Trends in Antiretroviral Drugs Prescribing at Public Health Facilities in Ethiopia: Compliance to Treatment Guidelines Authors: Hailu Tadeg and Negussu Mekonnen Presenting Author: Hailu Tadeg (B.Pharm, MSc, MPH) Management Sciences for Health Strengthening Pharmaceutical Systems (MSH/SPS) Ethiopia

Introduction  With the advent of ARV drugs, HIV/AIDS has become a treatable chronic disease  Currently, more than 4 million people are receiving ART in low- and middle-income countries  In Ethiopia, HIV was first reported in 1984  In 2008, an estimated 1.03 million people were living with HIV  More than people get newly infected every year, and an estimated 290,000 people need ART  Ethiopia started fee-based ART in 2003 and launched free ART in January 2005  As of March 2010, 511 health facilities (142 hospitals and 369 health centers) provide ART service throughout the country  Out of all ART clients, about 58% are female.  In terms of drug combination, the majority of patients are on 1 st line regimen while only 1% (1,079) of patients were switched to a 2 nd line regimen

Introduction (2)  Given the life-long nature of ART, its costs and public health implications, adequate monitoring of the program is essential  Evidence-based treatment guidelines are increasingly used to guide clinicians’ medical care decisions  The use of combination ARV medications has transformed HIV infection into a treatable chronic infection  However, the complexity of ARVs has reduced adherence and increased drug– drug interactions and metabolic toxicities.  Some ARV combinations are discouraged because of excess toxicities, regimen complexity, or adverse drug interactions  The FMOH of Ethiopia has revised the STG taking into account these complexity of ARVs management  The latest STG for ART was last revised in March 2008, launched nationally and used to guide national trainings on ART  The guideline was then distributed to prescribers and dissemination further strengthened during supportive supervision and mentoring visits  Understanding of prescribing patterns in comparison with STGs might show changes in practice and will help in suggesting the need for early interventions

Objectives  In spite of its importance the adherence of prescribers to STG for ART has not been systematically studied in Ethiopia.  The current study is conducted to fill this gap General Objective: To investigate trends in the prescribing of antiretroviral drugs in public health facilities and the level of compliance of prescribers to ART guideline Specific Objectives: To study trends in the patterns of choices of preferred 1 st line, alternative 1 st line and 2 nd line regimens by prescribers To examine the trends in the proportion of patients on D4T versus TDF based regimens To identify differences in ARVs prescribing trends amongst regions To compare ARVs prescribing practices and trends between hospitals and health centers

Methods  Data was extracted from the monthly activity reports of ART pharmacy received in October of the years 2008, 2009 and 2010  Data on regimens was compiled by region and level of health facility  The regimens were evaluated for compliance with the recommendations of the national STG DesignRetrospective descriptive study SettingART Pharmacies Seven regions in Ethiopia PopulationAll public health facilities providing ART services Sample Size154 Hospitals (70 Hospitals and 84 Health Centres) Inclusion Criteria All ART sites that had consistently reported on October of 2008, 2009, 2010.

Results Regimen Type Year #%#%#% D4T/3TC/NVP D4T/3TC/EFV ZDV/3TC/NVP ZDV/3TC/EFV TDF/3TC/NVP TDF/3TC/EFV ABC/3TC/NVP ABC/3TC/EFV ABC/3TC/ZDV ABC/3TC/LOP/r ABC/ddI/LOP/r ZDV/ddI/LOP/r ZDV/3TC/LOP/r D4T/3TC/LOP/r TDF/3TC/LOP/r TDF/3TC/ZDV TDF/ddi/LOP/r TDF/3TC/ABC/Lop/r Others Total50, , ,  Majority of prescribed regimens are a combination of nucleoside and non- nucleoside analogues  About 98% of prescribed regimens are picked from within the STG.  More than 97% of patients are taking three antiretroviral drug combinations. Aggregate number and percentage of patients on each regimen

Result (2)  # Patients on preferred first line regimen has increased from 32% in 2008 to 49% in 2010 while those on alternative first line regimen declined from 66% to 48%.  % of patients on regimens not recommended by the guideline increased by more than 5-fold between 2008 and 2010

Result (3)  The actual prescribing practice follows the recommended trends.  But, does this prove compliance to the STG?  Large proportion of new patients are being treated with D4T based regimen against guidelines recommendations!

Result (4)  Prescribing patterns follows more or less similar trends  The shift from D4T- based to TDF and ZDV- based regimens is slower in AA, Amhara and Tigray  The trend in Diredawa and Harari much better than other regions

Result (5)  Although the new STG recommend TDF-based regimen as preferred first option, the proportion of patients on this regimen is still very low in both hospitals (14%) and HCs (8%)  Overall prescribing practice follows similar trends irrespective of the level of health facility  Proportion of patients on D4T-based regimens is consistently higher in HCs than Hospitals  The shift to TDF-based regimens appears to be faster in HCs

Conclusion  A significant number of patients are still on alternative first-line regimens  Large number of patients including newly enrolled ones are on D4T-based regimens signifying an important safety and adherence concerns.  Differences in prescribing practice exist between regions and between hospitals & health centres  Prescribing combination of ARVs that are not recommended by STG increased over the study period  Overall, the findings of this study indicate that compliance to ART guidelines requires significant improvement.  Therefore, additional interventions, including revision of STG, are required to improve compliance to ART guideline recommendations

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