title: Incidence of atazanavir- associated adverse drug reactions in second -line drugs treated south Indian HIV-1 infected patients.
abstract: BACKGROUND
  Ritonavir-boosted atazanavir (ATV/r) is the preferred second-line protease inhibitor (PI) option for HIV patients in resource-limited settings; its pattern of adverse drug reactions (ADRs) has not been much reported from India; hence, in this study, we have analyzed the incidence of ATV/r-associated ADRs in Southern Indian HIV-1-infected patients.
  
  
  METHODS
  In this prospective study, 111 HIV patients treated with ATV/r were included with at least 2 years follow-up visits for the emergence of hyperbilirubinemia, hypertransaminasemia, and serum creatinine elevation. The causality assessment was done based on the WHO scale for the causality assessment of suspected ADR.
  
  
  RESULTS
  The incidence of severe hyperbilirubinemia, hypertransaminasemia, and creatinine elevation was 28.6, 0.76, and 1.62 cases/100 person years, respectively. 3TC/FTC + TDF (odds ratio [OR]: 6.07, confidence interval [CI]: 1.31-27.98,P= 0.015) nucleos (t) ide reverse transcriptase inhibitor backbone and male sex (OR: 18.64, CI: 2.13-162.93,P= 0.0082) were found to be significantly associated with hypertransaminasemia and creatinine elevation, respectively. The causality assessment of ADR was "possible" for all the participants. Kaplan-Meier analysis showed hyperbilirubinemia to emerge earlier (mean duration: 32.18 months, CI: 24.9-39.4 months) followed by hypertransaminasemia and creatinine elevation. Hyperbilirubinemia is an expected side effect associated with ATV/r which is benign, transient, and does not predispose to hypertransaminasemia.
  
  
  CONCLUSIONS
  Our study results show that patients starting ATV/r should be counseled for a good adherence in spite of the emergence of hyperbilirubinemia which generally reverts to normal range.
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Dhakshinamoorthy
authors.initials: D
authors.lastname: Subashini
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Thongadi Ramesh
authors.initials: TR
authors.lastname: Dinesha
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Jayaseelan
authors.initials: J
authors.lastname: Boobalan
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Lawrence Christopher
authors.initials: LC
authors.lastname: Samuel
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Selvamuthu
authors.initials: S
authors.lastname: Poongulali
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Ambrose
authors.initials: A
authors.lastname: Pradeep
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
authors.forename: Sunil Suhas
authors.initials: SS
authors.lastname: Solomon
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Suniti
authors.initials: S
authors.lastname: Solomon
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Pachamuthu
authors.initials: P
authors.lastname: Balakrishnan
authors.affiliation: Y.R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Hospital, Chennai, Tamil Nadu, India.
authors.forename: Shanmugam
authors.initials: S
authors.lastname: Saravanan
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001219:Aspartate Aminotransferases / Q000097:blood; D000069446:Atazanavir Sulfate / Q000009:adverse effects* / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000097:blood / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D015497:HIV-1; D006801:Humans; D006932:Hyperbilirubinemia / Q000097:blood / Q000139:chemically induced* / Q000453:epidemiology; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio
chemical_list: D019380:Anti-HIV Agents; D000069446:Atazanavir Sulfate; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: Adverse drug reaction; atazanavir; creatinine; hyperbilirubinemia; liver