Combined antiretroviral drugs containing lamivudine and zidovudine for the treatment of HIV infection


Sizova N.V., Korneeva T.S., Bratkova V.V., Sotnikova A.L., Rassokhin V.V.

1Saint Petersburg Center for Prevention and Control of AIDS and Communicable Diseases; 2Academician I.P. Pavlov First Saint Petersburg State Medical University
The paper presents the results of a clinical trial comparing two first-line antiretroviral therapy (ART) regimens including combined drugs containing lamivudine and zidovudine.
Objective. To compare the efficacy and safety of the brand-name drug combivir (AZT/3TC) and the generic drug dizaverox (AZT/3TC), by using the conventional comparison criteria.
Subjects and methods. The investigation enrolled 61 patients: Group 1 included 32 patients receiving dizaverox (AZT/3TC); Group 2 consisted of 29 patients taking combivir (AZT/3TC). The groups were matched for age, sex, and clinical characteristics of HIV infection. All the patients had not previously received ART, had indications for therapy initiation; after the use of antiretroviral drugs they were followed up during 24 weeks. In this period, the investigators evaluated the clinical and immunological efficacy of the drugs and the severity of adverse events during their development. All the patients underwent a standard examination within the scheduled time and, if necessary, an additional in-depth examination.
Results. With the comparable immunological efficacy of the drugs, the rate and amount of an increment in the number of CD4 lymphocytes were significantly higher in Group 1 than in Group 2 (230 and 144.5 cells/µl, respectively). At 24 weeks, the proportion of patients with suppressed HIV activity was also significantly higher in Group1 than in Group 2 (86.4% and 75%, respectively). In both groups, adverse events were recorded in 85% of the patients; anemia and hypercholesterolemia were most common; cytopenia, various gastrointestinal disorders, and hyperglycemia were encountered. The therapy was discontinued because of adverse reactions in 5 (15.6%) and 8 (27.6%) patients in Groups 1 and 2, respectively.
Conclusion. The results of the study showed that the combined drugs taken for 24 weeks by HIV-infected patients who have not previously received ART have comparable clinical, immunological, and virological effects. At the same time, immunological and virological improvements occurred significantly faster and more substantially and adverse events developed less frequently in Group 1 patients.
Keywords: CD4 lymphocytes, zidovudine, viral load, lamivudine, antiretroviral therapy, HIV infection, adverse events
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About the Autors

For correspondence: Natalia V. Sizova, natalia_v_sizova@mail.ru


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