Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy

Abstract

Background and Objectives The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the ‘probable' category (60.1%), and the rest were “possible”. ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

Evaluation of adverse drug reactions of first line antiretroviral drugs in a tertiary care centre of Telangana, India

“…16,17 The most commonly reported ADR towards tenofovir is gastrointestinal effects; tenofovir induced nephrotoxicity is explained by mitochondrial DNA depletion which causes mitochondrial toxicity; other reactions seen towards other NRTIs are less common with Tenofovir. [18][19][20] Causality assessment of ADRs as per WHO-UMC causality revealed 76.5% of adverse events as probable and 23.4% were found to be possible in the study. It is important to perform causality assessment according to WHO causality assessment scale of the suspected drug reaction in order to determine whether drug discontinuation is mandatory as well as to put emphasis on patient education in order to avoid development of adverse events in the future.…”

Mitochondrial Toxicogenomics for Antiretroviral Management: HIV Post-exposure Prophylaxis in Uninfected Patients

“…Regarding clinical manifestations and despite its short length (28 days according to up-to-date guidelines), serious complications were raised: the low compliance, the appearance of several secondary or toxic effects, and the little commitment of some patients led to further discontinuation of AZTcontaining regimens, herein demonstrated. As previous reported, the main secondary effects for both of these regimens that led to discontinuation were gastrointestinal symptoms (Chowta et al, 2018). These clinical side effects make PEP prone to become a difficult treatment to be fully completed.…”

Tenofovir Based First Line Therapy in Newly Diagnosed Case of HIV Infection: An Experience from a Tertiary Care Hospital in India

“…Most common ADR of gastro-intestinal system was anorexia (n = 11) followed by increased appetite (n = 9), atulence (n = 7), diarrhoea (n = 4) and gastritis (n = 4). Most common ADR of skin was maculopapular skin rashes (8) followed by itching (5). Neutropenia (n = 7) was the common laboratory abnormality seen in patients.…”