Transcript Causes the change of antiretroviral treatment during the HIV infection

CAUSES THE CHANGE OF
ANTIRETROVIRAL TREATMENT DURING
THE HIV INFECTION
Dr Frouk Hafsa
Regional Coordinator of pharmacovigilance in Souss-Massa region
Context
Unified Guidelines on the use of antiretroviral agents for
the treatment and prevention of HIV infection: WHO
recommendations for a public health approach in 2013
 The
involvement of Morocco and transition phase
following the new WHO recommendations
 The implementation of these new standards imposed to
raise a large ARV Management Challenge
 Perception practitioners on the percentage changes due
to side effects
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Study Objectives
Identify major TAR change causes at the Agadir RRC
 Identify and analyze the causes of change in
treatment
 Promoting rational use of antiretrovirals
 Contribute to streamlining the management of ARV:
ARV needs estimation
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Methodology
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Type of study: descriptive retrospective study
Target population: PLHIV on treatment followed at the
regional referral center in AGADIR who undergone a change
in treatment
Study duration: from 01 January 2014 to 31 December
2014
Collections of data:
The records of the therapeutic mediation
Medication management software (ODE)
Patient records
Data analysis: Excel
Results: Population characteristics
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Study Population: 65 PLHIV
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Average age: 38.2 years (17year- 64year)
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Sex ratio F / H: 1.82
Results: HIV diagnostic Circumstances
N=47
17%
4%
32%
Tuberculosis
4%
Oral candidiasis
Screening
17%
chronic diarrhea
25.50%
Others
Impaired general condition
Results:Therapeutic regimens used before
change
First Line regimens
Second Line regimens
AZT + 3TC + EFV
TDF + (3TC or FTC) + LPV/r
AZT + 3TC + NVP
AZT + 3TC + LPV/r
TDF + (3TC or FTC) + EFV
D4T+ 3TC + EFV
86.2% in 1st line
13.8% in 2nd line
Results:therapeutic regimens After changing
treatment
First Line regimens
Second Line regimens Third line regimens
AZT + 3TC + EFV
TDF + (3TC or FTC) +
Etravirine-darunavir+
LPV/r
Raltegravir-Rtonavir
AZT + 3TC + LPV/r
AZT + 3TC + NVP
TDF + (3TC or FTC) +
EFV
TDF + 3TC + NVR
58.5% in 1st line
33.8% in 2nd line
7.7% in the third line (5 PLHIV)
Results:TAR indicators of changes
Indicators
Value
Overall treatment rate of change
1.8%
Rate change to the Second line
0.6%
Rate change to the Third line
0.14%
Rate change in the first line
1.03%
Results: Treatment changes reasons
Stock shortage
14%
Therapeutic failure
43%
Side effects
48%
0%
10%
20%
30%
40%
50%
60%
Results: Adverse reactions responsible for the
change in treatment
Classification classe/organe
WHO-ART terminology
Total
N=31
haematological disorders
anemia
Skin and appendages
disorders
Allergy, diffuse lesion,
urticaria, rash.
19.3%
renal disorders
Renal colic, renal failure
0.06%
Psychiatric disorders
nightmare, depression
19.3%
Gastro-intestinal system
disorders
Vomiting, diarrhea
16.1%
Central nervous system
disorders
Left hemiplegia,
paresthesias of inferior
limb
0.06%
Cardiovascular disorders
25%
0.06%
Results: the molecules involved in changing
treatment because of side effects
1.
2.
3.
Zidovudine (AZT)
Effavirenz
Nevirapine
Discussion
Reasons for treatment change
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Reasons for treatment change in Dutch study performed
on 3995 PLHIV:
1st line Treatment:
Drug toxicity is responsible for half of the changes of TAR
Switching to a new drug available or simplification (27%)
Virological failure (7.5%)
Other: interaction, processing co-morbidity
2nd line treatment: same
Mikaela Smit and all: AIDS ,vol.26,n15,p1895-1906
Adverse reaction and treatment change
AR reported as a reason for initial treatment regimen
change in Addis Ababa
Adverse reaction
Peripheral
neuropathy
Total
39%
Rash
Anaemia
CNS toxicity
20%
13%
11%
Lip atrophy
Hepatoxicity
11%
5%
YOHANNES T. J and al.Causes for antiretroviral regimen change among HIV/AIDS patients in Addis Ababa, Ethiopia.Tanzania Journal of
Health Research Doi: Volume 15, Number 1, January 2013
Treatment failure and treatment change
The evaluation of treatment failure is at 3 levels:
 By clinical evaluation of the disease progression in
WHO clinical stages
 Immunoassay by measuring CD4
 Virological by measuring viral load.
These failures can be isolated or associated.
Treatment failure and treatment change
Absence of dosage of ARVs
+
Génotypage ( Resistance)
Treatement adherence
Treatment failure / adherence
A 95% treatment adherence is needed to achieve the
therapeutic objectives: extend life, reduce the frequency of
opportunistic infections, stop or slow down quickly and
permanently viral replication, restore or improve the
immunity of the infected person
Jong et al. Overshoot of HIV-1 viraemia after early discontinuation of antiretroviral treatment. AIDS. 1997 Sep;11(11):F79-84.
Mouala al. Assessment of compliance with ARV treatment in Africa. Med Trop (Mars). 2006 Dec;66(6):610-4.
Treatment failure / adherence
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Study in Casablanca: 92 patients were interviewed and 89
questionnaires analyzed. The duration of treatment ranged
from 2-67 months. Adherence by educators was good (>
90%) in 78 patients.
The main obstacles to good compliance identified were
related to the difficulty to comply with the dosing schedule
and remoteness of health facilities or the presence of side
effects and associated pathologies.
K. Benjaber,J.L. Rey, H. Himmich ,Étude sur l'observance du traitement antirétroviral à Casablanca (Maroc)
Conclusion
As a result of this study, we find that the side effects
associated with the use of ARVs are the leading cause of
treatment change.
To this end, an CEM study is still needed to:
 improve patient safety due to the use of antiretroviral drugs
 Evaluate the incidence of serious adverse effects of ARVs
 Establish a patient monitoring system for early detection of
complications (cardiovascular and metabolic ...)
Thank you