Appendix C. Detail on criteria for audit of the use of adefovir dipivoxil and peginterferon alfa-2a for chronic hepatitis B

Appendix C. Detail on criteria for audit of the use of adefovir dipivoxil and peginterferon alfa-2a for chronic hepatitis B

Possible objectives for an audit

An audit could be carried out to ensure that adefovir dipivoxil and peginterferon alfa-2a are being used appropriately for the treatment of people with chronic hepatitis B.

Possible patients to be included in the audit

An audit could be carried out on a reasonable number of people being treated for chronic hepatitis B, for audit purposes, for example, patients seen over 6 months, excluding people with chronic hepatitis B who are known to be co-infected with hepatitis C, hepatitis D or HIV.

Measures that could be used as a basis for an audit

The measures that could be used in an audit of adefovir dipivoxil and peginterferon alfa-2a for chronic hepatitis B are as follows.

Criterion

Standard

Exception

Definition of terms

A. For an adult with chronic hepatitis B (HBeAg-positive or -negative), peginterferon alfa-2a is considered as an option for initial treatment in accordance with its licensed indications

100% of adults with chronic hepatitis B (HBeAg-positive or -negative)

A. The person has a contra-indication to peginter-feron alfa-2a

Clinicians will need to agree locally on how consideration of the options for treatment is documented for audit purposes.

A contraindication is decompensated cirrhosis of the liver. See the 'Summary of product characteristics' for details of contraindications.

2. For an adult with chronic hepatitis B (HBeAg-positive or -negative), adefovir dipivoxil is considered as an option for treatment, in accordance with its licensed indications, if:

a. treatment with interferon alfa or peginterferon alfa-2a has been unsuccessful or

b. a relapse occurs after successful initial treatment or

c. interferon alfa or peginterferon alfa-2a is poorly tolerated or contraindicated

100% of adults with chronic hepatitis B (HBeAg-positive or -negative) who meet any of 2a–2c

B. The person has a contra-indication to adefovir dipivoxil

Clinicians will need to agree locally on the sources of evidence for 2a–c and how consideration of the options for treatment is documented for audit purposes.

'Interferon alfa' includes interferon alfa-2a or -2b.

'Successful' treatment is considered to be treatment that leads to HBeAG seroconversion (in the case of HBeAg-positive disease) or an adequate reduction in viral load (in the case of HBeAg-negative disease). Clinicians will need to agree locally on how success of treatment is assessed, and how relapse after initial treatment and tolerance to adverse effects are documented for audit purposes.

See the 'Summary of product characteristics' for details of contraindications.

3. Adefovir dipivoxil is given before treatment with lamivudine

0% of people with chronic hepatitis B for whom initial treatment options are being considered

C. There is a clinical justification for treating with adefovir dipivoxil before lamivudine

Clinicians will need to agree locally on clinical justifications for treating people with chronic hepatitis B with adefovir dipivoxil before lamivudine.

4. Adefovir dipivoxil is used either alone or in combination with lamivudine in either of the following circumstances:

a. treatment with lamivudine has resulted in viral resistance or

b. lamivudine resistance is likely to occur rapidly and development of lamivudine resistance is likely to have an adverse outcome

100% of the people with chronic hepatitis B for whom adefovir dipivoxil is being prescribed

None

Clinicians will need to agree locally on how treatment with lamivudine resulting in viral resistance and adverse outcomes are documented for audit purposes.

An example of lamivudine resistance being likely to occur rapidly is the presence of highly replicative hepatitis B disease.

An example of an adverse outcome is a flare of the infection that is likely to precipitate decompensated liver disease.

5. Drug treatment with peginterferon alfa-2a and adefovir dipivoxil is initiated by an appropriately qualified healthcare professional with expertise in the management of viral hepatitis

100% of people with chronic hepatitis B for whom peginterferon alfa-2a or adefovir dipivoxil is prescribed

None

Clinicians will need to agree locally on the definition of an appropriately qualified healthcare professional with expertise in the management of viral hepatitis, for audit purposes.

Calculation of compliance

Compliance (%) with each measure described in the table above is calculated as follows.

Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed

x 100

Number of patients to whom the measure applies

Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.