Bioequivalence of Generic and Brand HIV Medications in Uganda
Author Information
Author(s): Byakika-Tusiime Jayne, Chinn Leslie W., Oyugi Jessica H., Obua Celestino, Bangsberg David R., Kroetz Deanna L.
Primary Institution: University of California Berkeley
Hypothesis
Is the generic formulation of Triomune bioequivalent to its brand counterparts in HIV-infected Ugandan adults?
Conclusion
The generic formulation Triomune was not statistically bioequivalent to the brand formulations, although exposures were comparable.
Supporting Evidence
- The study included 18 participants who were HIV-positive adults.
- Participants had been on the generic formulation for at least 36 months.
- Mean adherence to medication was over 99% during the study.
Takeaway
This study looked at whether a cheaper version of HIV medicine works the same as the brand name. It found that while they are similar, the cheaper one isn't exactly the same.
Methodology
An open-label, randomized, crossover study comparing pharmacokinetics of generic and brand formulations in HIV-infected subjects.
Potential Biases
Potential sequence effects due to differences in health status between study groups.
Limitations
The study did not conduct drug content assays and in vitro dissolution tests.
Participant Demographics
18 HIV-positive adults (8 males, 10 females), aged 28 to 50 years.
Statistical Information
P-Value
p<0.0001
Confidence Interval
0.8–1.25
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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