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BACKGROUND: Posttraumatic stress (PTS) and anxiety are common mental health problems among parents of babies admitted to a neonatal unit (NNU). This review aimed to identify sociodemographic, pregnancy and birth, and psychological factors associated with PTS and anxiety in this population. METHOD: Studies published up to December 2022 were retrieved by searching Medline, Embase, PsychoINFO, Cumulative Index to Nursing and Allied Health electronic databases. The modified Newcastle-Ottawa Scale for cohort and cross-sectional studies was used to assess the methodological quality of included studies. This review was pre-registered in PROSPERO (CRD42021270526). RESULTS: Forty-nine studies involving 8,447 parents were included; 18 studies examined factors for PTS, 24 for anxiety and 7 for both. Only one study of anxiety factors was deemed to be of good quality. Studies generally included a small sample size and were methodologically heterogeneous. Pooling of data was not feasible. Previous history of mental health problems (four studies) and parental perception of more severe infant illness (five studies) were associated with increased risk of PTS, and had the strongest evidence. Shorter gestational age (≤ 33 weeks) was associated with an increased risk of anxiety (three studies) and very low birth weight (

Background Despite improvements in treatment and oral pre-exposure prophylaxis (PrEP) access, 1.3 million people acquired HIV in 2022. Six-monthly lenacapavir PrEP could benefit tens of millions of people at high risk of infection. However, prices are currently up to $44 819 per person per year (pppy). Objectives We projected minimum lenacapavir pricing based on generic mass production and a Cost-Plus (Cost+) model. Methods Current active pharmaceutical ingredient (API) and key starting materials (KSMs) costs were obtained from export databases. The routes of synthesis (ROS) were analysed to project a cost of goods (COGs). Formulation, vials and profit margin costs were included using standardized algorithms and Cost+ pricing. We estimated prices with scale-up to supply 1 million then 10 million treatment-years, comparing this with national list prices. Results The lenacapavir API is currently exported from India for $64 480/kg on 1 kg scale. Based on the ROS and KSMs, API COGs of $25 000/kg and $10 000/kg are achievable for a committed demand of 1 million (2 million tonnes/annum of API) and 10 million treatment-years, respectively. Including formulation steps, injectable lenacapavir could be mass produced for approximately $94 pppy for 1 million and $41 for 10 million treatment-years, if voluntary licences are in place and competition between generic suppliers substantially improves. Greater scale-up with improvements in manufacturers' ROS could reduce prices further. Currently lenacapavir costs $25 395–44 819 pppy. Conclusions Lenacapavir could be mass produced for <$100 pppy at launch. Voluntary licensing and multiple suppliers are required to achieve these low prices. This mechanism is already in place for other antiretrovirals. To date, Gilead has not agreed lenacapavir voluntary licences with the Medicines Patent Pool. [ABSTRACT FROM AUTHOR]

Early UK surveillance data revealed that people living with HIV were overrepresented among cases of monkeypox (mpox). However, it remains unknown whether mpox infection is more severe in people living with well-controlled HIV. All laboratory-confirmed mpox cases presenting between May and December 2022 to one London hospital service were identified via pathology reporting systems. We extracted demographic and clinical data to allow comparison of clinical presentation and severity of mpox among people with and without HIV. We identified 150 people with mpox (median age 36 years, 99.3% male, 92.7% reporting sex with other men). HIV status was available for 144 individuals, 58 (40.3%) of whom were HIV positive (only 3/58 had CD4 cell counts <200 cells/mm3 and 5/58 had HIV RNA >200 copies/mL). People with HIV had similar clinical presentations to those without HIV, including indicators of more widespread disease, such as extragenital lesions (74.1% vs. 64.0%, p = .20) and nondermatological symptoms (87.9% vs. 82.6%, p = .38). People with HIV also experienced a similar time from onset of symptoms to discharge from all inpatient or outpatient clinical follow-up (p = .63) and total time under follow-up (p = .88) compared with people without HIV. A similar proportion of people with HIV required review in the hospital emergency department (36.2% vs. 25.6%, p = .17) or admission to hospital (19.0% vs. 9.3%, p = .09). There were no recorded deaths. In this cohort of people with mpox, there was a high prevalence of HIV coinfection, the majority of which was well-controlled. We find no evidence that people with well-controlled HIV experienced more severe mpox infection. [ABSTRACT FROM AUTHOR]

Background Five severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are approved in North America and/or Europe: Pfizer/BioNTech, Moderna, Janssen, Oxford-AstraZeneca, and Novavax. Other vaccines have been developed, including Sinopharm, SinoVac, QazVac, Covaxin, Soberana, Zifivax, Medicago, Clover, and Cansino, but they are not approved in high-income countries. This meta-analysis compared the efficacy of US Food and Drug Administration (FDA)/European Medicines Agency (EMA)-approved and -unapproved vaccines in randomized clinical trials (RCTs). Methods A systematic review of trial registries identified RCTs of SARS-CoV-2 vaccines. Risk of bias was assessed using the Cochrane tool (RoB 2). In the meta-analysis, relative risks of symptomatic infection and severe disease were compared for each vaccine versus placebo, using Cochrane-Mantel Haenszel Tests (random effects method). Results Twenty-two RCTs were identified and 1 was excluded for high-risk of bias. Ten RCTs evaluated 5 approved vaccines and 11 RCTs evaluated 9 unapproved vaccines. In the meta-analysis, prevention of symptomatic infection was 84% (95% confidence interval [CI], 68%–92%) for approved vaccines versus 72% (95% CI, 66%–77%) for unapproved vaccines, with no significant difference between vaccine types (P  = .12). Prevention of severe SARS-CoV-2 infection was 94% (95% CI, 75%–98%) for approved vaccines versus 86% (95% CI, 76%–92%) for unapproved vaccines (P  = .33). The risk of serious adverse events was similar between vaccine types (P  = .12). Conclusions This meta-analysis of 21 RCTs in 390 459 participants showed no significant difference in efficacy between the FDA/EMA-approved and -unapproved vaccines for symptomatic or severe infection. Differences in study design, endpoint definitions, variants, and infection prevalence may have influenced results. New patent-free vaccines could lower costs of worldwide SARS-CoV-2 vaccination campaigns significantly. [ABSTRACT FROM AUTHOR]

Ivermectin is an antiparasitic drug being investigated for repurposing against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Ivermectin showed in vitro activity against SARS-COV-2, but only at high concentrations. This meta-analysis investigated ivermectin in 23 randomized clinical trials (3349 patients) identified through systematic searches of PUBMED, EMBASE, MedRxiv, and trial registries. The primary meta-analysis was carried out by excluding studies at a high risk of bias. Ivermectin did not show a statistically significant effect on survival (risk ratio [RR], 0.90; 95% CI, 0.57 to 1.42; P =.66) or hospitalizations (RR, 0.63; 95% CI, 0.36 to 1.11; P =.11). Ivermectin displayed a borderline significant effect on duration of hospitalization in comparison with standard of care (mean difference, –1.14 days; 95% CI, –2.27 to –0.00; P =.05). There was no significant effect of ivermectin on time to clinical recovery (mean difference, –0.57 days; 95% CI, –1.31 to 0.17; P =.13) or binary clinical recovery (RR, 1.19; 95% CI, 0.94 to 1.50; P =.15). Currently, the World Health Organization recommends the use of ivermectin only inside clinical trials. A network of large clinical trials is in progress to validate the results seen to date. [ABSTRACT FROM AUTHOR]