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




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Journal of Pharmaceutical Policy and Practice

, 9:5

First Online: 15 February 2016Received: 09 March 2015Accepted: 27 January 2016DOI: 10.1186-s40545-016-0054-x

Cite this article as: Kalemeera, F., Mengistu, A.T. & Gaeseb, J. J of Pharm Policy and Pract 2016 9: 5. doi:10.1186-s40545-016-0054-x

Abstract

BackgroundClinical 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.

MethodsAutomated dispensing records from January 2008 to November 2011 were accessed from the National Antiretroviral Dispensing Database NDB. Records of patients who were initiated on NVP-based ART were selected, and records showing a replacement of NVP with protease inhibitor PI were identified. The proportions of grade III and IV reactions were calculated per quarter, and Odds Ratios OR were calculated, with the confidence interval set at 95 % and a p-value of <0.05.

ResultsFrom 2008 to 2011 a total of 84,741 patients were started on ART. Of these 67,794 were initiated on NVP-containing ART. Of these, 211 females and 79 males were substituted from NVP to a PI. The OR for females was 2.4 95 % confidence interval CI 1.8 – 3.1. For males the OR was 2.4 OR 2.4; 95 % CI 1.4 – 3.8 which occurred nine months after the change observed in the females. The odds of a NVP-to-PI substitution in females compared to males before the launch of Namibia’s 2010 ART guidelines was the same as the odds after the publication of the guidelines before, OR 1.6; 95 % CI 1.1 – 2.5; after, OR 1.6; 95 % CI 1.2 – 2.2.

ConclusionsThere was an increase in substitutions of NVP with a PI following the increase in the CD4 threshold for initiating NVP-based HAART, meaning that there was an increase in grade III and IV reactions associated with NVP. Therefore the NVP-safety signal was confirmed to be a true signal, which contributed to the Ministry’s decision to review the use of NVP.

KeywordsNevirapine Reaction ratio Proportional reaction ratio Adverse reaction Signal Skin Liver Grade III Grade IV Abbreviations3TClamivudine

AMRadverse medicine reaction

ARadverse reaction

ARTantiretroviral therapy

ARVantiretroviral

CIconfidence interval

DHHSDepartment of Health and Human Services

NDBNational antiretroviral Dispensing Database

FTCemtricitabine

HAARThighly active antiretroviral therapy

HCWhealth care workers

HIVhuman immunodeficiency virus

MOHSSMinistry of Health and Social Services

NRTInucleoside reverse transcriptase inhibitors

NVPnevirapine

OROdds Ratio

PIprotease inhibitor

SDstandard deviation

TDFtenofovir

TIPCTherapeutics Information and Pharmacovigilance Centre

WHOWorld Health Organization

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Author: Francis Kalemeera - Assegid T. Mengistu - Johannes Gaeseb

Source: https://link.springer.com/







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