To Study Awareness of HIV/AIDS in Female HIV Positive Patient and Access Adverse Reactions in Female Patient on Anti Retro Viral Therapy along with Their Adherence to Therapy in Chhattisgarh.

Raj Purnima, Temburnikar Pankaj, Agrawal Avantika, Shrivastava P.K., Rathod Mritunjayand Verma V. B.

Chhattisgarh Institute of Medical Sciences, Bilaspur.

ABSTRACT:

Objective :To assess the awareness about HIV/AIDS in female HIV positive patients. To assess the adverse effects of antiretroviral therapy (HAART) and its adherence in HIV-infected female patients, in central Chhattisgarh, Bilaspur.

Materials and Methods: This was a study carried out at ART centre medical college hospital and Department of pharmacology, Government Medical College Bilaspur after approval from Institutional Human Research Ethics committee and written consent of patients. The study was in 3 steps. First step a set of questions were asked to the all 184 HIV positive female patient about their awareness of AIDS. In second step adverse drug reactions (ADRs) were recorded for 74 female patient on ART. All patients were asked symptoms on monthly basis and were screened clinically and investigated. Lastly to access adherence to treatment a questionnaire in a paper format regarding drug treatment regimen and adverse reactions given to female patient on ART, explained in detail prior to completion. Translation was done when translator and doctor was required.

Results: 184 HIV positive female patients were interviewed along with questionnaire. Among them, 69 (37.5%) were illiterate, 61(33%) with primary education, 40 (21%) with sec – education, and 10 were college and above. Out of them 125 patient were unaware of HIV, 39 were aware about it before treatment through radio or television, 21 patient were slightly aware through friends and relatives. Out of 74 patient on ART the most common ADR in our study was anemia in 45 patients (60.81%) due to drug zidovudine, followed by skin rashes in 26 patient (35.14%) due to nevirapine and neuro psychiatric complains in 25 patient (33.78%) due to efavirinz. Lack of adherence to treatment was seen only in 10 patients.

Conclusion : In spite of high ADRs, our female patient were adherent to the treatment because ART centre is funded by NACO supplying free medicine, free checkups, lab tests and counseling. Thus, the challenges remains are managing drug toxicites and resistance and increasing the awareness as most of the Indian population is illiterate and poor and lives in rural areas. Thus new strategies for public education on AIDS and its prevention are urgently needed in developing countries. Education has to be considered equally important for girls and boys. Parents have also found ways of taking care of the household chores that girls are usually engaged in, so that they can go to school.

KEYWORDS: Highly affective antiretroviral therapy, antiretroviral therapy, adverse drug reaction. National aids control organization.

INTRODUCTION:

India accounts for 10% of global HIV burden. Out of 2.5 million peoples living with HIV/AIDS in India, 1 million are women.¹ The ever-increasing number of women getting infected and dying from the human immunodeficiency virus (HIV) is a poignant feature of the worldwide expanding AIDS epidemic. The massive loss of life due to H.I.V. disease is only one symptom of a very sick country in which hundreds of life is lost without any modern medical care. Girls are at higher risk in some parts of the world, this is partly because girls are more likely to be pressured into having sex and less likely to be able to control with whom, when and how they have sex. Also, social attitudes to sex and sex education may make it more difficult for girls to get the information they need to protect themselves from the virus. Unfortunately, resource-limited settings such as India and other developing countries present unique challenges for the planning and implementation of organized screening programs that are dependent on skilled manpower and sustained resources. HIV a major global concern has a growing prevalence across all areas of Indian society resulting in growing number needing treatment and greater strain on services to provide ART.² Most important cause is lack of awareness of AIDS particularly in women.

In 1996 after the world AIDS conference in Vancouver, HAART became a popular and potent treatment option of AIDS. It has led to effective management and thus significant reduction in AIDS related morbidity and mortality.³ A successful regimen involves combination of at least 3 anti – retroviral drugs. A major factor involved in the treatment failure of the choice is the non- adherence to the therapy there by resulting in the development of difficult to handle drug resistance.⁴ Non – adherence rate is higher especially among the patients living in poverty who are unaware and illiterate about the consequences of AIDS.

In this view and lack of data for medication adherence in our state chhattisgarh this study aims to evaluate the awareness and adherence to ART among HIV patients at CIMS BILAPUR.

Objective:

To access the awareness about HIV/AIDS in female HIV positive patients. To assess the adverse effects of antiretroviral therapy (HAART) and its adherence in HIV-infected female patients, in central Chhattisgarh, Bilaspur

MATERIALS AND METHODS:

This was a study carried out at Anti Retro Viral Therapy centre medical college hospital and Department of pharmacology, Chhattisgarh institute of medical sciences Bilaspur, after approval from Institutional Human Research Ethics committee and written consent of patient. This study was carried between March 2010 to October 2010. The study was in 3 phases. In first phase 184 HIV positive female patients were considered. A set of questions were asked to the all HIV positive female patients about their awareness of aids.

In second phase adverse drug reactions (ADRs) were recorded for every female patient on ART. In this period, all HIV-positive cases who were already on ART and who were newly started on ART were included and were followed prospectively for the development of any ADRs. Seventy four HIV-positive cases that were on ART were included in this study. A detailed present and past history of every patient was taken. Baseline laboratory investigations such as hemoglobin (Hb), total CD4 counts, differential counts, erythrocyte sedimentation rate, urine analysis, serum venereal disease research laboratory (VDRL) test, serum hepatitis B surface antigen (HBsAg), Mantoux test (MT) and fine needle aspiration cytology (FNAC) of lymph nodes were carried out in each patient to rule out any opportunistic infection or specific contraindication to any drug. Patients were also subjected to liver function tests (LFTs), renal function tests (RFTs). Their lipid profiles and blood sugar levels were also monitored. Two types of HAART regimens were used: A: zidovudine, lamivudine, and nevirapine; B: Lamivudine, zidovudine, and efavirenz. Allotment of HAART regimen was based on physician's judgment. Efavirenz-based regimen was given to patients having TB. All cases on ART were periodically subjected to clinical and laboratory monitoring. They were also screened for opportunistic infections (OIs) and drug toxicity in each follow-up visit during this period. Response to ART was indicated by decreased frequency of infections (bacterial infections, oral thrush and other OIs). CD4 count was done after 2 months or more frequently if clinically indicated. In patients who were on zidovudine (AZT)-containing regimens, hemoglobin was measured before initiation and at 4, 8 and 12 weeks of therapy or in response to their symptoms. LFTs were done at 2, 4, 8 and 12 weeks in patients on nevirapine (NVP)-based regimens.

Lipid profile and serum lactate, serum amylase was done whenever indicated. A baseline interview was taken before initiating the therapy followed by further interrogation at first, fourth, and seventh month for the development of ADRs. Information on adverse reactions and data related to health care utilization variables were collected from the medical charts as well as through self-reporting by patients. An adverse reaction to ART was defined as any undesirable effect or symptom registered in the medical charts by the treating physician, that occurred up to 1 year of the first ART prescription. Patients themselves completed a paper format questionnaire, which was explained in detail prior to completion. Translation was done when translator and doctor was required.

Questionnaires elicited patient demographics, treatment regimens and side effects as well as subjective medication adherence. Medication adherence was recorded as taking all medications as prescribed by the prescribing physician (All medications at correct time on correct day). Last week, last month, last six month and lifetime adherence was recorded.

In third phase assessment of adherence to study medication was based on the patient's self-report and pharmacy records. Patients were asked to bring empty bottles and strips.

Both researchers and a translator were required to be present for patient participation in the study to achieve complete patient understanding and avoid any misinterpretations. All patients presenting to clinics, while researchers and translators were present, were eligible for inclusion in the study and therefore approached to participate.

RESULTS:

184 HIV positive female patients were interviewed along with questionnaire. Among them, 69 (37.5%) were illiterate, 61(33%) with primary education, 40 (21%) with sec – education, and 10 were college and above shown in Fig. 1. Out of them 125 patient were unaware of HIV, 39 were aware about it before treatment through radio or television, 21 patient were slightly aware through friends and relatives shown in Fig. 2 under. No one was aware about its mode of transmission of aids. Out of 74 patients on ART the most common ADR in our study was anemia in 45 patients (60.81%) due to drug zidovudine, followed by skin rashes in 26 patients (35.14%) due to nevirapine and neuro psychiatric complains in 25 patients (33.78%) due to efavirinz. Various ADR reported are represented in Fig. 3 under. Lack of adherence to treatment was seen only in 10 patients shown in Fig. 4 under in the form of doughnut chart.

Fig. 2: Pi- chart showing HIV- AIDS awareness rate among the enrolled patients

Fig. 3: Pi- chart showing the ADRs from the ART selected

Fig. 4: Percentage of non- adherence among the patients on ART at CIMS, Bilaspur

Seventy four cases on ART were observed over a period of 8 months. ADRs were observed in 50 of them (67.57%). A Swiss cohort reported ADRs in 74% of their cases.⁶ In a study done by Harminder et al, 79 patients on HAART regimens were observed over a period of 2 years. Adverse effects were seen in 86% of cases.⁷

Another study by Kumarasamy et al. has also shown peripheral neuropathy, anemia, and nail hyperpigmentation as the most common side effects.⁸ In their study, lipodystrophy was observed in 20.04% of cases, while in other studies it was seen in 14.5% of the cases.⁹ Saint-Marc et al. reported the incidence of lipodystrophy to be 46.5%.¹⁰In the study by Marc group, the most common ADR reported was peripheral neuropathy (31.64%), mainly with stavudine (d4t) containing regimens.

Another ADR commonly reported was anaemia, which is grade IV anemia seen in 7.4% cases in a study by Harminder sing as compared to 34% in an old study by Van Leeuwen et al.¹¹ In cases with grade IV anemia (Hb < 6.5 g/dl), AZT was replaced by d4T and the remaining cases were managed conservatively with iron and folic acid supplementation. Peripheral neuropathy was mainly seen with d4T and d4T was replaced by AZT in all cases. In their study, Lactic acidemia, a subtle manifestation of lactic acidosis, was observed in one female.

The common ADRs in our present study were PN (22.2%) and anemia (20%). Rash was mainly due to NVP. In all cases with rash, NVP was omitted and the rash was managed conservatively. Later on, EFV replaced nevirapine in the regimen.

The correlation between female sex and severe ADR was found to be statistically highly significant. It is not clearly known why sex difference exists in adverse reactions to antiretroviral drugs. Factors cited include differences in weight and body mass index, hormonal changes unique to females, and the effect of these changes on drug metabolism.Other possible factors include differences in fat composition (thereby affecting drug distribution) and genomic differences influencing the level of enzymes involved in drug metabolism.⁷

ADR to ART may depend on the baseline CD4+ cell count at initiation of therapy. A study by Center for Disease Control and Prevention on HIV outpatients suggested that some complications were more frequent and severe when therapy is started at lower CD4+ cell counts. Thus, patients may actually experience fewer side effects over a 10-20 year period of drug exposure if they start therapy 18-24 months earlier than if they delay therapy until the CD4+ cell count decreases to less than 0.200 x 10⁹ cells/L.¹² ART is becoming increasingly effective, but also increasingly complex. Adverse effects of therapy may cause symptoms that affect a variety of organ systems. Although current antiretroviral regimens are potent from an antiviral perspective, they often fail because of patient no adherence. To optimize adherence and hence efficacy, clinicians must focus on preventing adverse effects whenever possible, and distinguishing those that are self-limited from those that are potentially serious.

The measurement of viral loads and the standard of care for assessing efficacy and response to HAART are not possible everywhere, particularly in resource-restricted places. Also, as eradication of the disease is currently not possible, significant problems related to compliance and long-term toxicity can be anticipated with decade-long therapies. Patient compliance can be improved with proper education and counseling regarding the disease process and inherent but innocuous side effects of HAART. More research is needed to develop low-cost investigations and algorithms for prediction of adverse effects of existing regimen, along with generation of more efficacious and less toxic drugs.

In our study lack of adherence was only 5.43% shown in the form of doughnut graph above. Reason for such a low non adherence rate might be the financial and moral support in our ART with the help of NACO.

CONCLUSION:

In spite of high ADRs, our female patient were adherent to the treatment because ART centre funded by NACO could supply free medicines, free checkups, lab tests and counseling. Strengthening HIV screening, treatment, and care services needs to be prioritized through increased funding, mobilization, and public awareness. Benefits of ART continue to over weigh the disadvantages. Thus, management requires a highly precise balance between benefits of durable HIV suppression and the risks of drug toxicity to achieve the therapeutic goals, with conventional drugs or with newer less toxic agents. The challenges remains are managing drug toxicities and resistance and improving adherence. Improving access to ART. Most of the Indian population is illiterate and poor and lives in rural areas; these people do not have access to most channels of mass communication. Thus new strategies for public education on AIDS and its prevention are urgently needed in developing countries.

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Received on 22.03.2011

Accepted on 09.04.2011

Research J. Pharmacology and Pharmacodynamics. 3(4): July –August, 2011, 171-175