1. NIGERIA COUNTRY PRESENTATION By: Drs. Uzono Levi G and Adegboyega Adewumi 4 th September 2004

2. REMINDER – The main issues Which ARVs are available in your Country Do you have treatment guidelines What information is available to -Health professionals -The Public Is there any safety Monitoring in your Country

3. Presentation Outline About Nigeria Epidemiology of HIV/AIDS The National ART Programme The main Issues Conclusion

4. Important Statistics Population: 123.9m (1999) Life Expectancy at Birth (LEB): 52years Urban: Rural Ratio: 50:50 (approx) Adult Literacy Level: 55.6% External Debt: US$ 31.6 billion Poverty Level: 65% live below Poverty level HIV Prevalence: 5.0% (end of 2003) Estimated HIV Burden: 3.47million (2001) Estimated AIDS Burden: 1.2million (2001) Nigeria located in Western Africa, bordering the Gulf of Guinea, between Benin and Cameroon

5. Epidemiology of HIV/AIDS Since 1986 when the first AIDS case was detected in Nigeria, the epidemic has rapidly grown. The adult HIV prevalence has increased from 1.8% in 1991 to 4.5% in 1996 to 5.8% in 2001 and finally 5.0% at the end of 2003. Estimates using the 2001 HIV seroprevalence sentinel survey of women attending ante-natal clinics indicate that the more than 3.5 million Nigerians were infected with the virus in 2002.

6. The National ART Programme By the middle of 2004, approximately 13,500 people were receiving ARV treatment from these centres and many more were on waiting lists. In 2001 the Federal Government of Nigeria adopted a policy to provide antiretroviral treatment to people living with HIV/AIDS in the country. Implementation of the program began in 2002 with 25 centres selected to provide ART in various parts of the country.

7. < 5% 5 - 7% 7 -12% + HIV Prevalence per State end of 2003 and States with ARV Centers Sokoto State *Sokoto4.5% Kano State *Kano Kaduna State Borno State *Jos *Kaduna Benue State *Makurdi Kebbi State Zamfara State Katsina State Jigawa State Yobe State *Birnin Kebbi *Gusau *Jalingo *Yola *Gombe*Bauchi *Ilorin *Ibadan *Abeokuta *Osogbo *Ado Ekiti *Lokoja *Akure *Benin City *Asaba *Ikeja Bayelsa State *Port Harcourt *Owerri * Awka *Uyo *Calabar 2.5% 3.3% *Katsina 2.5% 4.1% *Dutse 2.0% *Damaturu 3.3% *Maiduguri 3.2% Gombe State 6.8% Adamawa State 7.6% Taraba State 6.0% Bauchi State 4.3% 6.0% Niger State *Minna 7.0% Kwara State 2.7% Kogi State 5.7% FCT 8.4% Nasarawa State *Lafia 6.5% Plateau State 6.3% 9.3% Edo State 4.3% Ekiti State 2.0% Ondo State 2.2% Osun State 1.2% Oyo State 3.9% Ogun State 1.5% Lagos State 4.7% Delta State 5.0% *Yenagoa 4.0% Rivers State 6.6% Akwa Ibom State 7.2% Imo State 3.1% Anambra State 3.3% Enugu State *Enugu 4.9% IAbia State 3.7 % Cross River State 12% Ebonyi State 7.2% ARV Centers * * Lagos Has 3 ARV Centers ** ** ** Abuja Has 7 ARV Centers MO-ARVS NASCP – FMOH 15 th June 2004

8. Treatment Needs Out of this, between 300,000 to 700,000 people are in urgent need of treatment. The epidemic has extended beyond the commonly classified high-risk groups to the general population. As at the end of 2001, at least three and a half million people are living with HIV/AIDS, which is expected to rise to well over four million in 2008. Cumulative deaths by 2008 are predicted to be between 3.6 to 4.2 million.

9. ?Which ARVs are available in your Country

10. 2 Non Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and Currently registered/listed in Nigeria either as single products or in fixed dose combinations we have 6 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), 5 Protease Inhibitors (PIs)

11. ARVs currently Registered with National Agency for Food and Drug Administration and Control (NAFDAC)

12. ?Do You have Treatment Guidelines GUIDELINES FOR THE USE OF ANTIRETROVIRAL (ARV) DRUGS IN NIGERIA FEDRAL MINISTRY OF HEALTH ABUJA, NIGERIA JULY 2001 Draft GUIDELINES FOR THE USE OF ANTIRETROVIRAL (ARV) DRUGS IN NIGERIA FEDERAL MINITRY OF HEALTHABUJA – NIGERIA AUGUST 2004 Yes!

13. Contents 1.0Introduction. 2.0Virology and Pathogenesis of HIV 3.0Diagnoses of HIV infection and AIDS 4.0Antiretroviral therapy (ART) i. Classes of ARV Drugs - Available ARV drugs ii. Criteria for initiation of therapy iii. Recommended and alternative regimen of ART iv. Adverse drug reactions and Interactions v. When to switch ART vi. When to stop ART 5.0Follow-up and Monitoring patients on ART 6.0Key issues in ART i.Adherence ii.Immune Reconstitution Syndrome iii.Treatment experienced patients iv. iv.Indications for Referral 7.0 Prevention of Mother to Child Transmission 8.0 Post Exposure Prophylaxis and Universal Safety Precautions 9.0Management of TB and Other Opportunistic Infections 10.0Supportive management i.Nutrition ii. Psychosocial Support iii. Palliative Care

14. Treatment Protocol Recommended and alternative regimens for adults and children First line regimen for adults d4T / 3TC / NVP Alternative first line drugs for special category of adults: üPregnant women or women of childbearing age ZDV / 3TC / NVP üAdults with tuberculosis co-infection (that require Rifampicin containing regimen for TB treatment) d4T / 3TC / EFV First line regimen for children d4T / 3TC / NVP Alternative first line drugs for special category of children: Children with tuberculosis co-infection (that require Rifampicin containing regimen for TB treatment) d4T / 3TC / EFV (not recommended for children below 3 years)

15. ?What information is available to -Health Professionals -The Public

16. ?Is there any Safety Monitoring in your Country Address the issues of counterfeit drugs and other regulatory products through -Public Enlightenment Campaigns -monitoring of Good Manufacturing Practices, -beefing up surveillance at the ports -Mopping-up fake / counterfeit drugs and other regulated products What we have is post marketing surveillance, which is the responsibility of NAFDAC

17. The Future The launching of Pharmacovigilance on the 9 th of September will initiate drug safety monitoring with special emphasis on ADRs

18. Conclusion -Pharmacovigilance in Nigeria We are compiling Sample reports to get fully registered with the Uppsala Monitoring Center Draft Guidelines for Pharmacovigilance has been developed Draft case reporting forms have been developed On the 9 th of September the official launching will take place