Monthly Archives: July 2024

Introduction

The paper “Sex-differences in response to treatment with liraglutide 3.0 mg” provides a critical analysis of how responses to obesity treatments can vary by sex, with a particular focus on the efficacy of liraglutide 3.0 mg in patients with obesity (BMI ≥ 30 kg/m2), but without type 2 diabetes (T2D) [1].

The emphasis on sex-specific responses in obesity places this study within a trend of increasing recognition, among clinicians and researchers, of the critical role of sex and gender at all levels of medical research [2]. Despite this growing awareness, sexual biology is often relegated to a specialized discipline rather than being integrated as a fundamental aspect [3], underscoring the need for integration of this analysis.

The authors provide a clear picture of the increasing rates of obesity in recent decades, and of the apparent sex differences in obesity prevalence, attitudes and behaviors [4].

While it is generally accepted that the prevalence of obesity appears to be slightly higher in women than in men, it is increasing in both sexes worldwide [5]. Interestingly, the authors report that recently in Italy, obesity appears to be higher in men than in women [6,7].

This discrepancy may explain why the authors chose to emphasize that, despite the overall higher prevalence of obesity in men, women are more likely to be included in obesity clinical trials, and to seek and to be prescribed anti-obesity pharmacotherapy [8].

In addition, although previous studies have suggested a sexually dimorphic response to GLP-1RAs, with greater weight loss in women than in men, as the authors note, most of these studies were conducted in people with T2D and, in any case, sex-specific analysis remains underexplored [2].

Overall, the study highlights the importance of better understanding sex-specific responses to obesity treatments, such as liraglutide, the first GLP-1 receptor agonist approved for weight management in Italy, in a real-world setting.

Results

The authors conducted a single-center, real-world, retrospective study at the Santa Maria Goretti Hospital in Italy, focusing on a specific cohort of patients with obesity, but without T2D. The study design includes criteria that help minimize confounding variables such as previous anti-obesity treatments or significant metabolic comorbidities or treatments, ensuring a more homogeneous sample. By including only patients who reached and maintained the maximum dose of liraglutide (3.0 mg) for at least 6 months, the study strengthens the validity of its findings regarding the effects of liraglutide on weight loss and improvements in metabolic parameters.

The results show significant sex differences in response to liraglutide. Men experienced significantly greater reductions in weight and BMI at both 3 (-10.7 vs -7.1 kg, -3.6 vs -2.6 kg/m²), and 6 months (-17.9 vs -11.9 kg, -6.0 vs -4.4 kg/m2) compared with women. In addition, the authors decided to include in the analysis the assessment of percentage weight loss (%WL) and the achievement of weight loss of >5% (WL>5%) and >10% (WL>10%), which are considered meaningful for clinicians, public health, and for anti-obesity drug targets [9,10]. A higher percentage of men achieved significant WL >5% (93.7% vs. 58.0%) and %WL (-9.2% vs. -6.5%) at 3 months than women, and this trend was maintained at 6 months, with WL >10% (87.5% vs. 29.0%) and %WL (-15.2% vs. -10.5%).

The inclusion of metabolic parameters adds depth to the study and has shown that men also experienced significantly greater improvements in total (-14.0 mg/dL vs. 9.5 mg/dL) and LDL cholesterol (-19.0 mg/dL vs. 6.8 mg/dL) and the fibrosis-4 index FIB-4 (-0.25 vs. -0.003) as an indicator of liver function than women. However, no significant sex-differences were observed in glucose metabolism or renal function [1].

Discussion

One of the key considerations in this study is the higher representation of women (65.9%) compared to men (34.0%) in the sample. This is consistent with other analyses in the literature suggesting that women are more likely than men to be enrolled in clinical trials of anti-obesity drugs [11], and may confirm that in the real world, women may also be more proactive in seeking weight management treatments in a clinical setting, possibly due to different attitudes and awareness of body weight than men [12].

In terms of results, while some previous studies have suggested superior weight loss in women with GLP-1 receptor agonists (GLP-1 RAs), this study found the opposite, confirming the complexity of sex-specific pharmacodynamics and pharmacokinetics.

The authors discuss possible explanations for these conflicting results, emphasizing that the majority of results have been obtained in people with T2D using other classes of GLP1-Ras [13-15]. Consistent with this, it has been suggested that the different molecules may have different pharmacokinetics and pharmacodynamics [13], and it is also known that diabetes is a known factor that can influence pharmacotherapy weight loss or changes in metabolic parameters in people with increased adiposity [16].

In addition, the authors noted that most studies reported different baseline body weights, and BMIs between the sex groups, describing a non-homogeneous sample. Despite in some studies researchers have hypothesized that the greater weight loss in women may be related to their greater exposure to the drug due to their lower body weight [13,15,17], while others have observed an association between women’s greater weight loss and their higher baseline BMI [15,18], these hypotheses remain contradictory.

Overall, the absence of baseline differences in weight, BMI, and comparison of percent body weight loss may have helped to attenuate any differences in the authors’ results, in addition to the absence of T2D and other metabolic treatments in a real-world setting, may potentially explain the different results from those reported in the literature.

Given the mean age of the cohort (50.8 years), the authors have also suggested that the contribution to the observed differences may be due to differences in body composition and hormonal changes experienced by women during the menopausal transition [19,20], which could also influence the pharmacokinetics and pharmacodynamics of the drugs [21]. Indeed, in a study conducted only in patients with obesity treated with liraglutide 3.0 mg, greater weight loss was observed in women than in men, but the mean age was 43.6 years [22], which may have influenced the results.

In line with the latter, it can be added that recent evidence suggests that central estrogen receptor (ER)α signaling is necessary for the effects of GLP-1 on food reward behavior [23,24], and that in ovariectomized animal models, lower estradiol (E2) levels were associated with hyperfagia and weight gain [25].

To date, weight loss interventions are not tailored to women’s menopausal status, nor to sex differences, and studies based on sex in response to liraglutide in people with obesity only remain very limited. This context allows to highlight the significance of these findings for clinical practice implications as a major strength of this paper. Given the recent increase in the prevalence of obesity in men and their underrepresentation in weight management programs, the findings of greater efficacy of liraglutide in men are particularly significant, and underscore the need for clinicians to be more proactive in engaging men in obesity treatment programs. In addition, given the higher cardiovascular risk in men, the notable improvements in total and LDL cholesterol and liver fibrosis in men raise important questions about the cardiometabolic benefits of liraglutide.

Conclusion

This paper makes a significant contribution to the field of obesity treatment by highlighting the importance of considering sex differences in clinical settings where, similar to lifestyle intervention trials, most pharmacological trials do not analyze weight loss separately for men and women due to the higher representation of women in pharmacological weight loss trials [11].

The potential for sex-specific tailoring of obesity treatments is in line with the need to develop more personalized treatment in the medical field, including dose adjustment where appropriate [24], with significant public health benefits.

Strengths of the study include its real-world setting, comprehensive data collection, and focus on a homogeneous cohort. However, the authors acknowledge several limitations, including the small sample size, retrospective design, and lack of data on changes in body composition, dietary habits, and physical activity levels.

Despite these limitations, the study provides valuable insights into the sex-specific effects of liraglutide and calls for further research into sex-specific responses to anti-obesity drugs to better understand the mechanisms behind these differences. In doing so, it paves the way for more effective, personalized obesity treatments that take into account the unique physiological and hormonal factors that influence treatment outcomes in men and women, and may increase men’s engagement in obesity treatment programs.

References

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Li JB, Qiu ZY, Liu Z, Zhou Q, Feng LF, et al. (2021) Gender Differences in Factors Associated with Clinically Meaningful Weight Loss among Adults Who Were Overweight or Obese: A Population-Based Cohort Study. Obes Facts. 14: 108-120. [crossref]
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL (2016) Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA 315: 2284-2291. [crossref]
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Italian Central Statistics Institute (Istituto Nazionale di Statistica). BES 2021: Equitable and Sustainable Well-Being in Italy. Available online: https: //www.istat.it/it/files/2021/10/BES-Report-2020.pdf (accessed on 22 June 2024).
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Kompaniyets L, Freedman DS, Belay B, Pierce SL, Kraus EM, et al. (2023) Probability of 5% or Greater Weight Loss or BMI Reduction to Healthy Weight Among Adults With Overweight or Obesity. JAMA Netw Open 6: e2327358. [crossref]
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Gallwitz B, Dagogo-Jack S, Thieu V, Garcia-Perez LE, Pavo I, et al. (2018) Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c. Diabetes Obes Metab 20: 409-418. [crossref]
Rentzeperi E, Pegiou S, Koufakis T, Grammatiki M, Kotsa K (2022) Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care. J Pers Med 12: 454. [crossref]
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Addressing Global Inequities in Poxvirus Vaccination: Strategies for a More Equitable Future

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DOI: 10.31038/IJVB.2024812

Abstract

There has been persistent vaccine inequity between high-income and low-income nations, resulting in the prevalence of infectious disease epidemics in Sub-Saharan African countries. While the global surge in poxvirus cases peaked in 2022, western and central African countries have struggled with this virus since the 1970s [1]. These nations face numerous barriers to accessing adequate vaccination. Wealthy nations acquire vaccines at higher rates due to their ability to bear the high costs, forcing poorer nations to rely on donations and low-cost subsidies. This situation is further complicated by inadequate healthcare infrastructure and socioeconomic, cultural, and geographical obstacles. To address these challenges, comprehensive, inclusive, and integrated approaches are essential, incorporating preventive measures, surveillance systems, low-cost vaccines, vaccine subsidies, the expansion of vaccine manufacturers, and vaccine education through multi-sectoral collaborations in both the public and private sectors.

Keywords

Poxvirus vaccination, Monkeypox, Disease surveillance, Vaccine awareness, Vaccine inequity

Preventive Measures and Community Involvement

Similar to other infectious diseases, preventive measures for the poxvirus include maintaining diligent sanitation, such as thoroughly washing hands with clean water and regularly cleaning and disinfecting spaces. However, these measures face significant obstacles in Africa due to limited access to clean water and inadequate water and sewage treatment facilities [2]. Resources need to be mobilized to develop water treatment plants, sanitation infrastructure, and waste management systems. Implementing preventive measures requires community involvement, with local village leaders playing a crucial role in educating residents about prevention and early treatment. To enhance prevention efforts, recruited local trainees can be mobilized.

Surveillance Systems

Since Mpox has both animal and human reservoirs, it is theoretically difficult to control and eradicate, necessitating the maintenance of active surveillance systems [3]. However, effective surveillance is challenging in most African countries due to a lack of diagnostic capacity to detect monkeypox [4]. Logistical barriers further contribute to the underreporting of cases, but this can be partially overcome by mobile phone apps, which allow for quick information delivery from remote areas to central health information systems. Effective surveillance relies on strengthening diagnostic capacity, providing affordable diagnostic tests, and ensuring adequate staff training.

Collaboration of Health Agencies

The 2022 Mpox outbreak led the WHO to create the Mpox Strategic Preparedness, Readiness, and Response Plan (SPRP) [5]. Collaboration between WHO staff and national and provincial health agencies is crucial for addressing global disparities in poxvirus vaccination. The WHO can adopt a proactive approach to assist countries in implementing the SPRP, increasing monkeypox vaccine production, donations, and subsidies, and enhancing disease surveillance systems and vaccine awareness campaigns.

Vaccines

Jynneos, Imvanex, and Imvamune vaccines can prevent Mpox, but the rollout of vaccination campaigns exposed significant global disparities in vaccine procurement and distribution. High-income countries or those with high vaccine production capacities were prioritized. In 2022, nearly 80% of the world’s Mpox vaccine supply was held by the U.S., while African nations faced considerable challenges in accessing vaccines [6]. The global shortage of Mpox vaccines, coupled with high prices, excluded low-income countries. Despite the U.S. allocating $1 billion for Mpox vaccines, only half of the affected countries received access [7].

To contain Mpox outbreaks in endemic African countries, subsidies for a low-cost vaccine are essential. A targeted vaccination approach, focusing on exposed and high-risk populations, requires fewer donated doses and is more cost-effective for donors. Despite facing high mortality rates from infectious diseases, Africa’s vaccine manufacturing capacity is limited. In response, the African Union and GAVI, The Vaccine Alliance, are expanding this capacity by increasing the number of manufacturers from 10 to 17 and diversifying vaccine portfolios [8]. American Tonix Pharmaceuticals, in collaboration with the Kenya Medical Research Institute, is also working on potential local vaccine production [9].

Vaccine Education

The distribution of the limited vaccines in African nations was impeded by an intricate tapestry woven from factors including unaffordable costs, lack of proximity to vaccination sites, inadequate medical services, and deeply entrenched socioeconomic and cultural barriers such as mistrust of vaccines, misinformation, and cultural opposition [10,11]. At the community level, vaccine advocates and opinion leaders should collaborate to disseminate vaccination knowledge to ensure that vulnerable populations understand the importance of vaccination and have easy access to it. Authorities should establish a monitoring system to engage with targeted communities, delivering timely and accurate information on poxvirus transmission, preventive measures, and treatment. Additionally, they should enhance access to vaccination sites through the use of mobile apps.

Conclusion

African nations are likely to experience more severe impacts from modern epidemics. Recognizing this sobering reality is essential for creating global cooperative pandemic-control organizations. Their collective efforts should focus on expanding vaccine procurement, production, and allocation in African nations. Drawing lessons from the global inequities in vaccination during the Covid-19 pandemic, high-income countries should support these nations, which face persistent infectious diseases and fragile healthcare infrastructures, by helping to expand preventive measures, vaccine donations, and subsidies [12]. As worldwide epidemics may occur routinely, healthcare decision-makers should continue to promote risk-mitigating behaviors, maintain open and transparent risk communication with the public, and foster community compliance. Future pandemic control efforts will depend heavily on global coordinated actions, cooperation, and communication, rather than competition and concealment, to develop affordable, widely distributed, broad-based, and long-lasting vaccines.

References

Son BWK, Wambalaba OW, Wambalaba WF (2024) A Multi-pronged Approach to Addressing Global Poxviruses Vaccine Inequity: A Case of Monkeypox. In: Rezaei N (eds) Poxviruses. Advances in Experimental Medicine and Biology, vol 1451. Springer, Cham. [crossref]
Mutono N, Wright J, Mutembei H, Muema J, Thomas M, Mutunga M, Thumbi SM (2020) The nexus between improved water supply and water-borne diseases in urban areas in Africa: a scoping review protocol. AAS Open Res 8(3): 12. [crossref]
Golden J, Hooper J (2011) The strategic use of novel smallpox vaccines in the post-eradication world. Expert review of vaccines 10(7): 1021-1035 [crossref]
Boodman C, Heymann D, Peeling R (2022) Inadequate diagnostic capacity for monkeypox—sleeping through the alarm again. The Lancet 23(2): 140-141 [crossref]
WHO (2022) Monkeypox Strategic Preparedness, Readiness, and Response Plan (SPRP)
Molteni M, Branswell H, Joseph A, Mast J (2022) 10 key questions about monkeypox the world needs to answer. Statnews. August 30, 2022.
Zarocostas J (2022) Monkeypox PHEIC decision hoped to spur the world to act. The Lancet 400(10349): P347 [crossref]
GAVI (2022) Expanding sustainable vaccine manufacturing in Africa: Priorities for Support. Gavi Vaccine Alliance.
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Son, B.W.K (2023) A Multipronged Approach to Combat COVID-19: Lessons from Previous Pandemics for the Future. In: Rezaei N (eds) Integrated Science of Global Epidemics. Integrated Science, vol 14. Springer, Cham.

Progress towards Elimination of Viral Hepatitis B and C

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DOI: 10.31038/IDT.2024514

Abstract

Worldwide the major causes of viral hepatitis are 5 viruses: the RNA hepatitis A virus (HAV), the NA hepatitis B virus (HBV), the RNA hepatitis C virus (HCV), the RNA hepatitis delta viroid (HDV) and the RNA hepatitis E virus (HEV). Their epidemiology, life cycle, diagnosis, clinical course and associated diseases have been studied in great detail. Furthermore, effective treatment strategies and preventive measures have been developed and entered clinical practice.

lmportantly, with recent political commitments, policy updates and universal availability of highly effective preventive and therapeutic strategies against viral hepatitis B and C, respectively, low- and middle-income countries are scaling up their viral hepatitis prevention and therapy programs. ln this context, Egypt was leading the way for a public health approach to eliminate viral hepatitis C in October 2023.

While better tools and data than ever are now available to prevent, diagnose and treat viral hepatitis, including chronic hepatitis B and chronic hepatitis C and the recent political commitment of low- and middle-income countries with a high burden of viral hepatitis, such as China, lndia and Pakistan, the latest data from WHO show that hepatitis B and C are still a major public health challenge and far from the WHO goal of their elimination by 2030.

Keywords

Chronic viral hepatitis B and C, diagnosis, treatment, prevention, morbidity, mortality

Introduction

Worldwide, the causes of viral hepatitis are 5 hepatotropic viruses: the RNA hepatitis A virus (HAV), the DNA hepatitis B virus (HBV) [Figures 1 and 2], the RNA hepatitis C virus (HCV) [Figures 1 and 3], the RNA hepatitis delta viroid (HDV) [Figure 1] and the RNA hepatitis E virus (HEV). They infect the liver and can present with a broad spectrum of clinical signs and symptoms, ranging from an asymptomatic carrier state to acute/ fulminant hepatitis or chronic hepatitis with the potential to progress to liver cirrhosis and its sequelae, including hepatocellular carcinoma (HCC) [1]. Thus, viral hepatitis can be associated with significant morbidity and mortality and represents a global health care problem. ln the following, the history and epidemiology of viral hepatitis B [2-7] and hepatitis C [8-10], the world-wide burden of these diseases and the goals for their global elimination will be addressed.

Figure 1: Hepatitis B virus (HBV), hepatitis delta viroid (HDV), hepatitis C virus (HCV)

Figure 2: Worldwide prevalence of HBV infection in 2005 [13]

Figure 3: Worldwide prevalence of HCV infection in 2005 [14]

Combined, hepatitis B and C cause daily 3,500 deaths with increasing mortality and 6,000 new infections [1]. Worldwide, an estimated 254 million people are infected with hepatitis B and 50 million with hepatitis C. ln numerous countries, many people remain undiagnosed and even when diagnosed, the number of people receiving treatment is incredibly low. Although therapeutic agents are available at affordable prices, many countries do not take full advantage of this situation. Similarly, many infants do not receive the hepatitis B birth dose vaccination, despite the low cost of this intervention. Unfortunately, funding for viral hepatitis remains limited given the fact that viral hepatitis is about eight times more prevalent than HIV infection but receives less than one tenth of funding [1].

The COVID-19 pandemy severely affected strategies aimed at the elimination of viral hepatitis B and C

The COVID-19 pandemy urged many countries worldwide to adjust their health care priorities. ln particular, the COVID-19 pandemy affected 10 out of 38 WHO focus countries for the viral hepatitis response (China, lndia, lndonesia, Nigeria, Pakistan, Ethiopia, Bangladesh, Vietnam, Philippines and the Russian Federation). Among these 10 countries which account for about 80% of the global disease burden of viral hepatitis B and C, nearly two thirds were very much restricted in their viral hepatitis programs [1]. Together with a universal access to diagnosis, treatment and prevention by the special effort of the African Region, it is the goal to regain the momentum for achieving the Sustainable Development Goals.

Key findings of the WHO Global Hepatitis Report 2024. Overall, 304 million people were living with hepatitis B and C in 2022: an estimated 254 million (84%) with hepatitis B and an estimated 50 million (16%) with hepatitis C. Half the burden of chronic hepatitis is among people between 30 and 54 years old. Approx. 58% of all patients had a history of medical injections or other medical procedures, of newborns and children at risk for mother-to-child transmission of hepatitis B, of indigenous populations and mobile and migrant populations from countries with higher prevalence rates as well of key populations, such as people who inject drugs, people in prison or other closed settings, and men who have sex with men.

According to recent data from 187 countries [1] the estimated number of deaths from viral hepatitis increased from 1.1 million in 2019 to 1.3 million in 2022. 83% were caused by hepatitis B and 17% by hepatitis C. The estimated number of individuals newly infected by viral hepatitis declined from 2.5 million in 2019 to 2.2 million in 2022. Of these, 1.2 million (55%) were infected by hepatitis B and 1.0 million (45%) by hepatitis C. This reduction is due to hepatitis B and C prevention through immunization against hepatitis B and safe injection practices and the initial impact of novel curative antivirals against hepatitis C. Both HBV vaccination and cure of hepatitis C by widely available directly active antiviral agents (DAAs) are central for a sustainable viral response. Taken together, deaths from viral hepatitis B and C, unfortunately, increased from 2019 to 2022 while infections decreased.

Diagnosis, treatment and prevention of hepatitis B and C is still too low to achieve their elimination by 2030. By the end of 2022, 13% of people have been diagnosed with hepatitis B and only about an estimated 3% (7 million) have received long-term antiviral therapy, e.g., adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate and tenofovir alafenamide [1-7].

Between 2015 and 2022, globally 36% of individuals with hepatitis C infection were diagnosed and 20% received curative treatment, e.g., genotype-specific or pangenotypic drugs or drug combinations (DAAs), After decades of interferon-based therapeutic strategies, the availability of DAAs has revolutionized the treatment of patients with chronic hepatitis C of any genotype with HCV elimination rates approaching 95-100% after treatment for 8-12 weeks [8-10]. The DAAs include protease inhibitors (e.g., telaprevir, boceprevir, asunaprevir, simeprevir, faldaprevir), non-nucleoside polymerase inhibitors (e.g., deleobuvir, filibuvir, setrobuvir, tegobuvir), NS5A inhibitors (e.g., daclatasvir, ledispavir) and NS5B polymerase inhibitors (e.g., sofosbuvir, mericitabine).

Vaccination against HBV infection, a cost-saving strategy in countries with high and intermediate endemicity, was applied to an estimated 45% of newborns within 24 hours after birth. Coverage varies between 18% in the African region and 80% in the Western Pacific Region [1].

To date, the global response to viral hepatitis B and C is off-track towards the global elimination of viral hepatitis and far below the global targets for eliminating viral hepatitis by 2030 [1-11]. Major public health activities are expected to reduce the incidence of chronic viral hepatitis by 95%, mortality by 65% and the cost by 15%. The benefits of achieving these global targets will save 2.85 million lives, avert 9.5 million new infections and 21 million cases of cancer. Looking to 2050, this will save nearly 23 million lives and prevent nearly 53 million new viral hepatitis infections and 15 million cases of cancer [1].

Summary and Perspectives

Overall, the worldwide prevalence of hepatitis B and C decreased from 2019 to 2022 while the deaths from these infections increased. ln 2022 about 1.3 million people died from chronic viral hepatitis, similar to the number of deaths from tuberculosis. lmportantly, the COVID-19 pandemy severely affected hepatitis services. The 2024 WHO report [1] presents information on access to health products from 38 WHO focus countries for viral hepatitis response. These countries account for about 80% of the global disease burden of hepatitis B and C. These 38 countries include 10 that account for nearly two thirds of the global burden: China, lndia, lndonesia, Nigeria, Pakistan, Ethiopia, Bangladesh, Viet Nam, Philippines and the Russian Federation. Universal access to prevention, diagnosis and treatment in these countries by 2026 together with a special effort in the African region should enable the global response to gain momentum for the elimination of HBV and HCV infections and their associated morbidities and mortalities by 2030.

The recent WHO report on the global health sector strategies for the period 2022-2030 [11] focuses on their implementation to achieve progress and to fill gaps in the worldwide elimination of HBV and HCV lnfection [12].

Conflict of interests

The author declares no conflict of interest.

Financial disclosure

The author has no financing to disclose.

Acknowledgement

The excellent contribution of Mr. Alain Conard to the content and formatting of the manuscript is gratefully acknowledged.

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