic class (OR = 0.48, CI: 0.29-0.79; = 0.003) significantly decreased the odds for experiencing IPV. Lower socioeconomic status (OR = 1.84, CI: 1.04-3.24; = 0.035) and being pregnant (OR = 1.63, CI: 1.16-2.29; = 0.005) or uncertain of pregnancy status (OR = 2.01, CI: 1.17-3.44; = 0.011) significantly increased the odds for reporting IPV. Additional qualitative research is needed to identify the underlying reasons and mechanisms of IPV in order to develop and implement prevention interventions

Intimate Partners Violence against Women during a COVID-19 Lockdown Period: Results of an Online Survey in 7 Provinces of the Democratic Republic of Congo.

Intimate Partners' Violence (IPV) is a public health problem with long-lasting mental and physical health consequences for victims and their families. As evidence has been increasing that COVID-19 lockdown measures may exacerbate IPV, our study sought to describe the magnitude of IPV in women and identify associated determinants. An online survey was conducted in the Democratic Republic of Congo (DRC) from 24 August to 8 September 2020. Of the 4160 respondents, 2002 eligible women were included in the data analysis. Their mean age was 36.3 (SD: 8.2). Most women (65.8%) were younger than 40 years old. Prevalence of any form of IPV was 11.7%. Being in the 30-39 and >50 years' age groups (OR = 0.66, CI: 0.46-0.95; = 0.026 and OR = 0.23, CI: 0.11-048; < 0.001, respectively), living in urban setting (OR = 0.63, CI: 0.41-0.99; = 0.047), and belonging to the middle socioeconomic class (OR = 0.48, CI: 0.29-0.79; = 0.003) significantly decreased the odds for experiencing IPV. Lower socioeconomic status (OR = 1.84, CI: 1.04-3.24; = 0.035) and being pregnant (OR = 1.63, CI: 1.16-2.29; = 0.005) or uncertain of pregnancy status (OR = 2.01, CI: 1.17-3.44; = 0.011) significantly increased the odds for reporting IPV. Additional qualitative research is needed to identify the underlying reasons and mechanisms of IPV in order to develop and implement prevention interventions

COVID-19 Vaccine Acceptance in the Democratic Republic of Congo: A Cross-Sectional Survey.

We investigated the level of willingness for COVID-19 vaccination in the Democratic Republic of Congo (DRC). Data were collected between 24 August 2020 and 8 September 2020 through an online survey. A total of 4131 responses were included; mean age of respondents was 35 years (standard deviation: 11.5); 68.4% were females; 71% had elementary or secondary school education. One fourth (24.1%) were convinced that COVID-19 did not exist. Overall, 2310 (55.9%) indicated they were willing to be vaccinated. In a multivariable regression model, belonging to the middle and high-income category (OR = 1.85, CI: 1.46-2.35 and OR = 2.91, CI: 2.15-3.93, respectively), being tested for COVID-19 (OR = 4.71, CI: 3.62-6.12; < 0.001), COVID-19 community vaccine acceptance (OR = 14.45, CI: 2.91-71.65; = 0.001) and acknowledging the existence of COVID-19 (OR = 6.04, CI: 4.42-8.23; < 0.001) were associated with an increased willingness to be vaccinated. Being a healthcare worker was associated with a decreased willingness for vaccination (OR = 0.46, CI: 0.36-0.58; < 0.001). In conclusion, the current willingness for COVID-19 vaccination among citizens of the DRC is too low to dramatically decrease community transmission. Of great concern is the low intention of immunization among healthcare workers. A large sensitization campaign will be needed to increase COVID-19 vaccine acceptance

Development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry method for the quantification of the antimalarial drug pyronaridine in human whole blood

Malaria remains a major health concern, aggravated by emerging resistance of the parasite to existing treatments. The World Health Organization recently endorsed the use of artesunate-pyronaridine to treat uncomplicated malaria. However, there is a lack of clinical pharmacokinetic (PK) data of pyronaridine, particularly in special populations such as children and pregnant women. Existing methods for the quantification of pyronaridine in biological matrices to support PK studies exhibit several drawbacks. These include limited sensitivity, a large sample volume required, and extensive analysis time. To overcome these limitations, an ultra-performance reversed-phase liquid chromatography tandem-mass spectrometry method to determine pyronaridine was developed and validated according to international guidelines. The method enabled fast and accurate quantification of pyronaridine in whole blood across a clinically relevant concentration range of 0.500-500 ng/mL (r2 &gt;= 0.9963), with a required sample volume of 50 mu L. Pyronaridine was extracted from whole blood using liquidliquid extraction, effectively eliminating the matrix effect and preventing ion enhancement or suppression. The method achieved a satisfactory reproducible sample preparation recovery of 77%, accuracy (as bias) and precision were within +/- 8.2% and &lt;= 5.3%, respectively. Stability experiments demonstrated that pyronaridine was stable for up to 315 days when stored at - 70 degrees C. Adjustments to the chromatographic system substantially reduced carry-over and improved sensitivity compared to prior methods. The method was successfully applied to quantify pyronaridine in whole blood samples from a selection of pregnant malaria patients participating in the PYRAPREG clinical trial (PACTR202011812241529) in the Democratic Republic of the Congo, demonstrating its suitability to support future PK studies. Furthermore, the enhanced sensitivity allows for the determination of pyronaridine up to 42 days post-treatment initiation, enabling assessment of the terminal elimination half-life