Summary of Changes from v.11.1 to v.12.0

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 https://www.eacsociety.org/home/covid-19-and-hiv.html

ART section
  • Change the order of priority of the third drug associated with 2 NRTIs when starting ART: preferably a second generation INSTI or alternatively a PI/b 
  • Recommendations for Initiation of ART in persons with Chronic Infection without Prior ART Exposure
    • Threshold of HIV VL lowered to < 200 cp/ml in a possible exception to immediate start of ART 
  • Primary HIV Infection
    • Specify that the treatment should be a 3DR and that a 2DR is not recommended 
  • Switch Strategies for Virologically Suppressed Persons
    • New paragraph on injectable CAB/RPV
  • Virological Failure
    • Add lenacapavir to the therapeutic spectrum
  • Treatment of Pregnant Women Living with HIV or Women Considering Pregnancy
    • Change phrasing about breastfeeding which is now not recommended
    • ABC moved out from recommended regimens to alternative regimens
    • Deletion of the foot notes rising concerns about DTG and TAF during pregnancy 
  • ART in TB/HIV Co-infection
    • Add TAF in antiretroviral regimens in TB/HIV co-infection 
  • PEP
    • Lighten recommendation of PEP in case of receptive oral sex with ejaculation and not on PrEP or low PrEP adherence 
  • PrEP
    • Need of a fourth generation HIV test before starting PrEP
    • Recommendation of vaccination for all persons under PrEP
    • Suggestions to propose doxycycline PEP on a case by case basis
    • New paragraph on the different drugs available for PrEP
    • Precision about population with the highest risk of adverse renal outcomes under PrEP
    • New paragraph on PrEP to PEP transition with specification of what is defined as low adherence 
DDI section
  • The section on long-acting cabotegravir and rilpivirine has been expanded to indicate factors that can potentially impact the drug release from the depot and factors that can increase the risk of virologic failure. The section includes also dosing recommendations in case of missed injections 
  • The capsid inhibitor lenacapavir administered subcutaneously every 6 months in combination with other antiretrovirals has been added to all DDI tables 
  • A novel table has been added for DDI between antiretrovirals and anti-infective drugs for opportunistic infections and sexually transmitted infections
  • All DDI tables have been updated to include changes implemented in the HIV drug interaction website (University of Liverpool) in the past year 
  • A novel resource has been added for drug classes to deprescribe in older person with HIV in presence of certain conditions
Co-morbidity section
  • A new section on the use of Patient Reported Outcome Measures has been added 
  • A new section on alcohol use has been added
  • Updated guidance on the management of cognitive and central nervous system symptoms in persons with HIV 
  • Updated guidance to the travel section 
  • Updated guidance on management of sexual and reproductive health 
  • Updated guidance on management of type 2 diabetes mellitus 
  • Updates to cancer screening including anal cancer are included 
  • Updates on deprescribing in persons with HIV are included 
  • Updated guidance on managing chronic lung disease 
Viral Hepatitis Co-infections section
  • Screening for complications 
    • HCC screening recommendations have been updated with special regard to validation of PAGE-B-score in persons with HIV
    • For Hepatitis B vaccination the use of the more immunogenic vaccination Heplisav B should be considered where available with the aim to potentially reach better responses
  • Treatment and Monitoring of Persons with HBV/HIV Co-infection 
    • Caution is warranted when switching from a TDF/TAF-based regimen to drugs with a lower genetic barrier, e.g. FTC or 3TC, and persons with HIV with isolated Anti-HBc concerning viral breakthrough or relapse of HBV. Transaminases and HBV-DNA should be checked regularly 
  • Management of Recently Acquired HCV Infection 
    • The algorithm for the management of acute HCV-infection has been removed as current guidelines recommend immediate treatment of all persons with HIV with recently acquired HCV
Opportunistic Infections and COVID-19 section
  • A section on clinical features and treatment of Mpox has been added 
  • COVID-19 section has been extensively modified according to the updated evidences from literature 
  • TMP-SMX has been moved from “alterative” to additional “preferred” 
  • treatment in toxoplasmic encephalitis. In addition, considerations on diagnostic value of toxoplasma PCR in CSF and corticosteroids use in the context of large lesions with mass effect have been added 
  • WHO-recommended single-dose liposomal amphotericin B+fluconazole regimen has been added as additional “preferred” regimen in resource limited settings for the treatment of cryptococcal meningitis. In addition, recommendations on primary prophylaxis have been reformulated 
  • Liposomal amphotericin B+miltefosine has been added as alterative regimen for the treatment of visceral leishmaniasis 
  • Recommendations on the ART initiation in the context of TB and crypto-coccal meningitis have been reformulated 
  • Hyperlinks to the table describing drug-drug interactions between selected anti-infective agents and ART have been added 
  • A comment on desensitization in the context of non-severe TMP-SMX allergy has been added 
  • Minor stylistic changes and rephrasing were made throughout the text 
Paediatric HIV Treatment section
  • Updated table 1 “Preferred and Alternative First Line Options in Children and Adolescents” to include the most recent treatment options for children 
  • Removed table 2: Antiretroviral Formulations Useful for Paediatric and Adolescent Dosing and Administration due to redundancy 
  • Added section on “General principles of postnatal prophylaxis and infant feeding” 
  • Minor edits in the other sections