De-simplifying antiretroviral therapy from a single-tablet to a two-tablet regimen: Acceptance, patient-reported outcomes, and cost savings in a multicentre study.

BACKGROUND: Antiretroviral therapy (ART), which is increasingly used by people with HIV, accounts for significant care costs, particularly because of single-tablet regimens (STRs). This study explored de-simplification to a two-tablet regimen (TTR) for cost reduction. The objectives of this study were: (1) acceptance of de-simplification, (2) patient-reported outcomes, and (3) cost savings. METHODS: All individuals on Triumeq®, Atripla® or Eviplera® in five HIV clinics in the Netherlands were eligible. Healthcare providers informed individuals of this study. After inclusion, individuals were free to de-simplify. An electronic questionnaire was sent to assess study acceptance, adherence, quality of life (SF12) and treatment satisfaction (HIVTSQ). After 3 and 12 months, questionnaires were repeated. Cost savings were calculated using Dutch drug prices. RESULTS: In total, 283 individuals were included, of whom 55.5% agreed to de-simplify their ART, with a large variability between treatment centres: 41.1-74.2%. Individuals who were willing to de-simplify tended to be older, had a longer history of HIV diagnosis, and used more co-medication than those who preferred to remain on an STR regimen. Patient-reported outcomes, including quality of life and treatment satisfaction, showed no significant difference between people with HIV who switched to a TTR and those who remained on an STR regimen. Furthermore, we observed a 17.8% reduction in drug costs in our cohort of people with HIV who were initially on an STR. CONCLUSIONS: De-simplification from an STR to a TTR within the Dutch healthcare setting has been demonstrated as feasible, leads to significant cost reductions and should be discussed with every eligible person with HIV in the Netherlands.

The effect of surgical strategy in difficult cholecystectomy cases on postoperative complications outcome: a value-based healthcare comparative study.

BACKGROUND: In patients undergoing laparoscopic cholecystectomy (LC) for complicated biliary disease, complication rates increase up to 30%. The aim of this study is to assess the effect of differences in surgical strategy comparing outcome data of two large volume hospitals. METHODS: A prospective database was created for all the patients who underwent a LC in two large volume hospitals between January 2017 and December 2018. In cases of difficult cholecystectomy in clinic A, regular LC or conversion were surgical strategies. In clinic B, laparoscopic subtotal cholecystectomy was performed as an alternative in difficult cases. The difficulty of the cholecystectomy (score 1-4) and surgical strategy (regular LC, subtotal cholecystectomy, conversion) were scored. Postoperative complications, reinterventions, and ICU admission were assessed. For predicting adverse postoperative complication outcomes, uni- and multivariable analyses were used. RESULTS: A total of 2104 patients underwent a LC in the study period of which 974 were from clinic A and 1130 were from clinic B. In total, 368 procedures (17%) were scored as a difficult cholecystectomy. In clinic A, more conversions were performed (4.4%) compared to clinic B (1.0%; p < 0.001). In clinic B, more subtotal laparoscopic cholecystectomies were performed (1.8%) compared to clinic A (0%; p = < 0.001). Overall complication rate was 8.2% for clinic A and 10.2% for clinic B (p = 0.121). Postoperative complication rates per group for regular LC, conversion, and subtotal cholecystectomy in difficult cholecystectomies were 45 (15%), 12 (24%), and 7 (35%; p = 0.035), respectively. The strongest predictor for Clavien-Dindo grade 3-5 complication was subtotal cholecystectomy. CONCLUSION: Surgical strategy in case of a difficult cholecystectomy seems to have an important impact on postoperative complication outcome. The effect of a subtotal cholecystectomy on complications is of great concern.

Comparison of the Performance of the PanBio COVID-19 Antigen Test in SARS-CoV-2 B.1.1.7 (Alpha) Variants versus non-B.1.1.7 Variants.

This study evaluates the performance of the PanBio COVID-19 antigen (Ag) test as part of a hospital infection control policy. Hospital staff was encouraged to get tested for COVID-19 when presenting with SARS-CoV-2-related symptoms. In a period of approximately 5 months, a steady decline in the performance of the Ag test was noted, epidemiologically coinciding with the rise of the SARS-CoV-2 B.1.1.7 (alpha) variant of concern (VOC) in the Netherlands. This led to the hypothesis that the diagnostic performance of the PanBio COVID-19 Ag test was influenced by the infecting viral variant. The results show a significantly lower sensitivity of the PanBio COVID-19 Ag test in persons infected with the B.1.1.7 (alpha) variant of SARS-CoV-2 in comparison with that in persons infected with non-B.1.1.7 variants, also after adjustment for viral load. IMPORTANCE Antigen tests for COVID-19 are widely used for rapid identification of COVID-19 cases, for example, for access to schools, festivals, and travel. There are several FDA- and CE-cleared tests on the market. Their performance has been evaluated mainly on the basis of infections by the classical variant of the causing virus, SARS-CoV-2. This paper provides evidence that the performance of one of the most widely used antigen tests detects significantly fewer cases of COVID-19 by the alpha variant than by the classical variants of SARS-CoV-2. This means that the role of antigen tests needs to be reevaluated in regions where other variants of SARS-CoV-2 predominate.

Treatment of Pregnant Women With Fear of Childbirth Using EMDR Therapy: Results of a Multi-Center Randomized Controlled Trial.

Fear of childbirth (FoC) occurs in 7. 5% of pregnant women and has been associated with adverse feto-maternal outcomes. Eye Movement Desensitization and Reprocessing (EMDR) therapy has proven to be effective in the treatment of posttraumatic stress disorder (PTSD) and anxiety; however, its effectiveness regarding FoC has not yet been established. The aim was to determine the safety and effectiveness of EMDR therapy for pregnant women with FoC. This single-blind RCT (the OptiMUM-study, www.trialregister.nl, NTR5122) was conducted in the Netherlands. FoC was defined as a score ≥85 on the Wijma Delivery Expectations Questionnaire (WDEQ-A). Pregnant women with FoC and a gestational age between 8 and 20 weeks were randomly assigned to EMDR therapy or care-as-usual (CAU). The severity of FoC was assessed using the WDEQ-A. Safety was indexed as worsening of FoC symptoms, dropout, serious adverse events, or increased suicide risk. We used linear mixed model analyses to compare groups. A total of 141 women were randomized (EMDR n = 70; CAU n = 71). No differences between groups were found regarding safety. Both groups showed a very large (EMDR d = 1.36) or large (CAU d = 0.89) reduction of FoC symptoms with a mean decrease of 25.6 (EMDR) and 17.4 (CAU) points in WDEQ-A sum score. No significant difference between both groups was found (p = 0.83). At posttreatment, 72.4% (EMDR) vs. 59.6% (CAU) no longer met the criteria for FoC. In conclusion, the results are supportive of EMDR therapy as a safe and effective treatment of FoC during pregnancy, albeit without significant beneficial effects of EMDR therapy over and above those of CAU. Therefore, the current study results do not justify implementation of EMDR therapy as an additional treatment in this particular setting.

Risk Factors for Sexual Transmission of Hepatitis C Virus Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men: A Case-Control Study.

Background. Since 2000, incidence of sexually acquired hepatitis C virus (HCV)-infection has increased among human immunodeficiency virus (HIV)-infected men who have sex with men (MSM). To date, few case-control and cohort studies evaluating HCV transmission risk factors were conducted in this population, and most of these studies were initially designed to study HIV-related risk behavior and characteristics. Methods. From 2009 onwards, HIV-infected MSM with acute HCV infection and controls (HIV-monoinfected MSM) were prospectively included in the MOSAIC (MSM Observational Study of Acute Infection with hepatitis C) study at 5 large HIV outpatient clinics in the Netherlands. Written questionnaires were administered, covering sociodemographics, bloodborne risk factors for HCV infection, sexual behavior, and drug use. Clinical data were acquired through linkage with databases from the Dutch HIV Monitoring Foundation. For this study, determinants of HCV acquisition collected at the inclusion visit were analyzed using logistic regression. Results. Two hundred thirteen HIV-infected MSM (82 MSM with acute HCV infection and 131 MSM without) were included with a median age of 45.7 years (interquartile range [IQR], 41.0-52.2). Receptive unprotected anal intercourse (adjusted odds ratio [aOR], 5.01; 95% confidence interval [CI], 1.63-15.4), sharing sex toys (aOR, 3.62; 95% CI, 1.04-12.5), unprotected fisting (aOR, 2.57; 95% CI, 1.02-6.44), injecting drugs (aOR, 15.62; 95% CI, 1.27-192.6), sharing straws when snorting drugs (aOR, 3.40; 95% CI, 1.39-8.32), lower CD4 cell count (aOR, 1.75 per cubic root; 95% CI, 1.19-2.58), and recent diagnosis of ulcerative sexually transmitted infection (aOR, 4.82; 95% CI, 1.60-14.53) had significant effects on HCV acquisition. Conclusions. In this study, both sexual behavior and biological factors appear to independently increase the risk of HCV acquisition among HIV-infected MSM.