Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial.

BACKGROUND: A randomized interventional phase 4 study in the Indian population confirmed the non-inferiority of the combination tenofovir/lamivudine/efavirenz (TLE)-400 to TLE600. The current manuscript describes in detail the safety profile and patient-reported safety outcomes obtained from the phase 4 study. METHODS: This investigation was part of a phase 4 non-inferiority study with a blinded assessment, conducted across 17 sites in India. The duration of the study was 24 weeks. Safety endpoints assessed included all the adverse events (AEs) related to the study treatment (TLE400 and TLE600). The depression anxiety stress 21-item scale questionnaire and efavirenz-related symptom questionnaire were also used to measure depression, anxiety, stress, and patient experience. RESULTS: A total of 68 patients (52.3%) reported 261 AEs and 87 patients (64.9%) reported 379 AEs related to study treatment in TLE400 group and TLE600 group respectively, P = .037. The reported AEs associated with central nervous system disorders were lower in the TLE400 group with 41 patients (31.5%) to 61 patients (45.5%) in the TLE600 group. The change from mean baseline value for depression anxiety stress 21-item scale at week 28 in TLE400 group and TLE600 group was -5.1 and -6.2 respectively. Similarly, the mean change from baseline score of efavirenz-related symptoms at week 28 in TLE400 group and TLE600 group were -5.1 and -4.1 respectively. CONCLUSION: The low dose efavirenz (400 mg) in combination with tenofovir and lamivudine had a better safety and tolerability profile than the standard dose of efavirenz (600 mg) in combination with tenofovir and lamivudine. Thus, low dose efavirenz should be preferred over the standard dose.

Efficacy and safety of 400 mg efavirenz versus standard 600 mg dose when taken with tenofovir and lamivudine combination in Indian adult patients with HIV-1 infection: An open-label, interventional, randomized, non-inferiority trial.

BACKGROUND: To evaluate the non-inferiority of low dose efavirenz (400 mg) to standard dose efavirenz (600 mg), when taken in combination with tenofovir and lamivudine in Indian patients with HIV-1 infection. METHODS: An open-label, interventional phase IV study with blinded assessment was conducted across 17 sites in India. HIV-1-infected antiretroviral therapy-naive adult patients (≥18 years of age) with a plasma HIV-1 viral load of at least 1000 copies per mL were randomized to receive either tenofovir/lamivudine/efavirenz (TLE) 400 or TLE 600. The primary endpoint was the difference in the proportion of patients achieving < 200 copies per mL at the end of 24 weeks. RESULTS: A total of 265 patients were enrolled and were randomized in 1:1 ratio to TLE 400 group (130 patients) and TLE 600 group (135 patients). At week 24, the proportion of patients with a viral load of less than 200 copies per mL was 80.70% for TLE 400 and 78.95% for TLE 600 (difference 1.75%, 90% confidence interval: -7.01, 10.49) which was within the predefined margin of -10% (90% confidence interval). Significantly lower study drug-related adverse events were observed in TLE 400 group compared to TLE 600 group (52.30%, n = 68 vs 64.92%, n = 87; P = .037). The treatment discontinuation percentage was marginally higher by 2.08% in TLE 600 group. CONCLUSION: The fixed-dose combination of TLE 400 is non-inferior to TLE 600 in terms of viral suppression and has an improved safety profile over 24 weeks in adult Indian patients with HIV-1 infection.

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1.

Purpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients. Methods: This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ cell count from the baseline. Safety analysis was conducted using Safety Analysis Set and efficacy analysis was carried out using Full Analysis Set and Per protocol set. Results: A total of 288 patients were screened; 250 were enrolled; and 229 completed the study. 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. One event of decreased creatinine clearance led to study discontinuation. One serious event of pyrexia was reported, which was unrelated to the study drug. The most common AEs were headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract infections (6%). No deaths were reported. At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells. Conclusion: This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.

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

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.

A "Handy" tool for hypertension prediction: Dermatoglyphics.

BACKGROUND: Fingerprints studied by dermatoglyphics are unique for a given individual. It depends on the genetic makeup of an individual. Hypertension, a harbinger of many complications, is determined by genetic and environmental factors. In this observational study, we tried to find an association of palmar dermatoglyphic parameters and hypertension. METHOD: Two hundred fifty known hypertensives as cases and 250 normotensives as controls were enrolled after considering inclusion and exclusion criteria. Dermatoglyphic patterns on tips of fingers obtained by digital imaging were noted in both the groups, and "atd" angle was calculated using "screen protractor" software. Collected data were statistically analyzed to find any association between dermatoglyphic qualitative and dermatoglyphic quantitative patterns and hypertension. RESULT: Mean "atd" angle was higher in cases than in controls. Comparison of dermatoglyphic patterns in both the groups in various ways-both hands together, the right hand and left hand separately, similar fingers on right and left hand together, and similar fingers separately-was performed which revealed that at every level, whorls were more frequent in cases than in controls and that distribution of dermatoglyphic patterns were statistically significant in cases than in controls. CONCLUSION: Fingerprint patterns can be reliably used to identify individuals likely at risk for hypertension, and accordingly, preventive measures can be targeted. This subject area demands a need for further research and analysis with large sample size to allow dermatoglyphics to evolve into a cost-effective and handy tool for identifying individuals at risk of hypertension.

HIV-Related Knowledge among PLWHA Attending a Tertiary Care Hospital at Coastal South India-A Facility-Based Study.

BACKGROUND: Adequate knowledge about HIV/AIDS among people living with HIV (PLHIV) is essential for the prevention of HIV transmission. METHODS: A cross-sectional study consisting of 409 PLHIV aged ≥18 years were interviewed regarding their HIV-related knowledge, from April 2014 to April 2015. HIV-related knowledge was assessed using the HIV knowledge questionnaire 18 . Univariate and multivariate analyses were done to determine the factors associated with high HIV-related knowledge. Odds ratios with its corresponding 95% confidence intervals were reported. A value of P < .05 was considered to be statistically significant. RESULTS: Among 409 PLHIV, 46.2% had high HIV-related knowledge. Univariate analysis yields factors like upper socioeconomic status, those who are literates, unemployed, and adherent to antiretroviral therapy (ART) were associated with higher HIV-related knowledge. On multivariate analysis, upper socioeconomic status and adherence to ART were the factors that remained significantly associated with higher HIV-related knowledge. CONCLUSION: HIV-related knowledge among PLHIV can be improved through HIV educational programs.

In-Patient Mortality among PLHIV: A 7-Year Hospital-Based Retrospective Study in Coastal South India.

BACKGROUND: With the wide usage of highly active antiretroviral therapy, the morbidity and mortality due to HIV have declined gradually. The aim of our study was to determine the cause of mortality among HIV-infected patients and the factors causing early death. METHODS: Using medical records of 73 inpatients who are dead, data were collected and analyzed using SPSS version 19 (IBM SPSS Statistics). Chi-square test was performed to determine the factors contributing to early death. A P value <.05 was considered significant. RESULTS: Among 73 deaths, 50 (68.5%) were AIDS related and 23 (31.5%) were non-AIDS related. The most common opportunistic infection causing death was Pneumocystis carinii pneumonia. Early deaths were strongly attributed to low CD4 counts at admission (<100 cells), antiretroviral therapy-naive status, late presentation, and fewer admissions ( P value <.05). CONCLUSION: Although AIDS-defining illness remains the main cause of death in HIV, there is significant number of deaths due to non-HIV-related causes.

Intimate Partner Violence, Depression, and Quality of Life among Women Living with HIV/AIDS in a Coastal City of South India.

BACKGROUND: Intimate partner violence (IPV) is a severe form of abuse prevalent in urban and rural areas of India with its effects on mental and physical health of the person receiving it, leading to a poorer quality of life. METHODS: A cross-sectional study was conducted among 99 women living with HIV, and information was collected using abuse assessment scale. The data were entered and analyzed using SPSS version 17.0. RESULTS: The IPV was reported by 19.2% of the respondents, of which psychological (14.1%) was most common followed by physical (4.1%) and sexual abuse (1.0%). The experience of IPV was significantly associated with socioeconomic status, number of children, marital status, and CD4 counts of the participants. CONCLUSION: The prevalence of IPV in our study was found to be less compared to previous studies, however, there were significant association among factors such as socioeconomic status, CD4 counts, and marital status of the participants.

Incidence of Opportunistic Infections among HIV-Positive Adults on Highly Active Antiretroviral Therapy in a Teaching Hospital, India: Prospective Study.

Oral manifestations in HIV infections are numerous and some of these are acknowledged as being of great importance in the early diagnosis of the disease. Many HIV-associated oral infections occur early in HIV disease, not infrequently as the presenting sign or symptom. Thus, early detection of the associated oral opportunistic infections should, in many cases, result in earlier diagnosis of HIV infection. Cytology, a simple, painless, and inexpensive method, has become a preferred method and was used in our study for early diagnosis of certain lesions. To determine the effect of highly active antiretroviral therapy on incidence rate of opportunistic infections among HIV-positive adults in a teaching hospital in India, a prospective study was conducted and the required sample size was 40. Study participants were selected randomly from the outpatient department of an HIV clinic who were currently on for antiretroviral therapy (ART). Data on age, gender, form of contagion, antiretroviral therapy at the time of review, number of CD4 lymphocytes per milliliter, and viral load were collected. Oral cytologic investigation was carried out and then stained for histopathological examination. A total of 40 individuals were examined and the incidence of opportunistic infections was 66.7% in individuals with CD4 counts less than 200, 55.6% in individuals with CD4 counts of 200 to 499, and 40.0% in individuals with CD4 counts more than 500. The incidence of opportunistic infection was higher in individuals with low CD4 counts in spite of being on ART.

Factors Influencing Quality of Life among People Living with HIV in Coastal South India.

BACKGROUND: Antiretroviral therapy (ART) has increased life expectancy of HIV/AIDS patients, but the quality of life (QOL) still remains the same. METHODS: In this cross-sectional study, 356 people living with HIV (PLHIV) were interviewed to assess their QOL using WHOQOL-HIV BREF questionnaire. The association between QOL with sociodemographic, clinical and cohabitation status of the participants was tested using ANOVA and Student t-test, and p value < .05 was considered statistically significant. RESULTS: Physical domain of QOL showed maximum score of 16.4, while a minimum score of 12.2 was seen in social relationship domain. Participants with higher socioeconomic status (SES) and self-motivated to take ART had shown better scores across all the domains of QOL ( p < .05). CONCLUSION: In our study, quality of life was high among males, younger patients, married participants, higher socioeconomic status, longer duration of ART, self-motivation to take ART, absence of opportunistic infection, and with higher CD4 count.

Prevalence of Vitamin B12 and folic acid deficiency in HIV-positive patients and its association with neuropsychiatric symptoms and immunological response.

BACKGROUND: Deficiency of micronutrients is prevalent even before the development of symptoms of HIV disease and is associated with accelerated HIV disease progression. AIMS: This study evaluates the prevalence of folate and Vitamin B12 deficiency in HIV-positive patients with or without tuberculosis (TB) and its association with neuropsychiatric symptoms and immunological response. SETTINGS AND DESIGN: Cross-sectional, observational study in an outpatient setting. PATIENTS AND METHODS: Four groups of HIV-positive patients with TB (Group I), HIV-positive patients with neuropsychiatric symptoms (Group II), HIV-positive patients without neuropsychiatric symptoms or TB (Group III), and HIV-negative controls with neuropsychiatric symptoms (Group IV). Vitamin B12 and folate estimation was done using carbonyl metallo-immunoassay method. STATISTICAL ANALYSIS USED: ANOVA, Kruskal-Wallis and Mann-Whitney, Pearson's correlation. RESULTS: The prevalence of folic acid deficiency was 27.1% in the Group I, 31.9% in the Group II, 23.4% in the Group III, and 32% in the Group IV being higher in patients with neuropsychiatric symptoms in both HIV and non-HIV patients. The prevalence of Vitamin B12 deficiency was 18.8% in Group I, 9.1% in Group II, 4.8% in Group III, and 16.7% in Group IV. The patients with folate deficiency had more severe depression and anxiety. CONCLUSION: Nearly, 30% of the HIV patients had a folic acid deficiency, and about 10% of the HIV patients had Vitamin B12 deficiency. The folate deficiency was highest among neuropsychiatric patients with or without HIV infection and Vitamin B12 deficiency was higher among HIV patients with TB.

Factors Influencing Adherence to Antiretroviral Therapy among People Living with HIV in Coastal South India.

BACKGROUND: Antiretroviral Therapy (ART) has transformed life threatening HIV/AIDS scenario into chronic manageable disease. METHODOLOGY: In this cross-sectional, 409 People Living with Human Immunodeficiency Virus (PLHIV) aged ≥ 18 years, who were on ART, were assessed regarding the adherence to ART and factors affecting adherence using semi-structured questionnaire. The association between factors affecting adherence and the level of adherence were analyzed using multiple logistic regression model and odds ratio (OR) with 95% confidence intervals (CI) were reported. RESULTS: Among 409 PLHIV, 70.4% showed adherence to ART (≥95%). Univariate analysis yielded many factor associated with adherence (P < 0.05). However, on multivariate analysis, PLHIV who do not forget to take ART and not consuming alcohol were the factors consistent with adherence to ART (P < 0.05). CONCLUSION: Regular patient education and counseling regarding the usage of memory aids and abstinence from alcohol could be useful for adherence and long term success of ART among PLHIV.

Effect of Vitamin B12 and folic acid supplementation on neuropsychiatric symptoms and immune response in HIV-positive patients.

BACKGROUND: Micronutrients such as B12 and folic acid deficiencies are found in higher number in HIV-infected patients. OBJECTIVE: We conducted a study to examine the effect of Vitamin B12 and folic acid supplementation on neuropsychiatric manifestations, CD4 count, and anthropometric measurements in HIV-positive patients. MATERIALS AND METHODS: Three different groups of HIV patients, namely, HIV patients with tuberculosis, HIV patients with neuropsychiatric manifestations, and asymptomatic HIV patients with 50 patients in each group were included in the study. Baseline and follow-up CD4 count, anthropometric measurements, neuropsychiatric assessments, Vitamin B12, and folic acid estimation were done. RESULTS: The prevalence of folic acid deficiency was 27.1% in Group I, 31.9% in Group II, and 23.4% in Group III. The prevalence of Vitamin B12 deficiency was 8.16% in Group I, 6.12% in Group II, and 4.16% in Group III. HIV patients with neuropsychiatric manifestations were noted to have the lowest mean mini-mental score. After the supplementation of vitamins, anthropometric measurements, MMSE as well as Hamilton depression scores, improved in all the three groups whereas Hamilton anxiety scores improved only in Group III. The CD4 count also improved in Groups I and II after the supplementation of vitamins. CONCLUSION: Folic acid deficiency was highest among neuropsychiatric patients. The majority of people who had a folic acid deficiency have shown improvement in their neuropsychiatric assessment scores as well as CD4 count after its supplementation.

HIV Status Disclosure Among People Living with HIV in the Era of Combination Antiretroviral Therapy (cART).

INTRODUCTION: As patients with HIV live longer due to Combination Anti-Retroviral Therapy (cART) serostatus disclosure becomes an important issue. Disclosure can have both positive and negative outcomes. Disclosure of HIV status has been associated with better adherence to medication and reduction in levels of psychological distress. Stigma and disruption of family relationships are barriers for disclosure. Most studies regarding disclosure status have been conducted in West. There are many cultural differences in Indian society when compared to west. There is a dearth of research in the field of disclosure of HIV infection in India. AIM: To determine the prevalence of HIV status disclosure among people living with HIV (PLHIV) in South India. MATERIALS AND METHODS: This descriptive cross-sectional study was done in the hospital attached to Kasturba Medical College (KMC), Mangalore, India from May-June 2013. PLHIV of age more than 18 years were included. During the study period 111 consecutive patients who consented for the study were enrolled. STATISTICAL ANALYSIS: Data was collected using a pre-tested interviewer administered semi structured questionnaire. Data collected was analysed using SPSS Version 11.5 statistical software. Descriptive statistics were done and the results are presented as proportions and mean. RESULTS: The mean age of the study population was 44.86 ± 10.8 years. Majority of the study subjects were men 76 (68.4%). Out of 111 study subjects, 102 (91.9%) had disclosed their HIV status to at least one person while 9 (8.1%) had not disclosed their HIV status to anyone. Disclosure on doctor's advice was the main reason for 56 (54.9%) participants to disclose their HIV status. The main reason for non-disclosure was fear of shame in family. CONCLUSION: Disclosure rate was high in our study in the era of cART. Society must stop discriminating against PLHIV so that they can disclose their serostatus and gain access to care and treatment services without any fear of stigma. In our study the main reason for disclosure was doctor's advice which clearly states the importance of the commitment of doctors in creating awareness among PLHIV about the need for voluntary disclosure.

Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital.

CONTEXT: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients. AIMS: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. SETTINGS AND DESIGN: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale. RESULTS: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'. CONCLUSIONS: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.

Dengue encephalitis-A rare manifestation of dengue fever.

The clinical spectrum of dengue fever ranges from asymptomatic infection to dengue shock syndrome. Dengue is classically considered a non-neurotropic virus. Neurological complications are not commonly seen in dengue. The neurological manifestations seen in dengue are encephalitis, meningitis, encephalopathy, stroke and Guillain-Barré syndrome. Dengue encephalitis is a rare disease. We report an interesting case of dengue encephalitis from Southern India. A 49-year-old gentleman presented with fever, altered sensorium and seizures. Dengue NS-1 antigen test was reactive. Dengue IgM was also positive. CSF PCR was negative for herpes simplex 1 & 2. Dengue encephalitis should be considered in the differential diagnosis of fever with altered sensorium, especially in countries like India where dengue is rampant.

Effect of Lipodystrophy on the Quality of Life among People Living with HIV (PLHIV) on Highly Active Antiretroviral Therapy.

BACKGROUND: Lipodystrophy is a known adverse effect of highly active antiretroviral therapy (HAART). Lipodystrophy resulting in body dysmorphism can lower the quality of life (QoL) among HAART recipients. The main aim of our study was to find the effect of lipodystrophy on QoL among people living with HIV (PLHIV) on HAART. METHODS: This cross-sectional study was conducted in a tertiary care hospital in south India. The participants were assessed for the presence of lipodystrophy. Their QoL was assessed using HIV-AIDS-targeted QoL questionnaire (HAT-QoL). Statistical analysis was carried out using SPSS version 11.5. RESULTS: Lipodystrophy was present in 21 participants (42%). The QoL among individuals with lipodystrophy was found to be significantly lower in terms of disclosure worries (P = .023) and financial worries (P = .049). CONCLUSIONS: Lipodystrophy adversely affects QoL among PLHIV. There is a need for studies analyzing factors that can potentially improve the QoL in such individuals.

An Interesting Case of Dysphagia in a HIV Patient.

Oesophageal tuberculosis is a rare disease. Tuberculosis (TB) can cause dysphagia due to oesophageal ulcers, Tracheo-Oesophageal Fistulas (TOFs) and an extrinsic compression which is caused by the mediastinal lymph nodes. A 33-year-old gentleman was admitted to our hospital for the evaluation of fever, dysphagia and cough. His chest X-ray was suggestive of miliary tuberculosis. A CT scan of his chest revealed miliary tuberculosis, mediastinal lymphadenopathy and pneumomediastinum. His sputum AFB (acid-fast bacilli) test was positive. An upper gastrointestinal endoscopy revealed a large ulcer in the oesophagus with a fistulous opening which was suggestive of a tracheo-oesophageal fistula. A biopsy from the ulcer was positive for AFB. The test for HIV-1 was positive. A nasogastric feeding tube was placed and the Anti Tubercular Therapy ( ATT) was started. The main aim of this case report is to sensitize the clinicians about the fact that Tuberculosis can present with dysphagia, especially in HIV patients.

The Evaluation of Carotid Atherosclerosis in Patients with the HIV-1 Infection: The Role of the Antiretroviral Therapy.

BACKGROUND AND OBJECTIVE: The recognition and the assessment of the carotid intimal thickness helps in predicting the risk of the cardiovascular events in Human Immunodeficiency Virus (HIV) infected patients who are on Antiretroviral Therapy (ART). The objective of this study was to assess and compare the carotid intimal thickness in HIV positive individuals who were on antiretroviral therapy with HIV positive individuals who were not on anti-retroviral therapy. SUBJECTS AND METHODS: All the HIV positive individuals who were 20 years old and above, who had been diagnosed by the National AIDS Control Organization (NACO) guidelines were included in the study. The HIV positive individuals who were diagnosed with diabetes mellitus and hypertension were excluded from the study. The study subjects were divided into 2 groups i.e. HIV patients who were on anti-retroviral therapy and HIV patients who were not on anti-retroviral therapy. The patients had to be on anti-retroviral therapy for a minimum of 6 months for them to be included in the first group. The data was collected by using a semi structured, pre-tested proforma, which included the demographic details, the duration of the HIV infection, details of the antiretroviral treatment, a history of smoking/ alcohol consumption and details on the assessments of the metabolic syndrome. RESULTS: A total of 42 patients were included in the study. Among them, 28 were males (66.7%) and 14 were females (33.3%). Twenty six patients were on ART and the remaining patients were treatment naive. There were significant differences with regards to their age and the duration of the HIV infection, which was longer in the patients who were on ART (p= 0.049, p=0.003 respectively). The Body Mass Index (BMI), the waist: hip ratio, the mid-arm circumference, the waist circumference, the skin fold thickness and the carotid intimal-media thickness were higher in the HIV patients who were on ART as compared to those in the treatment naive patients, though the difference was statistically insignificant. CONCLUSION: The carotid intimal thickness was higher in the HIV patients who were on ART as compared to those in the treatment naïve HIV infected patients.

Adherence to Antiretroviral Therapy Among People Living with HIV.

BACKGROUND: Acquired immune deficiency syndrome (AIDS) is now considered as a manageable chronic illness. There has been a dramatic reduction in human immunodeficiency virus (HIV) related morbidity and mortality due to antiretroviral therapy. A high level of adherence (>95%) is required for antiretroviral therapy to be effective. There are many barriers to adherence in both developed and developing countries. AIM: The aim of our study was to determine adherence levels and factors influencing adherence to antiretroviral therapy among people living with HIV. MATERIALS AND METHODS: Using a cross-sectional study design, 116 HIV positive patients receiving antiretroviral therapy for at least 1 year were interviewed using a semi structured questionnaire. The collected data was analyzed using Statistical Product and Service Solutions (SPSS) version 11.5. Chi-square test was done. A P value of < 0.05 was considered statistically significant. RESULTS: Of 116 participants, 63.7% reported adherence ≥ 95%. Mean adherence index was 91.25%. Financial constraints, forgetting to take medication, lack of family care, depression, alcohol use, social stigma and side effects to antiretroviral therapy were barriers for adherence in our study. CONCLUSION: Adherence to antiretroviral therapy in south India is suboptimal. Intensive adherence counseling should be provided to all patients before initiation ofantiretroviral therapy. Health care providers must identify possible barriers to adherence at the earliest and provide appropriate solutions.