Summary of Changes from v12.0 to v12.1

• Assessment of Initial & Subsequent Visits
  • CD4 T-cell count and HIV should be monitored every 3 to 12 months
  • STIs should be screened every 3 to 12 months depending on exposure risk
• Initial Regimens
  • ABC and RAL containing regimens moved from recommended regimens to alternative regimens 
• Primary HIV Infection
  • In case of PHI in the context of LA CAB PrEP, a DRV/b regimen should be immediately started until resistance test is available 
• Switch Strategies for Virologically Suppressed Persons
  • It is possible to switch to BIC or DTG containing regimens even without full activity of 2 NRTIs
  • Recent data suggest possible use of CAB/RPV dual therapy in persons with A1 subtype
• Virological Failure
  • Lenacapavir and Maraviroc are key in the therapeutic spectrum
• Treatment of Pregnant Women Living with HIV or Women Considering Pregnancy
  • RAL containing regimens moved from recommended regimens to alternative regimens
  • BIC/TAF/FTC qd is now an alternative regimen in case of pregnancy
• ART in TB/HIV Co-infection
  • TXF/XTC + DTG bid moved to recommended regimens
• PEP
  • In case of contact > 15 min of mucous membrane or non-intact skin, PEP is recommended only if the source person is a viraemic HIV-positive person or with serostatus unknown
• PrEP
  • Documented negative fourth generation HIV test can be done a week prior or on the day PrEP is initiated 
  • Long-acting cabotegravir can be considered if available as an alternative to TXF/FTC. The effectiveness of LA-CAB has been evaluated in comparison to daily TDF/FTC in men, transgender women and women
  • In all populations and all regimens PrEP should start with two tablets taken together as this achieves highly effective levels in all compartments 2 hours later
  • For men on on demand PrEP, low adherence leading to PEP has been changed to non-compliance with 2-1-1 scheme

• All DDI tables have been updated to include changes implemented in the HIV drug interaction website (University of Liverpool) in the past year. Apixaban was notably changed from red to amber with boosted ARV as the US label and real-life reports suggest that Apixaban can be used at a redused dose with strong inhibitors. A QT interval prolongation risk was added for EFV to align with the label recommendation. EFV was shown to prolong the QT interval above the regulatory threshold of concern in homozygous carriers of the CYP2B6*6/*6 allele (516T variant).
  
• The administration of ARV in persons with swallowing difficulties was updated for TAF/FTC/BIC, TAF/FTC/EVGc, ABC/3TC/DTG and 3TC/DTG.

Section 4 - Treatment and prevention of other infections

This section now encompasses the recommendations on: Viral Hepatitis Co-infection, Oppotunistic infections & other Co-infections, Sexually transmitted infection, and Immunisation in PWH.

• Additional guidance on HCV post-treatment monitoring in settings where liver stiffness measurement is available was provided
• Recommendations for HDV treatment have been updated according to recently released EASL guidelines

• Results from a recently published clinical trial on the use of corticosteroids in TB meningitis have been discussed (N Engl J Med 2023;389:1357-1367). No modifications have been made on the recommendation to use corticosteroids as adjunctive therapy in this setting
• The amphotericin B deoxycholate-based regimen has been removed from treatment options in cryptococcal meningitis, prioritizing the single-dose liposomal amphotericin B (L-AMB)-based regimen in resource-limited settings and the 2 weeks liposomal amphotericin B (L-AMB) + flucytosine regimen in high-resource settings. Recommendations on alternative regimens in case of (L-AMB) or flucytosine unavailability have been edited
• Therapeutic considerations on Mpox have been modified and reformulated, waiting results from ongoing clinical trials
• The possibility to use alternative all-oral regimens for MDR-TB treatment in persons/groups not eligible to BPaLM has been added, in accordance with recently released WHO recommendations
• Recommendations for treatment of latent tuberculosis have been edited, prioritizing once weekly rifapentine+isoniazid regimen as treatment choice if rifapentine is available
• Recommendations on IRIS prevention and management in cryptococcal meningitis and TB have been edited
• A comment on the possible use of foscarnet in HSV and VZV infections has been added
• Section on COVID-19 has been edited

• Wording of prophylaxis for bacterial STIs was updated taken into consideration the latest evidence suggesting a lower effectiveness of Doxy-PEP against gonorrhoea
• Indication to consider CSF examination in isolated late-latent syphilis was removed

• Added additional guidance on Hepatitis B status and immunity in the context of ART selection
• Added information on PEP outside the neonatal period
• Updated table 1 “Preferred and Alternative First Line Options in Children and Adolescents” to include the most recent treatment options for children and the newest licensing and formulation information
• Minor edits in the other sections

• A new section on ChemSex has been introduced
• Cardiovascular and Metabolic Health:
  • Guidance on the primary prevention of cardiovascular disease has been updated in line with the EACS "Interim Guidance on the Use of Statin Therapy for the Primary Prevention of Cardiovascular Disease in People with HIV"
  • The algorithms for the management of hypertension and dyslipidaemia have been updated
• Within the Cancer section:
  • anal cancer screening is recommended for MSM and trans women (TW) aged > 35 years, men who have sex with women (MSW) and cis-women (CisW) aged >45 years. The recommended screening interval is 1 year or up to 2 years if both cytology and high-risk HPV or HPV16 are negative
  • cervical cancer screening interval has been revised to 1 year (or every 3 years if 3 consecutive negative PAP and CD4 ≥ 350/µl and HIV-RNA <200 cp/ml or, in women>30 years, 1 negative PAP/HPV co-testing)
• The nomenclature of metabolic dysfunction-associated steatotic liver-disease (MASLD) has been introduced to replace non-alcoholic fatty liver disease
• Within the Liver Cirrhosis: Management section, HCC screening guidance has been updated to recommend HCC screening for all people with cirrhosis, regardless of the cause of cirrhosis. This also applies to people with cured HCV infection and/or with medically suppressed HBV replication
• Regarding the surveillance algorithm for upper gastrointestinal tract endoscopy it has been clarified that the Baveno VII recommendations only apply to patients with Child-Pugh A cirrhosis. People with Child-Pugh B and C cirrhosis should undergo annual gastroscopy independently of the Baveno VII criteria
• In the Work-up and Management of Persons with Increased ALT/AST, excluding syphilis as a potential cause has been included
• An overarching bone health section has been introduced, that incorporates the existing Bone Disease: Screening and Diagnosis, Vitamin D Deficiency: Diagnosis and Management and Approach to Fracture Reduction sections
• In the Travel section, online resources www.hivtravel.org or https://visaguide.world/news/countries-with-visa-restrictions-for-people-living-with-hiv/ have been included