A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.

Time frame: Up to 5-year FU period

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of \>10 x upper limit of normal (ULN).

Time frame: Up to 5-year FU period

Population: The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.

Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter\[g/L\]), White blood cells (WBC) (3.0-18.0 \^10\^9/L), Platelets (100-550 \^10\^9/L), Neutrophils (1.50-9.25 \^10\^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter \[U/L\]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter \[umol/L\]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter \[mmol/L\]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430

Time frame: Up to 5-year FU period

Population: The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.

HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

The percentage of participants with HBV-DNA suppression \< 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

The percentage of participants with HBV-DNA suppression \< 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

The percentage of participants with HBV-DNA suppression \< 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.

Time frame: Annually, for up to 5 years

Population: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.