Research Article: Short-Term Rationing of Combination Antiretroviral Therapy: Impact on Morbidity, Mortality, and Loss to Follow-Up in a Large HIV Treatment Program in Western Kenya

Date Published: May 29, 2012

Publisher: Hindawi Publishing Corporation

Author(s): April J. Bell, Kara Wools-Kaloustian, Sylvester Kimaiyo, Hai Liu, Adrian Katschke, Changyu Shen, Gilbert Simiyu, Beverly S. Musick, John E. Sidle, Abraham Siika, Paula Braitstein.


Background. There was a 6-month shortage of antiretrovirals (cART) in Kenya. Methods. We assessed morbidity, mortality, and loss to follow-up (LTFU) in this retrospective analysis of adults who were enrolled during the six-month period with restricted cART (cap) or the six months prior (pre-cap) and eligible for cART at enrollment by the pre-cap standard. Cox models were used to adjust for potential confounders. Results. 9009 adults were eligible for analysis: 4,714 pre-cap and 4,295 during the cap. Median number of days from enrollment to cART initiation was 42 pre-cap and 56 for the cap (P < 0.001). After adjustment, individuals in the cap were at higher risk of mortality (HR = 1.21; 95% CI : 1.06–1.39) and LTFU (HR = 1.12; 95% CI : 1.04–1.22). There was no difference between the groups in their risk of developing a new AIDS-defining illness (HR = 0.92 95% CI 0.82–1.03). Conclusions. Rationing of cART, even for a relatively short period of six months, led to clinically adverse outcomes.

Partial Text

Since the beginning of the HIV pandemic, almost 60 million people have been infected with HIV and 25 million have died from HIV-associated illnesses [1]. Sub-Saharan Africa is the region most affected by the pandemic and is home to 68% of all people living with HIV worldwide [1]. Since 2002, the international drive to scale up antiretroviral treatment has gained tremendous momentum [2], and by the close of 2009, an estimated 5.2 million persons were receiving combination antiretroviral treatment (cART). While this represents important progress, this still is only about 35% of the people who are estimated in need of treatment according to current standards of care [1].

These data suggest that even a relatively brief restriction of cART initiation among otherwise eligible patients independently contributes to a higher risk of mortality and loss to follow-up. This is in spite of triaging the sicker patients (as measured by CD4 and WHO clinical stage) to receive cART before the healthier ones. These findings underscore the negative effects that can be expected from even a short-term delay in the initiation of cART among otherwise eligible patients. We believe that our study did not show an effect of increased morbidity while still showing increased mortality and LTFU because patients who developed new AIDS-defining illnesses died or became lost to follow-up before these illnesses could be diagnosed and/or documented in the clinical encounter.

Given the certainty that more people will become eligible as early start strategies are implemented and that early start, itself, is a prevention strategy, this study highlights the need for international funding organizations and national governments to continue and expand their commitment to HIV care and treatment. Treatment programs can make the best use of resources through task-shifting [23–25] and other innovative models, such as community ART group models [26], to ensure the continuous provision of cART to those in need in resource-limited settings. The stakes for patients are high and these data demonstrate that even small delays in treatment initiation among patients who are immune suppressed can be fatal. As the HIV pandemic begins to stabilize in sub-Saharan Africa, and as the population and economic benefits of treating HIV infection begin to accrue there as elsewhere [20, 27], these data remind us that turning back the clock and restricting even sick patients from accessing treatment is simply not a reasonable option.