Assessment of the nevirapine safety signal using data from the national antiretroviral dispensing database: a retrospective study

Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based antiretroviral therapy (ART) was initiated in female and male patients with baseline CD4 cell counts ≥250 and ≥400, respectively. Some studies reported no difference in risk between the high and low CD4 count groups. Consequently, the use of NVP-based ART in all patients with a CD4 cell count <350, was recommended. In 2011, the Pharmacovigilance Centre detected an increase in reports of grade III and IV reactions. The center was required to determine if there was an increase in NVP-related reactions.

Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based antiretroviral therapy (ART) was initiated in female and male patients with baseline CD4 cell counts ≥250 and ≥400, respectively. Some studies reported no difference in risk between the high and low CD4 count groups. Consequently, the use of NVP-based ART in all patients with a CD4 cell count <350, was recommended. In 2011, the Pharmacovigilance Centre detected an increase in reports of grade III and IV reactions. The center was required to determine if there was an increase in NVP-related reactions.