1. Management of ART in Albania : From the European Guidelines to the real practice. Arjan Harxhi MD, MSc, PhD University Hospital Center of Tirana Mother Theresa, Albania

2. Instead of introduction: Globally, HIV medicine is considered the most dynamic field of medicine A lot of evidence-based documents and guidelines: feasibility & sustainability in the local context Application of EACS guidelines in the context of constrained resources

3. Initial assessment and follow-up Medical history & PE - yes Laboratory evaluation –HIV antibody - yes –HIV RNA – not always available –CD4 count – yes (recently) –Resistance testing – not available –Clinical bio-chemistry –yes –Serology (CMV, Toxo, hepatitis, syphilis) - yes

4. Initial assessment and follow-up HLA B*5701 – not available (ABC ?) STI screen – not routinely Pap smear – not available at the clinic Psychological support – yes Pneumococcal vaccination - no

5. ARVs available in Albania N(t)RTI –Zidovudine –Lamivudine –Stavudine –Didanozine –Abacavir –Tenofovir NNRTI –Efavirenz –Nevirapine PI –Lopinavir/r

6. Provision of ARV ARV drugs are not available commercially in the local market (only few patent drugs registered, actual drug law prevents registration of drugs not used or registered in EU, USA) ARVs are provided by UNICEF (agreement between Albanian Government and UNICEF) to avoid tender/registration requirements and assure quality Majority of drugs are generics (produced in India) Patent or generics ? Cost efficacy?

7. Criteria for initiation of ART Based mainly on WHO 2006 guidelines: new recommendations: adaptation, cost implications? Symptomatic / OI – start CD4 < 200 start CD4 200 -350 consider treatment (if asymptomatic - defer) No genotypic testing available Repetition of CD4 testing – not always Preparing the patient for therapy - weak

8. Number of adult patients with ART in the past 4 years

9. CD4 nadir level at HIV diagnosis (36 new cases diagnosed in 2009)

10. ART profile There are 122 adult patients and 15 pediatric patients currently taking ARTc in Albania Most used combinations: –1 st line: ZDV/3TC + EFV: 75 adult patients –2 nd line: ddI + TDF + LPV/rtv: 10 patients

11. Combinations of TAR:1 st line, 2 nd line

12. ART profile Back-bone nuces –ZDV + 3TC available as co-formulation –TDF + FTC not available (appropriate for HIV/HBV co-infection) NNRTI based initial regimen preferred Most preferred NNRTI – efavirenz The only PI available – LPV/r LPV/r – (liquid, capsules) refrigeration an issue, this year tablets will be available

13. Management of HIV/Hepatitis coinfection Screening – yes (around 40% HbsAg +) HBV-DNA; HCV-RNA – not available all the time Genotyping – not available Monitoring of status of liver (fibroscan, serum fibro markers) not available Antiviral drugs not available (TDF/FTC, adefovir, telbivudine, PEG-IFN)

14. Problems Late stage diagnosis Coinfections (HBV, TB) and co-morbidities (Thalasemia) Planning and managing issues for ARVs Adaptation in limited resource settings, new WHO recommendations, Professional guidelines (lobbying and advocacy to policymakers) Evidence based medicine vs. cost-effectiveness approaches (d4T case) Public health approach vs. individualistic approach (professional guidelines)