Incidence and determinants of mortality among adult HIV infected patients on second-line antiretroviral treatment in Amhara region, Ethiopia: a retrospective follow up study

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Abstract

Introduction

Mortality of adult patients who are on antiretroviral therapy (ART) is higher in low-income than in high-income countries. After the failure of standard first-line treatment, patients switch to second-line regimens. However, there are limited data about the outcome of patients after switching to a second-line regimen in the study area. This study aimed to measure the rate of mortality and its determinants among HIV patients on second-line ART regimens.

Methods

Multicenter institution based retrospective follow up study was conducted among 1192 adult patients who started second-line ART between 2008 and 2016 in eight selected hospitals of Amhara region. Patients who started second-line treatment after the failure of first-line treatment were included. Patient medical records, registration books, and computer database were used to collect the data. Time to death after a switch to second-line ART was the primary outcome of interest. Cox proportional hazard model was fitted to identify determinant factors of mortality.

Results

Among 1192 patients who were on second-line ART, 136 (11.4%) died with 3,157 person-years of follow up. Over the study period, the mortality rate was 4.33 per 100 person-years. Not taking isoniazid preventive therapy (IPT) (Adjusted Hazard Ratio (AHR): 6.6; 95% CI: 2.9, 15.0), did not make modification on second-line regimen (AHR: 4.4; 95% CI: 2.8, 6.8), poor clinical adherence (AHR: 2.5; 95% CI: 1.4, 4.5), functional status of bedridden (AHR: 2.7; 95% CI: 1.5, 4.8), and having attained a tertiary level of education (AHR: 0.4; 95% CI: 0.2, 0.8) were independent determinants of mortality.

Conclusion

The incidence rate of mortality was high and most of the deaths occurred within 12 months after switching to second-line ART. Higher mortality among adult HIV-infected patients was associated with poor adherence, no formal education, not taking IPT, being bedridden at the time of the switch, and not modifying second-line treatment. Improving treatment adherence of patients by providing consistent adherence counseling, providing INH prophylaxis and monitoring patient's regimen more closely during the first twelve months after switch could decrease mortality of HIV patients on a second-line regimen.

Most cited references 21

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Five-year outcomes of the China National Free Antiretroviral Treatment Program.

Fujie Zhang, Zhihui Dou, Ye Ma … (2009)

China's National Free Antiretroviral Treatment Program began in 2002 and, by August 2008, included more than 52 000 patients. To report 5-year outcomes on adult mortality and immunologic treatment failure rates and risk factors. Open cohort analysis of a prospectively collected, observational database. China. All patients in the national treatment database from June 2002 to August 2008. Patients were excluded if they had not started triple therapy or had missing treatment regimen information. Antiretroviral therapy according to Chinese national treatment guidelines. Mortality rate and immunologic treatment failure rate, according to World Health Organization criteria. Of 52 191 patients, 48 785 were included. Median age was 38 years, 58% were men, 53% were infected through plasma or blood, and the median baseline CD4 cell count was 0.118x10(9) cells/L. Mortality was greatest during the first 3 months of treatment (22.6 deaths per 100 person-years) but decreased to a steady rate of 4 to 5 deaths per 100 person-years after 6 months and maintained this rate over the subsequent 4.5 years. The strongest mortality risk factors were a baseline CD4 cell count less than 0.050x10(9) cells/L (adjusted hazard ratio [HR] compared with a count>or=0.200x10(9) cells/L, 3.3 [95% CI, 2.9 to 3.8]) and having 4 to 5 baseline symptom categories (adjusted HR compared with no baseline symptom categories, 3.4 [CI, 2.9 to 4.0]). Treatment failure was determined among 31 070 patients with 1 or more follow-up CD4 cell counts. Overall, treatment failed for 25% of patients (12.0 treatment failures per 100 person-years), with the cumulative treatment failure rate increasing to 50% at 5 years. Immunologic treatment failure does not necessarily correlate well with virologic treatment failure. The National Free Antiretroviral Treatment Program reduced mortality among adult patients in China with AIDS to rates similar to those of other low- or middle-income countries. A cumulative immunologic treatment failure rate of 50% after 5 years, due to the limited availability of second-line regimens, is of great concern.

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Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients' response, survival, and drug resistance.

Gideon Rukundo, D Ochola, Peter Mugyenyi … (2002)

Little is known about how to implement antiretroviral treatment programmes in resource-limited countries. We assessed the UNAIDS/Uganda Ministry of Health HIV Drug Access Initiative--one of the first pilot antiretroviral programmes in Africa--in which patients paid for their medications at negotiated reduced prices. We assessed patients' clinical and laboratory information from August, 1998, to July, 2000, from three of the five accredited treatment centres in Uganda, and tested a subset of specimens for phenotypic drug resistance. 912 patients presented for care at five treatment centres. We assessed the care of 476 patients at three centres, of whom 399 started antiretroviral therapy. 204 (51%) received highly active antiretroviral therapy (HAART), 189 (47%) dual nucleoside reverse transcriptase inhibitors (2NRTI), and six (2%) NRTI monotherapy. Median baseline CD4 cell counts were 73 cells/microL (IQR 15-187); viral load was 193817 copies/mL (37013-651 716). The probability of remaining alive and in care was 0.63 (95% CI 0.58-0.67) at 6 months and 0.49 (0.43-0.55) at 1 year. Patients receiving HAART had greater virological responses than those receiving 2NRTI. Cox's proportional hazards models adjusted for viral load and regimen showed that a CD4 cell count of less than 50 cells/microL (vs 50 cells/microL or more) was strongly associated with death (hazard ratio 2.93 [1.51-5.68], p=0.001). Among 82 patients with a viral load of more than 1000 copies/mL more than 90 days into therapy, phenotypic resistance to NRTIs was found for 47 (57%): 29 of 37 (78%) who never received HAART versus 18 of 45 (40%) who received HAART (p=0.0005). This pilot programme successfully expanded access to antiretroviral drugs in Uganda. Identification and treatment of patients earlier in the course of their illness and increased use of HAART could improve probability of survival and decrease drug resistance.

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Improved survival among HIV-infected patients after initiation of triple-drug antiretroviral regimens.

K Craib, Lisa Schechter, Vera Y B Yip … (1999)

The efficacy of triple-drug antiretroviral regimens in the treatment of patients infected with HIV has been established in several randomized clinical trials. However, the effectiveness of these new regimens in patient populations outside clinical trials remain unproven. This study compared mortality and AIDS-free survival among HIV-infected patients in British Columbia who were treated with double- and triple-drug regimens. The authors used a prospective, population-based cohort design to study a population of HIV-positive men and women 18 years or older for whom antiretroviral therapy was first prescribed between Oct. 1, 1994, and Dec. 31, 1996; all patients were from British Columbia. Rates of progression from the initiation of antiretroviral therapy to death or to diagnosis of primary AIDS were determined for patients who initially received an ERA-II regimen (2 nucleoside analogue reverse transcriptase inhibitors [NRTIs] including lamivudine or stavudine, or both) and for those who initially received an ERA-III regimen (triple-drug regimen consisting of 2 NRTIs and a protease inhibitor [indinavir, ritonavir or saquinavir] or a non-NRTI [nevirapine]). A total of 500 men and women (312 receiving an ERA-III regimen and 188 an ERA-III regimen) were eligible. Patients in the ERA-III group survived significantly longer than those in the ERA-II group. As of Dec. 31, 1997, 40 patients had died (35 in the ERA-II group and 5 in the ERA-III group), for a crude mortality rate of 8.0%. The cumulative mortality rates at 12 months were 7.4% (95% confidence interval [CI] 5.9% to 8.9%) for patients in the ERA-II group and 1.6% (95% CI 0.7% to 2.5%) for those in the ERA-III group (log rank p = 0.003). The likelihood of death was more than 3 times higher among patients in the ERA-II group (mortality risk ratio 3.82 [95% CI 1.48% to 9.84], p = 0.006). After adjustment for prophylaxis for Pneumocystis carinii pneumonia or Mycobacterium avium infection, AIDS diagnosis, CD4+ cell count, sex and age at initiation of therapy, the likelihood of death among patients in the ERA-II group was 3.21 times higher (95% CI 1.24 to 8.30, p = 0.016) than in the ERA-III group. Cumulative rates of progression to AIDS or death at 12 months were 9.6% (95% CI 7.7% to 11.5%) in the ERA-II group and 3.3% (95% CI 1.8% to 4.8%) in the ERA-III group (log rank p = 0.006). After adjustment for prognostic variables (prophylaxis for P. carinii pneumonia or M. avium infection, CD4+ cell count, sex and age at initiation of treatment), the likelihood of progression to AIDS or death at 12 months among patients in the ERA-II group was 2.37 times higher (95% CI 1.04 to 5.38, p = 0.040) than in the ERA-III group. This population-based cohort study confirms that patients initially treated with a triple-drug antiretroviral regimen comprising 2 NRTIs plus protease inhibitor or a non-NRTI have a lower risk of morbidity and death than patients treated exclusively with 2 NRTIs.

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Author and article information

Journal

Journal ID (nlm-ta): Pan Afr Med J

Journal ID (iso-abbrev): Pan Afr Med J

Journal ID (publisher-id): PAMJ

Title: The Pan African Medical Journal

Publisher: The African Field Epidemiology Network

ISSN (Electronic): 1937-8688

Publication date (Electronic): 06 June 2019

Publication date Collection: 2019

Volume: 33

Electronic Location Identifier: 89

Affiliations

[1 ]Department of Epidemiology and Biostatistics, University of Gondar, College of Medicine and Health Sciences, Institute of Public Health, Gondar, Ethiopia

[2 ]Department of Epidemiology and Biostatistics Ethiopia, Dilla University, College of Medicine and Health Sciences, Dilla, Ethiopia

Author notes

[& ]Corresponding author: Adino Tesfahun Tsegaye, Department of Epidemiology and Biostatistics, University of Gondar, College of Medicine and Health Sciences, Institute of Public Health, Gondar, Ethiopia

Article

Publisher ID: PAMJ-33-89

DOI: 10.11604/pamj.2019.33.89.16626

PMC ID: 6711683

PubMed ID: 33708305

SO-VID: 7b93409d-4c41-491f-8bed-7f3c19ffbcf7

License:

The Pan African Medical Journal - ISSN 1937-8688. This is an Open Access article distributed under the terms of the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Incidence and determinants of mortality among adult HIV infected patients on second-line antiretroviral treatment in Amhara region, Ethiopia: a retrospective follow up study

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Abstract

Introduction

Methods

Results

Conclusion

Most cited references 21

Five-year outcomes of the China National Free Antiretroviral Treatment Program.

Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients' response, survival, and drug resistance.

Improved survival among HIV-infected patients after initiation of triple-drug antiretroviral regimens.

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