Clinical amd immunological markers of virologic failure in patients taking antiretroviral therapy at joint clinical research centre.

Abstract

About 33.2 million adults and children are living with HIV/AIDS and of these, 22.5 million live in Sub- Saharan Africa. The Uganda government is providing free voluntary counselling and testing and antiretroviral therapy and as a result, many treatment centres have been set up. In Uganda, there are 94,000 patients accessing ARVs with 1000 new ones being put on drugs every month. With increased access to treatment, long term follow-up in poor resource setting is a challenge in monitoring treatment failure. Laboratory tests to monitor treatment outcome are not only expensive but also not available in all treatment centres. There are clinical and immunological makers for virological failure. The research aimed at studying these particular makers to help clinicians in low resource settings where viral load testing is not easily available. OBJECTIVES: This study aimed at determining the clinical and immunological makers of virological failure, the types of AIDS defining illnesses as markers of virologic failure in ARV treated patients attending Joint Clinical Research Centre (JCRC). The study also assessed the weight patterns and their association with virologic failure. METHODS: This was nested case control retrospective study. Patients with virologic failure with HIV-1 RNA load above 1000 copies/ml were cases, while those with HIV-1 RNA of 1000 copies/ml and below were categorized a controls. The study was done at joint clinical research centre. Using computer generated list of possible eligible patients, systematic randomised sampling of potential recruits on the list, and however, 100 patients were selected consecutively. Pre HAART and follow up CD4 counts, weights and past AIDS defining illnesses were recorded at recruitment. The CD4, viral load and physical examination were done at recruitment. Patients were recruited as unmatched cases and controls. RESULTS: Of 100 participants, 57 were females of whom 31 were controls. The mean HAART duration for cases was 36.6 (12-52) months and 30.6(12-52) months for control (p=0.115). Self reported weight loses (Patients response on whether they had lost weight) were found to be statistically significant (OR=1.107, p value= <0.001). Low CD4 cell count was not a marker of virologic failure (p=0.478). Poor adherence to therapy (measured by self reported missed pills for days, weeks or months) was significant independent clinical marker of virologic failure (OR=0.059, P-value<0.001). Poor quality of life at enrolment was a significant clinical marker for virologic failure. The quality of life variables were used; being unwell in the last one month (p=0.002), interference of work by illness (p=0.008), ill health limiting socialization (p=0.003), hospitalisation (p=0.001) and were all associated with virologic failure. Marital status was statistically significant (OR=3.182, p-value 0.006). The sex (p value= 0.313) and age (p-value=0.54) were not associated with virologic failure. No specific opportunistic infections were found to be associated with virologic failure. Weights at baseline (p-value=0.253) and enrolment (p=0.744) of both groups were not markers of virologic failure. Antiretroviral regimens (p=0.790) and the associated adverse events (p=0.689) did not affect virologic outcome. CONCLUSION: Poor adherence, poor quality of life and self-reported weight loss were found to be strong clinical markers of virologic failure. Low CD4 at three years of HAART was an immunologic marker of virologic failure. The study did not find any specific AIDS defining illnesses and baseline CD4 count as significant markers of virologic failure. Married patients were likely to have virologic failure compared to single ones. This needs further study to establish the possible associated social factors that contribute to treatment failure.