Short-term efficacy and safety of stavudine in pretreated HIV-infected patients
Villalba, N.; Soriano, V.; Gómez-Cano, M.; Castilla, J.; Mas, A.; González-Lahoz, J.
Antiviral Therapy 2(3): 185-189
1997
ISSN/ISBN: 1359-6535 PMID: 11322273 Document Number: 477453
This paper summarizes the results of adding 40 mg stavudine twice daily to previous therapies in patients with mild to advanced immunological disease (mean CD4 T-cell count 178 cells/mmsuperscript 3; range 6-480 cells/mmsuperscript 3). In an intention-to-treat, prospective, open trial, 64 patients (84.4% men; mean age 35.2 years) were analysed. Their average time on previous antiretroviral therapy was 19.8 months (range 6-52). Plasma HIV RNA load fell by a mean of 0.64 and 0.74 log at 1 and 3 months, respectively, after the start of stavudine therapy (P<0.001 Sign rank test). The CD4 cell count increased by a mean of 25.1 cells/mmsuperscript 3 in the third month (P = 0.002 Sign rank test). Antiviral activity was independent of the CD4 cell count at baseline, but more pronounced declines in viral load were seen in patients with shorter periods of previous antiretroviral therapy and in those in whom stavudine was combined with didanosine or lamivudine rather than zidovudine. Ten (15.6%) patients discontinued the drug during the first 6 months of treatment because of the development of toxicity; all but one of them had CD4 counts<200 cells/mmsuperscript 3. Another 2 patients stopped treatment voluntarily. The remaining 52 patients tolerated the drug well for the first 6 months and had a high level of compliance with treatment. In conclusion, stavudine is generally well tolerated and has significant antiretroviral activity when it is administered to patients with extensive previous treatment with multiple reverse transcriptase (RT) inhibitors.