Can patients with hepatitis C take Suboxone (buprenorphine/naloxone)?

Buprenorphine/Naloxone (Suboxone) Safety in Patients with Hepatitis C

Patients with hepatitis C can safely take Suboxone (buprenorphine/naloxone), though caution is warranted in those with moderate to severe hepatic impairment. 1, 2

Safety Profile in Hepatitis C Patients

• Buprenorphine/naloxone can be used in patients with hepatitis C who have normal liver function or mild hepatic impairment without significant dose adjustments 2
• No clinically significant drug interactions have been documented between buprenorphine and direct-acting antivirals (DAAs) used to treat hepatitis C 1
• Studies show that stabilization on buprenorphine may actually decrease the frequency of transaminase abnormalities associated with HCV in opioid-dependent individuals 3
• Long-term studies comparing short-term versus long-term buprenorphine/naloxone treatment in injection drug users found no significant difference in hepatotoxicity risk, suggesting most hepatic events during treatment are due to other factors rather than buprenorphine itself 4

Precautions Based on Hepatic Function

• For patients with moderate hepatic impairment (Child-Pugh B):

  • Buprenorphine/naloxone should be used with caution as naloxone exposure increases significantly (317.6% higher total exposure) 2
  • Buprenorphine exposure also increases moderately (163.9% higher total exposure) 2
  • Consider dose reduction and careful monitoring of liver function tests 2

• For patients with severe hepatic impairment (Child-Pugh C):

  • Buprenorphine/naloxone combination products should generally be avoided 2
  • Naloxone exposure increases dramatically (1401.9% higher total exposure) 2
  • Buprenorphine exposure increases substantially (281.4% higher total exposure) 2

Monitoring Recommendations

• Baseline liver function tests should be obtained before initiating therapy 3
• Regular monitoring of liver enzymes is recommended, particularly in the first few months of treatment 3
• Patients should be educated about signs of hepatotoxicity (jaundice, fatigue, abdominal pain, nausea) 5
• Consider more frequent monitoring in patients with:
  • Active HCV infection with detectable viral load 3
  • Concurrent use of other potentially hepatotoxic medications 1
  • History of elevated liver enzymes 3

Rare Cases of Hepatotoxicity

• There have been rare case reports of acute hepatitis attributed to buprenorphine at therapeutic doses in HCV-infected patients 6, 5
• These cases typically resolved with dose reduction or discontinuation 5
• The mechanism may involve mitochondrial toxicity in susceptible individuals 6
• Risk appears higher in those injecting crushed buprenorphine tablets rather than using them sublingually as prescribed 5

Clinical Decision-Making Algorithm

1. Assess hepatic function:

   • If normal or mild impairment: Standard dosing is appropriate 2
   • If moderate impairment: Use with caution, consider lower initial dose 2
   • If severe impairment: Generally avoid buprenorphine/naloxone combination; consider buprenorphine monotherapy if treatment is essential 2

2. Monitor liver function:

   • Baseline and follow-up testing at 4,8, and 12 weeks, then periodically 3
   • More frequent monitoring for patients with active HCV 3

3. If transaminase elevations occur:

   • <5× upper limit of normal: Continue treatment with close monitoring 3
   • ≥5× upper limit of normal: Consider dose reduction or temporary discontinuation 5

4. For patients receiving HCV treatment:

   • No significant interactions between buprenorphine and modern DAA regimens have been reported 1
   • Coordinate care between addiction and hepatitis treatment providers

Remember that untreated opioid use disorder poses significant risks, and the benefits of buprenorphine/naloxone therapy often outweigh potential hepatic risks in most patients with hepatitis C 4.