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Hepatitis B Virus and HIV Coinfection: Results of a Survey on Treatment Practices and Recommendations for Therapy

Hepatitis B
Virus Image
HIV 3-D Image

As new therapies have become available that can treat both hepatitis B virus (HBV) infection and HIV infection, various consensus panels have updated or published new treatment guidelines for HIV-HBV coinfected patients. The inconsistencies among the different sets of guidelines and the increasing use of tenofovir (Viread) off-label for the treatment of HBV infection is a reflection of the complexities involved in treating such individuals.

There are few data evaluating the use of the various sets of guidelines by practicing clinicians. To address this important issue, Dr. Paul Gaglio and colleagues of the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) Hepatitis Working Group conducted a survey on how clinicians "in the real world" are managing HIV-HBV coinfected patients.

The survey was sent to providers in CPCRA network, a federally funded, national network of community-based clinical treatment centers. These sites are comprised of geographically diverse facilities that include community clinics, academic and federal hospital outpatient practices, and the offices of private physicians.

The survey sought to define various issues regarding HIV-HBV coinfection, including the following:

Screening for HBV infection and hepatocellular carcinoma;
Initiation or discontinuation of anti-HBV therapy;
Requirement for liver biopsy;
Threshold for HBV viremia (viral load) to initiate therapy;
Differences in treatment recommendations regarding hepatitis B "e" antigen-positive versus "e" antigen-negative HBV infection;
Treatment choices for HBV infection in patients receiving or not receiving concurrent anti-HIV therapy.

Following is a summary of the survey results, which appear in the September 1, 2007 issue of Clinical Infectious Diseases [1].

Results

Of 161 sites, 78 completed the survey (a response rate of 48.4%).
86% vaccinated HIV-infected patients who were not immune to HBV infection.
98.7% screened patients for HBV infection and 91% for hepatocellular carcinoma.
79% made treatment decisions without referral to a hepatologist or gastroenterologist.
42% of the sites initiated therapy when patients' ALT and AST levels were elevated and HBV DNA level was >105 copies/mL.
49% of the sites initiated therapy in the presence of any detectable HBV DNA level.
Antiviral treatment choices for patients who were not concurrently receiving antiretroviral therapy were lamivudine (Epivir-HBV) plus tenofovir (Viread), adefovir (Hepsera), or interferon.
Patients concurrently receiving antiretroviral therapy received lamivudine plus tenofovir preferentially, followed by tenofovir plus emtricitabine (Emtriva), adefovir, or interferon.
The survey did not include entecavir (Baraclude) or telbivudine (Tyzeka) as therapeutic options for HBV-infected patient, because the survey preceded approval of these drugs.
Decisions regarding the performance of liver biopsy, threshold to initiate therapy, and criteria to discontinue therapy varied, reflecting inconsistencies in available treatment guidelines.
Treatment decisions reflected concerns regarding future drug resistance in patients who are naive to antiretroviral therapy and the emergence of drug resistance in patients receiving antiretroviral therapy.
The vast majority of participants in the survey recommended therapy for patients with "wild type" ("e" antigen-positive) HBV infection, abnormal liver enzyme levels, and an HBV DNA level >105 copies/mL, as well as for HBV "e" antigen-negative patients with abnormal liver enzyme levels and an HBV DNA level >104 copies/mL, in accordance with recently published guidelines for HBV-monoinfected patients [2].

After reviewing and assessing the survey responses, the study authors formulated recommendations that included the following:

Future consensus conferences on coinfection with HBV and HIV should make recommendations that address issues regarding requirement for liver biopsy and the threshold of HIV DNA level to initiate therapy, and to clearly define when HBV therapy can be discontinued in coinfected patients.
All patients with detectable HBV DNA arguably should be treated.
Patients coinfected with HBV and HIV who are not receiving antiretroviral therapy and are not anticipated to require antiretroviral therapy in the near future should be treated with an anti-HBV drugs that do not target HIV infection or that are dosed in a manner that does not affect HIV replication (i.e., interferon, adefovir, or entecavir). [NOTE: recent data suggest that entecavir is in fact active against HIV, and guidelines have recently been revised to state that entecavir should not be used in such patients.
Coinfected patients receiving antiretroviral therapy should receive therapies that are effective against both viruses; lamivudine plus tenofovir or emtricitabine plus tenofovir are potential choices.
Effective therapy against HBV infection should not be discontinued unless another drug with activity against HBV infection is substituted or the patient has achieved seroconversion from HBV surface antigen to surface antibody.

Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; Divisions of Gastroenterology, Hepatology, and Infectious Diseases, Virginia Commonwealth University School of Medicine, Richmond; Social and Scientific Systems, Silver Springs, Maryland; and Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania.

08/10/07

References

1. P J Gaglio, R Sterling, E Daniels, and others (for the Terry Beirn Community Programs for Clinical Research on AIDS Hepatitis Working Group). Hepatitis B Virus and HIV Coinfection: Results of a Survey on Treatment Practices and Recommendations for Therapy. Clinical Infectious Diseases 45(5): 618-623. September 1, 2007.

2. E B Keeffe, D T Dieterich, S H Han, and others. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: an update. Clinical Gastroenterology and Hepatology 4: 936-962. 2006.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA-approved
Monotherapies for HBV

Baraclude
  (entecavir)
 Epivir-HBV
  (lamivudine; 3TC)
Intron A
  (interferon alfa-2b)
Hepsera
  (adefovir dipivoxil)
Pegasys
  (peginterferon alfa-2a)
Tyzeka
  (telbivudine)

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