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People living with human immunodeficiency virus (PLWH) constitute a population among whom elimination of hepatitis C virus (HCV) is a priority [1]. In April 2015, Spain—which provides universal and free access to healthcare—elaborated on a recommendation for the prioritization of HCV treatment based mainly on the liver fibrosis stage. This recommendation was updated in September 2017, considering treatment uptake for every patient with a detectable HCV viral load. This change in statement facilitates micro-elimination in high-priority populations such as PLWH.

Objective Despite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted life year (QALY) for one-time universal screening followed by treatment of people infected with HCV as compared with a no screening policy in Punjab, India. Study design Decision tree integrated with Markov model was developed to simulate disease progression. A societal perspective and a 3% annual discount rate were considered to assess incremental cost per QALY gained. In addition, budgetary impact was also assessed with a payer’s perspective and time horizon of 5 years. Study setting Screening services were assumed to be delivered as a facility-based intervention where active screening for HCV cases would be performed at 22 district hospitals in the state of Punjab, which will act as integrated testing as well as treatment sites for HCV. Intervention Two intervention scenarios were compared with no universal screening and treatment (routine care). Scenario I—screening with ELISA followed by confirmatory HCV-RNA quantification and treatment. Scenario II—screening with rapid diagnostic test (RDT) kit followed by confirmatory HCV-RNA quantification and treatment. Primary and secondary outcome measures Lifetime costs; life years and QALY gained; and incremental cost-effectiveness ratio for each of the above-mentioned intervention scenario as compared with the routine care. Results Screening with ELISA and RDT, respectively, results in a gain of 0.028 (0.008 to 0.06) and 0.027 (0.008 to 0.061) QALY per person with costs decreased by –1810 Indian rupees (–3376 to –867) and –1812 Indian rupees (–3468 to –850) when compared with no screening. One-time universal screening of all those ≥18 years at a base coverage of 30%, with ELISA and RDT, would cost 8.5 and 8.3 times more, respectively, when compared with screening the age group of the cohort 40–45 years old. Conclusion One-time universal screening followed by HCV treatment is a dominant strategy as compared with no screening. However, budget impact of screening of all ≥18-year-old people seems unsustainable. Thus, in view of findings from both cost-effectiveness and budget impact, we recommend beginning with screening the age cohort with RDT around mean age of disease presentation, that is, 40–45 years, instead of all ≥18-year-old people.

Objectives Most patients are unaware they have liver cirrhosis until they present with a decompensating event. We therefore aimed to develop and validate an algorithm to predict advanced liver disease (AdvLD) using data widely available in primary care. Design, setting and participants Logistic regression was performed on routinely collected blood result data from the University Hospital Southampton (UHS) information systems for 16 967 individuals who underwent an upper gastrointestinal endoscopy (2005–2016). Data were used to create a model aimed at detecting AdvLD: ‘CIRRhosis Using Standard tests’ (CIRRUS). Prediction of a first serious liver event (SLE) was then validated in two cohorts of 394 253 (UHS: primary and secondary care) and 183 045 individuals (Care and Health Information Exchange (CHIE): primary care). Primary outcome measures Model creation dataset: cirrhosis or portal hypertension. Validation datasets: SLE (gastro-oesophageal varices, liver-related ascites or cirrhosis). Results In the model creation dataset, 931 SLEs were recorded (5.5%). CIRRUS detected cirrhosis or portal hypertension with an area under the curve (AUC) of 0.90 (95% CI 0.88 to 0.92). Overall, 3044 (0.8%) and 1170 (0.6%) SLEs were recorded in the UHS and CHIE validation cohorts, respectively. In the UHS cohort, CIRRUS predicted a first SLE within 5 years with an AUC of 0.90 (0.89 to 0.91) continuous, 0.88 (0.87 to 0.89) categorised (crimson, red, amber, green grades); and AUC 0.84 (0.82 to 0.86) and 0.83 (0.81 to 0.85) for the CHIE cohort. In patients with a specified liver risk factor (alcohol, diabetes, viral hepatitis), a crimson/red cut-off predicted a first SLE with a sensitivity of 72%/59%, specificity 87%/93%, positive predictive value 26%/18% and negative predictive value 98%/99% for the UHS/CHIE validation cohorts, respectively. Conclusion Identification of individuals at risk of AdvLD within primary care using routinely available data may provide an opportunity for earlier intervention and prevention of liver-related morbidity and mortality.

To characterize hepatitis C virus (HCV) infection epidemiology in Mongolia.

by Tewodros Tesfa, Behailu Hawulte, Abebe Tolera, Degu Abate Background Hepatitis B virus (HBV) is a highly contagious pathogen that has become a severe public health problem and a major cause of morbidity and mortality, particularly in developing countries. Medical students are at high occupational risk during their training. However, no facility-based studies were found among medical students in eastern Ethiopia. Thus, this study aimed to investigate the seroprevalence of Hepatitis B Virus and associated factors among medical students in eastern Ethiopia. Methods A facility-based cross-sectional study was conducted among 407 randomly selected medical students from March to June 2018. A pretested and structured questionnaire was used to collect data on socio-demographic characteristics and other risk factors. A 5ml blood was collected, and the serum was analyzed for Hepatitis B surface antigen (HBsAg) using the Instant Hepatitis B surface antigen kit. Data were entered using Epidata version 3.1 and analyzed using SPSS statistical packages version 22. Outcome and explanatory variables were described using descriptive summary measures. Binary and multivariable logistic regression was conducted at 95% CI and an association at P-value < 0.05 was declared statistically significant. Results The seroprevalence of hepatitis B virus surface antigen was 11.5% (95%CI = 8.6, 14.7). Poor knowledge of universal precaution guideline (AOR = 2.58; 95% CI = [1.35–4.93]), history of needle stick injury (AOR = 2.11; 95% CI = [1.07–4.18]) and never been vaccinated for HBV (AOR = 2.34; 95% CI = [1.17–4.69]) were found statistically significantly associated with HBsAg positivity after multivariate analysis. Conclusion Hepatitis B virus infection rate is high among health care trainees in eastern Ethiopia. Improvement at health care practice centers safety through training on universal precaution guidelines, and scaling up HBV vaccination is mandatory.

New England Journal of Medicine, Ahead of Print.

Background: We assessed the impact of health literacy and hepatitis C (HCV) knowledge on HCV treatment willingness among people living with HIV (PLWH) at an academic HIV clinic. Methods: Cross-sectional analysis of PLWH co-infected with HCV who completed health literacy, HIV literacy, and HCV knowledge inventories. We estimated the prevalence of low health literacy, HIV knowledge, and HCV knowledge sampled from 3-comparison groups: PLWH not referred for HCV, referred but who “no-showed” to HCV clinic, and referred and attended HCV clinic. We used mixed-model linear and logistic regression to ascertain predictors of low health literacy, HIV knowledge, HCV knowledge, and predictors of willingness to start HCV treatment. Results: We enrolled 151 PLWH; 17% were female, 38% non-white, and 60% without a high-school education. Approximately 68% were men who have sex with men, of whom 62% used intravenous drugs. The prevalence of low health, HIV knowledge, and HCV knowledge was 10%, 32%, and 29%, respectively. Predictors of low health literacy were being Hispanic, cirrhotic, and not completing high school education. Low HCV knowledge was observed in female, non-white, and those diagnosed with HCV for a decade. In adjusted analyses, PLWH living with HCV for a decade (OR: 0.23) were less likely to be very willing to be treated for HCV. In contrast, those with high HCV knowledge were more likely to be very willing to receive treatment (OR: 1.27). Conclusion: Low HCV knowledge and living with HCV for at least a decade are under-recognized negative predictors for PLWH’s willingness to receive HCV treatment. Clinical Trials Registration ClinicaTrials.gov identifier: NCT20170991 Please address correspondence to: Edward Cachay MD, MAS, 200 west arbor drive, San Diego, CA 92103-8186, Ph: 619-543-3882, Fax: 619-543-3178, Email: ecachay@health.ucsd.edu The authors report no conflicts of interest related to this work. Funding Support: This work was supported in part by a grant funded by an investigator-initiated project sponsored by MSIP # 56162 of Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The University of California San Diego Center for AIDS Research [AI036214], and the Pacific AIDS Education and Training Center (PAETC). The funders had no role in study design, decision to publish, or preparation of the manuscript. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Background: Transgender persons are at high risk for HIV infection. Testing is a key component of the national effort to end the HIV epidemic in the United States. Setting: Sixty-one local and state health departments (HDs) and 150 community-based organizations (CBOs) funded by the Centers for Disease Control and Prevention (CDC) to conduct HIV testing programs. Methods: We analyzed HIV testing data submitted to CDC by funded HDs and CBOs during 2012-2017. Descriptive analysis examined patterns of HIV testing and key outcomes (diagnosis of HIV infection, linkage to HIV medical care, and interview for partner services) among transgender persons. Multivariate robust Poisson regression was used to assess associations between HIV testing outcomes and demographic characteristics, census region, and test setting. Results: A total of 82,818 HIV tests were provided to transgender persons. Of these, 2,280 (2.8%) transgender persons were diagnosed with HIV infection; 1,556 (1.9%) received a new and 724 (0.9%) a previous diagnosis with HIV infection. The highest percentage of new HIV diagnosis was found among persons tested in correctional settings (4.6%), non-Hispanic Blacks (3.5%) and transgender women (2.4%).Among newly diagnosed persons, 85.0% were linked to HIV medical care ≤90 days after diagnosis and 63.5% were interviewed for partner services. Conclusions: HIV positivity was high, and the delivery of partner services was low, among transgender persons. HIV testing outcomes among transgender persons varied significantly by demographic characteristics and test setting. HIV prevention programs that are responsive to the needs of transgender persons may address gender-related disparities in HIV testing outcomes. Corresponding Author: Mesfin S. Mulatu, PhD, MPH, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE, MS US8-2, Atlanta, Georgia 30333, E-mail: mmulatu@cdc.gov; Phone: 404-630-2066; Fax: 404-639-0929 The authors report no conflicts of interest related to this work. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Background: Concerns have been voiced that the exclusion of pregnant women from clinical trials results in a lack of safety and pharmacokinetic data for antiretroviral drugs (ARVs) in pregnancy, creating clear risks to pregnant women living with HIV (PWLHIV) and their infants. Setting: The World Health Organization convened a Paediatric Antiretroviral Drug Optimization (PADO) group meeting, December 10-12, 2018, in Geneva, Switzerland Methods: The group, comprised of clinicians, scientists, HIV programme managers, regulators and community representatives, were tasked to: consider how ARVs are studied in PWLHIV; define alternative approaches to studying ARVs in PWLHIV; identify ways to shorten the timeline to determine safe use of new agents during pregnancy; and define strategies to collaborate with regulators and industry to change longstanding practices. Results: Most new ARV’s are not studied in pregnant populations until after drug licensure, primarily opportunistically among women who become pregnant while taking the ARV of interest. Acceleration of the timeline will require earlier completion of preclinical studies and a a new paradigm: namely - under certain conditions - allow women who become pregnant while participating in Phase III ARV studies the option of remaining on study and enroll pregnant women into Phase III trials of new agents to obtain preliminary safety and dosing and efficacy data. Conclusion: A revision of the current approach to the study of antiretrovirals in pregnant women is urgently needed to improve timely access and safe use of new agents during pregnancy Corresponding author: Dr Martina Penazzato, Global HIV, Hepatitis and STIs Programme, WHO, Avenue Appia, 20, CH-1202, Geneva, Switzerland T) +41 22 7913306; E) penazzatom@who.int Conflicts of Interest and Source of Funding: EJA and LMM participated in ViiV Dolutegravir Neural Tube Defect Advisory Board (no honorarium); AP has been an advisor to Merck Inc, Gilead Sciences, ViiV and Janssen; SK has received research support from Janssen, Merck, Gilead and ViiV, and provided advice to Merck and ViiV; WFV has received drug donations from ViiV and Gilead, and participated in the Dolutegravir Neural Tube Defect Advisory Board, and received honoraria for talks and board membership for: Gilead, Viiv, Mylan, Merk, Adcock-Ingram, Aspen, Abbott, Roche, J&J; MM has received research support from Merck, Gilead and ViiV. Sources of Support: This work was developed with the generous contribution of Unitaid. This article was also made possible by the support of the American people through the United States Agency for International Development (USAID) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Background: Heplisav-B, a hepatitis B virus (HBV) vaccine with an immunostimulatory adjuvant, was FDA-approved in 2017 for adults >18 years. In randomized controlled trials, Heplisav-B demonstrated seroprotection rates (SPR) of 90-95% versus 65-80% for Engerix-B. No studies have included people with HIV (PWH), and the SPR and its predictors in this population are unknown. Setting: Quaternary care center HIV clinic. Methods: This retrospective cohort study evaluated PWH aged >18 years without current HBV seroprotection (anti-HBV surface antibody level…

Summary : Men with acute hepatitis B virus (HBV) infection in the Multicenter AIDS Cohort Study (MACS) from 1985–2013 had serological testing to determine proportions with HBV recovery or chronic hepatitis B (CHB). A similar proportion of men without HIV and men with HIV receiving HBV-active ART developed CHB (8.2%, 95% CI 3.8–15.0% versus 7.7%, 95% CI 2.00–36.0%). In contrast, 17.5% (95% CI 8.7–29.9%) of men living with HIV, not on HBV-active ART developed CHB. HBV-active ART protects against developing CHB. Correspondence to Oluwaseun Falade-Nwulia, Johns Hopkins University, 725 N. Wolfe Street, Room 215, Baltimore MD 21205, USA; e-mail: ofalade1@jhmi.edu. Received 16 December, 2020 Accepted 2 February, 2021 Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (http://www.AIDSonline.com). Copyright © 2021 Wolters Kluwer Health, Inc.

Background: Although combination antiretroviral therapy reduced the prevalence of HIV-associated dementia, milder syndromes persist. Our goals were to (1) predict cognitive impairment of the Multicenter AIDS Cohort Study (MACS) participants 5 years ahead and (2) from a large pool of factors, select the ones that mostly contributed to our predictions. Design: Longitudinal, natural and treated history of HIV infection among men who have sex with men. Methods: The MACS is a longitudinal study of the natural and treated history of HIV disease in men who have sex with men; the neuropsychological substudy aims to characterize cognitive disorders in men with HIV disease. Results: We modelled on an annual basis the risk of cognitive impairment five years in the future. We were able to predict cognitive impairment at individual-level with high precision and overperform default methods. We found that while a diagnosis of AIDS is a critical risk factor, HIV infection per se does not necessarily convey additional risk. Other infectious processes, most notably hepatitis B and C, are independently associated with increased risk of impairment. The relative importance of an AIDS diagnosis diminished across calendar time. Conclusions: Our prediction models are a powerful tool to help clinicians address dementia in early stages for MACS paticipants. The strongest predictors of future cognitive impairment included the presence of clinical AIDS and Hepatitis B or C infection. The fact that the pattern of predictive power differs by calendar year suggests a clinically critical change to the face of the epidemic. Correspondence to Natalia L. Oliveira, Department of Statistics and Data Science and Machine Learning Department, Carnegie Mellon University, Pittsburgh PA USA; e-mail: nlombard@andrew.cmu.edu Received 19 August, 2020 Revised 4 January, 2021 Accepted 11 January, 2021 Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (http://www.AIDSonline.com). Copyright © 2021 Wolters Kluwer Health, Inc.

Hsu Y-C, Chen C-Y, Chang I-W, et al. Once-daily tenofovir disoproxil fumarate in treatment-naive Taiwanese patients with chronic hepatitis B and minimally raised alanine aminotransferase (TORCH-B): a multicentre, double-blind, placebo-controlled, parallel-group, randomised trial. Lancet Infect Dis 2021; published online Jan 29. https://doi.org/10.1016/S1473-3099(20)30692-7—In Figure 2 of this Article, the key's labels were incorrect. The red box should have accompanied the “Progressed” label and the green box should have accompanied the “Improved” label.

Tenofovir disoproxil fumarate reduces the risk of progression in liver fibrosis in patients with chronic hepatitis B and minimally raised ALT, but its effect on necroinflammation is non-significant.

Yao-Chun Hsu and colleagues1 have published a long-awaited paper in The Lancet Infectious Diseases to cease the debate on antiviral treatment in patients with chronic hepatitis B and minimally raised serum alanine aminotransferase (ALT) concentrations.

Purpose of review Evidence of the protective effect of voluntary medical male circumcision (VMMC) against HIV is well established. However, evidence of the protective effect of VMMC against other sexually transmitted infections (STIs) has been inconsistent or scarce across different populations and settings. This review summarizes the current evidence on the effect of VMMC for HIV prevention on acquisition and transmission of other STIs in heterosexual men, women, and men who have sex with men (MSM). Recent findings Recent findings continue to strongly support the protective effect of male medical circumcision against acquisition and transmission of herpes simplex virus type 2 (HSV-2), human papillomavirus (HPV) and syphilis infections in heterosexual men and women, and bacterial vaginosis and trichomoniasis in women. There is emerging evidence on the protective effect of VMMC against acquisition of hepatitis B and Mycoplasma genitalium infections in heterosexual men, and HSV-2, HPV, and syphilis in MSM. Summary Evidence on the protective effect of VMMC against acquisition and transmission of common STIs is available for heterosexual men and women but more evidence is required for MSM. This review supports policy recommendations for the protective benefits of VMMC against STIs.

Tropical Medicine & International Health, EarlyView.

Tropical Medicine & International Health, EarlyView.