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Clinical Research in Infectious Diseases

Cite this article: Emmanuel EN, Patrice HM, Sandrine ND, Christiane KD, Pascal NG, et al. (2016) Predictive Factors of Clinical and Biological Evolution of HIV Patients under Antiretroviral Treatment in Douala- Cameroon. Clin Res Infect Dis 3(2): 1027.

*Corresponding author

Essomba Noel Emmanuel, Department of Public Health, University of Douala- Cameroon, PO BOX: 106, Douala, Camerron, Tel: 00237 677551808 ; Email:

Submitted: 15 April 2016

Accepted: 05 July 2016

Published: 08 July 2016

ISSN: 2379-0636

Copyright© 2016 Emmanuel et al.

OPEN ACCESS

Keywords•Predictive factors•Evolution•HIV•Antiretroviral•Douala-Cameroon

Research Article

Predictive Factors of Clinical and Biological Evolution of HIV Patients under Antiretroviral Treatment in Douala- CameroonEssomba Noel Emmanuel1*, Halle Marie Patrice2, NkomoAssoh Diane Sandrine1, KedyKoum Danielle Christiane3, Ngaba Guy Pascal4, Ngo Ngwe Madeleine Irma1, Leopold Gustave4, and Coppieters Yves5

1Department of Public Health, University of Douala, Cameroon 2Department of Internal Medicine, University of Douala, Cameroon3Department of Pediatrics, University of Douala, Cameroon4Department of Biology, University of Douala, Cameroon5Department of Public Health, Ecole de Santé Publique de Bruxelles, Belgium

Abstract

Background: Data concerning good prognostic factors on the evolution of HIV infected patients under treatment are scanty in sub-Saharan Africa in general and in Cameroon in particular. This study aimed to determine the factors associated with good evolution of HIV positive patients in Cameroon.

Methods: This was a cross sectional and analytical study carried out in three hospitals in Douala from November 2014 to May 2015, including all HIV-positive patients > 18 years, under antiretroviral treatments for at least 06 months. Information on the management of patients was extracted from medical records, out consultations and pharmacy registers. Patients were divided into 2 groups: Evolution was good when an increase of ≥ 10% of the initial weight and/or an increase in CD4 count ≥ 500cells/mm3 occurred and bad in the contrary. Multiple logistic regressions were used to determine factors associated with good evolution.

Results: A total of 1.057 files were included. Mean age of patients was 39±10 years with a sex ratio M/F of 0.46 and 51.9% (p = 0.01) were single. M mean initial weight was 67.8 ± 13.3. Half of patients were at stage III (WHO) of disease, mean initial CD4 was 203 ± 157 and 313 (29.6 %) had opportunistic diseases. Patients with an average initial weight ≥ 59.4 ± 11.6 had a good evolution. No significant difference was found between the different WHO stages of the disease (p= 0.1). Encephalitis and tuberculosis were associated with the group of those presenting bad evolution. (P= 0,0001 and p= 0,02). Patients with average initial CD4 ≥ 168 ± 52 had a good evolution (p = 0.008). No significant difference between the different protocols of ARV treatments was observed (p = 0.093). The absence of opportunistic diseases [OR 2,58 (1,38-4,85)], been married [OR 2,39 (1,25-4,52)], and good adherence to treatment [OR 2,40 (0,16-3,20)] were factors associated to good evolution.

Conclusion: This study showed that been married, the absence of opportunistic diseases and good adherence to the treatment were factors of good prognostic of HIV infected patients under treatment. Therefore early screening and treatment are necessary.

ABBREVIATIONSHIV: Human Immunodeficiency Virus; WHO: World Health

Organization; ART: Anti Retroviral Treatment; BMI: Body Mass Index; PLWHIV: People Living with HIV; NDHS III: National Demographic and Health Survey 3rd edition; NS: Non Significant

BACKGROUNDThe evolution of HIV epidemic in the world has improved

over the past years, due to the significant expansion of access to antiretroviral treatment (ART), which contributes to the reduction of morbidity and mortality of infected patients [1]. The diagnosis and management of HIV infection has progress considerably in the past 20 years, with the development of ART

and various possibilities of quantification of lymphocytes cells CD4 and viral load [2,3]. In 2013 more than 12.9 million people living with HIV in the world were under ART, among who 11.7 million were from low-income or middle-income countries [2].

Despite this, the efficiency of ART depends on a good therapeutic observance of patients [4,5]. Clinical and biological evolution are means to appreciate this observance [6], but several other factors have an impact on good clinical evolution of these patients [7]: an advanced age at seroconversion, an initial low CD4 count, the occurrence of pathology classifying the patient at AIDS level such as progressive multifocal leucoencephalopathy [8] and the coinfection with hepatitis C. Studies on survival have shown that a high CD4 count at diagnosis was associated with

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good outcome [6,9]. A cohort study shown that the risk of death was 1.7 times higher among patients co-infected with hepatitis C [10-13]. Moreover, a study in Thailand showed that in low income countries where CD4 and viral load dosage are not routinely available patients at high risk of death could be identified by the combination of total lymphocytes, anemia and body mass index (BMI) [14].

It is clear from the literature that issue of good prognosis factors is quite complex, diversified and depend on many factors. In a setting characterized by various difficulties regarding diagnosis and access to treatment such as Cameroon, identifying factors of good prognosis could contribute to improvement of the care of HIV positive patients. The purpose of this study was therefore to determine factors associated with good evolution among patients under ART treated from 2009 to 2014 in Douala.

METHODSStudy Setting

This was a cross-sectional and analytical study conducted from November, 2014 to May, 2015 in three hospitals in Douala: one referral, one regional hospital and a district hospital. Douala the economic capital of Cameroon is a cosmopolitan city with almost 3 million inhabitants with divergent socio-cultural and economic realities [15]. The city of Douala is the most requested town within the Littoral region of Cameroon, regarding support and care of people living with HIV (PLWHIV) and the second in the country [16].

Study population

We included medical files of all HIV positive patients, aged 18 years and above, on ART for at least 6 months followed-up in one of 3 hospitals. Subjects in transit, transferred in another region, or with incomplete files were excluded. A consecutive and exhaustive sampling was used. The Institutional Ethics Committee of the Douala University approved the study.

Data collection

Data were collected with a pre-established, standardized and anonymous questionnaire. Information on the management of patients was extracted from medical records, consultation and pharmacy’s registers of the care units. Various variables were analyzed among which, a dependent variable: good clinical and biological evolution of patients. Independent variables were; 1)- socio-demographic data (age, sex, residence, ethnicity, religion, profession, marital status, socioeconomic status), 2)- clinical data (tumors, malnutrition, HIV-associated nephropathy, heart disease. Opportunistic diseases: tuberculosis, candidiasis, severe bacterial infections pneumonia, empyema, pyomyositis, meningitis, Kaposi’s sarcoma, toxoplasmosis, cryptococcosis, salmonellosis, HIV-associated mucocutaneous infections and others), co-infections with hepatitis B and C; 3)- nutritional status (diet), 4)- biological variables (CD4 count, viral load, hemoglobin, white blood cell levels, creatinine, transaminases, glucose, cholesterol, triglycerides, amylase), 5)- Psychological support 6)- treatment regimen and adherence.

Operational definition of terms

Good clinical and biological evolution of patients is defined

by two of the following three criteria: an increase in CD4 count > 500/ml and/or, an undetectable viral load, and/or an increase of weight ≥10 % of the baseline weight. Non adherence or compliance was defined in two ways: i) - Either the patient missed more than a daily intake of drugs during the last 7 days preceding the beginning of the survey, or the patients missed for a whole week or more their treatment during the month preceding the beginning of the survey or since the initiation of treatment [17]; ii) – either by the ratio between the number of dispensed prescriptions and the theoretical quantity of expected prescriptions (corresponding to the number of month of follow-up on treatment). The patient was declared non observant when the ratio was lower than 0.95 [17-19] (Table 1).

Data analysis

Data were analyzed with SPSS software version 16.0 2007. The comparison of qualitative variables was made using Chi2 test, and the exact probability of Fisher was determined in case of dichotomous variables. Differences were considered significant for p < 0.05. Multi logistic regression analysis was used to determine factors associated with good evolution. The selection of variables in the model was made for p<0.1. The adequacy of the model was tested using the Hosmer-Lemeshow test. The model was considered adequate for a p = 0.73. The odds ratio and its confidence interval at 95 % were determined to quantify the association between good clinical evolution and the various explanatory variables of the model.

RESULTS

Sociodemographic data

A total of 1.057 files were included in this study. The mean age of patients was 39±10 years, and 68.3 % were female. The most represented age was that of (30-40) years old 402 (38.03 %), single were significantly represented 549 (51.9%) (P = 0.01), the mean initial weight was 67.8 ± 13.3. The WHO clinical stage III of disease was the most frequent 531 (50.3%), the mean initial CD4 was 203 ± 157 and313 (29.6 %) had opportunistic diseases. Concerning the gender, 89 (12.3 %) women presented a good evolution against 40 (11.9 %) men (p=0,07). Married patients had a good evolution as compared to single, (p=0.01) (Table 2).

Patients with mean weight ≥ 70.1 ± 13.2 at 6th months and ≥ 69.6 ±13.6 at 12th month of follow-up presented a good evolution (p<0.0001) and (p=0.009) respectively (Table 2).

Clinical and biological evolution and opportunistic diseases

The presence of opportunistic disease was associated with bad evolution (p <0.001) especially the presence of encephalitis and tuberculosis compared to others diseases (Table 3). Patients with mean CD4 count ≥168 ±152 at initiation and those with an average CD4 count ≥ 422± 218 at 6th months had a good evolution.

Therapeutic, psychological and nutritional parameters

No significant difference was found between the different protocols of ART and the duration of treatment. 82.9 % of patients with good therapeutic observance had a good evolution

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Table 1: Presentation of the independent variables of the study.

Variables Définition and terms Measure

Sociodemographic data Age, gender, place of residence, ethnic group, religion, profession, marital status, socioeconomic level Declaration

Clinical data

Opportunistic disease :tuberculosis, candidose, bacterial infections (pneumonia, empyéme, pyomyosite, osteoarticular infections, meningitis, Kaposi sarcom, toxoplasmosis and others)

Medical record

Co-infections Viral hepatitis B and C Medical record

Nutritional data Balanced diet Declaration

Biological data (level of CD4, viral load, level of white blood cells, level of hemoglobine, creat, ASAT/ALAT level, blood sugar level, cholestérolémie, triglycéridémie, amylasémie)

Medical record

Therapeutic data

a) Related to ARV (the duration of the ARV therapy, the actual protocol) b)Related to the prophylaxis of opportunistic infectionsc) Related to therapeutic observance

Medical record and declaration

Table 2: Sociodemographic distribution of the patients and clinical and biological evolution.

Bad evolution Good evolution

n % n % p

Gender Female 633 87.7 89 12.3

Male 295 88.1 40 11.9 NS

Age group

< 30 163 84.9 29 15.1

30 - 40 350 87.1 52 12.9

40 - 49 270 88.5 35 11.5

50 - 59 119 90.8 12 9.2

≥ 60 26 96.3 1 3.7 NS

Marital status

Single 498 90.7 51 9.3

Divorced 40 87.0 6 13.0

Married 277 83.4 55 16 .6

Widowed 113 86.9 17 13.1 0.01

Place of residenceRural 49 87.5 7 12.5

Urban 879 87.8 122 12.2 NS

Income(FCfa)

< 50 000 394 85.8 65 14.2

50 - 100 000 242 90.6 25 9.4

100 – 200 000 238 88.8 30 11.2

≥ 250 54 85.7 9 14.3 NS

NS : Non Significant

compared to those non observant (p= 0,001). None of the patients was subjected to a particular diet and 89.2% of patients who benefited from a psychological support, presented a good evolution as compared to those not accompanied (p=0,003) (Table 4).

In multivariate analysis, factors associated with good evolution were age [OR 1.05(1.02 – 1.07)], been married [OR 2.56 (1.31 – 4.99)], therapeutic protocols containing either AZT + 3TC [OR 3.11 (1.93 – 10.35)], or TDF + 3TC [OR 3.78 (1.02 – 14.00)] and absence of opportunistic disease [OR 2.32 (1.55 – 3.48)]

(Table 5).

DISCUSSIONThe present study aims to determine the factors, which

predispose to good clinical and biological evolution of adults, HIV positive patients under ART in Douala.

Sociodemographic aspects and evolution

Our study population was mostly female (68.3 %) and this is in accordance with the demographic and health survey III (DHS

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Table 3: Distribution of the evolution according to the opportunistic diseases

Bad evolution Good evolution

n ¨% n % p

Opportunistic disease no 673 90.5 71 9.5

yes 255 81.5 58 18.5 < 0.0001

Encephalitis no 925 88.0 126 12.0

yes 3 50.0 3 50.0 0.02

Pulmonary tuberculosis no 813 89.0 100 11.0

yes 115 79.9 29 20.1 0.003

Extrapulmonary tuberculosis no 893 87.9 123 12.1

yes 35 85.4 6 14.6 0.8

Candidose no 890 88.2 119 11.8

yes 38 79.2 10 20.8 0.1

Kaposi sarcoma no 904 87.8 126 12.2

yes 24 88.9 3 11.1 0.9

Toxoplasmosis no 917 87.7 129 12.3

yes 11 100 0 0 0.4

Table 4: Presentation of the clinical and biological evolution of the patients according to the protocols of antiretrovirals, the psychosocial support and the therapeutic observance.

Bad evolution Good évolution

n % N % p

3TC+AZT+EV 13 86.7 2 13.3

3TC+AZT+NV 211 84.4 39 15.6

3TC+D4T+EFV 17 100 0 0

3TC+D4T+NP 93 83.8 18 16.2

3TC+TDF+EFV 493 90.6 51 9.4

3TC+TDF+LPr 13 92.9 1 7.1

3TC+TDF+NP 76 84.4 14 15.6

Autre protocole 12 75.0 4 25.0 NS

ObservantM 7 5.4 31 24.0F 23 17.8 68 52.7

Non observantM 292 31.4 9 0.9

0.001F 606 65.3 21 2.2

Yes for support M 2 1.9 19 18.1F 7 6.6 77 73.3

No for support M 313 32.8 5 0.5F 606 63.6 28 2.9 0.04

Table 5: Multivariate analysis presenting the predictive factors of good clinical and biological evolution of the patients.

OR IC à 95% p

Age< 30 ans 1.05 1.02 1.07 <0.0001

Gender Female Ref

Male 1.08 0.66 1.75 0.77

Marital status Single Ref

Married 2.56 1.31 4.99 0.01

Place of résidence Rural Ref

Urban 1.11 0.47 2.64 0.81

Income (×1000 fcfa) < 50 Ref

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50 – 100 0.75 0.42 1.35 0.34

100 - 200 0.57 0.24 1.33 0.19

≥ 200 0.70 0.41 1.17 0.17

Patient under MOI Yes 1.14 0.49 2.62 0.77

Patient under ARV Yes 0.004 0.002 174.92 0.99

Other Ref

ARV Protocols 3TC+AZT+ 3.11 1.93 10.35 0.03

3TC+D4T+ 1.92 0.56 6.56 0.30

3TC+TDF+ 3.78 1.02 14.00 0.065

Type of HIV NS Ref

type 1 1.02 0.11 9.74 0.99

type 2 2.48 0.27 22.49 0.42

Stage of the disease Stage I Ref

Stage II 1.56 0.60 4.05 0.36

Stage IV 1.24 0.57 2.71 0.59

Opportunistic disease No 2.32 1.55 3.48 <0.0001

Candidose Yes 1.11 0.57 2.18 0.75

Encéphalite Yes 4.68 0.86 25.58 0.08

Pulmonary TB Yes 1.25 0.50 3.09 0.63

Extrapulmonary TB Yes 5.40 0.97 30.06 0.05

Toxoplasmosis Yes 0.005 0.001 234.45 0.99

Good observance Yes 1.09 0.70 1.69 0.01

III) in Cameroon that revealed that 2/3 of PLHIV are female [4]. Our result is also similar to the general trend in Africa (66.6%), but different compared to European and American studies were females represent 33.5% and 11.5% respectively [20]. Economic and sociocultural parameters specific to Africa are likely to explain this feminization of the infection [21-23].

Also I this study married people presented a trend to good evolution (16.6 %) with a significant difference compare to single patients. A similar result was found by Mbopi-kéou et al., (40.5 %) [24]. This can be explained by the fact that married people may show solidarity and mutual support in case of disease [25]. This solidarity opens to financial, psychological and physical benefits. Patients with psychosocial support presented a better tendency to good evolution than the others (p=0.04) [26].

Weight gain and nutritional supplement

Manisha et al., found in their works that a weight gain of 5 to 10kg was associated with a low mortality rate among HIV infected patients after 12 months of follow-up [27]. In the present study, patients with good evolution had a significant positive difference in average weight at 6th and 12th month of treatment compared to the baseline weight. The weight gain was more pronounced during the first six months. This observation is similar to that of Ndombi et al., found an average weight gain of 3.1 ± 4.8kg in the first six months of treatment and 0.8 ± 3.0kg the next six months [28].

Influence of the clinical stage of the disease

In study, good evolution was not associated with the WHO clinical stage of the disease. This suggests that independently

from clinical stage the patients a good evolution. The latter is conditioned by other criteria, such as good therapeutic follow-up, psychosocial support and good observance [29,30]. However Reda et al., found that an advanced WHO clinical stage was associated with difficulties to gain weight after initiation of ART [31]. Bizuwork et al., in Malawi showed that patients on ART for 6 months had a gradual increase in weight, with an average of 6.0kg in males and 5.0kg in females. Besides, they noted that patients at WHO clinical stage 3 and 4 had a slight increase in weight as compared to those at stage 1 and 2, although this was only significant at 6 months between women at stage 4 as compared to women at stage 1 and 2 (p < 0,05) [32].

Opportunistic infections and disease progression

Among the opportunistic infections, encephalitis (50.0 %) and tuberculosis (20.1 %) were associated with bad clinical and biological evolution. The prevalence of tuberculosis in this study was higher compared to the results of Mbopikeou et al., (15.4%) and Déguénonvo et al., (36%) [33,34]. Tuberculosis is the most frequently observed opportunistic disease and is globally the first causes of death among PLHIV [35]. The prevalence of encephalitis in our study was extremely high compared to the finding in the literature [36]. One explanation is the fact that diagnostic criteria are not standardized in our setting and all clinical unexplained neurological disorders persistent with headaches are considered as encephalitis.

CD4 count at the initiation of ARV therapy and evolution of the disease

Regarding the biological aspects, similar results were

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published by Ford et al., who found average rates CD4 at initiation and at six months of treatment of 161.1 ±104.2 and 295.1±166.4 cells/mm3 respectively [37]. Almost all studies addressing this aspect associate late submission with a lower probability of survival and with a good evolution when the average CD4 count at initiation of treatment is > 150/mm3 [39,40]. Efforts of vulgarization of CD4 count dosage should be encouraged to improve the time of treatment initiation.

Erlandson et al., in their study, by comparing various therapeutic protocols and their effects on weight gain and the increase of CD4 level in PLHIV, found that the association Abarcavir / Lamuvidine against Tenofovir / Emtricitabine do not differ in the change of weight and CD4 count. On the other hand, patients receiving association nucleoside reverse transcriptase inhibitors- Atazanavir /r against Efavirenz showed more weight gain [40]. Our results in contrario presented no significant difference between the various ARV protocols.

Interest of the psychosocial support

Concerning psychosocial support of patients, we found a significant difference between patients who benefited from it and the others. The majority of the supported patients tend to experience a good evolution. This result confirms that of Essomba et al., who figured an association between psychosocial and family support, observance in ART, absence of opportunistic diseases and good evolution [17]. Several authors also agree on the fact that psychosocial factors can influence directly on health parameters of PVVIH, as viral load depending on the quality of therapeutic observance [41-43].

Factors independently associated to a good evolution of the disease

In the study of Agaba et al., in Nigeria, the presence of opportunistic diseases and particularly tuberculosis, been single and a CD4 count <100 / mm3, were predictive factors of mortality [44]. As for Pillay et al., been single, tuberculosis and the academic level were factors independently associated to bad clinical evolution [45]. In the present study, age < 30 years, been married, and the absence of opportunistic diseases were predictive factors of good clinical and biological evolution of our patients. Only the quality of the therapeutic protocol does not seem to be enough to ensure a good evolution. Except for Stavudine dissuaded for its adverse effects, the other therapeutic plans seem susceptible to garantee good results [46]. Several other works confirm the impact of a combination of several factors on the quality of evolution of the management of patients [47]. Of these factors, non-adhesion to treatments finds itself in several studies as influencing the outcome of patients on treatment [47,48].

In Cameroon, national policy on the global management of PLHIV integrates the prevention and the management of opportunistic infections. This support provides free access to drugs. In this study, 29 % of the people presented an opportunistic infection, and in their study in Ethiopia, Debasu et al., found a prevalence of 19.7 %. This raises once more the issue of the prevention of these infections in Africa in general. The policy of African governments in their great majority is centered on the free access to ARV and drugs against opportunistic infection.

Yet the prevalence of these diseases remains important, unlike the countries of the North. Several aspects can explain this, in particular the late screening, the difficulties in obtaining CD4 count and viral load, the deadlines at initiating ART, the short of stock of drugs and the therapeuticobservance. An accent must be put on raising awareness of various actors for an improvement of these barriers, as well as enhancement of psychosocial support that remains a “luxury” in our setting [17,49,50].

LIMITATIONSThis study did not take into account the academic level

and the religion of the patients, which have proved in certain studies to influence the fate of their care [17,47]. Besides, a more important sample should certainly give satisfactory results. The difficulties at obtaining the viral load in our context remain a permanent problem.

CONCLUSIONThis study presented good factors of clinical and biological

evolution. It states that the type of treatment protocol weakly influenced this evolution. That been married, the absence of opportunistic diseases and good adherence to the treatment were factors of good prognostic of HIV infected patients under treatment. Therefore early screening and treatment are necessary.The reaction to this finding should integrate early management of patients.Including screening and early antiretroviral therapy. Psychosocial support which is still neglected in the care of our patients should be strengthened in the strategies implemented by the government .

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

The study was submitted and received the approval of the National Ethics Committee of Cameroon. The consent of the patients was obtained after explaining the purpose of the study. The information obtained was kept confidential.

AUTHORS CONTRIBUTIONSENE and KKDC designed the study. HMP, NAD and NNM

undertook the data collection. CY, LLG and ENE undertook the statistica lanalysis. All the authors drafted the manuscript. All have approved the submitted version of the manuscript.

ACKNOWLEDGEMENTSWe want to thank the Director of the Laquintinie hospital

and all his staff. The department of public health of the Douala University for its guidance during this work.

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