Antiviral effect and safety of triple combination therapy in human immunodeficiency virus (HIV)-infected persons

Hong, Sung Kwan; Park, Yoon Soo; Cho, Jeong Ho; Roh, Hyun Jung; Kim, Hyo Yeol; Chang, Kyung Hee; Song, Young Goo; Kim, June Myung

Abstract

BACKGROUND
Antiretroviral combination therapy with one protease inhibitor and two reverse transcriptase inhibitors is profoundly suppressive of HIV replication. To determine the efficacy and safety of the triple combination therapy in persons with HIV infection in Korea, we analyzed the response of therapy in terms of immunity and viral load.
METHODS
Ten persons with HIV infection, who were treated with triple combination therapy at least 12 months at Yonsei University College of Medicine from 1997 to 1999 were studied. The triple combination therapy regimen consisted of two reverse transcriptase inhibitors (zidovudine or didanosine, lamivudine) and one protease inhibitor (indinavir). We analyzed the levels of HIV RNA, CD4+ cell counts, beta2MG, and p24Ag before and after treatment. Adverse drug reactions during therapy were described.
RESULTS
The mean age of patients at treatment was 38.7 years. Nine patients were male, and 1 patient was female. Six patients received triple combination therapy as initial treatment, while 4 patients received it as re-treatment. The mean level of HIV RNA was 129,222 copies/mm3 before treatment. RNA level decreased to less than 500 copies/mm3 (non-detectable range) at 1 month in 7 of 10 patients, at 12 months in 9 of 10 patients. The mean CD4+ cell counts was 206/mm3 before treatment, and 376/mm3 after 12 months treatment. The beta2MG decreased to 2.7 mg/L from 2.8 mg/L after 12 months of treatment. The p24Ag was positive in 3 of 10 patients and negative in all of the patients at 3 months treatment. Mild hyperbilirubinemia (5 cases) was the most frequent adverse reaction followed by flank pain (3 cases), skin rash (2 cases), abdominal discomfort (2 cases), and mild elevation of AST/ALT (1 case).
CONCLUSION
The triple combination therapy in HIV infection appeared to be generally well tolerated, and was able to profoundly sustain suppression of HIV replication.