What Antiretroviral Therapy (ART) regimen is optimal for patients coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV)?

From the Guidelines

The optimal ART regimen for HIV and HBV coinfected patients typically includes tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) as the nucleoside reverse transcriptase inhibitor (NRTI) backbone, combined with a third antiretroviral agent. A recommended regimen would be:

• TDF 300 mg or TAF 25 mg once daily
• FTC 200 mg once daily
• Plus one of the following:
  • Dolutegravir 50 mg once daily
  • Bictegravir 50 mg once daily (as part of a single-tablet regimen)
  • Raltegravir 400 mg twice daily This regimen is effective because:

1. TDF/TAF and FTC are active against both HIV and HBV, as supported by the 2020 recommendations of the International Antiviral Society-USA panel 1.
2. The third agent (an integrase inhibitor) provides potent HIV suppression.
3. This combination reduces the risk of developing drug resistance in both viruses. It's crucial to never discontinue the HBV-active drugs (TDF/TAF and FTC) without close monitoring, as this can lead to severe HBV flares, as noted in the 2018 recommendations of the International Antiviral Society-USA panel 1. Patients should be counseled on adherence and the importance of regular follow-up for both HIV and HBV monitoring. Liver function tests and HBV viral load should be checked periodically to assess treatment response and detect any hepatic complications, in line with the guidelines from the Journal of Hepatology 1.

Key considerations in managing HIV and HBV coinfected patients include:

• The use of TDF or TAF in combination with lamivudine or emtricitabine, and a third component, as recommended by the 2016 International Antiviral Society-USA panel 1.
• The importance of not switching to a regimen that excludes TDF or TAF without alternative HBV suppressive therapy, as advised in the 2020 recommendations 1.
• Regular monitoring for toxicity, particularly renal and bone toxicity, and adjusting the regimen as necessary, as suggested in the 2018 guidelines 1.

Overall, the choice of ART regimen for HIV and HBV coinfected patients should prioritize the use of TDF or TAF, along with emtricitabine, and a third antiretroviral agent, to effectively manage both infections and minimize the risk of drug resistance and hepatic complications, as supported by the most recent and highest quality evidence 1.

From the FDA Drug Label

1. 3 Patients Coinfected with HIV-1 and HBV Due to the risk of development of HIV-1 resistance, tenofovir disoproxil fumarate should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.

The optimal Antiretroviral Therapy (ART) regimen for patients coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) is a combination regimen that includes tenofovir disoproxil fumarate, as it is effective against both HIV and HBV.

• The regimen should be chosen based on the individual patient's needs and medical history.
• It is essential to test all patients for HIV-1 and HBV before initiating therapy with tenofovir disoproxil fumarate.
• Patients coinfected with HIV and HBV should be closely monitored for signs of liver disease and renal impairment. 2

From the Research

Optimal Antiretroviral Therapy (ART) Regimen for HIV and HBV Coinfection

The optimal ART regimen for patients coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) is a combination of antiretroviral drugs that have dual activity against both viruses.

• The combination of tenofovir disoproxil fumarate (TDF), lamivudine (3TC), and efavirenz (EFV) has been shown to be safe and effective in treating HIV/HBV coinfected patients, with 71% of patients achieving undetectable HBV DNA levels and 90% achieving undetectable HIV RNA levels by week 48 3.
• Other studies have also demonstrated the efficacy of combination ART regimens containing TDF, emtricitabine (FTC), and EFV in treating HIV/HBV coinfected patients, with significant reductions in HBV DNA and HIV RNA levels 4.
• The use of antiretroviral drugs with anti-HBV activity, such as emtricitabine, lamivudine, TDF, and tenofovir alafenamide, is recommended for patients with HIV/HBV coinfection 5, 6.
• A recent study compared the efficacy of bictegravir, emtricitabine, and tenofovir alafenamide with dolutegravir, emtricitabine, and TDF in treating HIV-1 and HBV coinfection, and found that both regimens were effective in suppressing HIV-1 RNA and HBV DNA levels, with the bictegravir-based regimen being non-inferior to the dolutegravir-based regimen 7.

Key Considerations

• The choice of ART regimen for HIV/HBV coinfected patients should be based on the individual patient's needs and medical history, as well as the potential for drug interactions and side effects.
• Patients with HIV/HBV coinfection should be screened for HBV infection and monitored for liver function and HBV DNA levels during ART treatment.
• The development of new drugs with dual activity against HBV and HIV is necessary to address the limitations of current treatments, including drug resistance and side effects 5.