Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial).

Access to Hepatis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multi-country open-label trial TAC ANRS 12311 allowed assessing the feasibility, safety, efficacy of a specific care model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa. Between November 2015 and March 2017, with follow-up until mid 2019, treatment-naïve patients with HCV without decompensated cirrhosis or liver cancer were recruited to receive 12 week-treatment with either sofosbuvir + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosbuvir + velpatasvir + voxilaprevir in case of virological failure. The primary outcome was sustained virological response at 12 weeks after end of treatment (SVR12). Secondary outcomes included treatment adherence, safety and SVR12 in patients who were retreated due to non-response to first-line treatment. The model of care relied on both viral load assessment and educational sessions to increase patient awareness, adherence and health literacy. The study recruited 120 participants, 36 HIV-co-infected, and 14 cirrhotic. Only one patient discontinued treatment because of return to home country. Neither death nor severe adverse event occurred. SVR12 was reached in 107 patients (89%): (90%) in genotype 1 or 2, and 88% in GT-4. All retreated patients (n = 13) reached SVR12. HCV treatment is highly acceptable, safe and effective under this model of care. Implementation research is now needed to scale up point-of-care HCV testing and SVR assessment, along with community involvement in patient education, to achieve HCV elimination in Sub-Saharan Africa.

Costs of integrating hepatitis B screening and antiviral prophylaxis into routine antenatal care in Burkina Faso: Treat all versus targeted strategies.

OBJECTIVE: Economic feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly endemic African countries remains uncertain. Prevention of MTCT (PMTCT) involves screening pregnant women for hepatitis B surface antigen (HBsAg), identifying those with high viral loads or hepatitis B e antigen (HBeAg), and administering tenofovir prophylaxis to high-risk women. We estimated the costs of integrating PMTCT services into antenatal care in Burkina Faso, based on four different strategies to select women for tenofovir prophylaxis: (1) HBV DNA (≥200 000 IU/mL), (2) HBeAg, (3) hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) and (4) all HBsAg-positive women. METHODS: Using a micro-costing approach, we estimated the incremental economic cost of integrating each strategy into routine antenatal care in 2024, compared to neonatal vaccination alone. Sensitivity analyses explored variations in prevalence, service coverage, test and tenofovir prices. RESULTS: HBcrAg-RDT strategy was the least expensive, with a total economic cost of US$3959689, compared to HBV DNA (US$6128875), HBeAg (US$4135233), and treat-all (US$4141206). The cost per pregnant woman receiving tenofovir prophylaxis varied from US$61.88 (Treat-all) to US$1071.05 (HBV DNA). The Treat-All strategy had the lowest marginal cost due to a higher number of women on tenofovir (66928) compared to HBV DNA (5722), HBeAg (10020), and HBcrAg-RDT (7234). In sensitivity analyses, the treat-all strategy became less expensive when the tenofovir price decreased. CONCLUSION: HBcrAg-RDT minimizes resource use and costs, representing 0.61% of Burkina Faso's 2022 health budget. This study highlights the potential economic feasibility of these strategies and provides valuable resources for conducting cost-effectiveness analyses.

Cannabidiol use in France in 2022: Results from a nationwide representative sample of adults.

INTRODUCTION: Cannabidiol (CBD) is a non-intoxicating cannabis compound found in diverse commercial products worldwide. However, its use may not be fully harmless. Accordingly, it is important to document the prevalence of CBD use and user characteristics in the general population. METHODS: We conducted a nationwide survey from a random sample of adults living in France using computer-assisted telephone interviews between 2 March and 9 July 2022. We estimated the prevalence of CBD awareness and CBD use, and explored the different routes of administration. We also performed logistic regression models to identify factors associated with past-year CBD use. RESULTS: Based on data from 3229 participants, we estimated that 71.0% (95% confidence interval) (69.0-73.0) of the French adult population had heard of CBD, and 10.1% (8.7-11.4) had used it in the previous year. Past-year CBD use was associated with younger age, a higher educational level, not living in a middle-sized urban unit, tobacco consumption and e-cigarette use. The most common route of administration was smoking (56.1%). DISCUSSION AND CONCLUSION: Past-year CBD use prevalence in France appeared to be as high as that for cannabis. Proper prevention, regulation and control of CBD products is necessary to ensure that people have access to safe and high-quality products. Reliable information on CBD should be sought and disseminated, especially regarding the harms associated with smoking the compound.

A novel community-based therapeutic education program for reducing alcohol-related harms and stigma in people with alcohol use disorders: A quasi-experimental study (ETHER study).

INTRODUCTION: Alcohol use disorder (AUD) is associated with a significant disease burden in France, where alcohol use is deeply rooted in culture. However, the treatment gap is large because of several barriers, including stigmatisation and drinkers' apprehension about total abstinence. However, standardised and evidence-based interventions based on controlled-drinking for people with AUD are lacking. We aimed to assess the effectiveness of a novel community-based French therapeutic patient education (TPE) program for people with AUD named Choizitaconso. METHODS: A before-after non-randomised quasi-experimental study, named ETHER, was designed and implemented with people living with AUD, over a period of 6 months. The primary outcome was percentage change in the number of alcohol-related harms experienced. Secondary outcomes were percentage changes in psycho-social patient-reported and community-validated outcomes. Participants in the intervention group (n = 34) benefited from the 10-week TPE program Choizitaconso, while the comparison group (n = 58) received standard care. The Kruskall-Wallis and chi-squared or Fisher's exact tests were used to compare before-after changes in variables in both groups. Linear regression models were used to test for the effect of study group on each outcome and to test for the effect of alcohol consumption as a confounder. RESULTS: At 6 months, all outcomes but one either remained stable or numerically improved in both groups. Internalised stigma significantly improved in the intervention group (p = 0.026) but not in the comparison group (p = 0.207), with a significant group effect (p = 0.014). DISCUSSION AND CONCLUSIONS: This study demonstrates the effectiveness of the Choizitaconso TPE program on community-validated outcomes, especially internalised stigma.

Adherence to opioid agonist therapy predicts uptake of direct-acting antivirals in people who use drugs: results from the French national healthcare database (the ANRS FANTASIO study).

BACKGROUND: Opioid agonist therapy (OAT) is associated with reduced injection, reduced HCV transmission, and more opportunities to initiate hepatitis C virus (HCV) treatment in people who use drugs (PWUD). We aimed to study the extent to which adherence to OAT was predictive of increased uptake of direct-acting antivirals (DAA) in PWUD with chronic HCV infection. METHODS: Using the French national healthcare system database, we targeted PWUD (i.e. with a history of OAT) who had chronic HCV infection and were eligible for DAA during 2014-2016. Adherence to OAT was computed as a time-varying variable expressing the proportion of days covered by OAT receipt, over any six-month interval before DAA receipt. We used a Cox proportional hazards model to estimate the association between adherence to OAT and the rate of DAA uptake after adjustment for age, sex, alcohol use disorder, socioeconomic status, and liver disease severity. RESULTS: Among the 22,615 persons included in the ANRS FANTASIO study, 3438 (15.2%) initiated DAA during the study period. After multivariable adjustment, adherence to OAT was associated with a higher rate of DAA initiation. However, this association was not linear, and only individuals on OAT for 20% or more of the time in the previous six-month period had a higher rate of DAA initiation (adjusted hazard ratio [95% confidence interval]: 1.28 [1.18-1.38]). Other variables associated with DAA initiation were male sex, older age, cirrhosis or liver cancer, and higher socioeconomic status. CONCLUSIONS: Adherence to OAT is a major predictor of DAA initiation in PWUD living with chronic HCV infection in France. Our results also suggest that even moderate adherence to OAT can facilitate DAA uptake. Adequate HCV training for OAT prescribers together with interventions to ensure adherence to OAT will help improve DAA initiation rates and reach HCV elimination goals.

Cannabidiol use and perceptions in France: a national survey.

BACKGROUND: Cannabidiol (CBD), a safe, non-intoxicating cannabis component, is growing in popularity in Europe and worldwide. However, CBD EU regulation is blurry, and consequent labelling and product quality issues may have implications for public health. There is therefore a need to assess the prevalence and perceived harmfulness of CBD use in EU countries, as well as to characterise CBD users. We aimed to do so in the French population. METHODS: In December 2021, an online survey was conducted in a sample respecting the French adult population structure for key demographic variables. Sociodemographic, behavioural and CBD perception data were collected. Three separate regressions were performed to identify correlates of i) having heard of CBD, ii) using CBD, iii) perceived harmfulness of CBD. A hierarchical classification was also performed to identify profiles of CBD users. RESULTS: The study sample comprised 1969 adults, of whom 69.2% had heard of CBD and 10.1% used it. Less than half (46.8%) of the former considered it harmful. Having heard of CBD was associated with younger age, being born in France, tobacco use, and cannabis use. CBD use was associated with younger age, tobacco use, cannabis use, poor self-reported general health status, and positive perception of alternative medicines. Cluster analysis revealed four different CBD user profiles based on socio-demographics and behavioural characteristics. CONCLUSION: Ten percent of the adults in this French study used CBD, and several user profiles emerged. Our results indirectly advocate clearer European CBD regulations to ensure safe and high-quality products.

Management of NAFLD in primary care settings.

Non-alcoholic fatty liver disease (NAFLD) affects at least 25% of the general population and is an increasingly important cause of cirrhosis and hepatocellular carcinoma. Although it is the research focus of the hepatology field, it is clear that primary care physicians are seeing the majority of NAFLD patients and are in a pivotal position to provide quality care. In this article, we review the role of primary care in the management of NAFLD. NAFLD is common in patients with diabetes, obesity and other metabolic risk factors. Abdominal ultrasonography is the most commonly used method to diagnose fatty liver. Simple fibrosis scores have high negative predictive values in excluding advanced liver fibrosis and future liver-related events and can be used in primary care as initial evaluation. An abnormal result should be followed by subsequent workup or specialist referral. Primary care is the ideal setting to institute multidisciplinary care, especially the involvement of dietitians and physical activity trainers in lifestyle intervention, as well as initiating the discussion of bariatric surgery in patients with severe obesity. Although specific drug treatment for steatohepatitis would require a more precise diagnosis, metabolic drugs that improve both steatohepatitis and cardiovascular outcomes (e.g. glucagon-like peptide-1 receptor agonists) may be considered in patients with NAFLD.

A Community-Based Therapeutic Education Programme for People with Alcohol Use Disorder in France: A Qualitative Study (ETHER).

Therapeutic patient education (TPE) aims to help people with chronic disease strengthen their empowerment and psychosocial skills to better manage their condition. Although TPE has great potential for addiction medicine, studies on its benefits for reducing alcohol-related harms and increasing empowerment are sparse. We conducted a qualitative study of people with alcohol use disorder (AUD) who participated in the community-based TPE programme Choizitaconso to assess their perceptions and experiences of it. Semi-structured interviews were conducted with 16 participants who had completed the TPE programme at least six months previously. The interviews were transcribed and analysed using a sequential thematic analysis. We identified four general themes: (1) the context of participation: the TPE programme could be a strategy to facilitate engagement in AUD care; (2) representations and experiences: the programme helped to "normalize" participants' relationship with alcohol use by increasing empowerment; (3) TPE strengths: improved knowledge about alcohol use, self-image, weight loss, self-stigma reduction; (4) TPE limitations: difficulty putting learning into practice after the programme ended. The Choizitaconso programme met participants' health and psychosocial expectations, strengthening their empowerment and reducing self-stigma, thereby facilitating engagement in AUD care.

Smoking increases the risk of post-acute COVID-19 syndrome: Results from a French community-based survey.

INTRODUCTION: We aimed to estimate the prevalence and incidence of specific symptoms and predictors of post-acute COVID-19 syndrome using data collected from an anonymous online survey. METHODS: We included adult participants with symptoms ≥60 days (D60+), fulfilling the World Health Organization COVID-19 cases definition, and/or hospitalized for COVID-19 at the time of infection (D0). Self-reported symptoms were collected at D0 and D60+. Logistic regression was performed to identify factors associated with self-reported cutaneous signs prevalence and self-reported tachycardia and/ or HBP incidence on D60+. RESULTS: From April to June 2020, 956 members of a Twitter long-term COVID-19 community were included in the study population: 81% were women, 81% were aged <50 year, 22% were smokers, and 95% have never been hospitalized. At D60+, the 956 participants reported a broad spectrum of symptoms which were also present at D0+. At D60+, 16% and 39% of participants reported cutaneous signs and tachycardia and/or hypertension, respectively. The incidence of self-reported tachycardia and/or hypertension at D60+ was 12%. Female gender (AOR=2.56; 95% CI: 1.22-6.1) and smoking (AOR=2.34; 95% CI: 1.39-3.92) were associated with prevalence of cutaneous signs at D60+. Smoking (AOR=2.05; 95% CI: 1.2- 3.47) was the main correlate of tachycardia and/or HBP incidence at D60+. CONCLUSIONS: The incidence of self-reported tachycardia and/or hypertension is not negligible and suggests an interaction between COVID-19 and smoking. Reinforcing symptoms monitoring of people after acute COVID-19, mainly women and smokers, and expanding the promotion of smoking cessation strategies are novel priorities in this COVID-19 era.

Perceived stigma, substance use and self-medication in night-shift healthcare workers: a qualitative study.

BACKGROUND: Many risk factors related to altered circadian rhythms impact the health of night-shift hospital workers (NSHW), resulting in mental and somatic disorders. Easy access to psychoactive substances (PS) may facilitate addictive behaviors in NSHW. They are also exposed to a stressful work environment, which may further affect sleep quality. This study aimed to explore the link between sleep deprivation, work-related psychosocial stress and psychoactive substance use as a self-medication response in NSHW. METHODS: Qualitative study to verify the plausibility of the self-medication theory applied to addictive behaviors. Semi-structured interviews (N = 18 NSHW) and thematic analysis, following consolidated criteria for reporting qualitative research recommendations. RESULTS: Stigma against NSHW was a primary element of a stressful work environment. The stressful and stigmatizing environment, together with night-shift work, further affected NSHW sleep and their mental and physical health. The use of PS appeared to be for self-medication, encouraged by social and professional environments, source(s) of stress, discrimination, and isolation. The work environment, through aggravated sleep disorders, led NSHW to use non-prescribed sleeping pills. Alcohol after work and smoking were used as a social break but also as a means to reduce stress. CONCLUSION: Anti-stigma interventions in the healthcare setting and screening of mental/somatic disorders in NSHW can help reduce harmful self-medication behaviors and improve hospital care in the COVID-19 era.

Severe liver fibrosis in the HCV cure era: Major effects of social vulnerability, diabetes, and unhealthy behaviors.

Background & Aims: After HCV cure, not all patients achieve significant liver fibrosis regression. We explored the effects of clinical and socio-behavioral factors on liver fibrosis, before and after HCV cure with direct-acting antivirals. Methods: We analyzed data from the ongoing ANRS CO22 HEPATHER cohort, which prospectively collects clinical and socio-behavioral data on HCV-infected patients. Mixed-effects logistic regression models helped identify predictors of longitudinal measures of severe liver fibrosis, defined as a fibrosis-4 index >3.25. We also estimated the adjusted population attributable fractions (PAFs) for modifiable risk factors. Results: Among the 9,692 study patients (accounting for 24,687 visits over 4 years of follow-up, 48.5% of which were post-HCV cure), 26% had severe fibrosis at enrolment. After multivariable adjustment, HCV-cured patients had an 87% lower risk of severe fibrosis. An inverse dose-response relationship was found for coffee consumption, with the risk of severe fibrosis diminishing by 58% per additional cup/day (adjusted odds ratio (aOR 0.42; 95% CI 0.38-0.46). Unemployment, low educational level, and diabetes were associated with a higher severe fibrosis risk (aOR 1.69; 95% CI 1.32-2.16, aOR 1.50; 95% CI 1.20-1.86, and aOR 4.27; 95% CI 3.15-5.77, respectively). Severe fibrosis risk was 3.6/4.6-fold higher in individuals with previous/current unhealthy alcohol use than in abstinent patients. All these associations remained valid after HCV cure. The risk factors accounting for the greatest severe fibrosis burden were unemployment, low education level, and diabetes (PAFs: 29%, 21%, and 17%, respectively). Conclusions: Monitoring liver fibrosis after HCV cure is crucial for patients with low socioeconomic status, previous/current unhealthy alcohol use, and diabetes. Innovative HCV care models for the most socially vulnerable individuals and interventions for healthier lifestyles are needed to reinforce the positive effects of HCV cure on liver health. Lay summary: After hepatitis C virus (HCV) cure, not all patients achieve significant liver fibrosis regression. Herein, we studied the effects of clinical and socio-behavioral factors on the risk of severe liver fibrosis. Coffee consumption was strongly inversely associated with severe fibrosis, while diabetes, previous and current unhealthy alcohol use were associated with a 4.3-, 3.6- and 4.6-fold higher risk of severe fibrosis, respectively. Unemployment and low educational level were also associated with a higher risk of severe fibrosis. All these associations remained valid after HCV cure. These results demonstrate the need to continue liver fibrosis monitoring in at-risk groups, and to facilitate healthier lifestyles after HCV cure as a clinical and public health priority.

A "Good" Smoke? The Off-Label Use of Cannabidiol to Reduce Cannabis Use.

Background: Although cannabis use is common in France, it is still criminalized. Cannabidiol (CBD) products, including CBD-rich cannabis, are legally available. Although previous results suggested that CBD may have benefits for people with cannabis use disorder, there is a lack of data on cannabis users who use CBD to reduce their cannabis consumption. We aimed to identify (i) correlates of this motive, and (ii) factors associated with successful attempts to reduce cannabis use. Methods: A cross-sectional online survey among French-speaking CBD and cannabis users was conducted. Logistic regressions were performed to identify correlates of using CBD to reduce cannabis consumption and correlates of reporting a large reduction. Results: Eleven percent (n = 105) of our study sample reported they primarily used CBD to reduce cannabis consumption. Associated factors included smoking tobacco cigarettes (adjusted odds ratio (aOR) [95% confidence interval (CI)] 2.17 [1.3-3.62], p = 0.003) and drinking alcohol (aOR [95%CI] 1.8 [1.02-3.18], p = 0.042). Of these 105, 83% used CBD-rich cannabis to smoke, and 58.7% reported a large reduction in cannabis consumption. This large reduction was associated with non-daily cannabis use (aOR [95%CI] 7.14 [2.4-20.0], p < 0.001) and daily CBD use (aOR [95%CI] 5.87 [2.09-16.47], p = 0.001). A reduction in cannabis withdrawal symptoms thanks to CBD use was the most-cited effect at play in self-observed cannabis reduction. Conclusions: Cannabis use reduction is a reported motive for CBD use-especially CBD-rich cannabis to smoke-in France. More studies are needed to explore practices associated with this motive and to accurately assess CBD effectiveness.

HCV cure: an appropriate moment to reduce cannabis use in people living with HIV? (ANRS CO13 HEPAVIH data).

BACKGROUND: Thanks to direct-acting antivirals, hepatitis C virus (HCV) infection can be cured, with similar rates in HCV-infected and HIV-HCV co-infected patients. HCV cure is likely to foster behavioral changes in psychoactive substance use, which is highly prevalent in people living with HIV (PLWH). Cannabis is one substance that is very commonly used by PLWH, sometimes for therapeutic purposes. We aimed to identify correlates of cannabis use reduction following HCV cure in HIV-HCV co-infected cannabis users and to characterize persons who reduced their use. METHODS: We used data collected on HCV-cured cannabis users in a cross-sectional survey nested in the ANRS CO13 HEPAVIH cohort of HIV-HCV co-infected patients, to perform logistic regression, with post-HCV cure cannabis reduction as the outcome, and socio-behavioral characteristics as potential correlates. We also characterized the study sample by comparing post-cure substance use behaviors between those who reduced their cannabis use and those who did not. RESULTS: Among 140 HIV-infected cannabis users, 50 and 5 had reduced and increased their use, respectively, while 85 had not changed their use since HCV cure. Cannabis use reduction was significantly associated with tobacco use reduction, a decrease in fatigue level, paying more attention to one's dietary habits since HCV cure, and pre-HCV cure alcohol abstinence (p = 0.063 for alcohol use reduction). CONCLUSIONS: Among PLWH using cannabis, post-HCV cure cannabis reduction was associated with tobacco use reduction, improved well-being, and adoption of healthy behaviors. The management of addictive behaviors should therefore be encouraged during HCV treatment.

Cost-utility analysis of four WHO-recommended sofosbuvir-based regimens for the treatment of chronic hepatitis C in sub-Saharan Africa.

BACKGROUND: Although direct-acting antivirals (DAA) have become standard care for patients with chronic hepatitis C worldwide, there is no evidence for their value for money in sub-Saharan Africa. We assessed the cost-effectiveness of four sofosbuvir-based regimens recommended by the World Health Organization (WHO) in Cameroon, Côte d'Ivoire and Senegal. METHODS: Using modelling, we simulated chronic hepatitis C progression with and without treatment in hypothetical cohorts of patients infected with the country's predominant genotypes (1, 2 and 4) and without other viral coinfections, history of liver complication or hepatocellular carcinoma. Using the status-quo 'no DAA treatment' as a comparator, we assessed four regimens: sofosbuvir-ribavirin, sofosbuvir-ledipasvir (both recommended in WHO 2016 guidelines and assessed in the TAC pilot trial conducted in Cameroon, Côte d'Ivoire and Senegal), sofosbuvir-daclatasvir and sofosbuvir-ledipasvir (two pangenotypic regimens recommended in WHO 2018 guidelines). DAA effectiveness, costs and utilities were mainly estimated using data from the TAC pilot trial. Secondary data from the literature was used to estimate disease progression probabilities with and without treatment. We considered two DAA pricing scenarios: S1) originator prices; S2) generic prices. Uncertainty was addressed using probabilistic and deterministic sensitivity analyses and cost-effectiveness acceptability curves. RESULTS: With slightly higher effectiveness and significantly lower costs, sofosbuvir/velpatasvir was the preferred DAA regimen in S1 with incremental cost-effectiveness ratios (ICERs) ranging from US$526 to US$632/QALY. At the cost-effectiveness threshold (CET) of 0.5 times the 2017 country's per-capita gross domestic product (GDP), sofosbuvir/velpatasvir was only cost-effective in Senegal (probability > 95%). In S2 at generic prices, sofosbuvir/daclatasvir was the preferred regimen due to significantly lower costs. ICERs ranged from US$139 to US$216/QALY according to country i.e. a 95% probability of being cost-effective. Furthermore, this regimen was cost-effective (probability> 95%) for all CET higher than US$281/QALY, US$223/QALY and US$195/QALY in Cameroon, Côte d'Ivoire and Senegal, respectively, corresponding to 0.14 (Côte d'Ivoire and Senegal) and 0.2 (Cameroon) times the country's per-capita GDP. CONCLUSIONS: Generic sofosbuvir/daclatasvir is very cost-effective for treating chronic hepatitis C in sub-Saharan Africa. Large-scale use of generics and an increase in national and international funding for hepatitis C treatment must be priorities for the HCV elimination agenda.

Metabolic Disorders in Patients with Chronic Hepatitis B Virus Infection: Coffee as a Panacea? (ANRS CO22 Hepather Cohort).

People living with chronic hepatitis B virus (HBV) infection are at high risk of liver disease progression, which is positively associated with metabolic disorders, but inversely associated with dyslipidemia. Diet, including dietary antioxidants, is a lever of metabolic disorder management. In particular, elevated coffee consumption is associated with different metabolic outcomes in the general population. We aimed to test whether such associations occur in HBV-infected people. Based on cross-sectional data from the ANRS CO22 Hepather cohort, we performed logistic regression models with (i) dyslipidemia, (ii) hypertension, and (iii) diabetes as outcomes, and with demographic, clinical, and socio-behavioral (including coffee consumption) data as explanatory variables. Among 4746 HBV-infected patients, drinking ≥3 cups of coffee per day was associated with a higher risk of dyslipidemia (adjusted odds ratio [95% confidence interval] 1.49 [1.10-2.00], p = 0.009) and a lower risk of hypertension (0.64 [0.50-0.82], p = 0.001). It was not associated with diabetes. Elevated coffee consumption was associated with a higher risk of dyslipidemia and a lower risk of hypertension in HBV-infected patients, two effects expected to be associated with favorable clinical outcomes. Further studies should test whether such metabolic benefits translate into reduced mortality risk in this population.

Knowledge of liver fibrosis stage among adults with NAFLD/NASH improves adherence to lifestyle changes.

BACKGROUND & AIMS: Though lifestyle interventions can reverse disease progression in people with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), unawareness about disease severity might compromise behavioural changes. Data from this first international cross-sectional survey of individuals with NAFLD/NASH were used to identify correlates of both unawareness about fibrosis stage and its association with adherence to lifestyle adjustments. METHODS: Adults with NAFLD/NASH registered on the platform Carenity were invited to participate in an online 20-min, six-section survey in Canada, France, Germany, Italy, Spain and the United Kingdom to describe their experience with NAFLD/NASH and its care (N = 1411). Weighted binary and multinomial logistic regressions were performed to estimate the effect of explanatory variables on unawareness of fibrosis stage and poor adherence to lifestyle changes respectively. RESULTS: In the study group, 15.5% had obesity and 59.2% did not know their fibrosis stage. After multiple adjustments, individuals with a body mass index (BMI) ≥35 were over twice as likely to not know their fibrosis stage. People with a BMI >30 had a threefold higher risk of having poor adherence to lifestyle changes. Unawareness about fibrosis stage was also significantly associated with poor adherence to lifestyle adjustments. CONCLUSIONS: As fibrosis stage is becoming the main predictor of NAFLD progression, improving patient-provider communication-especially for people with obesity-about liver fibrosis stage, its associated risks and how to mitigate them, is needed. Training for healthcare professionals and promoting patient educational programmes to support behaviour changes should also be included in the liver health agenda.

Elevated coffee consumption is associated with a lower risk of elevated liver fibrosis biomarkers in patients treated for chronic hepatitis B (ANRS CO22 Hepather cohort).

BACKGROUND AND AIMS: Patients chronically infected with hepatitis B virus (HBV) are at high risk of liver fibrosis, cirrhosis and liver cancer, despite recent therapeutic advances. It is therefore crucial to find non-pharmaceutical options for liver fibrosis prevention in this population. Using cross-sectional data from the ANRS CO22 Hepather cohort, we aimed to identify socio-demographic and modifiable risk factors for significant fibrosis in chronic HBV patients. METHODS: Logistic regression or Firth's penalized maximum likelihood logistic regression (according to outcome prevalence) multivariable models were used to test for associations between explanatory variables and significant fibrosis, as assessed by three non-invasive markers: aspartate aminotransferase to platelet ratio index (APRI), FIB-4, and gamma glutamyltransferase to platelet ratio (GPR). Analyses were stratified by HBV treatment status. RESULTS: The study population comprised 2065 untreated and 1727 treated chronic HBV patients. Elevated coffee consumption was consistently associated with a lower risk of elevated fibrosis biomarkers in all three treated-participant models, suggesting a dose-response relationship (adjusted odds ratios for ≥3 cups/day versus 0 cups/day: 0.16, 0.35 and 0.62, p ≤ 0.002, according to APRI, FIB-4 and GPR, respectively). Other modifiable risk factors included tobacco and alcohol use. CONCLUSION: Elevated coffee consumption was consistently associated with a lower risk of significant liver fibrosis, as assessed by three non-invasive markers in treated chronic HBV patients. This result can be immediately used in real-world situations, as increasing coffee consumption may be beneficial for patients at risk of advanced liver disease.

Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER).

BACKGROUND: ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or Therapeutic education for alcohol-related harm reduction) is a multicentre community-based mixed-methods study, which aims to evaluate the effectiveness of the innovative therapeutic patient education (TPE) programme 'Choizitaconso' in a sample of French people with alcohol use disorder (people with AUD). Choizitaconso teaches people with AUD psychosocial skills to help them (re)establish controlled drinking and reduce alcohol-related harms. Recruitment started in October 2019. We present here the protocol of the ETHER study. METHODS: ETHER's quantitative component involves a 6-month controlled intervention study which evaluates Choizitaconso's effectiveness by comparing 30 people with AUD following the programme with a control group of 60 people with AUD not enrolled in it, using a questionnaire co-constructed by the research team and members of the people with AUD community. Thirty-four alcohol-related harms are assessed and summed to provide an individual measure of the 'harm burden' from consuming alcohol (primary outcome). Secondary outcomes are anticipated and internalized stigma, alcohol consumption measures, craving for alcohol, coping strategies, health-related quality of life, self-confidence to control or abstain from drinking, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments, and capabilities (a measure of wellbeing in adults). Data will be collected in face-to-face and phone-based interviews at enrolment and 6 months later. Linear regression models will be used to assess the impact of the TPE programme on changes in the primary and secondary outcomes, while adjusting for other correlates and confounders. The study's qualitative component comprises semi-structured interviews with 16 people with AUD who have already completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis. RESULTS AND CONCLUSIONS: ETHER is the first evaluation study of an innovative TPE programme specifically designed to reduce alcohol-related harms and reach controlled drinking in France. The involvement of the people with AUD community in selecting which experienced and perceived alcohol-related harms to measure ensures that ETHER will provide healthcare staff and researchers with a relevant set of harm reduction criteria for use in future research. Finally, ETHER will provide scientific justification for implementing novel alcohol-related harm reduction approaches and champion controlled drinking as a therapeutic goal. Trial registration ClinicalTrials.gov, NCT03954054. Registered 17 May 2019-Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03954054?cond=alcohol&cntry=FR&city=Marseille&draw=1&rank=1 .