Longitudinal Analysis of Adherence to First-Line Antiretroviral Therapy: Evidence of Treatment Sustainability from an Indian HIV Cohort.

INTRODUCTION: Given the chronic nature of HIV infection and the need for life-long antiretroviral therapy (ART), maintaining long-term optimal adherence is an important strategy for maximizing treatment success. In order to understand better the dynamic nature of adherence behaviors in India where complex cultural and logistic features prevail, we assessed the patterns, trajectories and time-dependent predictors of adherence levels in relation to virological failure among individuals initiating first-line ART in India. METHODS: Between July 2010 and August 2013, eligible ART-naïve HIV-infected individuals newly initiating first-line ART within the national program at three sites in southern India were enrolled and monitored for two years. ART included zidovudine/stavudine/tenofovir plus lamivudine plus nevirapine/efavirenz. Patients were assessed using clinical, laboratory and adherence parameters. Every three months, medication adherence was measured using pill count, and a structured questionnaire on adherence barriers was administered. Optimal adherence was defined as mean adherence ≥95%. Statistical analysis was performed using a bivariate and a multivariate model of all identified covariates. Adherence trends and determinants were modeled as rate ratios using generalized estimating equation analysis in a Poisson distribution. RESULTS: A total of 599 eligible ART-naïve patients participated in the study, and contributed a total of 921 person-years of observation time. Women constituted 43% and mean CD4 count prior to initiating ART was 192 cells/mm3. Overall mean adherence among all patients was 95.4%. The proportion of patients optimally adherent was 75.6%. Predictors of optimal adherence included older age (≥40 years), high school-level education and beyond, lower drug toxicity-related ART interruption, full disclosure, sense of satisfaction with one's own health and patient's perception of having good access to health-care services. Adherence was inversely proportional to virological failure (IRR 0.55, 95%CI 0.44-0.69 p<0.001). Drug toxicity and stigma-related barriers were significantly associated with virological failure, while forgetfulness was not associated with virological failure. CONCLUSION: Our study highlights the overall high level of medication adherence among individuals initiating ART within the Indian national program. Primary factors contributing towards poor adherence and subsequent virological failure in the proportion of individuals with poor adherence included drug toxicity, perceived stigma and poor access to health care services. Strategies that may contribute towards improved adherence include minimizing drug interruptions for medical reasons, use of newer ART regimens with better safety profiles and increasing access with more link ART centers that decentralize ART dispensing systems to individuals.

A Hospital-based Retrospective Study on Frequency and Distribution of Viral Hepatitis.

BACKGROUND: Viral hepatitis is a major public health problem throughout the world. It is the inflammation of the liver due to the infection of any of the five main hepatic viruses A to E and it affects the liver through different modes of transmission. This study mainly aims at the frequency and distribution of viral hepatitis based on age and sex during a time period of 5 years. MATERIALS AND METHODS: This is a hospital-based retrospective study of 5 years at a tertiary level hospital in Kerala state in India. Medical records department of the hospital follow the guidelines of International Classification of Diseases-10 for coding the diseases. The data on frequency and distribution of viral hepatitis based on age and sex during a period of 5 years from April 2005 to March 2010 were collected and analyzed and 'z' test was used for finding out the difference in proportions. RESULT: Out of 818 cases, 76.03% were males and 23.96% were females. The preponderance of males was apparent in all types of viral hepatitis infection. The high risk groups were the adults in the age group of 20-39 years. The main cause in the present study was hepatitis E virus (HEV) and followed by hepatitis A virus (HAV). Of total viral hepatitis cases, 31.54% were due to HAV, 6.35% hepatitis B virus, 0.85% hepatitis C virus and 61.24% were due to HEV respectively. In the present study, there was no case of hepatitis D virus has reported. The case fatality rate of viral hepatitis in the present study was minor than 1% (0.98%); whereas males were 0.96%; females of 1.02%. CONCLUSION: Taking the safety measures including vaccination and proper management of waste materials are the only solution to control or eradicate this infection.

A Study on Mental Disorders: 5-year Retrospective Study.

BACKGROUND: "Mental disorder" is the most common used term in the modern life and the main reason behind this may be the mechanical way of life or stress and strain among youth. AIM: To find the pattern of mental disorders of hospitalized patients in a medical college hospital from 1(st) April 2005 to 31(st) March 2010. SETTINGS AND DESIGN: A retrospective study conducted among the patients admitted with mental disorders in a medical college hospital from 1(st) April 2005 to 31(st) March 2010. MATERIALS AND METHODS: Data collected from the registers maintained in the medical records department. STATISTICAL ANALYSIS: Z test is used for the comparison of proportions. RESULTS: A total of 7908 mental disorder cases reported in the medical college hospital, 5564 (70.36%) were males and 2344 (29.64%) were females. Most cases occurred in the age group of 30-44 years. Mental disorder was more among females than males in 0-29 years and ≥ 60 years, but in 30-59 years males were more. In each year, mental disorders were reported more in males than females. Of the cases, most of them were mood disorders. Mental and behavioral disorders due to psychoactive substance use were more among males but schizophrenia, delusional disorders, mood disorders, stress-related disorders, mental retardation, and so on were more among females. CONCLUSION: Mood disorder was the most occurred mental disorder and the next leading mental disorder was mental and behavioral disorders due to psychoactive substance use. Counseling can be helpful for preventing most of the mental disorders. Improve the mental health care facilities will be the solution for controlling the mental disorders.

Influence of adverse drug reactions on treatment success: prospective cohort analysis of HIV-infected individuals initiating first-line antiretroviral therapy in India.

INTRODUCTION: Adverse drug reactions related to antiretroviral therapy (ART) remain a challenge in resource-limited settings, often causing significant morbidity and impaired adherence leading to treatment failure. This 2-year prospective study aimed to describe patterns and predictors of adverse reactions to first-line ART and assess the impact of these events on treatment success. METHODS: Between 2010-2013, 321 ART-naïve eligible adults were enrolled at two clinics in southern India. ART regimens included zidovudine or stavudine plus lamivudine, plus nevirapine or efavirenz. Pill count adherence, immunological and virological monitoring, and laboratory-based adverse drug reactions were measured prospectively and analyzed. RESULTS: Among 321 patients in the study, 289 (90.0%) patients experienced at least 1 adverse reaction, and 85 (26.5%) experienced at least 1 severe reaction. The incidence rate was 52 and 15 per 100 person-years for all reactions and severe reactions respectively. The cumulative incidence of zidovudine-induced anemia was 37.1% over 2 years. At 12 and 24 months, the proportion of patients with optimal adherence, undetectable viral load and CD4 counts >350 cells/mm3 were similar between patients who experienced or did not experience severe adverse drug reactions. CONCLUSIONS: Our results highlight the high frequency of ART-related adverse drug reactions among individuals initiating first-line ART in India, underscoring the importance of detailed counseling and monitoring for maintaining ART durability. Severe drug-induced anemia needs to be addressed urgently with alternative first-line agents, and close laboratory surveillance. High treatment efficacy despite decreased drug safety seen here may be because patients have limited treatment options. Our results support the use of currently recommended safer first-line ART regimens that minimize the risk of severe life-threatening toxicities and provide for a better quality of life. TRIAL REGISTRATION: ISRTCN Registry: ISRCTN79261738.

'What do I know? Should I participate?' Considerations on participation in HIV related research among HIV infected adults in Bangalore, South India.

BACKGROUND: India has the highest number of HIV infected persons in the world after South Africa. Much HIV related behavioral, clinical and laboratory based research is ongoing in India. Yet little is known on Indian HIV patients' knowledge of research, their processes of decision making and motives for participation. We aimed to explore these areas among HIV infected individuals to understand their reasons for participating in research. METHODOLOGY/PRINCIPAL FINDINGS: This is a cross sectional survey among 173 HIV infected adults at a tertiary level hospital in Bangalore, India, done between October 2010 and January 2011. A pre-tested questionnaire was administered to the participants by trained research assistants to assess their knowledge regarding research, willingness to participate, decision making and determinants of participation. Participants were presented with five hypothetical HIV research studies. Each study had a different level of intervention and time commitment. Of respondents, 103(60%), said that research meant 'to discover something new' and 138(80%) were willing to participate in research. A third of the respondents were unaware of their right to refuse participation. Willingness to participate in research varied with level of intervention. It was the lowest for the hypothetical study involving sensitive questions followed by the hypothetical drug trial; and was the highest for the hypothetical cross sectional questionnaire based study (p<0.0015). Individual health benefits and altruism were the primary motives for participation in research and indicate the presence of therapeutic misconception. Women were less likely to make autonomous decisions for participation in interventional studies. CONCLUSIONS/SIGNIFICANCE: Despite a majority willing to participate, over a third of respondents did not have any knowledge of research or the voluntary nature of participation. This has ethical implications. Researchers need to focus on enabling potential research participants understand the concepts of research, promote autonomous decisions, especially by women and restrict therapeutic misconception.

Supporting adherence to antiretroviral therapy with mobile phone reminders: results from a cohort in South India.

BACKGROUND: Adherence is central to the success of antiretroviral therapy. Supporting adherence has gained importance in HIV care in many national treatment programs. The ubiquity of mobile phones, even in resource-constrained settings, has provided an opportunity to utilize an inexpensive, contextually feasible technology for adherence support in HIV in these settings. We aimed to assess the influence of mobile phone reminders on adherence to antiretroviral therapy in South India. Participant experiences with the intervention were also studied. This is the first report of such an intervention for antiretroviral adherence from India, a country with over 800 million mobile connections. STUDY DESIGN: Quasi-experimental cohort study involving 150 HIV-infected individuals from Bangalore, India, who were on antiretroviral therapy between April and July 2010. The intervention: All participants received two types of adherence reminders on their mobile phones, (i) an automated interactive voice response (IVR) call and (ii) A non-interactive neutral picture short messaging service (SMS), once a week for 6 months. Adherence measured by pill count, was assessed at study recruitment and at months one, three, six, nine and twelve. Participant experiences were assessed at the end of the intervention period. RESULTS: The mean age of the participants was 38 years, 27% were female and 90% urban. Overall, 3,895 IVRs and 3,073 SMSs were sent to the participants over 6 months. Complete case analysis revealed that the proportion of participants with optimal adherence increased from 85% to 91% patients during the intervention period, an effect that was maintained 6 months after the intervention was discontinued (p = 0.016). Both, IVR calls and SMS reminders were considered non-intrusive and not a threat to privacy. A significantly higher proportion agreed that the IVR was helpful compared to the SMS (p<0.001). CONCLUSION: Mobile phone reminders may improve medication adherence in HIV infected individuals in this setting, the effect of which was found to persist for at least 6 months after cessation of the intervention.

Supporting patient adherence to antiretrovirals using mobile phone reminders: patient responses from South India.

There has been exponential growth in the use of mobile phones in India over the last few years, and their potential benefits as a healthcare tool has raised tremendous interest. We used mobile phone reminders to help support adherence to antiretroviral therapy (ART) among HIV patients at an infectious disease clinic in a tertiary hospital in Bangalore. Between March and June 2010, 139 adult HIV patients taking regular ART for at least a month received weekly reminders to support adherence. These reminders consisted of a weekly interactive call and a non-interactive neutral pictorial short message service (SMS). After four weeks of the intervention, participants were interviewed to study perceptions on preference, usefulness, potential stigma and privacy concerns associated with this intervention. Majority of the participants were urban (89%), and had at least a secondary education (85%). A total of 744 calls were made, 545 (76%) of which were received by the participants. In addition, all participants received the weekly pictorial SMS reminder. A month later, 90% of participants reported the intervention as being helpful as medication reminders, and did not feel their privacy was intruded. Participants (87%) reported that they preferred the call as reminders, just 11% favoured SMS reminders alone. Only 59% of participants viewed all the SMSs that were delivered, while 15% never viewed any at all. Participants also denied any discomfort or stigma despite 20% and 13%, respectively, reporting that another person had inadvertently received their reminder call or SMS. Mobile phone interventions are an acceptable way of supporting adherence in this setting. Voice calls rather than SMSs alone seem to be preferred as reminders. Further research to study the influence of this intervention on adherence and health maintenance is warranted.