Track topics on Twitter Track topics that are important to you
Hepatitis C is an important health problem in Myanmar affecting around 3% of the population. New drugs have been developed which have transformed the treatment of this disease around the world with very high success rates. Two of these drugs are now registered for use in Myanmar. In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be assessed and started on the new treatment. We will observe them and measure treatment effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug measurements to describe the effect of the drugs on patients in Myanmar in more detail.
Data concerning Hepatitis C virus (HCV) prevalence in Myanmar is scarce. Preliminary results of a survey, conducted in 2015 in different areas in Myanmar estimated a seroprevalence of HCV of around 2.65 %, which represents 1.3 million infected patients. Genotype 6 was mostly found in the northern cities and genotype 3 in the southern and western cities of Myanmar. However, treatment options for HCV in Myanmar remain limited currently, including for patients with HIV co-infection who are generally considered high priority given their increased risk for liver disease.
New direct acting antiviral therapies which can achieve high rates of sustained virological response (SVR) (>90%), defined as complete suppression of the virus 12 weeks after completion of antiviral therapy, are becoming increasingly available worldwide.
In Myanmar, in mid-2015, the guideline for the treatment of chronic hepatitis C infection of the Myanmar GI and Liver Society was revised in line with the recent development of Directly Acting Antiviral (DAA) drugs. This observational study will follow the recommendations for patient care presented in this guideline. Two hundred patients with chronic hepatitis C (100 with HIV co-infection) will be recruited in this observational study of routine care with two newly available antiviral drugs (sofosbuvir+ daclatasvir) in two different groups of patients (with and without HIV coinfection) at two centres in Yangon, Myanmar. Their response to treatment will be monitored. In addition a pharmacokinetic study is planned in a subset of patients to characterise any determinants of treatment response or tolerability in patients in Myanmar. This study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirements
Sofosbuvir 400 mg
Not yet recruiting
Myanmar Oxford Clinical Research Unit
Published on BioPortfolio: 2017-05-18T15:23:21-0400
The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral repl...
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no pa...
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluate...
The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previo...
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected pati...
There are limited data regarding the real world effectiveness of direct acting antivirals (DAA) for the therapy of chronic genotype 3 hepatitis C virus (HCV) infection. All HCV genotype 3 infected pat...
Few patients from developing countries can afford brand name direct-acting antiviral agents for treatment of hepatitis C virus (HCV) infection, and controversy regarding the bioequivalence of generics...
Reactivation of the hepatitis B virus (HBV) has been reported in patients with occult infection (OBI), i.e. HBV surface antigen (HBsAg) negative, HBV core antibody (anti-HBc) positive ± antibodies ag...
To assess the impact of treatment with ledipasvir/sofosbuvir (LDV/SOF) on the health-related quality of life (HRQL) of pediatric patients with chronic hepatitis C virus (HCV) infection.
A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.
INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).
A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).
A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.
INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...