Polly Clayden, HIV i-Base
A report from the ESTHER treatment programme - a collaboration between Rwanda and Luxembourg - described good quality generic drugs and good adherence in 70 Rwandan patients at the Centre Hopital de Kigali.
The study performed an analysis of antiretroviral generic drugs (tablets, capsules and syrups) available in Rwanda. Zidovir, Nevimune and Lamivir are manufactured by Cipla, and Avolam, Coviro and Triviro by Ranbaxy.
Drug contents as a percentage of the manufacturer’s claim are described in the following table:
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Drugs analysed |
Label claim (mg/mL) |
Mean amount (mg/mL) |
Drug content/ Label claim (%) |
SYRUPS |
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CIPLA |
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ZIDOVIR |
zidovudine |
10 |
9.4 |
94.0 |
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NEVIMUNE |
nevirapine |
10 |
8.1 |
81.0 |
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LAMIVIR |
lamivudine |
10 |
10.5 |
105.0 |
TABLETS/CAPSULES |
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RANBAXY |
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AVOLAM |
lamivudine |
150 |
158.9 |
105.9 |
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TRIOVIR |
lamivudine |
150 |
151.9 |
101.3 |
|
LNS30 |
stavudine |
30 |
28.0 |
93.3 |
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nevirapine |
200 |
183.2 |
91.6 |
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COVIRO |
lamivudine |
150 |
158.2 |
105.5 |
|
LS 40 |
stavudine |
40 |
39.8 |
99.5 |
CIPLA |
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NEVIMUNE |
nevirapine |
200 |
176.0 |
88.0 |
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ZIDOVIR 100 |
zidovudine |
100 |
107.6 |
107.6 |
|
ZIDOVIR 300 |
zidovudine |
300 |
330.0 |
110.0 |
The investigators concluded: “Average drug content/label claim = 99.0%, results are in accordance with the manufacturers’ claims. Good quality generic drugs are available in Rwanda.”
The study also assessed adherence in two groups of patients by measuring their NNRTI levels at four hours post dose: efavirenz by HPLC/UV-DAD (n=27) and nevirapine by GC/MS-SIM (n=43).
The investigators reported 87% of patients overall to be in the therapeutic range or above and therefore considered them to be adherent.
comment
Although it is encouraging to see this study, it is important to note that this analysis describes pharmaceutical equivalence not bioequivalence - ie the study reports drug content in vitro. So we do not have the complete story and it would not be possible to extrapolate PK from these data.
Using TDM to assess adherence is probably not its best use but again it is encouraging to note that 87% of patients in this group were in the therapeutic range.
Ref: Schneider S, Schuman M, Omes et al. Antiretroviral therapy among advanced stage, indigent patients in the funded ESTHER programme in Kigali, Rwanda. Abstract 1. Poster 1.1.
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