A prospective study of highly active antiretroviral therapy in a tertiary-care hospital in south India

Abstract

Background: Acquired immunodeficiency syndrome (AIDS) caused by human immunodeficiency virus (HIV) is an important health concern worldwide, and AIDS-related morbidity and mortality have seen a sharp decline due to the introduction of highly active antiretroviral therapy (HAART). To address the problems of high cost, poor compliance, lack of awareness, social stigma, and occurrence of adverse effects in India, National AIDS Control Organization (NACO) has organized a simplified drug regimen with regular monitoring, counseling, and follow-up by specially trained personnel with necessary laboratory facilities and infrastructure. Objectives: The present study was taken up to assess the efficacy of the NACO-recommended HAART regimen in subjects with HIV in the south Indian population. Materials and Methods: HAART, consisting of two nucleoside reverse transcriptase inhibitors and one non-nucleoside reverse transcriptase inhibitor, was instituted in 158 properly selected subjects. The initial therapy in most of the subjects was zidovudine (AZT)+lamivudine (3TC)+nevirapine (NVP). AZT was substituted by stavudine (d4T) in patients with Hb %o8 g, whereas NVP was substituted by efavirenz (EFV) in the event of non-availability, adverse effects, or possible interactions. All subjects received cotrimoxazole prophylaxis. Patients were monitored at regular intervals for 24 weeks. Efficacy was assessed by response based on CD4 count; total lymphocyte count; and improvement assessed in terms of general health, weight gain, functional status, and improvement in WHO clinical staging. Results: There was good clinical improvement with increase in CD4 count in the majority of the subjects. Antiretrovirals were well tolerated, with only mild, tolerable, and controllable adverse events, and death occurred only in 5.71% the subjects. Conclusion: The NACO-sponsored HAART regimen was found to be effective and well tolerated in the majority of the subjects, with minimum and tolerable adverse effects.

A Prospective Study of Antiretroviral Therapy Naive Patients in Tertiary Care Hospital, Maharashtra

“…(15,16,17) The overall incidence of OIs occurring during the study period was 28.33%. A similar pattern of OIs have been reported by a study conducted in Banglore, India by Kumaraswamy et al (6) Other studies have also reported an almost similar pattern of OIs like tuberculosis, candidiasis, diarrhoea, herpes zoster, PCP, cryptococcal meningitis, cerebral toxoplasmosis, cytomegalovirus retinitis. (18,19) However, the incidence of tuberculosis and herpes zoster in the present study is very low and none of the patient had PCP, cryptococcal meningitis, cerebral toxoplasmosis or cytomegalovirus retinitis.…”

“…All the subjects received cotrimoxazole prophylaxis from baseline till the raise of CD4 count to >350 cells/mm 3 . Other studies conducted by Kumaraswamy et al (6) and Seddon et al (20) have reported similar pattern of drug therapy for OIs which mainly included ATT, antifungal drugs (clotrimazole, fluconazole), antiviral drugs (acyclovir, ganciclovir), cotrimoxazole (therapeutic dose for PCP) and pentamidine inhalation (for PCP) and other antibiotics depending upon the type of infections. Thus, the present study indicates that the NACO recommended HAART involving 2NRTIs and 1NNRTI has shown good efficacy in overall clinical improvement, increasing the CD4 count and preventing OIs, even with the limited observation period and follow up of six months, and also good tolerability with mild tolerable, selflimiting and controllable adverse effects.…”

“…Similar pattern of ART substitutions has been reported in other studies. (6,7) Table 2 summarizes the outcome of antiretroviral therapy on the basis WHO clinical stage, weight (kg) and functional status at the end of six months. Out of 120 subjects included for the study, only 109 subjects were available for the follow up monitoring at the end of six months.…”