Adverse effects of antiretroviral treatment at a tertiary care hospital in India: a prospective observational study

Sweta V. Vaghani, Ashok K. Gagiya, Deepak K. Shukla, Vishal P. Patel


Background: Data on adverse drug reactions (ADRs) related to antiretroviral (ARV) use in public health practice are few indicating the need for antiretroviral therapy (ART) safety surveillance in clinical care.

Methods: 143 patients on ART were studied prospectively over a period of two years. All patients were asked to visit the clinic if they developed any symptoms or on a monthly basis. They were screened clinically and investigated suitably for any ADRs.

Results: 143 HIV positive patients were analyzed. At least one ADR was seen in 87 (60.83%) subjects. The most common ADR observed was peripheral neuropathy in 54 (37.76%) patients, followed by lipodystrophy (13.98%), anemia (10.48%) and hyperlipidemia (6.29%). Patients with peripheral neuropathy and lipodystrophy were mainly on stavudine based regimes, while patient with anemia and hyperlipidemia were on zidovudine based regimes.

Conclusions: In spite of high ADRs, highly active antiretroviral therapy (HAART) is the only answer to HIV/AIDS. To optimize adherence and thus, efficacy of ART, clinicians must focus on preventing adverse effects whenever possible, and distinguish those that are self-limited from those that are potentially serious.


Adverse drug reaction, Antiretroviral therapy, Acquired immune deficiency syndrome

Full Text:



Murri R. Highly active antiretroviral therapy. BMJ 2005;330:681-2.

National AIDS Control Organization. Ministry of Health and Family Welfare, Government of India. Antiretroviral Therapy Guidelines for HIV-Infected Adults and Adolescents Including Post-exposure Prophylaxis. May 2007.

Subbaraman R, Chaguturu SK, Mayer KH et al. Adverse Effects of Highly Active Antiretroviral Therapy in Developing Countries. Clinical Infectious Diseases 2007;45:1093-101.

Nagpal M, Tayal V, Kumar S, et al. Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study. Indian Journal of Medical Sciences 2010;64:245-52.

d'Arminio Monforte A, Lepri AC, Rezza G, Pezzotti P, Antinori A, Phillips AN, et al. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naïve patients. I.C.O.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients. AIDS 2000;14:499-507.

Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Ann Intern Med 1999;131:81-7.

Valentina Montessori, Natasha Press, Marianne Harris. Adverse effects of antiretroviral therapy for HIV infection. CMAJ 2004,170:229-38.

International monitoring of adverse reactions to drugs. WHO Adverse Reaction Terminology, The Uppsala Monitoring Centre: Uppsala, 2007.

Fellay J, Bousaker K, Ledergerber B, Bernasconi E, Furrer H, Battegay M, et al. Prevalence of adverse drug events associated with potent antiretroviral treatment: Swiss HIV cohort study. Lancet 2001;358:1322-7.

Singh H, Dulhani N, Tiwari P, Singh P, and Sinha T. A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resource-restricted tribal population of Chhattisgarh. Indian J Pharmacol 2009;41:224-6.

Sharma A, Vora R, Modi M, Sharma A, Marfatia Y. Adverse effects of antiretroviral treatment. Indian J Dermatol Venereol Leprol 2008;74:234-7.

Kumarasamy MP, Balakrishnan. Safety, tolerability and effectiveness of locally produced generic antiretroviral drugs in persons with HIV disease in Southern India. Int Cong Drug Ther HIV 2002;6:298.

Balakrishnan K. Safety, tolerability and effectiveness of locally produced generic antiretroviral drugs in persons with HIV disease in Southern India. Int Cong Drug Ther HIV 2002;6:298.

Saint-Marc T, Partisani M, Poizot-Martin I, Bruno F, Rouviere O, Lang JM, et al. A syndrome of peripheral fat wasting (Lipodystrophy) in patients receiving long term nucleoside analogue therapy. AIDS 1999;13:1659-67.

Jena A, Sachdeva RK, Sharma A, Wanchu A. Reverse Transcriptase Inhibitor-Based Antiretroviral Regimen: A 24-Week Prospective Study. Journal of the International Association of Physicians in AIDS Care (JIAPAC) 2009;8:318-22.

Maniar J, Desai S. Antiretroviral therapy: Real challenges for developing World. Int Cong Drug Ther HIV 2000;5:249.