Management of ART in Albania : From the European Guidelines to the real practice.

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: • 1st line: ZDV/3TC + EFV: 75 adult patients • 2nd line: ddI + TDF + LPV/rtv: 10 patients

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