Summary of Changes from v.11.0 to v.11.1

The COVID-19 situation is rapidly changing, and evidence is constantly accumulating. Therefore, we refer to the regularly updated BHIVA, DAIG, EACS, GESIDA & Polish Scientific AIDS Society Statement on risk of COVID-19 for

ART section
  • Initial Combination Regimen for ART-naïve Adults
    • ABC should not be used for same day start
    • Precision that DOR has not been compared to an INSTI and was shown to be non-inferior to EFV and DRV
    • Specification that EFV should be used at 400 or 600 mg qd and that if rifampicin-based regimen for tuberculosis is used 600 mg must be used
    • DRV/r should be used with caution in persons with a high CVD risk 
  • Switch strategies for virologically suppressed persons
    • EVG/c and unboosted ATV have been removed from alternatives
    • Intermittent therapy remains a not recommended strategy, with new wording about QUATUOR
  • Virological failure
    • TDF and TAF can be used in association with 3TC or FTC if genotype shows only limited NRTI mutation(s)
    • EVG/c has been removed form alternatives
  • Treatment of pregnant women living with HIV or women considering pregnancy
    • New wording about DTG and neural tube defects
    • Reference to EVG/c has been removed
  • ART and TB co-infection
    • ATV/r and LPV/r have been removed from combinations to use with rifabutin
DDI section
  • The antiviral drugs molnupiravir, nirmatrelvir/ritonavir, sotrovimab and the immunosuppressant drug infliximab have been added to the COVID-19 drug interaction table
  • The antimycobacterial drugs linezolid and pretomanid have been implemented in the anti-tuberculosis drug interaction table. Furthermore, a footnote has been added for EFV to indicate that EFV should be dosed at 600 mg qd in presence of rifampicin but can be dosed at 400 mg or 600 mg qd in absence of rifampicin
  • All tables have been updated to include changes implemented in the HIV drug interaction website (University of Liverpool) in the past year
  • A footnote was notably added to the contraceptive table to indicate a higher risk of sub-therapeutic intramuscular medroxyprogesterone concentrations at week 12 in women with higher BMI on EFV treatment. Dosing medroxyprogesterone every 8-10 weeks in women with a higher BMI on EFV and particularly on EFV plus rifampicin prevent this risk
Co-morbidity section
  • The impact of comorbid mental health disorders on adherence to opiate substitution therapy and the use of fixed dose combination with naloxone to reduce risk of overdose with buprenorphine have been included in the Opioid Addiction, Pharmacological Treatment section
  • A new resource for information on cancer drug interactions has been added to the Cancer: Treatment monitoring section
  • Updated guidance on HBV, pneumococcal and SARS-CoV-2 vaccination
  • Updated guidance on management of varices
  • Updated guidance on nutrition of cirrhotic persons and management of hepatic encephalopathy
  • Updated dietary advice for the management of non-alcoholic fatty liver disease (NAFLD)
  • Updated guidance on management of Hepatorenal Syndrome - Acute Kidney Injury (HRS-AKI)
Viral Hepatitis Co-infections section
  • Hepatitis D and E infection:
    • Hepatitis D Virus:
      6. Bulevirtide (2mg/d s.c) in combination with TDF/TAF is recommended in HDV-RNA positive persons with compensated liver disease and should be used where available. The optimal duration of treatment remains unclear. Treatment should be performed in centers with sufficient experience
Opportunistic Infections and COVID-19 section
  • COVID-19 section has been extensively modified according to the updated evidences from literature
  • TB treatment guidelines have been reformulated according to the recently published updates from WHO
  • Results from a large clinical trial on treatment of cryptococcal meningitis in resource-limited settings have been added in the comments section of cryptococcal meningitis induction therapy
  • A comment on the results of a clinical trial investigating addition of miltefosine to amphotericin B for visceral leishmaniasis has been added
  • Recommendations for toxicity monitoring in TMP-SMX therapy have been added
  • Diagnostic recommendations for HSV and VZV infections have been reformulated
  • Recommendation for secondary prophylaxis discontinuation in CMV retinitis has been reformulated
  • Minor stylistic changes were made throughout the text
Paediatric HIV Treatment section
  • Relevant toxicities to paediatric/adolescent ART have been added in table 1
  • Minor edition in the other sections