Home-based provision of antiretroviral therapy has excellent results, according to a study conducted in Africa and published in the March 1st edition of The Lancet. Mortality fell significantly in patients receiving home-based anti-HIV treatment and care, with CD4 cell counts increasing and almost all patients achieving an undetectable viral load. The study also showed benefits for other family members, with mortality falling amongst the HIV-negative children of HIV-positive parents after home-based HIV care was provided.
Anti-HIV treatment is becoming increasingly available in resource-limited settings. But antiretroviral therapy is still not reaching the majority of patients who need it in poorer countries. This is because of cost, a lack of medical personnel, poorly equipped clinics and, for many patients in rural districts, long distances to medical facilities.
To try and overcome these obstacles home-based HIV care is sometimes used. This uses trained lay people who visit HIV-positive individuals in their home to deliver medication, gather information, provide adherence support and refer patients with symptoms to specialist care.
Investigators looked at outcomes of patients provided with home-based care in rural Uganda. Firstly they looked at the effect of co-trimoxazole prophylaxis on mortality. They then looked at the impact of treatment with both antiretroviral therapy and co-trimoxazole on rates of death. Information was also gathered on the effect of both treatment strategies on CD4 cell count and viral load and admission to hospital. In addition the investigators recorded deaths in HIV-negative family members.
A total of 446 HIV-positive adults and 1481 HIV-negative family members were enrolled in the study, which had an observation design, in 2001. For the first five months no treatment was provided, but participants received weekly home-care visits. In the second phase of the study HIV-positive patients were provided with co-trimoxazole. Once again there were weekly home-care visits and this phase of the study lasted for a median of 18 months. In the final phase of the study, patients who had severe symptoms of HIV or who had a CD4 cell count below 250 cells/mm3 were provided with antiretroviral therapy in addition to their prophylactic treatment, Once again, there were weekly home-care visits.
First-line antiretroviral therapy consisted of d4T and 3TC with either efavirenz or nevirapine. The available second-line drugs were AZT, ddI, tenofovir and lopinavir/ritonavir.
A total of 233 (17%) HIV-positive patients died as did 40 (1%) of HIV-negative household members.
Treatment had a significant effect on the risk of death. Compared to receiving co-trimoxazole alone, mortality was 55% lower during the first 16 weeks of antiretroviral therapy and 92% less after 16 weeks. Antiretroviral therapy and co-trimoxazole combined reduced mortality by 95% compared to the no treatment phase.
The investigators found that the benefits of antiretroviral therapy increased over time. Compared to treatment with co-trimoxazole alone, the first 16 weeks of antiretroviral therapy and co-trimoxazole combined saved one life-year for every 14 people treated. After 16 weeks, one life-year was saved for every eight people treated annually. And compared to no treatment at all, only four people would need treatment with anti-HIV drugs and co-trimoxazole to save one life year.
Men had a 40% higher risk of death than women (p = 0.017), and 99% of all deaths in patients were medically related. Hospital admission fell by 43% in the period when antiretroviral therapy was used compared to the period when patients only took co-trimoxazole.
Anti-HIV treatment was well-tolerated, and during follow-up only 4% of patients changed treatment from NNRTI-based therapy to protease inhibitor-based treatment. Adherence was excellent with between 89 – 97% of patients reporting taking the target 95% or more of their anti-HIV drug doses.
CD4 cell count increased by a median of 101 cells/mm3 per year during antiretroviral therapy, and after two years of anti-HIV treatment 96% of patients had a viral load below 400 copies/ml (the lower limit of detection of the assays used in the study).
Anti-HIV therapy had benefits for other family members as well. Compared to treatment with co-trimoxazole alone, when an adult was also taking anti-HIV drugs mortality in HIV-negative children aged under ten was reduced by 77% (p = 0.001). And compared with no treatment, provision of antiretrovirals and co-trimoxazole reduced a child’s risk of orphanhood by 78% (p
“A home-based antiretroviral and co-trimoxazole programme was associated with a 90% reduction in mortality in adults with HIV in rural Uganda”, comment the investigators, who add “provision of antiretroviral therapy to adults was also associated with a large reduction in mortality in their HIV-negative children, and with substantial reductions in the rate of orphanhood.”
The investigators conclude, “our findings support efforts to bring antiretroviral therapy to people with HIV throughout the world, irrespective of geographic location or socioeconomic background.”
Mermin J et al. Mortality in HIV-infected Ugandan adults receiving antiretroviral treatment and survival in their HIV-uninfected children: a prospective cohort study. The Lancet 371: 752 – 705, 2008.