138 HRQLrather than only improving survival114 and this has been evidenced by the positive change in health for respondents in the present study. Furthermore, going by the WHO definition of health as: “.... a state of complete physical, mental and social well-being ....” it is reasonable to suppose that the positive change in health was probably holistic, thus leading to both improved vitality and mental health. Regarding satisfaction with the general care received at the ARV clinic, patient satisfaction is recognized as an important indicator of both quality of care and outcome of care for adults with HIV/AIDS.19 Therefore, the findings of the present study imply that respondents were receiving good quality care that was achieving treatment goals as expressed by good general health.
In the present study, experiencing side effects was a predictor of the less likelihood of good vitality and good general health. Generally, side effects to ARVs are common and are mostly transient, but they can still make a patient feel sicker. However, serious side effects are rare; but when they occur, can be potentially dangerous and even life-threatening.117 In another study, experiencing difficulties as a result of adverse HIV treatment reactions was also shown to be associated with an unacceptably low physical HRQL;66 whereas, physical and mental HRQL were not associated with any ART adverse drug reactions in another study.73
non-AIDS-139 defining while 8 were AIDS-defining illnesses] only 5 remained by 12-months of HAART. The number of respondents still experiencing clinical events had also appreciably declined by the 12th month of treatment. Furthermore, none of the AIDS-defining clinical events that were observed at baseline remained by 12-months of HAART. The 7 commonest occurring events at baseline were: diarrhoeal illnesses >7days, chronic dermatitis, recurrent genital ulcers, peripheral neuropathy, vulvo-vaginal candidiasis, oral candidiasis and wasting syndrome; and these had completely disappeared by the 12th month of treatment, further substantiating the effectiveness of HAART. In addition, the incidence of peripheral neuropathy had declined from 37 to 7 persons only. However, regarding the lingering occurrence of peripheral neuropathy, two plausible reasons might explain this. Firstly, though Stavudine had been phased out from the treatment protocol, its long term side effect of peripheral neuropathy117 was still being experienced by some of the respondents. Secondly, the peripheral nervous system is also a target in HIV infection and several types of neuropathies have been identified.118The most common is HIV-associated polyneuropathy, which is a chronic, predominantly sensory and sometimes painful neuropathy.119
12-month immunologic and virologic response to HAART, HIV-related clinical events; and correlates
With regards to 12-month response to HAART, there were statistically significant increases in CD4 cell counts and weight gain above baseline (pre-HAART) values; which was accompanied by a statistically significant decrease in viral load and decline in number of clinical events below baseline values. Moreover, over half, well over three-quarters and nearly three-quarters of the respondents had achieved immunologic response, virologic response and weight gain,
140 respectively, by the 12th month of HAART. The findings of the present study further confirm the primary goals of ART which include restoration and preservation of immunologic function as evidenced by CD4 cell count increase; durable viral suppression as evidenced by viral load reduction to below detectable levels; reduction of HIV-associated morbidity as evidenced by the lower risk of both AIDS-defining and non-AIDS-defining conditions;120 and weight gain.8-11 However, it is important to note that in the present study, the proportion of respondents that had achieved virologic response (87.5%) was much higher than the proportion of those that had achieved immunologic response (57.2%). To plausibly explain this disparity, authors have found that in most adults and children, CD4 cell counts rise when ART is initiated and immune recovery starts.However, this increase is seen to occur during the first year of treatment, which later plateaus, and then continues to rise further during the second year of treatment.121 In some studies, CD4 cell counts seemed to reach a plateau after the first 2–3 years of ART.77,122-123 Whereas in other studies, for selected groups of patients with a well-suppressed HIV-1 RNA load, there were continuous, though small increases in CD4 T cell counts even after 3–4 years of ART.124-125 As a consequence, authors have suggested that there is the need to further evaluate long-term CD4 T cell recovery including its modulating factors.91
In the present study, the presence of an AIDS-defining illness at baseline was a predictor of both virologic response and weight gain at 12-months of HAART; while TDF-containing regimens were found to predict weight gain. These findings demonstrate that viral suppression and clinical improvement had occurred in majority of the patients, especially those on TDF-containing regimens. In support of these findings, other studies of patients with baseline history of an AIDS-defining condition and/or CD4 counts <200 cells/mm3 have provided strong evidence which
141 demonstrate that ART improves survival and delays disease progression.126-128 Likewise, other data that compared earlier ART (i.e., initiated at CD4 count >200cells/mm3) with later treatment (i.e., initiated at CD4 count <200 cells/mm3) also provide the same strong evidence.129-131 Furthermore, considering the severity of their illness, those patients with AIDS-defining conditions at baseline in the present study were probably more motivated to adhere to their treatment which in turn led to better outcomes; especially given that adherence to ART is strongly correlated with HIV viral suppression, increase in survival and improved quality of life.132-133 The present study also demonstrated that TDF-containing regimens predict weight gain and this further substantiates the 2013 WHO consolidated guidelines134 which strongly recommend TDF-containing regimens as the preferred first-line for initiating ART as this has proved to be superior in terms of CD4 response, virologic suppression and clinical response when compared with zidovudine-containing regimens.135
Although chronic HBV does not substantially alter the progression of HIV infection and does not influence HIV suppression or CD4 cell responses following ART initiation,136-137 patients with HBV co-infection in the present study were seen to significantly gain weight by 12-months of HAART. Two reasons may probably explain this occurrence. Firstly, knowing that they were also HBV co-infected, those patients were probably more adherent to medical advice such as abstaining from alcohol which is known to be immunosuppressive and toxic to the liver; and were probably likelier to be more adherent to their drugs. Secondly, according to the treatment protocol, the choice of ART regimen would have included TDF which has both strong anti-HBV and strong anti-HIV activity.120 It is important to note here that although the presence of AIDS-defining illnesses at baseline had predicted virologic response; and that baseline HBV
co-142 infection and AIDS-defining illnesses had predicted weight gain, the findings of the present study must be interpreted with caution. That is because in the first months of treatment, complications are commonest when individuals starting ART already have advanced HIV disease with severe immunodeficiency and existing co-infections.138-139 Therefore, clinicians must not unnecessarily delay ART initiation in patients who are deemed eligible by the current National treatment guidelines.
In the present study, prior ARV experience was associated with the less likelihood of weight gain. It is probable that those ARV-experienced patients were those that had initially been on the FGN ART programme and had been rolled-over into the PEPFAR programme. Results similar to the present study were found in Nairobi, Kenya.140 In the study, baseline and follow-up measures (weight change, CD4 cell counts and survival) were compared in a retrospective analysis between antiretroviral experienced (ARV-E) and antiretroviral-naive (ARV-N) patients that were enrolled into a center for infectious diseases. Both groups of patients were receiving HAART and were followed-up for a median of 9 months (interquartile range: 4-16 months).
Compared to ARV-N, ARV-E had substantially higher weight (median kg, 62 versus 57, P <
0.001) and higher CD4 count (median cells/mm3, 193 versus 95, P < 0.001) at baseline; but significantly lower rates of change in weight (-0.24 kg/month; 95% CI, -0.35 – - 0.14) and change in CD4 (-9.2 cells/mm3/month; 95% CI, -11.4 – -7.0) over 12 months; whereas mortality was significantly higher in ARV-N than ARV-E (P = 0.001). The authors concluded by reporting that ARV-E patients form a growing group that differ significantly from ARV-N patients; and as such, ARV-E patients require a distinctive approach of management from ARV-N patients. They
143 suggested that streamlining care for E patients may allow focused attention on early ARV-N patients whose mortality risks are substantially higher.
144 5.2 CONCLUSIONS
Predictors of good HRQL dimensions were: age <40 years and being currently employed (role-physical); having a care giver and disclosing one’s HIV-positive status (vitality);
experiencing an improvement in self-evaluated health transition (vitality and mental health); and being satisfied with the general care received at the ARV clinic (general health).
Predictors of the less likelihood of good HRQL dimensions were: enjoying social support (role-physical and mental health); being without a spouse/partner (general health); and experiencing side effects (vitality and general health).
Significantly over half, well over three-quarters and nearly three-quarters of the respondents had attained immunologic response, virologic response and weight gain, respectively, by their 12th month of HAART; and this was accompanied by significant increases in CD4 cell counts, significant decreases in viral loads, significant increases in weight and significant decreases in the number of HIV-related clinical events.
There were 20 documented HIV-related clinical events at baseline and of these, 12 were non-AIDS-defining while 8 were AIDS-defining illnesses. By the 12th month of HAART, only 5 non-AIDS-defining illnesses had remained.
Predictors of virologic response were AIDS-defining illnesses; while predictors of weight gain were HBV co-infection, AIDS-defining illnesses and TDF-containing regimens. On the other hand, prior ARV experience had predicted the less likelihood of weight gain.
The results of this survey have practical implications for improving treatment outcomes of PLWHA. Firstly, patients’ health status can be informed through subjective assessment of their HRQL. Secondly, while some socio-demographic factors that influence HRQL cannot be modified by the clinician such as age, employment status, being without a spouse/partner and
145 having a care giver; clinicians’ responsiveness to other factors such as providing quality treatments that cause an improved transition in health, ensuring that patients are satisfied with the care they receive, and managing side effects could lead to patients’ improved vitality, general and mental health. Lastly, baseline factors such as AIDS-defining illnesses, HBV co-infection and prior ARV experience should be borne in mind when reviewing response to treatment through the objective assessment of CD4 cell counts, viral load and HIV-related clinical events;
as this will better inform clinical decision-making.