Transcript ARVs Presentation

NIGERIA
COUNTRY PRESENTATION
By:
Drs. Uzono Levi G and
Adegboyega Adewumi
4th 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
Nigeria located in Western Africa, bordering the
Gulf of Guinea, between Benin and Cameroon
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)
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
• 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.
• By the middle of 2004, approximately 13,500
people were receiving ARV treatment from
these centres and many more were on waiting
lists.
HIV Prevalence per State end of 2003 and
States with ARV Centers
Sokoto State
4.5%
*Sokoto
*Katsina
*Birnin
Kebbi
Yobe State
Katsina
State *Kano
*Gusau
Zamfara State
2.5%
Jigawa State
Kano
State
3.3%
Kebbi State
Borno State
3.3%
2.0%
*Dutse
3.2%
*Damaturu
*Maiduguri
4.1%
2.5%
Bauchi
State
4.3%
Niger
State
*Kaduna
Kaduna
State
7.0%
Kwara
State
*Minna
6.8%
*Bauchi
6.3%
FCT
Nasarawa
8.4% State
6.5%
*Lokoja
*Abeokuta
1.5%
Ogun State
4.7% *Ikeja
Lagos State
*
*Osogbo
1.2%
Osun
State
Ekiti State
*Lafia
Kogi
State
*Akure
Edo
2.2%
State
Ondo
4.9%
4.3%
3.3% Enugu
State
State
*Benin
*Enugu
*Asaba
City
Adamawa
State
7.6%
< 5%
*Yola
5 - 7%
Taraba
State
5.7%
2.0%
*Ado Ekiti
*Jalingo
Plateau
State
**
**
*Ilorin
3.9%
*Ibadan
*Gombe
*Jos
6.0%
2.7%
Oyo State
Gombe
State
*Makurdi
6.0%
9.3%
7 -12% +
Benue
State
ARV Centers
7.2%
*Awka
5.0%
Delta
State
*Yenagoa
3.1%IAbia
Imo
State
*Owerri
12%
State
3.7
%
Rivers
4.0%
State
Bayelsa
6.6%
*Port Harcourt
State
Cross
River
State
7.2%
*Calabar
*Uyo
Akwa
Ibom
State
Lagos Has 3 ARV Centers
*
Abuja Has 7 ARV Centers
**
MO-ARVS NASCP – FMOH 15th June 2004
Treatment Needs
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.
Out of this, between 300,000 to 700,000 people
are in urgent need of treatment.
?Which ARVs are available in
your Country
Nucleoside Reverse
Transc riptase Inhibitors
(NsRTIs)
Zidovudine (ZDV, AZT)
Didanosine (ddI)
Zalcitabine (ddC)
Sta vudine (d4T)
Lami vudine (3TC)
Abacavir (ABC)
Emtrici tabine (FTC)
Nucleotide Reverse
Transc riptase
Inhibitor (NtRTI)
Non-Nucleoside
Reverse
Transc riptase
Inhibitors (NNRTIs)
Fusion
Inhibitors
Protease
Inhibitors (PIs)
Tenofovir (Disoproxil
Fuma ra te {TDF})
Nevirapine (NVP)
Efavirenz (EFZ)
Delavirdine (DLV)
Enfuvi trid
e (T-20)
Saquinavir (SQV)
Ritona vir (RTV) {as
pharmacoenhancer}
Indinavir (IDV)
Nelfinavir (NFV)
Amprenavir (APV)
Lopinavir-ri tona vir
(LPV/r)
Atazanavir (AZV)
Tipranavir
Currently registered/listed in Nigeria either
as single products or in fixed dose
combinations we have
6 Nucleoside Reverse Transcriptase
Inhibitors (NRTIs),
•2 Non Nucleoside Reverse Transcriptase
Inhibitors (NNRTIs) and
5 Protease Inhibitors (PIs)
ARVs currently Registered with National Agency
for Food and Drug Administration and Control
(NAFDAC)
Nucleoside Reverse
Transcriptase
Inhibitors (NRTIs)
Non-Nucleoside
Reverse
Transcriptase
Inhibitors (NNRTIs)
Protease Inhibitors
(PIs)
Fixed dose combinations
Zidovudine (ZDV,
AZT)
Didanosine (ddI)
Zalcitabine (ddC)
Stavudine (d4T)
Lamivudine (3TC)
Abacavir (ABC)
Nevirapine (NVP)
Efavirenz (EFZ)
Saquinavir (SQV)
Ritonavir (RTV)
Indinavir (IDV)
Nelfinavir (NFV)
Amprenavir (APV)
D4T+3TC+NVP
D4T+3TC
ZDV+3TC+NVP
ZDV+3TC
ABC+ZDV+3TC
?Do You have Treatment
Guidelines Yes!
Draft
GUIDELINES FOR THE USE OF
ANTIRETROVIRAL (ARV) DRUGS IN
NIGERIA
FEDRAL MINISTRY OF HEALTH
ABUJA, NIGERIA
JULY 2001
GUIDELINES FOR THE USE OF
ANTIRETROVIRAL (ARV) DRUGS IN
NIGERIA
FEDERAL MINITRY OF
HEALTHABUJA – NIGERIA
AUGUST 2004
Contents
1.0 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 ART
6.0 Key issues in ART
i.
Adherence
ii. Immune Reconstitution Syndrome
iii. Treatment experienced patients
iv. Indications for Referral
7.0
8.0
Prevention of Mother to Child Transmission
Post Exposure Prophylaxis and Universal Safety Precautions
9.0 Management of TB and Other Opportunistic Infections
10.0 Supportive management
i.Nutrition
ii. Psychosocial Support
iii. Palliative Care
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:
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
• What we have is post marketing surveillance,
which is the responsibility of NAFDAC
• 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
The Future
The launching of Pharmacovigilance on the 9th
of September will initiate drug safety
monitoring with special emphasis on ADRs
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 9th of September the official launching
will take place