Hugues Cordel

BACKGROUND: The global mpox outbreak that started in May 2022 was caused by a novel clade IIb variant of the mpox virus (Orthopoxvirus monkeypox, MPXV). It differed from the traditional Western and Central Africa disease in transmission patterns and clinical presentation. METHODS: To address the need for detailed clinical and virologic data, we conducted an observational cohort study (MOSAIC) during May 2022-July 2023 in individuals with confirmed MPXV infection enrolled in 6 European countries. Case management decisions were left to the attending physician. Participants were monitored for up to 6 months for clinical signs/symptoms and clinical and virologic outcomes through hospital visits, phone interviews, and self-administered questionnaires. Outcomes included time to lesion resolution, clinical status, and virus clearance. RESULTS: The 518 participants not receiving any specific treatment ("untreated") were diagnosed a median 5 days from symptom onset; 90% were managed as outpatients. Lesions were mostly cutaneous (88%) and perigenital (74%). By day 14 from the first polymerase chain reaction (PCR)-positive sample, 39% had resolved lesions. Time to 95% unculturable virus was longest in cutaneous lesions (52 days). A putative systemic antiviral was available for 57 participants, 44% as inpatients; 34% and 58% had resolved lesions by day 14 from the first PCR-positive sample and from treatment start, respectively. Time to 95% unculturable virus was 60 days in skin and oropharynx. No death or recrudescence occurred by day 180. CONCLUSIONS: MOSAIC provides comprehensive insights into the clinical and virologic characteristics of mpox caused by the clade IIb variant. The study forms the basis of clinical characterization for ongoing mpox outbreaks.

BACKGROUND: The impact of the variant of concern (VOC) Alpha on the severity of COVID-19 has been debated. We report our analysis in France. METHODS: We conducted an exposed/unexposed cohort study with retrospective data collection, comparing patients infected by VOC Alpha to contemporaneous patients infected by historical lineages. Participants were matched on age (± 2.5 years), sex and region of hospitalization. The primary endpoint was the proportion of hospitalized participants with severe COVID-19, defined as a WHO-scale > 5 or by the need of a non-rebreather mask, occurring up to day 29 after admission. We used a logistic regression model stratified on each matched pair and accounting for factors known to be associated with the severity of the disease. RESULTS: We included 650 pairs of patients hospitalized between Jan 1, 2021, and Feb 28, 2021, in 47 hospitals. Median age was 70 years and 61.3% of participants were male. The proportion of participants with comorbidities was high in both groups (85.0% vs 90%, p = 0.004). Infection by VOC Alpha was associated with a higher odds of severe COVID-19 (41.7% vs 38.5%-aOR = 1.33 95% CI [1.03-1.72]). CONCLUSION: Infection by the VOC Alpha was associated with a higher odds of severe COVID-19.

Objectives: BICSTaR is a multinational, prospective, observational study that aimed to evaluate bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV treatment-naïve (TN) and treatment-experienced (TE) participants in routine clinical practice. Methods: Month 12 analysis of the French cohort with respect to virologic effectiveness, drug-related adverse events (DRAEs), emergence of resistance, body weight, and patient-reported outcomes using the HIV Symptom Index and the HIV Treatment Satisfaction Questionnaire. Results: A total of 240 participants initiated B/F/TAF in January-July 2019 (56 TN, 184 TE), 79% of whom were male, with a median age of 50 years. At baseline, 63% (TN: 46%, TE: 68%) presented with comorbidities. At month 12, HIV-1 RNA was <50 cp/mL in 92% (43/47) of TN and 96% (134 of 139) of TE in missing = excluded analysis (discontinuation = failure analysis: TN: 92% [43 of 47], TE: 92% [134 of 146]). No major mutations associated with B/F/TAF resistance emerged. A total of 7% (16 of 240) discontinued B/F/TAF, including 4% (10 of 240) due to DRAEs and none for virologic reasons. DRAEs were reported in 13% (30 of 240) (no renal DRAE). The median changes in body weight were +6.5 kg in TN and +1.0 kg in TE. The number of bothersome symptoms decreased in the TN group, and treatment satisfaction significantly increased in the TE group. Conclusions: These French real-world data confirm the effectiveness, safety, and tolerability of B/F/TAF in TN and TE participants with a high prevalence of comorbidities.