title: Adverse Drug Reaction Profile in Patients on Anti-tubercular Treatment Alone and in Combination with Highly Active Antiretroviral Therapy.
abstract: OBJECTIVE
  Adverse drug reactions are very common among patients on anti-tubercular treatment alone or in combination with highly active antiretroviral therapy but comparatively studied very less. Hence, the current study was done to evalaute the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT) and ATT with highly active antiretroviral therapy (HAART).
  
  
  METHODS
  A one year prospective, cross-sectional observational study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India.
  
  
  RESULTS
  Seventy four patients receiving ATT & 32 patients on both ATT & HAART presented with 74 and 45 adverse drug events (ADE) respectively. Males were more affected than females in both the groups. DOTS category- 1 regimen was mostly responsible for ADE in both the groups. Epigastric pain was the most common ADE in TB patients, while anaemia was the most common presentation in TB with HIV group. On comparison, ADE rate of TB with HIV co-morbid patients was more (55.8%) than TB patients (0.36%) (p < 0.001). Urban population presented more with ADR in TB/HIV group unlike rural population in TB group (p<0.0001). Whereas, illiterate were more involved in TB group unlike literate in TB/HIV group (p<0.05). Type A reactions were more common in TB group (p < 0.001). Addition of drugs for the management of ADR events was more in TB/HIV group (p < 0.001) as compared to TB group. Rest all the parameters were comparable.
  
  
  CONCLUSIONS
  The study underscores that concomitant HAART and ATT, result in more ADRs in comparison to ATT alone demanding collaboration & integration of National AIDS Control programme and PvPI to enhance drug safety in this field.
authors.affiliation: Postgraduate, Department of Pharmacology and Therapeutics, GMC , Jammu, India .
authors.forename: Shamiya
authors.initials: S
authors.lastname: Sadiq
authors.affiliation: Associate Professor, Department of Pharmacology and Therapeutics, GMC , Jammu, India .
authors.forename: Vijay
authors.initials: V
authors.lastname: Khajuria
authors.affiliation: Assistant Professor, and In-charge ADRM Centre (Under PvPI) Postgraduate Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu, J&K, India .
authors.forename: Vishal R
authors.initials: VR
authors.lastname: Tandon
authors.affiliation: Professor and Head, Department of Internal Medicine, Govt Medical College , Jammu, J&K, India .
authors.forename: Annil
authors.initials: A
authors.lastname: Mahajan
authors.affiliation: Lecturer, Department of Internal Medicine, Govt Medical College , Jammu, J&K, India .
authors.forename: Jang B
authors.initials: JB
authors.lastname: Singh
keywords: HIV; Pharmacovigilance; Tuberculosis