{"id":56276,"date":"2024-03-20T10:40:50","date_gmt":"2024-03-20T10:40:50","guid":{"rendered":"https:\/\/biomedpharmajournal.org\/?p=56276"},"modified":"2024-04-02T04:17:11","modified_gmt":"2024-04-02T04:17:11","slug":"adherence-to-antiretroviral-therapy-and-quality-of-life-in-people-living-with-hiv-a-prospective-study","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol17no1\/adherence-to-antiretroviral-therapy-and-quality-of-life-in-people-living-with-hiv-a-prospective-study\/","title":{"rendered":"Adherence to Antiretroviral Therapy, and Quality of Life in People Living with HIV: A Prospective Study"},"content":{"rendered":"\n

Introduction<\/strong><\/p>\n\n\n\n

Combination antiretroviral therapy (cART) is the\ncornerstone of management of patients who have been infected with Human\nImmunodeficiency Virus (HIV). With a lot of research and funding, highly effective\nantiretroviral drugs are currently combined and prescribed, thus bringing about\nsignificant disease control.1,2<\/sup><\/p>\n\n\n\n

Antiretroviral therapy (ART) regimen is a multi-drug\nregimen of three drugs often consisting of two NRTIs (nucleoside reverse\ntranscriptase inhibitor) and one NNRTI (non- nucleoside reverse transcriptase\ninhibitor) in a fixed dose combination. Each of these drugs have their own specific\ndosage and side effects. For the patient to get a positive response to\ntreatment, a good adherence to the regimen is of vital importance.3,4,5<\/sup>  According to a study, the percentage of\npatient with viral load less than 400 copies per millilitre fall below 60% when\nadherence to the regimen is less than 95%. Once the therapy fails, drugs in the\nregimen are unable to inactivate the virus, hence cannot be used for future\ntherapy, thereby limiting the choice of drugs available. The preferred regimen\nfor first line failure include a protease inhibitor (PI) based therapy which\ninvolves inclusion of ritonavir in low doses to increase the bioavailability to\nthe primary protease inhibitor.6<\/sup><\/s><\/p>\n\n\n\n

Many of the anti-retroviral drugs are known to cause several\nadverse effects. These adverse effects can range from being mild to even life\nthreatening; and can in turn affect the compliance of the therapy as well.7<\/sup>\nWith strict adherence to the therapy, PLHIV can have a near-normal life\nexpectancy, but their quality of life (QoL) is low compared to the general\npopulation even when the viral load is under control.8,9<\/sup> <\/p>\n\n\n\n

Studies conducted in the past regarding these\nsituations, suggest that social circumstances, relationship issues,\ncomorbidities and stigma affect the QoL of PLHIV in addition to the underlying\ndisease.10,11<\/sup> Observations from earlier studies also include a\npressing need to promote income generating activities among people infected\nwith HIV, in order to empower themselves.12,13<\/sup><\/s><\/p>\n\n\n\n

With newer once a day regimens, there could be a\npositive impact on both the adherence levels to therapy and the quality of\nlife; assessing these factors is the purpose of conducting this project.<\/p>\n\n\n\n

Materials\nand Methods<\/strong><\/p>\n\n\n\n

The study was conducted at a teaching hospital in\nCoastal Karnataka catering to a wide area of the region with varied patient\ncharacteristics; the participants comprised of HIV positive subjects of both genders\non antiretroviral therapy. This was an observational longitudinal study,\nspanning over a period of eight months (March 2018 to October 2018). The sample\nsize was assessed to be 198, based on an earlier study which showed 70%\nadherence to treatment, using the formula 4pq\/d2<\/sup>.13<\/sup><\/p>\n\n\n\n

All patients aged over 18 years, who were already\ndiagnosed to be HIV positive and on ART from at least one month were included. Severely\nill patients, patients on anti-tubercular treatment \/ other conditions that\ncould independently affect the quality of life and adherence to therapy were\nexcluded.<\/p>\n\n\n\n

Data was collected by directly\ninterviewing the patient through the questionnaire at the ART clinic. All details\nregarding HIV infection was collected. Antiretroviral treatment details\ncollected included the type of regimen, date started, switch-over to other\nregimens. The questionnaire used for the study was based on\nthe Medication Adherence Questionnaire to assess the adherence,14,15<\/sup>\nand for the quality of life, the WHO- Quality of Life HIV questionnaire was\nused.16<\/sup> The translated and validated version of the questionnaire in\nthe local language was used for the study.<\/p>\n\n\n\n

The Medication Adherence Questionnaire\nhas been one of the most popular scales to assess adherence to medication, and\nhas been earlier used in patients on ART containing a protease inhibitor. It is\nshort and easy to use, and helps to identify factors that act as barriers to\nadherence. The adherence is classified as being low, medium, or\nhigh. Also, a pictorial scale was added to assess the adherence. An adherence\nof more than 95% was considered high adherence.14,17<\/sup><\/p>\n\n\n\n

The WHO- Quality of Life HIV questionnaire has been designed to identify various factors that affect a patient\u2019s overall health status. Questions asked included aspects relating to patient\u2019s sense of well-being, sleep, memory, opportunities, daily routine activities, ability to work, thoughts about the future, pain status, and any symptoms related to HIV, etc. The questions asked specifically assess the patients\u2019 health and wellbeing over the past two weeks.<\/p>\n\n\n\n

Table 1: Outline of the WHO- Quality of life questionnaire16<\/sup><\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Section <\/strong><\/p>\n<\/td>\n

\n

Questions <\/strong><\/p>\n<\/td>\n

\n

Response range<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/p>\n<\/td>\n

\n

How much a patient has experienced certain things in the last two weeks, such as happiness<\/p>\n<\/td>\n

\n

Not at all (1), A little (2), A moderate amount (3), Very much (4), An extreme amount (5)<\/p>\n<\/td>\n<\/tr>\n

\n

2<\/p>\n<\/td>\n

\n

How completely the patient was able to do certain things in the last two weeks, such as activities related to daily living<\/p>\n<\/td>\n

\n

Not at all (1), A little (2), Moderately (3), Mostly (4), Completely (5)<\/p>\n<\/td>\n<\/tr>\n

\n

3<\/p>\n<\/td>\n

\n

How satisfied, happy or good the patient felt about various aspects of life over the last two weeks, such as family life<\/p>\n<\/td>\n

\n

Very dissatisfied (1), Dissatisfied (2), Neither satisfied nor dissatisfied (3), Satisfied (4), Very satisfied (5)<\/p>\n<\/td>\n<\/tr>\n

\n

4<\/p>\n<\/td>\n

\n

How often the patient has felt or experienced certain things, such as family support, or negative experiences such as feeling unsafe<\/p>\n<\/td>\n

\n

Never (1), Seldom (2), Quite often (3), Very often (4), Always (5)<\/p>\n<\/td>\n<\/tr>\n

\n

5<\/p>\n<\/td>\n

\n

Questions refering to any “work” that the patient does, such as studying, house work, childcare, etc.<\/p>\n<\/td>\n

\n

Not at all (1), A little (2), Moderately (3), Mostly (4), Completely (5)<\/p>\n<\/td>\n<\/tr>\n

\n

6<\/p>\n<\/td>\n

\n

How well the patient was able to move around<\/p>\n<\/td>\n

\n

Very poor (1), Poor (2), Neither poor nor good (3), Good (4), Very good (5)<\/p>\n<\/td>\n<\/tr>\n

\n

7<\/p>\n<\/td>\n

\n

Questions concerned with the patients\u2019 personal beliefs (religion\/ spirituality)<\/p>\n<\/td>\n

\n

Not at all (1), A little (2), A moderate amount (3), Very much (4), An extreme amount (5)<\/p>\n<\/td>\n<\/tr>\n

\n

8<\/p>\n<\/td>\n

\n

Importance questions (how important various aspects of life are to the patient)<\/p>\n<\/td>\n

\n

Not important (1), A little important (2), Moderately important (3), Very important (4), Extremely important (5)<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The collected data was analysed using\nSPSS, version 16. A p-value <0.05 was considered statistically significant. The\nstudy was begun only after obtaining due permission from the \u201cinstitutional ethics\ncommittee (IEC)\u201d. Patients were included in the study once they were explained in\ndetail about the same and if they agreed to provide a written informed consent.\nThe individuals in the study sample were identified by a code, and no personal\ninformation was recorded. Any personal identifiers were not included.<\/strong><\/p>\n\n\n\n

Results <\/strong><\/p>\n\n\n\n

A\ntotal of 198 patients were interviewed, and were assessed for adherence to ART\nalong with the quality of life using the \u201cWHOQOL\u201d questionnaire.<\/p>\n\n\n\n

Of the total patients, 103 were male patients and the rest were female. Majority of the patients interviewed were married (81.2%), while 14.2% were single; the rest were either widowed\/ divorced\/ separated. The average age of the participants was 45 \u00b1 9.6 years (Mean \u00b1 SD). The average CD 4 count was 466 \u00b1 276.2 cells\/mm3 (Mean \u00b1 SD); the average duration of illness was 5 \u00b1 4.34 years (Mean \u00b1 SD). The largest percentage of patients had received an education up to primary school level (57.1%), while about 14% of the patients had gone to University. Among the participants, 50.3% of them had been HIV positive for a duration of 1 \u2013 5 years, 29.7% had tested positive 5 – 10 years back, and 12.6% of them have had the disease for more than 10 years. <\/p>\n\n\n\n

Table 2: Baseline Characteristics of the Patients<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n
\n

Gender<\/strong><\/p>\n<\/td>\n

\n

103 M, 95 F<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Age (years)<\/p>\n

No. of patients<\/p>\n<\/td>\n

\n

<30 years<\/p>\n<\/td>\n

\n

31 \u2013 40 years<\/p>\n<\/td>\n

\n

41 \u2013 50 years<\/p>\n<\/td>\n

\n

51 \u2013 60 years<\/p>\n<\/td>\n

\n

>60 years<\/p>\n<\/td>\n<\/tr>\n

\n

15<\/p>\n<\/td>\n

\n

45<\/p>\n<\/td>\n

\n

87<\/p>\n<\/td>\n

\n

43<\/p>\n<\/td>\n

\n

8<\/p>\n<\/td>\n<\/tr>\n

\n

Duration of illness (years)<\/p>\n<\/td>\n

\n

< 5 years<\/p>\n<\/td>\n

\n

5 \u2013 10 years<\/p>\n<\/td>\n

\n

> 10 years<\/p>\n<\/td>\n<\/tr>\n

\n

112<\/p>\n<\/td>\n

\n

62<\/p>\n<\/td>\n

\n

21<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

A\nlarge majority of the patients, when asked in general about how they felt their\nhealth was, said it was neither bad nor good; less than 1% gave a positive\nreply of their health being very good. However, at the same time, none of the\npatients said they considered themselves \u2018ill\u2019. Of the total patients included,\nmajority of the patients (87.5%) had WHO stage I disease, 1.1% of patients had\nstage II disease, 6.2 % had stage III disease, and 5.6% patients had stage IV\ndisease. <\/p>\n\n\n\n

The\nstandard regimen of treatment according to the NACO guidelines included three\ndrugs, the most common regimen being a combination of tenofovir, lamivudine,\nefavirenz (39.89%), followed by the next combination of zidovudine, lamivudine,\nnevirapine (25.75%). The other combinations included tenofovir + lamivudine +\nnevirapine, tenofovir and lamivudine along with a protease inhibitor such as\natazanavir + ritonavir. The adherence was assessed using the Medication\nAdherence Questionnaire (MAQ) scale described earlier. According to this scale,\na medium<\/em> to high<\/em> level of adherence was observed in 97.5% of the patients\n(score 0 = high adherence, score of 1 or 2 = medium adherence). When the\npatients were asked to assess the percentage of medicines taken in the last\nmonth using a pictorial scale, about 95% of the patients said they took the\nmedicines \u2018most<\/em>\u2019 of the time. The\nremaining patients who did not take the pills on time when asked about the\nreason for the same, the most common response was that they forgot to take the\nmedication routinely. <\/p>\n\n\n\n

Table 3: Medication Adherence Questionnaire<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Question<\/strong><\/p>\n<\/td>\n

\n

Number of patients with response \u201cNo\u201d <\/strong><\/p>\n

(No=0)<\/strong><\/p>\n<\/td>\n

\n

Number of patients with response \u201cYes\u201d <\/strong><\/p>\n

(Yes=1)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Do you sometimes forget to take your pills?<\/p>\n<\/td>\n

\n

192<\/p>\n<\/td>\n

\n

6<\/p>\n<\/td>\n<\/tr>\n

\n

Over the past two weeks did you skip taking your pills, for reasons other than forgetting?<\/p>\n<\/td>\n

\n

195<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n<\/tr>\n

\n

Have you anytime stopped taking your pills without telling your doctor, because you felt worse when you took the pills?<\/p>\n<\/td>\n

\n

196<\/p>\n<\/td>\n

\n

2<\/p>\n<\/td>\n<\/tr>\n

\n

When you travel or leave home, do you forget to carry your medication with you?<\/p>\n<\/td>\n

\n

197<\/p>\n<\/td>\n

\n

1<\/p>\n<\/td>\n<\/tr>\n

\n

Did you take you pills yesterday?<\/p>\n<\/td>\n

\n

189<\/p>\n<\/td>\n

\n

9<\/p>\n<\/td>\n<\/tr>\n

\n

When you feel your health is under control and you\u2019re feeling okay, do you stop taking the medication?<\/p>\n<\/td>\n

\n

198<\/p>\n<\/td>\n

\n

0<\/p>\n<\/td>\n<\/tr>\n

\n

Do you ever feel fed up of taking medication every day?<\/p>\n<\/td>\n

\n

189<\/p>\n<\/td>\n

\n

9<\/p>\n<\/td>\n<\/tr>\n

\n

How often do you have difficulty in remembering to take all your medication?<\/p>\n

(Please circle the correct number)<\/p>\n

<\/p>\n

Never\/Rarely (0) \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026 194<\/p>\n

Once in a while (1)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.. 04<\/p>\n

Sometimes (2)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\u2026\u2026\u2026……\u2026\u2026\u2026\u2026\u2026… 00<\/p>\n

Usually (3)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u2026\u2026\u2026…\u2026\u2026\u2026\u2026\u2026… 00<\/p>\n

All the time (4)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u2026\u2026……………………… 00<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The\nquality of life was assessed using the WHOQOL questionnaire. The first section\nof the questionnaire assessed if the patients had experienced emotions such as\npositive feelings, happiness or contentment, over the past two weeks. Majority\nof the patients reported little to moderate discomfort\/ pain, were not tired\neasily, and had no sleep disturbance (Score 2). Also, the patients\u2019 ability to\nconcentrate as well as the confidence in themselves was positive in majority of\nthe patients. However, more than 50% of the patients responded as having\nmoderate level of financial difficulties (Score 3). <\/p>\n\n\n\n

The\nsecond section looked at the patients\u2019 ability to do certain specific things\nsuch as activities of daily life in the last two weeks- of the total patients\u2019\ninterviewed, 43% of them responded to having good energy levels and being able\nto perform their daily activities without difficulty (scores 4 or 5). However,\nabout 60% of the patients felt that the support received from others and the\nacceptance was moderate to little (Score 3 or below).  <\/p>\n\n\n\n

The\nnext section assessed the patient\u2019s ability to do the work that they did for a\nliving. A very positive trend was observed; over 80% of the patients responded\nto being able to work normally, and being able to carry out their duties, along\nwith being satisfied with their capacity to work (scores 4 or 5). The fourth\nsection focussed on how satisfied, happy or good the patients felt about\nvarious aspects of their life over the last two weeks. Overall, majority of the\npatients felt they were satisfied with their capacity to work, energy, ability\nto perform daily activities, access to health facilities, support from\nimmediate family\/ friends, and the quality of life (score 4 or 5). <\/p>\n\n\n\n

The\nnext section revolved around the patients\u2019 beliefs, and how these beliefs\naffected their quality of life. Over 65% of the patients felt little to\nmoderately guilty about being HIV positive, and were scared of what the future\nholds (score 3). About 25% of them responded saying that their personal beliefs\nplayed a very important role in helping them to face various difficulties. The\nlast section dealt with \u201cimportance\u201d questions- meaning how important various\naspects of life were to the patients. Over 70% patients responded by saying\ntheir quality of life, health, a pain-free and energetic life, with a good\nquality of sleep, was extremely important to them (score 5). <\/p>\n\n\n\n

Discussion<\/strong><\/p>\n\n\n\n

We began this study with the aim of\nassessing the adherence to antiretroviral therapy in patients with HIV, and\nassessing the quality of life while taking the medications. Of the 198 patients\nincluded, 103 were male patients, and the gender distribution was not\nsignificantly different. The baseline characteristics did not significantly\nvary between genders. According to a study conducted in India, the quality of\nlife in women was worse than men infected with HIV.13<\/sup> In our study\ntoo, a similar trend was observed though not statistically significant. This\nmay be attributable to various socio-cultural nuances present in the society,\nacross various communities and cultures. <\/p>\n\n\n\n

The adherence to treatment was observed\nto be more than 95% in majority of the patients. This is an important\nobservation that plays a major part in determining the response to therapy and\nthe success of antiretroviral therapy. An earlier study conducted to study the\nadherence to treatment, concluded that patient education and counselling,\nincluding alcohol abstinence, could contribute to increasing the adherence to\ntreatment as well as success of ART among people living with HIV.18<\/sup> The\nMedication Adherence Questionnaire was initially designed to assess the\nadherence to antihypertensive medications in 1986. It was shown to have a good\npredictive validity, and subsequently it was used in diabetes, psychoses,\nosteoporosis, asthma, HIV, among others. The psychometric properties of this\nscale help to determine the factors affecting adherence.14,19<\/sup><\/p>\n\n\n\n

A study conducted in Myanmar reported\nan adherence of  >95%, in 84% of the\nstudy population; the main reason for not being regular with the medication was\nbeing busy or not being at home, or forgetting to take the medication.20<\/sup>\nAnother study conducted on South Africa found that 77% of the study population\nhad an adherence of >95%, which was considered suboptimal.21<\/sup> In\nanother study conducted in Lao PDR, an adherence of more than 95% was seen only\nin 60% of the patients.22<\/sup> An earlier study had suggested that the\nMAQ had a component to look at the psychological factors associated with taking\nmedication, along with the patients\u2019 behaviour. Both these components play a\nvital role in success of any medications prescribed to the patients.23<\/sup>\nAn adherence of >95% was observed in our study in majority of the patients.\nAn earlier study in the same settings had reported a suboptimal adherence, and\nhad suggested an intensive adherence counselling.24<\/sup> <\/p>\n\n\n\n

For the success of antiretroviral\ntherapy, measured in terms of CD4 count and viral load, along with quality of\nlife, the single most factor that can affect the success of therapy is the\npatients\u2019 adherence to treatment. Skipping doses leads to resistance and may\neven result in failure of first line regimen. Hence, this observation from our\nstudy is a positive and encouraging trend. This observation also suggests that\nthe tolerability to adverse effects among patients has improved and that the\npatients are motivated enough to not stop the medications by themselves if side\neffects do happen. This is achieved with personal, professional counselling at\nthe ART clinic before initiating the treatment, and regular follow up to check\nfor the adherence thereafter.<\/p>\n\n\n\n

Coming to the second aspect of our\nstudy, the quality of life in patients living with HIV. An earlier study to\nassess the QOL, in patients with HIV had concluded that good family support and access\nto healthcare were important factors that contributed to QOL.13,25<\/sup> Another\nstudy that used the WHOQOL instrument found that overall, all the domains\npertaining to various aspects of life fell into the category of \u201cmoderate\u201d,\nwith a focus on the patients\u2019 spirituality being more than their social\nrelationship.26<\/sup> <\/p>\n\n\n\n

However, all the factors under various domains were perceived to\nbe \u201csatisfactory\u201d by majority of the patients in our study, which is again a\ngood sign of our healthcare settings. Anxiety and depression which are major\nfactors in PLHIV that can affect the QOL adversely, were observed to be \u201clittle\nto moderate\u201d in our study.27,28<\/sup><\/p>\n\n\n\n

The quality of life is a factor that is as important as the clinical\nsuccess of therapy. An improvement in the quality of life and being able to\nlead a life as close to what is considered \u201cnormal\u201d as possible, is finally\nwhat matters the most from the patient\u2019s point of view. Hence, when we measure\nthe success of antiretroviral therapy, along with the laboratory parameters,\nthe quality of life has to be assessed. The observations from our study are a\ngood sign indeed as to how over the years, with the availability of better-tolerated\nand more effective drugs, the patients are largely able to lead a \u201cnormal\u201d\nlife, along with being able to do all activities of daily living. Also, being\nable to indulge in work and leisure, helps patients to integrate with the\nsociety at large and this gives a huge mental boost to the patients as well.<\/p>\n\n\n\n

Our study did have certain limitations, the main being that it was\na single centre study. Hence the results may not be generalizable in all\npopulations. Plus the region caters to a population where the literacy levels\nare higher. Also, we relied mainly on the information obtained from patients,\nand recall bias may <\/em>not have been\nfully eliminated. Another issue that we faced is the questionnaire being a long\none, we could not get some patients to complete it fully. Hence a final score\nto interpret the questionnaire was not obtainable, which otherwise would have\nadded more relevance to the data. <\/p>\n\n\n\n

Ensuring good health for one and all is one of the sustainable\ndevelopmental goals (SDG) of the United Nations; such research that studies\ndiseases of public health importance, will help in utilizing the available\nresources in the best possible way so as to try and ensure quality life for all\ncitizens.29<\/sup><\/p>\n\n\n\n

Conclusion<\/strong><\/p>\n\n\n\n

The adherence to antiretroviral\ntherapy was observed to be >95% in majority of the patients when assessed\nusing the Medication Adherence Questionnaire. The quality of life was deemed \u201csatisfactory\u201d\nwhen assessed using the WHOQOL questionnaire. However, further studies which\nfollow-up the patients for a longer period, are warranted to be able to better\nunderstand the factors that affect the quality of life and adherence to\ntreatment in patients living with HIV.<\/p>\n\n\n\n

Acknowledgement<\/strong><\/p>\n\n\n\n

We would like to acknowledge the support rendered by the staff of the ART Clinic, the Medicine OPD and most important of all, the patients, without whose support this study would not have been possible.<\/p>\n\n\n\n

Conflict of Interest<\/strong><\/p>\n\n\n\n

There is no conflict of interest.<\/p>\n\n\n\n

Funding Sources<\/strong><\/p>\n\n\n\n

There are no funding sources.<\/p>\n\n\n\n

References<\/strong><\/p>\n\n\n\n

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