The efficacy and safety of a second-generation nonnucleotide reverse transcriptase inhibitor as part of combination antiretroviral therapy in HIV-infected patients

Isaeva G.N., Kovelenov A.Yu.

Leningrad Regional Center for Prevention and Control of AIDS and Infectious Diseases, Saint Petersburg
The design of second-generation non-nucleotide reverse transcriptase inhibitors (NNRTIs) has made a great contribution to the treatment of HIV infection. The first representative of this group of antiretroviral drugs is etravirine (ETR) characterized simultaneously by high efficacy and favorable safety profile.
Objective. Тo evaluate the efficiency and safety of using ETR as part of combined antiretroviral therapy (ARVT) for HIV infection in patients with the inefficiency or intolerance of the regimens involving first-generation NNRTIs or protease inhibitors.
Subjects and methods. Ten patients were followed up. They all had the clinical manifestations of varying degrees of adverse events (AEs), which might be associated with the use of antiretroviral drugs (ARVDs). Efavirenz (EFV)-induced psychoneurologic disorders were most common (in 7 of the 10 patients). Furthermore, there were gastrointestinal AEs in 2 patients, whose treatment regimen included lopinavir/ritonavir (LPV/r); polyneuropathy; lipoatrophy in 1 patient taking stavudine (d4T); hematological changes, elevated levels of liver transaminases and bilirubin. All the above side effects were absolutely associated with ARTV and required that the treatment regimens be modified.
Results. Seven men and 3 women at the age of 27 to 53 years (mean age 37.2 years) were followed up. The duration of HIV infection was 2 to 11 years (mean 7.6 ± 0.9 years). The clinical manifestations of secondary diseases were recorded in all the patients. Before the first treatment regimen was initiated, the CD4 lymphocyte counts varied from 106 to 305 cells/µl and averaged 203±24.2 cells/µl. At the start of ARVT, HIV RNA averaged 383 797 ± 166 721 copies/ml. A treatment regimen was given to all the patients in accordance with the standard treatment for HIV infection; it included zidovudine/lamivudine (ZDV/3TC) + EFV in 6 patients. All the patients had the clinical manifestations of varying degrees of AEs that might be associated with ARVT. Psychoneurological disorders were observed most frequently (in 7 patients). Among the laboratory indicators, the higher levels of liver enzymes were more common (in 4 patients). In all the patients, ARVT regimens were changed because of AEs. The goal of incorporating ETR into the therapy regimen was to improve tolerance and to enhance therapeutic effectiveness. The duration of ETR administration was 1 to 22 months. All the patients reported that AEs ceased with the use of ETR versus EFV. At a further follow-up, all the patients achieved an undetectable viral load and an increase in CD4 lymphocyte counts (an average of 361 ± 53.6 cells/µl). After therapy correction, both clinical and laboratory AEs regressed.
Conclusion. The experience with ETR used in a daily dose of 400 mg confirmed the high therapeutic effect in patients with a different history of ARVD use. ARVT in combination with ETR was well tolerated with a low incidence of AEs.

About the Autors

Isaeva Galina Nikolaevna, Head, Clinical Department, Leningrad Regional Center for Prevention and Control of AIDS and Infectious Diseases
Address: 15/17, Professor Popov St., Build. C, Saint Petersburg 197376

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