Background & Aims
Data from Europe and North America have been published regarding the risk of developing hepatocellular carcinoma (HCC) after treatment with direct antiviral agents (DAA). We proposed to evaluate cumulative incidence and associated risk factors for de novo HCC.
Methods
This was a prospective multicentre cohort study from Latin America including 1400 F1‐F4‐treated patients with DAAs (F3‐F4 n = 1017). Cox proportional regression models (hazard ratios, HR and 95% CI) were used to evaluate independent associated variables with HCC. Further adjustment with competing risk regression and propensity score matching was carried out.
Results
During a median follow‐up of 16 months (IQR 8.9‐23.4 months) since DAAs initiation, overall cumulative incidence of HCC was 0.02 (CI 0.01; 0.03) at 12 months and 0.04 (CI 0.03; 0.06) at 24 months. Cumulative incidence of HCC in cirrhotic patients (n = 784) was 0.03 (CI 0.02‐0.05) at 12 months and 0.06 (CI 0.04‐0.08) at 24 months of follow‐up. Failure to achieve SVR was independently associated with de novo HCC with a HR of 4.9 (CI 1.44; 17.32), after adjusting for diabetes mellitus, previous interferon non‐responder, Child‐Pugh and clinically significant portal hypertension. SVR presented an overall relative risk reduction for de novo HCC of 73% (CI 15%‐91%), 17 patients were needed to be treated to prevent one case of de novo HCC in this cohort.
Conclusions
Achieving SVR with DAA regimens was associated with a significant risk reduction in HCC. However, this risk remained high in patients with advanced fibrosis, thus demanding continuous surveillance strategies in this population.
During the coronavirus disease 2019 (COVID-19) pandemic, health systems all over the world are either stressed to their maximum capacity or anticipating becoming overwhelmed. The population is advised not to attend hospital unless strictly necessary, yet this advice seems to apply to all but healthy women during childbirth.Specialized hospital care during childbirth can be lifesaving in case of obstetric complications or for COVID-19 symptomatic women, while strong evidence suggests the appropriateness of midwifery units that are integrated into the healthcare system for eligible women. We must ask ourselves whether obstetric units are the appropriate birthing facilities for healthy women during the pandemic.We have learned from previous crises that the needs of women and children are often badly served during disasters. The COVID-19 pandemic raises concerns over escalation of mistreatment and abuse media are already reporting on restrictions to the rights of birthing women in Europe and the US. In addition, concerns have emerged over increased risk of infection to COVID-19 among birthing women and familied by concentrating all women in obstetric units and lack of optimal care due to pressure on staff and resources. Women's rights in childbirth are being threatened by lack of care during labor, restrictions on accompaniment, unnecessary interventions including inductions, separation of mother and baby and prohibition on breastfeeding.An effective response to the crisis depends on strong and coordinated health care systems where mothers can birth safely, and the needs of the newborn babies are met.The interpretation of what constitute safe care is a stimulus for a strong debate between those who argue for strengthening community and primary care services and those who recommend for centralization of all births in hospitals. This debate is particularly salient during this pandemic and in preparation of future pandemics.We propose a strategic response in the face of the pandemic by expanding the use of midwifery units both alongside the obstetric unit and freestanding (in the community). Where midwifery units are absent pop-up units can be created quickly following the example of the Netherlands.
Luna Maya is a Mexican NGO that operates two full-scope midwifery centers in Mexico City and Chiapas, Mexico, providing woman-centered, culturally appropriate midwifery model maternity care on a sliding cost scale. The COVID-19 health crisis has made it necessary for Luna Maya to quickly incorporate safety protocols for out-of-hospital maternity care. Yet many of the emerging guidelines on maternity care have focused on high-income and hospital settings; there are no specific guidelines for such care in out-of-hospital settings in low- and middle-income countries. Thus we have had to create our own, based on best available and emerging evidence. In this article, we describe the guidelines and protocols we have created in response to COVID-19, the international evidence and recommendations on which we base them, and precisely how we carry them out in practice. We also present and analyze the results of qualitative interviews we conducted for this article with eight of our midwives and eight of our midwifery clients. These interviews reveal the tremendous stresses both midwives and pregnant and birthing women are experiencing as a result of the pandemic, their creative adaptations, and the structural flaws, deficiencies, and inequities of the Mexican healthcare system. The article also addresses Luna Maya’s ongoing challenges in continuing to provide care completely outside of governmental support and in difficult economic times, and demonstrates the extreme need for improvements in the Mexican system of maternity care and for full integration of community-based midwives and out-of-hospital birth.
BACKGROUND
The prevalence of chronic hepatitis B virus (HBV) infection is high in patients with end‐stage renal disease and in kidney transplant recipients, and there is little experience with treatment using the newer antiviral drugs. The aim of this study was to assess the efficacy and safety of entecavir in HBV infection in this difficult‐to‐treat population.
METHODS
Eleven male patients—1 with stage 4 chronic kidney disease, 7 undergoing hemodialysis, and 3 kidney transplant recipients‐were included in the study evaluation. Six were treatment naïve, and 5 were lamivudine resistant. Entecavir was administered at a dose of 0.1–1 mg qd according to the patients' renal function. All were HBsAg positive: 9 were HBeAg (+)/antiHBe (−), and the remaining 2 were HBeAg (−)/antiHBe (+).
RESULTS
After a median treatment of 2 ± 0.86 years, entecavir therapy was associated with a significant decrease in HBV DNA viral load: it was 6.84 ± 1.45 log10 UI/mL (range 5.21–9.04) at baseline and at the time of evaluation had dropped to 1.73 ± 2.11 log10 UI/mL (range <0.78–4.72). The rate of HBV DNA clearance was 54.5% (n = 6). The rate of anti–HBe seroconversion was 77.7% (7/9 HBeAg‐positive patients). The rate of anti‐HBs seroconversion was 9.1% (1/11 patients). There were no significant changes in renal function or hematological parameters.
CONCLUSIONS
This small study demonstrates that entecavir therapy is safe and efficient in HBV‐positive patients with varying degrees of renal dysfunction.
Hepatitis B virus (HBV) serology has become extremely refined. As well as the recognised hepatitis B surface (HBs), hepatitis B core (HBc), and hepatitis B e (HBe) antigen-antibody systems, new markers have been introduced including pre-Sl, pre-S2 for the envelope and the functional X protein.
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