NIGERIA

COUNTRY PRESENTATION

By: Drs. Uzono Levi G and Adegboyega

Adewumi4th September 2004

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

Presentation Outline

• About Nigeria

• Epidemiology of HIV/AIDS

• The National ART Programme

• The main Issues

• Conclusion

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

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.

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.

< 5%< 5%

5 - 7%5 - 7%

7 -12% +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 StateYobe 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

*Minna7.0%Kwara

State2.7%

Kogi State5.7%

FCT

8.4%NasarawaState

*Lafia

6.5%

Plateau State

6.3%

9.3%Edo State

4.3%

Ekiti State2.0%

Ondo State

2.2%

Osun State

1.2%

Oyo State3.9%

Ogun State1.5%

Lagos State

4.7%

Delta State

5.0%

*Yenagoa

4.0%Rivers State

6.6%Akwa Ibom State

7.2%

Imo State

3.1%

An

amb

ra

Sta

te

3.3% Enugu State

*Enugu

4.9%

IAbia State

3.7%

Cross River State

12%Ebonyi State

7.2% ARV CentersARV Centers**

**Lagos Has 3 ARV CentersLagos Has 3 ARV Centers

****

****

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Abuja Has 7 ARV CentersAbuja Has 7 ARV Centers

MO-ARVS NASCP – FMOH 15th June 2004

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.

?Which ARVs are available in your Country

Saquinavir (SQV)Ritonavir (RTV) {aspharmacoenhancer}I ndinavir (I DV)Nelfi navir (NFV)Amprenavir (APV)Lopinavir-ritonavir(LPV/ r)Atazanavir (AZV)Tipranavir

Enf uvitride (T-20)

Nevirapine (NVP)Ef avirenz (EFZ)Delavirdine (DLV)

Tenof ovir (Disoproxil Fumarate {TDF})

Zidovudine (ZDV, AZT)Didanosine (ddI ) Zalcitabine (ddC)Stavudine (d4T)Lamivudine (3TC)Abacavir (ABC)Emtricitabine (FTC)

Protease Inhibitors (PI s)

Fusion Inhibitors

Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Nucleotide Reverse Transcriptase Inhibitor (NtRTI )

Nucleoside Reverse Transcriptase Inhibitors

(NsRTI s)

Saquinavir (SQV)Ritonavir (RTV) {aspharmacoenhancer}I ndinavir (I DV)Nelfi navir (NFV)Amprenavir (APV)Lopinavir-ritonavir(LPV/ r)Atazanavir (AZV)Tipranavir

Enf uvitride (T-20)

Nevirapine (NVP)Ef avirenz (EFZ)Delavirdine (DLV)

Tenof ovir (Disoproxil Fumarate {TDF})

Zidovudine (ZDV, AZT)Didanosine (ddI ) Zalcitabine (ddC)Stavudine (d4T)Lamivudine (3TC)Abacavir (ABC)Emtricitabine (FTC)

Protease Inhibitors (PI s)

Fusion Inhibitors

Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Nucleotide Reverse Transcriptase Inhibitor (NtRTI )

Nucleoside Reverse Transcriptase Inhibitors

(NsRTI s)

•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)

D4T+3TC+NVPD4T+3TCZDV+3TC+NVPZDV+3TCABC+ZDV+3TC

Saquinavir (SQV)Ritonavir (RTV)Indinavir (IDV)Nelfinavir (NFV)Amprenavir (APV)

Nevirapine (NVP)Efavirenz (EFZ)

Zidovudine (ZDV, AZT)Didanosine (ddI) Zalcitabine (ddC)Stavudine (d4T)Lamivudine (3TC)Abacavir (ABC)

Fixed dose combinationsProtease Inhibitors (PIs)

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

D4T+3TC+NVPD4T+3TCZDV+3TC+NVPZDV+3TCABC+ZDV+3TC

Saquinavir (SQV)Ritonavir (RTV)Indinavir (IDV)Nelfinavir (NFV)Amprenavir (APV)

Nevirapine (NVP)Efavirenz (EFZ)

Zidovudine (ZDV, AZT)Didanosine (ddI) Zalcitabine (ddC)Stavudine (d4T)Lamivudine (3TC)Abacavir (ABC)

Fixed dose combinationsProtease Inhibitors (PIs)

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

ARVs currently Registered with National Agency for Food and Drug Administration

and Control (NAFDAC)

?Do You have Treatment Guidelines

GUIDELINES FOR THE USE OF ANTIRETROVIRAL (ARV) DRUGS

IN NIGERIA

FEDRAL MINISTRY OF HEALTHABUJA, NIGERIA

JULY 2001

Draft

GUIDELINES FOR THE USE OF ANTIRETROVIRAL (ARV) DRUGS

IN NIGERIA

FEDERAL MINITRY OF HEALTHABUJA – NIGERIA

AUGUST 2004

Yes!

Contents1.0 Introduction .

2.0 Virology and Pathogenesis of HIV

3.0 Diagnoses of HIV infection and AIDS

4.0 Antiretroviral 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

5.0 Follow-up and Monitoring patients on ART6.0 Key issues in ART

i. Adherence ii. Immune Reconstitution Syndromeiii. Treatment experienced patientsiv. Indications for Referral

7.0 Prevention of Mother to Child Transmission

8.0 Post Exposure Prophylaxis and Universal Safety Precautions

9.0 Management of TB and Other Opportunistic Infections10.0 Supportive management

i.Nutritionii. Psychosocial Supportiii. Palliative Care

Treatment ProtocolRecommended and alternative regimens

for adults and childrenFirst line regimen for adults d4T / 3TC / NVP

Alternative first line drugs for special category of adults:

ü Pregnant women or women of childbearing age

ZDV / 3TC / NVP

ü Adults 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)

?What information is available to-Health Professionals

-The Public

?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

The Future

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

Conclusion -Pharmacovigilance in

NigeriaWe are compiling Sample reports to get fully registered with the Uppsala Monitoring CenterDraft Guidelines for Pharmacovigilance has been developed

Draft case reporting forms have been developed

On the 9th of September the official launching will take place