Efficacy and Tolerability of Tenofovir/Lamivudine/Dolutegravir among Antiretroviral Therapy Naive Human Immunodeficiency Virus Infected Patients of a Tertiary Care Center in Eastern India.

BACKGROUND: Although many drug regimens have been used in the treatment of human immunodeficiency virus (HIV) infection, the National AIDS Control Organization (NACO) of India recommends the use of a fixed-dose combination of tenofovir/lamivudine/dolutegravir (TLD) as a first-line regimen since 2020. In spite of much global data on the use of this combination, experience in the Indian population is still limited. We aim to find out the efficacy and tolerability of this novel regimen, in a tertiary care center of Eastern India. MATERIALS AND METHODS: A descriptive observational study, longitudinal in design performed in the antiretroviral therapy (ART) center of a tertiary care hospital in Kolkata, West Bengal, India. All patients who attended the ART center from April 2021 to October 2022 were enrolled in the study following inclusion and exclusion criteria. A detailed history, clinical examination, necessary biochemical tests, and CD4 count of all patients were done at baseline. Subsequently, they were followed up for 6 months with monthly visits when they were enquired about any adverse effects requiring therapy interruptions. At the end of 6 months, CD4 count and viral load were measured. RESULTS: Out of a total sample of 249 patients, the TLD regimen was efficacious in 99.2% (n = 247) in whom viral load was suppressed to <1,000 copies/mL after 6 months of treatment. The regimen had to be temporarily discontinued in 6% of patients (n = 15). The most common cause of treatment interruption was hepatic dysfunction (3.2%) followed by cutaneous manifestation (2.4%). In 14 out of 15 patients, the regimen could be reintroduced and was safely tolerated afterward. Only one patient had to be shifted to an alternative regimen due to tenofovir-induced nephrotoxicity. Thus TLD was tolerated in 99.6% (n = 248) patients. CONCLUSION: The fixed-dose combination of TLD is a highly efficacious and well-tolerated first-line regimen for ART naïve patients with HIV infection having >95% adherence. How to cite this article: Sengupta D, Ghosh S, Pain S, et al. Efficacy and Tolerability of Tenofovir/Lamivudine/Dolutegravir among Antiretroviral Therapy Naive Human Immunodeficiency Virus Infected Patients of a Tertiary Care Center in Eastern India. J Assoc Physicians India 2023;71(9):72-74.

An Observational Study on Metabolic Derangements in People Living with HIV.

BACKGROUND: HIV infection is a global pandemic. The adult HIV prevalence in India is 0.22%. Successful therapy is transforming HIV into a chronic medical condition, and there are many metabolic complications. This study aimed to evaluate the metabolic abnormalities in people living with HIV (PLHIV) who were on antiretroviral therapy (ART) for at least 2 years and compare it with ART-naïve patients as well as the effect of protease inhibitor-based (PI-based) and non-protease inhibitor-based (non-PI-based) ART was assessed. METHODOLOGY: Adult HIV-positive patients both ART-naïve and on ART for more than 2 years were included. Detailed history and clinical examination, including blood pressure and anthropometric measurements were done. This was followed by investigations like lipid profile including total cholesterol, triglyceride, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), fasting plasma glucose, and hemoglobin A1c (HbA1C) estimation. Standard statistical tools were utilized to assess derangements and association to therapy. RESULTS: The study was conducted for 1.5 years in a tertiary care hospital. A total of 70% of the study population was male with mean age of participants being 43.2 years, 40% were ART-naïve, 37% received non-PI-based ART, and 23% PI-based ART. The mean total cholesterol level and mean triglyceride value were significantly higher in the PI-based ART group than in the therapy-naïve group. The ART-naïve group was seen to have more subjects with abnormally low HDL-C values. The PI-based ART study subjects were found to have a greater number of cases of glucose intolerance in relation to the rest of the two groups significantly (p-value <0.001). The LDL-C systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI), and waist circumference had no association with the different ART regimens or with the HIV infection itself. CD4 T cell count at diagnosis in the three study groups was compared with all the variables of metabolic syndrome and no association was found. CONCLUSION: Total cholesterol, triglycerides, and glucose levels are the main parameters found to be affected in PLHIV on therapy.

Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome?

BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) is a chronic relapsing disorder characterized by abdominal pain-discomfort and altered bowel habits. The IBS-diarrhoea predominant subtype (IBS-D) is defined as >25% of bowel movements representing type 6 or 7 of the Bristol Stool Form Scale. Management of IBS-D is mainly symptomatic, including lifestyle modification. Due to absence of standard treatment, multiple drugs are used. A controlled release (CR) form of mebeverine, recommended for spasmodic gastrointestinal disorders (including IBS) has recently been introduced in Indian market. We have conducted a placebo-controlled double blind randomized controlled trial [CTRI/2018/03/012897] to evaluate the effectiveness and safety of this product. METHODS: 40 patients of IBS-D were recruited from medicine out-patient department (OPD) of a tertiary care hospital and randomized to two parallel groups. One received mebeverine 200 mg CR tablets twice daily for 8 weeks, while other received matching placebo. Outcome parameters were number of bowel movements per day over past 7 days (NoBM7d), severity of abdominal cramps and IBS quality of life (IBSQoL) score. Medication adherence record and treatment emergent adverse events were captured. RESULTS: Mebeverine group showed modest but statistically significant improvement in NoBM7d, cramps and IBSQoL from baseline to 4 and 8 weeks. The changes within the placebo group were not statistically significant. Also, the intergroup differences at both 4 and 8 weeks were not statistically significant. Adherence was better in mebeverine group and both interventions were well tolerated. CONCLUSIONS: Mebeverine 200 mg CR twice daily has modest effect in IBS-D and therefore will not be a good choice for patients with severe symptoms.

A Study on Deliberately Self-Poisoned In-Hospital Patients in a Tertiary Health Care Center in Northeast India: A Cross-Sectional Review.

BACKGROUND: The nature and profile of different modes of poisoning vary significantly in different parts of India. The assessment of the magnitude of suicidal poisoning is an area of paramount importance not only for appropriate management but also for raising social awareness and framing government policies for the prevention of same. OBJECTIVES: We aimed to determine the pattern of poisoning, the sociodemographic profile of patients who poison themselves, and the in-hospital outcome of self-poisoned patients over a 1-year period. METHODS: This was a cross-sectional observational study conducted between May 2015 and April 2016 that included 492 patients >12 years of age who were admitted to our hospital after consuming poison with the intention of deliberate self-harm. Relevant history with respect to the nature and amount of poison ingested were taken and recorded, and the patients' sociodemographic profiles and outcome (as either discharge or death) were noted. RESULTS: Most of the patients were 13-28 years of age (69%). Males (n = 293 [59.55%]) predominated over females and the majority were farmers (n = 193 [39.23%]). Rural cases (n = 373 [75.81%]) outnumbered urban cases. The major causes of deliberate self-harm attempts were impulsive actions (n = 442 [89.84%]). Pesticides (n = 393 [79.88%]) were the most commonly consumed poison. The overall mortality rate was 12%, with paraquat (94.74%) topping the list of fatal substances. CONCLUSION: Young adults and males constitute majority of the population in this study. Agricultural poisons made up the bulk of the cases, mostly taken by rural population. Paraquat, an herbicide banned in several countries, had the highest mortality rate in this study.

Characterization of human immunodeficiency virus-infected patients of suspected first-line antiretroviral treatment failure within 5 years - Evidence from a tertiary hospital, Kolkata.

OBJECTIVES: Antiretroviral therapy (ART) has immense survival benefit on human immunodeficiency virus (HIV)-infected people. However, every year, a proportion of patients were failing to the first-line drugs. The aim of this study is to characterize the patients developing first-line failure within 5 years of ART. MATERIALS AND METHODS: A retrospective observational study was carried out at the Centre of Excellence in HIV care, School of Tropical Medicine, Kolkata. A total of 190 referred patients' data of suspected first-line treatment failure who failed first-line ART within 5 years of initiation were collected and analyzed using R software. RESULTS: Among 190 patients, 100 (52.4%) patients had virologic failure. Male patients 78 (41.05%) outnumbered females 22 (11.57%) and needed to switch to the second-line drugs. The median age was 37 years (range 8-65 years), and the median duration of first-line ART taken was 2.85 years. Among the first-line failed patients, zidovudine, lamivudine, and nevirapine (23.6%) was the most common antiretroviral regimen and 77 (40.5%) referred in the WHO stage I of illness. Seventy-three (38.42%) patients were referred for immunological failure, 26 (13.7%) for both immunological and clinical failure, and only 1 (0.52%) had only clinical failure at the time of referral. We found a significant association of suboptimal adherence (P < 0.05) and high viral load in this study. CONCLUSION: This study enables that poor adherence was the most important factor responsible for the first-line treatment failure. As adherence is a dynamic process, interventions in every visit following ART initiation should be optimized, and a multidisciplinary approach toward adherence is needed to get the highest treatment outcome benefit.

Study of bone marrow changes in antiretroviral naive human immunodeficiency virus-infected anemic patients.

BACKGROUND: Bone marrow changes are common throughout the course of HIV infection. There is scanty data addressing this issue in Indian subcontinent. The present study was aimed at characterizing the bone marrow changes in the antiretroviral naive HIV-infected Indian patients with anemia. MATERIALS AND METHODS: This was a nonrandomized cross-sectional observational study undertaken over a period of 2 years. Forty-six randomly selected patients with documented anemia served as the study population. None of them was on any antiretroviral therapy or suffering from any known causes of anemia. All the patients underwent thorough evaluation, including bone marrow examination. RESULTS: Majority of the patients had normocytic-normochromic anemia (63%), in tune with the available data. In most of the cases bone marrow was hypercellular (63.04%), although in a significant proportion it was found to be hypocellular (19.57%). Erythropoiesis was suppressed in 36.96% of patients. Dysplastic changes involving isolated cell lines ranged from 13.04% to 45.65%, dysmegakaryopoiesis being the most common, followed by dyserythropoiesis. Marrow plasmacytosis was detected in 23.91% of patients. No statistically significant correlation was detected in between immunological status (CD4 count) and marrow cellularity, myelodysplastic changes or marrow plasmacytosis. In a fair number of cases bone marrow examination aided in the diagnosis of opportunistic infections. CONCLUSIONS: Bone marrow changes are common in Indian HIV-infected anemic population, particularly in the advanced stages of the disease. HIV infection should be considered in the differential diagnosis of patients with secondary myelodysplasia or unexplained bone marrow changes.

Diagnostic yield of bone marrow examination in HIV associated FUO in ART naïve patients.

A bone marrow (BM) aspiration and biopsy is often believed to be a much needed diagnostic procedure in the work up of patients with fever of unknown origin (FUO), especially in the setting of AIDS. Is it worthwhile to proceed with this invasive diagnostic method? The usefulness of a BM aspiration or biopsy to assist in the diagnosis of FUO or prolonged fever in AIDS patients has been reported previously to range from 4% to 40%. The purpose of this study was to assess the usefulness of a BM aspiration and biopsy in diagnosing the cause of FUO in patients with AIDS and to identify the utility of the procedure for the diagnosis of malignancies/other hematological disorders resulting in the FUO. In this study, comprising of 30 patients, we have tried to find the diagnostic yield of bone marrow examination in finding the etiology of "FUO associated with HIV infection". Though similar studies have been reported in the literature but it is lacking from eastern India. The majority of BM examination in this series revealed infections followed by hematological disorders. Our study showed the diagnostic yield of bone marrow examination in "HIV associated FUO" to be 26.7%. It was found to be positive in 33.3% of the patients, who had the final diagnosis of an infective etiology and 100% of the patients, who had a final diagnosis of an underlying hematological etiology.

Echocardiographic profile of ART naïve human immunodeficiency virus (HIV) infected patients in a tertiary care hospital in Kolkata.

AIMS AND OBJECTIVE: Cardiac affection in human iummunodeficiency virus (HIV) infection is a recognized entity. Some form of heart disease is demonstrable at autopsy in approximately 40 percent of cases and by echocardiography in approximately 25 percent of patients with HIV. the studies indicate that cardiac involvements associated with HIV are mainly characterized by cardiomyopathy and pericardial disease. HIV infection is a global pandemic which is also rapidly spreading in india. We conducted the study to have some insight into the profile oflndian patients. MATERIAL & METHODS: In this cross sectional hospital based study, we evaluated immunological (CD4 count) and echocardiographic status of 45 asymptomatic HIV seropositive patients who did not receive anti-retroviral therapy. The results were compared with age and sex matched controls. Statistical analysis was done using appropriate statistical methods. RESULTS: Most common cardiovascular abnormalities were diastolic dysfunction (18%) followed by pericardial effusion (13%) and systolic dysfunction (7%). When compared with controls the study population had statistically higher number of diastolic dysfunction (p value = 0.035) but not systolic dysfunction (p value = 0.61); none of the control population was having pericardial effusion. Low CD4 count was significantly associated with pericardial effusion (p value 0.048) but the association with diastolic dysfunction (p value = 0.46) or systolic dysfunction (p value = 0.84) was not statistically significant. CONCLUSION: Cardiovascular complications are common among HIV infected patients in india, most common being diastolic dysfunction and pericardial effusion. Low CD4 counts are associated significantly with pericardial effusion. These abnormalities are likely to be found with greater frequency in clinical practice as management of opportunistic infections continues to improve.

Rheumatological manifestations in diabetes mellitus.

A study was undertaken in the department of medicine from November 2003 to July 2005 with a view to find out the prevalence of different rheumatological problem in Indian diabetic population. Although several such studies have been conducted in western population very limited data are available from our country. A total of 80 patients were studied out of which 43 had some form of rheumatological manifestations. Dupuytren's contracture was found in highest number of cases (n = 23) followed by limited joint mobility in 16 patients; adhesive capsulitis in 19 patients; trigger finger in 4 patients; aglodystrophy, carpal tunnel syndrome and hyperostosis were found in 2, 3 and 2 cases respectively. Symptomatic osteo-arthritis was found in 19 cases.