Gastroenterology, hepatology and liver transplant exchanges between the USA and Cuba have mainly consisted of scientific events and short visits. This has facilitated Cuba's inclusion in recognized ...scientific organizations, familiarity with Cuba's biotech products for treatment of liver disease, and access by Cuban professionals to the highest level of scientific information for clinical practice. It has also given health professionals in the US a more accurate picture of Cuba's health sector. The results of the Global Alcoholic Liver Disease Survey, which included Cuba and was designed and coordinated in the USA, opened doors to joint research and scientific publications. Until now, there have been no protocols for ongoing cooperation to enable bilateral clinical trials or continuing professional development in diagnostic, therapeutic and surgical techniques for hepatology and liver transplantation. There are many mutually beneficial research prospects in these areas. What has been accomplished to date, described in this article, is encouraging and sets the stage for future collaboration. KEYWORDS Hepatology, liver transplant, health, medicine, science, Cuba, USA.
Introducción: La cirrosis hepática (CH) se ubica entre las principales causas de muerte en Cuba, una de sus complicaciones, el carcinoma hepatocelular (CHC), es responsable de la muerte en estos ...pacientes lo que ha motivado un incremento del interés clínico por los aspectos diagnósticos y de tratamiento. Métodos: Se desarrolló un estudio descriptivo, prospectivo con componente analítico, en 203 pacientes con CH, en el Instituto de Gastroenterología, en el período de 2005 a 2007. La muestra estuvo constituida por 105 hombres y 98 mujeres, de 56,4 años de edad promedio, la mayoría de causa viral y en diferentes estadios de progresión de la enfermedad. Se evaluaron las características clínicas y criterios de tratamiento en el momento del diagnóstico mediante métodos estadísticos descriptivos y el análisis de supervivencia se realizó mediante las curvas de Kaplan-Meier. Resultados: La frecuencia de presentación de CHC fue del 15,5 %, la causa más frecuente asociada fue la infección crónica por el virus de la hepatitis C, prevaleció en ambos sexos y en edades avanzadas. Predominaron las lesiones nodulares únicas mayores de 2 cm en el lóbulo hepático derecho, en el 77,7 % de los casos, asociadas a hipertensión portal. La supervivencia al año fue menor de 45 %. Conclusiones: El diagnóstico de la enfermedad se estableció en estadios donde las alternativas de tratamiento y curación fueron escasas. La vigilancia del CHC en los pacientes con CH es insuficiente. La supervivencia pudiera mejorar con el diagnóstico precoz y la aplicación de las opciones terapéuticas pertinentes.
Non-alcoholic fatty liver disease (NAFLD) affects 20-25% of the general population and is associated with morbidity, increased mortality, and elevated health-care costs. Most NAFLD risk factors are ...modifiable and, therefore, potentially amenable to being reduced by public health policies. To date, there is no information about NAFLD-related public health policies in the Americas. In this study, we analysed data from 17 American countries and found that none have established national public health policies to decrease NAFLD-related burden. There is notable heterogeneity in the existence of public health policies to prevent NAFLD-related conditions. The most common public health policies were related to diabetes (15 88% countries), hypertension (14 82% countries), cardiovascular diseases (14 82% countries), obesity (nine 53% countries), and dyslipidaemia (six 35% of countries). Only seven (41%) countries had a registry of the burden of NAFLD, and efforts to raise awareness in the Americas were scarce. The implementation of public health policies are urgently needed in the Americas to decrease the burden of NAFLD.
An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are ...available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects. The development of a new treatment modality is needed. One possible modality could be specific immunotherapy. Terap C is a therapeutic vaccine candidate composed of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120.
To assess the safety and efficacy of concomitant therapy with the candidate vaccine, Terap C, IFN α-2b and ribavirin in untreated individuals with HCV genotype 1 infection.
This was a Phase II randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of Terap C concomitant with IFN α-2b/RBV in 92 treatment-naïve patients with HCV genotype 1 infection. The study was conducted at the Gastroenterology Institute in Havana, Cuba. Patients were randomly assigned to 1 of 5 groups. The control group (Group 1) received IFN α-2b/RBV and placebo for 48 weeks. Groups 2 and 3 were administered Terap C 6 and 9 times, respectively, in addition to standard IFN α-2b/RBV treatment. In groups 4 and 5, Terap C was introduced 12 weeks after the initiation of IFN α-2b/RBV and administered 6 and 9 times, respectively, concomitant with IFN α-2b/RBV.
All patients showed some adverse events. Out of 3615 adverse events, only 18.8% were considered to be probably associated with administration of Terap C. Most events (47.4%) were considered to be improbably associated with of administration Terap C. Only 33.8% were considered possibly temporarily associated with Terap C, and can be explained by the use of conventional IFN α-2b + RBV or by HCV itself. The most common adverse events (≥65%) observed were pain at the injection site, headache, asthenia, psychiatric disturbances, fever, and gastrointestinal symptoms. Regarding sustained virological response, a 20% superiority was observed in the patients who received concomitant Terap C treatments from the beginning of the study compared with those who started after Week 12.
Vaccination with Terap C in patients with chronic HCV infection was safe and well tolerated. Clinical trial protocol code: IG/VHI/HC/0701; Public Register Code: RPCEC00000074.
En el tratamiento de la cirrosis hepática compensada de etiología vírica la respuesta viral sostenida con el interferón y ribavirina es menor y se acompaña de mayor frecuencia e intensidad de efectos ...adversos en relación con pacientes no cirróticos. No obstante, dadas las pocas opciones terapéuticas para este grupo de pacientes y la necesidad de retrasar la aparición de las complicaciones, nos motivamos a la realización de este trabajo. Se presentan los resultados de un grupo de 36 pacientes con diagnóstico de cirrosis hepática por el virus de la hepatitis C (VHC) en estadio de Child A incluidos en un ensayo clínico multicéntrico, liderado por el Instituto de Gastroenterología, a los que se les administró un esquema terapéutico de interferón alfa-2b más ribavirina por 48 sem, se evaluó su tolerancia a través de los eventos adversos tantos clínicos como hematológicos. Los resultados demuestran que esta alternativa de tratamiento es segura y bien tolerada.
Despite recent advances in treatment of viral hepatitis, liver-related mortality is high, possibly owing to the large burden of advanced alcohol-related liver disease (ALD). We investigated whether ...patients with ALD are initially seen at later stages of disease development than patients with hepatitis C virus (HCV) infection or other etiologies.
We performed a cross-sectional study of 3453 consecutive patients with either early or advanced liver disease (1699 patients with early and 1754 with advanced liver disease) seen at 17 tertiary care liver or gastrointestinal units worldwide, from August 2015 through March 2017. We collected anthropometric, etiology, and clinical information, as well as and model for end-stage liver disease scores. We used unconditional logistic regression to estimate the odds ratios for evaluation at late stages of the disease progression.
Of the patients analyzed, 81% had 1 etiology of liver disease and 17% had 2 etiologies of liver disease. Of patients seen at early stages for a single etiology, 31% had HCV infection, 21% had hepatitis B virus infection, and 17% had nonalcoholic fatty liver disease, whereas only 3.8% had ALD. In contrast, 29% of patients seen for advanced disease had ALD. Patients with ALD were more likely to be seen at specialized centers, with advanced-stage disease, compared with patients with HCV-associated liver disease (odds ratio, 14.1; 95% CI, 10.5-18.9; P < .001). Of patients with 2 etiologies of liver disease, excess alcohol use was associated with 50% of cases. These patients had significantly more visits to health care providers, with more advanced disease, compared with patients without excess alcohol use. The mean model for end-stage liver disease score for patients with advanced ALD (score, 16) was higher than for patients with advanced liver disease not associated with excess alcohol use (score, 13) (P < .01).
In a cross-sectional analysis of patients with liver disease worldwide, we found that patients with ALD are seen with more advanced-stage disease than patients with HCV-associated liver disease. Of patients with 2 etiologies of liver disease, excess alcohol use was associated with 50% of cases. Early detection and referral programs are needed for patients with ALD worldwide.
The epidemiologic and demographical features of nonalcoholic fatty liver disease (NAFLD) vary significantly across countries and continents. In this review, we analyze current data regarding ...prevalence of NAFLD in Latin America and Caribbean and Australia and review some peculiarities found in these regions. We stress the need of greater awareness of NAFLD and the development of cost-effective risk stratification strategies and clinical care pathways of the disease. Finally, we highlight the need of effective public health policies to control the main risk factors for NAFLD.
ABSTRACT Gastroenterology, hepatology and liver transplant exchanges between the USA and Cuba have mainly consisted of scientific events and short visits. This has facilitated Cuba’s inclusion in ...recognized scientific organizations, familiarity with Cuba’s biotech products for treatment of liver disease, and access by Cuban professionals to the highest level of scientific information for clinical practice. It has also given health professionals in the US a more accurate picture of Cuba’s health sector. The results of the Global Alcoholic Liver Disease Survey, which included Cuba and was designed and coordinated in the USA, opened doors to joint research and scientific publications. Until now, there have been no protocols for ongoing cooperation to enable bilateral clinical trials or continuing professional development in diagnostic, therapeutic and surgical techniques for hepatology and liver transplantation. There are many mutually beneficial research prospects in these areas. What has been accomplished to date, described in this article, is encouraging and sets the stage for future collaboration.
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