الفهرس 
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Abstract
Nowadays, it has been proved that HBV pregenomic RNA (pgRNA) is also exist in serum; the relevance of pgRNA as a biomarker during CHB infection is now under research. The capability of HBV to maintain chronic infection is because of the existence of cccDNA which acts as template for HBV RNAs, including pgRNA and mRNAs. (65)
Serum Pregenomic RNA (pgRNA) is a new biomarker of chronic hepatitis B. While it is considered the main primer for viral particles and DNAs, additional new functions for it have recently been discovered. These results extend for pgRNA roles in HBV replication cycle. Here, we focus on the role of HBV pgRNA in directing antiviral treatment including nucleot(s)ide analogues and as a marker of hepatitis activity. (70)
The aim of our research was to assess serum hepatitis B pregenomic RNA in patients with: low viremia (HBV PCR less than 2000 IU/ml) to identify new criteria for treatment of those patients and high viremia (HBV PCR more than 2000 IU/ml) to determine new treatment endpoints.
All patients in our study were subjected to:
I. Detailed history and thorough clinical examination.
II. Laboratory investigations including:
1. Routine laboratory investigations and liver functions tests (CBC, ALT, AST, ALP, PT, INR, bilirubin, direct bilirubin, serum albumin, serum creatinine and blood urea).
2. Hepatitis B specific investigations (HBsAg, HBeAg, anti HBc IgG) were performed.
3. HBV pregenomic RNA, HBV DNA were measured and calculated at the time of diagnosis in patients of group A, before the beginning of treatment and after six months of entecavir treatment in patients of group B.
4. Noninvasive liver fibrosis activity markers: FIB 4 Score (Age xAST/Plateletx √ALT), APRI [(AST/(ULN) AST x100] /Platelet Count, AST/ALT and Age/PLT. were measured and calculated at the time of diagnosis in patients of group A, before the beginning of treatment and after six months of entecavir treatment in patients of group B.
III. Radiological studies: Ultrasound abdomen and pelvis was done to exclude cirrhosis and portal hypertension.
Statistical analysis of the data obtained from the present study revealed the following results:
HBV DNA and HBV pregenomic RNA were higher for group B before treatment than group A (P<0.001). Moreover, APRI and FIB 4 score were higher for group B before treatment than group A (P<0.001).
HBV pregenomic RNA values were significantly lower after 6 months of treatment than in pretreatment values (p <0.001). Furthermore, ALT, AST, FIB 4 score and APRI were significantly lower after 6 months of treatment than pretreatment values (p< 0.001). As regard HBV DNA, after 6 months of follow up; 35 patients had undetectable HBV DNA while 5 patients had detectable values.
In group B, after 6 months of treatment, 35 patients showed undetectable levels of HBV DNA, with median pregenomic RNA = 11000 IU /ml, whereas 5 patients showed detectable levels of HBV DNA, the median HBV pregenomic RNA was 20000 IU/ml. Although the median of HBV pregenomic RNA was lower in HBV DNA negative patients than that of HBV DNA positive patients, but it was statistically insignificant (P=0.183).
In group A, there was statistically significant positive correlation among HBV pregenomic RNA and DNA (P=0.001).Meanwhile there was insignificant relation between hepatitis B pregenomic RNA and other noninvasive markers; FIB4, APRI (P=0.156, 0.075 respectively).
In group B, before the start of therapy, there was statistically significant positive correlation among HBV pregenomic RNA and DNA (P<0.001).Meanwhile there was insignificant relation between hepatitis B pregenomic RNA and the other noninvasive markers; FIB4, APRI (P=0.810, 0.732 respectively).
The sensitivity and specificity of hepatitis B pregenomic RNA to predict the disease activity (virological activity) showed that at cut off value of 4000 of hepatitis B pregenomic RNA (Iu/ml), the area under the curve was 0.999, The sensitivity , NPV 100% ,specificity , PPV 97.5 and accuracy was 98.75%