A study on adverse drug reactions to first-line antiretroviral therapy in HIV infected patients at a tertiary care hospital in Northeast India

Background

Assam state of Northeast India is surrounded with the states which are very critical in terms of HIV/AIDS. The first line drugs recommended by National AIDS Control Organization for the treatment of HIV infected patients consist of zidovudine (AZT), lamivudine (3TC), nevirapine (NVP), efavirenz (EFV), tenofovir (TDF), and stavudine (d4T). It was observed that the reporting of adverse drug reactions (ADRs) due to these antiretroviral drugs from this region is very low.

Aim

To study and identify adverse drug reactions to first line treatment in HIV infected patients reported by the nodal centre of antiretroviral therapy (ART) at a tertiary care hospital.

Method

In this cross-sectional study, 100 HIV infected patients with ADR were reported within 2 months from the nodal ART Centre of Gauhati Medical College and Hospital (GMCH) situated at Guwahati, Assam, Northeast India. WHO-system organ class-body system was used to classify reported ADRs. Causality assessments to reported ADRs were performed by using WHO-UMC causality assessment system.

Results

In this study, most of the patients have received TDF + 3TC + EFV (83%) regimen followed by AZT + 3TC + NVP (10%), AZT + 3TC + EFV (4%), TDF + 3TC + NVP (2%), and d4T + 3TC + EFV (1%). Efavirenz was commonly implicated drug which was suspected in 81 patients. In this study, 216 ADRs were reported during study period. Of which, 87 ADRs were related to nervous system disorders and 81 ADRs were under gastrointestinal disorders as per WHO-system organ class-body system. Vertigo (22.68%) and vomiting (13.88%) were commonly reported ADR. In this study, substitution of ART regimen was done in 15 patients after detecting ADR while in 85 patients regimen was continued without any change. As per WHO-UMC causality assessment system, causality was possible in 85 patients while it was probable in 15 patients.

Conclusion

Vertigo and vomiting were the most commonly reported ADR and regimens containing EFV were more likely to induce ADR.