Randomized,controlled study of the effects of a short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1

OBJECTIVE: To examine the effect of 2 weeks of treatment with prednisone on the incidence of nevirapine-associated rash in HIV-1-infected patients receiving combination antiretroviral therapy. METHODS: This was a 24-week, prospective, randomized, open-label, international study. Patients were randomized to receive nevirapine plus open-label prednisone (40 mg once daily for 14 days) (n = 69) or nevirapine alone (n = 69). All patients received at least two other antiretroviral drugs. Nevirapine was administered at the lead-in dosage of 200 mg once daily. After the initial 2 weeks of the study, the nevirapine dosage was increased to 200 mg twice daily. RESULTS: During the first 6 weeks of treatment, rash was not reduced in the patients who received prednisone: prednisone treatment group, 23 (33%)/69; nonprednisone treatment group, 13 (19%)/69 (one-tailed Fisher exact test for prednisone reducing the incidence of rash, p =.984). There tended to be more severe rashes (7% versus 1%, respectively) and more therapy discontinuations due to rash (16% versus 9%, respectively) in the prednisone treatment group than in the nonprednisone treatment group. Risk factors for rash included higher pretreatment CD4 cell count, lower HIV-1 RNA level, female sex, and higher trough nevirapine concentrations. The prednisone treatment group had a marked increase in the median CD4 cell count in the first 2 weeks, which stabilized at a level similar to that in the nonprednisone treatment group. HIV-1 RNA responses were similar between the two groups. Treatment-naive patients had similar decreases in plasma HIV-1 RNA levels at week 24: approximately 2.3 log(10) copies/mL. CONCLUSIONS: This study demonstrated that 2 weeks of concomitant therapy with prednisone does not decrease the occurrence of nevirapine-associated rash. The use of prednisone is not recommended to prevent rash in patients receiving nevirapine. Prednisone administration had no adverse effects on the virological responses or on CD4 cell count changes at 24 weeks.