What are the considerations for using Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) in patients with liver failure?

From the Guidelines

Biktarvy should be used with caution in patients with liver failure, and its use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). When considering the use of Biktarvy in patients with liver failure, it is essential to weigh the potential benefits against the risks, particularly in those with severe hepatic impairment.

• The components of Biktarvy, including bictegravir, emtricitabine, and tenofovir alafenamide, undergo hepatic metabolism to some degree, which may impact liver function in patients with pre-existing liver disease 1.
• Patients with chronic hepatitis B virus (HBV) infection are at increased risk of liver function abnormalities during antiretroviral therapy and should be monitored according to standard practice 1.
• The European Association for the Study of the Liver (EASL) recommends that nucleos(t)ide analogs (NAs) with a high barrier to resistance, such as tenofovir alafenamide, be used in patients with decompensated liver disease or liver transplants 1.
• In patients with HBV coinfection, close monitoring for at least several months after stopping Biktarvy is necessary due to the risk of serious acute exacerbations of hepatitis B when emtricitabine or tenofovir-containing products are discontinued 1.
• Liver function should be monitored before and during treatment with Biktarvy, and temporary interruption or discontinuation of treatment may be necessary if worsening liver disease is evident 1.

From the FDA Drug Label

BIKTARVY is not recommended in patients with severe hepatic impairment. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing FTC and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY Patients coinfected with HIV-1 and HBV who discontinue BIKTARVY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment

Considerations for using Biktarvy in patients with liver failure:

• BIKTARVY is not recommended in patients with severe hepatic impairment.
• Patients with liver failure should be closely monitored for signs of hepatitis B exacerbation if they are coinfected with HIV-1 and HBV.
• If appropriate, anti-hepatitis B therapy may be warranted in patients with advanced liver disease or cirrhosis. 2 2 2

From the Research

Considerations for Using Biktarvy in Patients with Liver Failure

• The use of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) in patients with liver failure requires careful consideration of the potential risks and benefits.
• According to a study published in Xenobiotica 3, bictegravir is primarily eliminated by hepatic metabolism, followed by excretion of the biotransformed products into feces.
• However, there is limited information available on the use of Biktarvy in patients with liver failure.
• A study published in Viruses 4 found that switching to a bictegravir-based regimen was associated with a significant reduction in liver steatosis, as assessed by Fibroscan, in patients with HIV.
• Another study published in PloS one 5 found that bictegravir/emtricitabine/tenofovir alafenamide was effective and well-tolerated in treatment-naive and treatment-experienced patients with HIV, but did not specifically address the use of the regimen in patients with liver failure.
• A study published in Clinical infectious diseases 6 found that switching to bictegravir/emtricitabine/tenofovir alafenamide was safe and effective in virologically suppressed adults with HIV, but did not address the use of the regimen in patients with liver failure.
• A study published in HIV medicine 7 found that bictegravir/emtricitabine/tenofovir alafenamide was effective and well-tolerated in patients with HIV and end-stage kidney disease on hemodialysis, but did not address the use of the regimen in patients with liver failure.

Key Findings

• Bictegravir is primarily eliminated by hepatic metabolism, followed by excretion of the biotransformed products into feces 3.
• Switching to a bictegravir-based regimen may be associated with a reduction in liver steatosis 4.
• Bictegravir/emtricitabine/tenofovir alafenamide is effective and well-tolerated in treatment-naive and treatment-experienced patients with HIV 5.
• Switching to bictegravir/emtricitabine/tenofovir alafenamide is safe and effective in virologically suppressed adults with HIV 6.

Implications for Clinical Practice

• Healthcare providers should carefully consider the potential risks and benefits of using Biktarvy in patients with liver failure.
• Patients with liver failure should be closely monitored for adverse effects and changes in liver function while taking Biktarvy.
• Further studies are needed to fully understand the safety and efficacy of Biktarvy in patients with liver failure.