Vol. 2, Issue 12, Part L (2016)

Methodology: The study was a prospective, observational and descriptive study done at Siddhartha Medical College, Vijayawada from December 2015 to November 2016.

Results: All patients underwent disease staging as per WHO staging and underwent evaluation as per NACO guidelines. 200 patients which consisted of male and female patients (M:F=1.2:1) with an mean age of 34.9+9.6 yrs (16 to 70 yrs) were recruited for the study. The mean age of female was lower than that of male [32.1+10.1yrs (16 to 70yrs) Vs 37.2+8.5yrs (23 to 66yrs)]. Nearly 3/4^thof the study population was between 3^rd to 4^th decades. 3.5% of our patients were under 20 yrs of age (16yr to 20yrs). One third of our population was illiterates and more than 80% were unskilled workers. Loss of weight and appetite was reported by 2/3^rd of our patients as a presenting symptom. More than 1/3^rd had BMI<18.5. Those who had loss of weight at the time of recruitment also showed a positive trend towards higher prevalence of ADR (p=0.088). Most of our patients had advanced disease with 37.5% having stage IV followed by stage I (22.5%), stage II (2.5%) and stage III (18.5%). However, within six months of HAART therapy, nearly half of the patients with stage IV changed over to lower stage of the disease demonstrating the efficacy of treatment even within shorter duration. The major opportunistic infection in our study population was caused by M. Tuberculosis with pulmonary manifestations (50%). Nevirapine base regime was instituted in nearly 2/3^rd of our patients. Almost one third were on Efavirenz base regime and only 3% were on Stavudine base regime. Unlike other Indian studies, the compliance was 100% which may suggest more efficacies in the health care system. Less than one third required interchange of regime due to ADR or drug interactions. Almost 2/3^rd of our patients (60%) manifested with the adverse drug reactions within six months of HAART. Gastrointestinal manifestations were the most common ADR in our patients (40.8%) which was followed by fatigue (25.9%). Other ADR included hematological (17.3), dermatological (7.1%), head ache (5.1%), IRIS (1.6%), lactic academia (0.8%), peripheral neuropathy (0.8%) and vivid dreams (0.4%). Dermatological manifestations such as skin rashes and nail hyperpigmentation correlated significantly with the nevirapine use (p=0.008). Peripheral neuropathy was significantly more with the stavudine base regime (p=0.05). Although the mean CD4 count was lower in patients with opportunistic infection, this was not statistically significant (153.96+112.55 Vs 166.25+83.81 cells/cmm; p=0.392).

Conclusion: More research is needed to develop low-cost investigations and algorithms for prediction of adverse drug reactions to existing regimes, along with the generations of more efficacious and less toxic drugs.