This trial is evaluating whether SOC NrtI will improve 3 primary outcomes and 11 secondary outcomes in patients with Hepatitis, Chronic. Measurement will happen over the course of Week 48.
This trial requires 60 total participants across 2 different treatment groups
This trial involves 2 different treatments. SOC NrtI is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
There is an annual prevalence of hepatitis, chronic in the U.S. that far exceeds the prevalence of hepatitis, chronic in the WHO world. Further research in this area is warranted.
Hepatitis, chronic is more common in Asians and Ameras, and is due to HCV infection. It is estimated that about 7% of hepatitis, chronic individuals are carriers, that is, they have chronic HCV infection but are asymptomatic.
Although a cure may not be possible by any currently proven treatment modality, several factors seem to confer a reduced risk of progression to cirrhosis with time. These factors include a virologic control of the hepatitis C virus, a low level of ALT activity within the normal range, a long pretreatment duration, and lack of liver-related symptoms. Liver transplantation remains the ideal treatment for liver cirrhosis secondary to HCV-related cirrhosis.
Chronic, or long-standing infection due to hepatitis B viruses, is the most significant risk factor for liver cancer. Other risk factors that contribute to liver cancer are cirrhosis, exposure to non-steroidal anti-inflammatory drugs, alcohol misuse, hepatitis C virus infection, and non-alcoholic fatty liver disease. In this article, we review the risk of hepatitis B virus as a contributor to liver cancer. Further, we describe the diagnosis and the treatment of hepatitis.
Hepatitis is not usually noticed in this population. Symptoms such as abdominal pain and jaundice are often non-specific. Fever, an enlarged liver and a painful spleen are also suggestive of hepatitis. The presence of symptoms suggestive of coexistent diseases should prompt further investigation. Abnormal laboratory findings are the main signs associated with viral hepatitis.
There is no specific treatment for hepatitis. In addition, there is no cure for liver disease, so treatment is aimed toward management of symptoms and maintaining liver function. There is no definitive proof that antibiotics confer any benefit in the treatment of viral hepatitis.
Recently new drugs for treating hepatitis C have been introduced. Patients who are infected or have contracted hepatitis B will receive a more definitive approach than those infected with hepatitis C alone. Some patients with cirrhosis may benefit from transplantation with good quality patient-survival rates.
The data collected from this study show that an individual from the general Indian population will need to carry a total of 9 drugs (5+1+3) a day to get treatment for NRTI. There are also other hurdles like cost to be overcome in the treatment of NRTI.
The incidence of chronic HCV in a family is associated with a high frequency of PDA. In particular, PDA in a boy with chronic HCV is likely to be caused by the interaction of the male X chromosome with the viral genome. Although gender predisposition alone cannot be considered enough to explain the high female to male HCV prevalence, we propose that it may be partly connected to HCV-related X chromosomal conditions, which may interact with gender and/or hepatitis C virus-related modifiers. To our knowledge, this report is the first to show genetic associations of PDA and HCV infection in an Indian population.
In this small study, we can show that soc only significantly improved liver enzymes, however, this improvement was neither significantly better nor worse than the control group. This is a new finding, and we need to explore this further before adopting the method at the general population. This method could prove useful at the beginning and for all the patients with chronic viral hepatitis.
Hepatitis is a spectrum of diseases with different causes and manifestations, varying from asymptomatic and subclinical to frank overt disease. Chronic hepatitis is a heterogeneous, complex, and often chronic disease with many possible causes. The main causative factors are viral (hepatitis B virus [HBV] and hepatitis C virus [HCV]), immunologic (such as with autoimmune hepatitis), and idiopathic. These factors cause hepatocellular carcinoma, hepatic fibrosis, and immune mediated hepatitis. Other causes include non-hepatic causes (chronic myelogenous leukemia, multiple sclerosis, thalassemia, sickle cell disease, and others).
Data from a recent study of this study show that social nrti may increase the risk of liver damage and death in HIV/HCV coinfectious patients.