Monitoring of patients receiving interferon therapy for the treatment of hepatitis D virus infection

Assessment point	Laboratory tests
Baseline*	CBC with differential (including platelet count) Hepatic panel^¶, creatinine, glucose INR TSH Serum HDV RNA Serum HBV DNA Serum HBeAg and anti-HBe^Δ Serum HBsAg^◊ Pregnancy test^§
Week 4	CBC with differential (including platelet count) Hepatic panel^¶ INR
Week 12	CBC with differential (including platelet count) Hepatic panel^¶ INR Pregnancy test^§ Serum HDV RNA (optional) Serum HBV DNA (optional)
Week 24	CBC with differential (including platelet count) Hepatic panel^¶, creatinine, glucose INR Serum HDV RNA Serum HBV DNA Serum HBeAg and anti-HBe^Δ Serum HBsAg (quantitative), if available^¥ TSH Pregnancy test^§
Week 48	CBC with differential (including platelet count) Hepatic panel^¶, creatinine, glucose Serum HDV RNA Serum HBV DNA Serum HBeAg and anti-HBe^Δ Serum HBsAg^◊ TSH Pregnancy test^§
Week 12 post-treatment	CBC with differential (including platelet count) Hepatic panel^¶ INR Serum HDV RNA (optional) Serum HBV DNA (optional)
Week 24 post-treatment	CBC with differential (including platelet count) Hepatic panel^¶, creatinine, glucose Serum HDV RNA Serum HBV DNA Serum HBeAg and anti-HBe^Δ TSH Pregnancy test^§
Week 48 post-treatment	CBC with differential (including platelet count) Hepatic panel^¶, creatinine, glucose Serum HDV RNA Serum HBV DNA Serum HBeAg and anti-HBe^Δ Serum HBsAg^◊ TSH Pregnancy test^§

This table focuses on monitoring patients who are receiving interferon treatment for HDV. More detailed information on monitoring response to treatment for HBV is presented separately.

CBC: complete blood count; INR: international normalized ratio; TSH: thyroid-stimulating hormone; HDV: hepatitis D virus; HBV: hepatitis B virus; HBeAg: hepatitis B e antigen; anti-HBe: hepatitis B e antibody; HBsAg: hepatitis B surface antigen; ALT: alanine aminotransferase; AST: aspartate aminotransferase.

* Prior to initiating therapy, noninvasive test for liver stiffness or a liver biopsy should be performed to assess for the presence of fibrosis and cirrhosis. In persons with advanced fibrosis or cirrhosis, liver ultrasound should be repeated at week 24 and every 6 months thereafter to evaluate for hepatocellular carcinoma. Elastography may be repeated every 2-3 years to assess for progression/regression.

¶ Hepatic panel includes: ALT, AST, albumin, bilirubin, and alkaline phosphatase.

Δ Only for patients who are HBeAg-positive at baseline.

◊ Quantitative HBsAg should be performed, if available. Quantitative HBsAg should be performed at baseline, week 24 and 48 of treatment, and week 48 post-treatment. If only qualitative HBsAg testing is available, it should be performed at baseline and then repeated at week 48 of treatment and week 48 post-treatment if HBV DNA becomes undetectable.

§ Only for persons of childbearing potential.

¥ This can be used to assess utility of continued therapy.

Graphic 141098 Version 1.0

خرید پکیج

Monitoring of patients receiving interferon therapy for the treatment of hepatitis D virus infection