Anti-retroviral therapy (ART) regimens and associated adverse events: A prospective observational study in a Tertiary Care Hospital of South Odisha

  • Chinmaya SopiMahapatra Department of Pharmacolgy, M.K.C.G. Medical College & Hospital, Berhampur, Odisha
  • Jai Prakash Senior PrincipalScientific Officer,Indian Pharmacopoeia commission, UP
  • Y Roja Ramani Department of Pharmacolgy, M.K.C.G. Medical College & Hospital, Berhampur, Odisha
  • Prasanna Kumar Kar ART centre, MKCG medical college, Odisha.
  • Supriya Sahoo ART centre, MKCG medical college, Odisha.


Background: HIV prevalence in Odisha has reduced to 0.13% from 0.31 % (2010) since the advent of antiretroviral therapy (ART).  It has been proven to be efficacious and also lifesaving in patients living with HIV (PLHIV). However their associated adverse events [AEs] are a matter of serious concern. Therefore the present study was conducted to evaluate the AEs following various ART regimens.

Methods: This was a prospective observational study (September 2018 - August 2019) among PLHIV and receiving ART from the outpatient setting of ART centre of M.K.C.G. Medical College & Hospital, Berhampur, Odisha. Data were collected and analyzed to find out the demographic characteristics, causality and severity of adverse events (AEs) with different ART regimens.

Results: The study showed that, 317 patients were identified to be suffering from one or more adverse events. Female gender, 40-49 years age group were more prone to adverse events. Among them, Eight (8) cases were labeled as serious category and were hospitalized. 97.5% patients were graded as possible’ [WHO-UMC causality assessment scale]. Patients were administered 10 types of ART regimen of which most AEs (217) were observed with Tenofovir + Lamivudine + Efavirenz (TLE). Most commonly observed adverse events were acid peptic disease (89), myalgia (85), acute respiratory tract infection (18), anemia (15), neuritis (15).

Conclusion: ART regimen has considerably reduced the morbidity and mortality of PLHIV, but increased numbers of AEs, demands intensive monitoring and timely intervention for tackling the associated AEs to improve patient compliance and quality of life.