People in Uganda starting antiretroviral therapy (ART) with higher CD4 counts can achieve excellent outcomes, investigators report in the online edition of AIDS. Asymptomatic adults who started therapy with a CD4 count above 350 cells/mm3 were monitored for twelve months. Almost all were retained in care, 97% achieved an undetectable viral load, adherence was excellent and toxicities and side-effects were rare. The participants in the study received stream-lined, nurse-led care.
“Our results challenge current concerns that individuals with high CD4+ cell count may not desire or adhere well to ART, or be able to achieve robust virologic suppression,” write the authors.
Access to ART is being rapidly scaled-up in resource-limited settings and the World Health Organization (WHO) estimates that, in 2013, some 9.7 million people were in receipt of HIV therapy.
Individuals with higher CD4 counts – above 350 cells/mm3 – have only recently become eligible for ART in sub-Saharan Africa. Some researchers have expressed concern that people in good health will not adhere to their treatment or will drop out of care, meaning that many would not achieve virologic suppression.
To settle this question, investigators designed a prospective, open-label study involving asymptomatic, ART-naive adults with CD4 counts above 350 cells/mm3. They started therapy with a combination of emtricitabine/tenofovir and efavirenz (ritonavir/lopinavir was available for people unable to tolerate efavirenz). The investigators reported on retention in care over 48 weeks, rates of virological suppression (viral load below 400 copies/ml) at weeks 24 and 48, adherence (self-reported three-day recall) and rates of toxicities and side-effects. Care was nurse-led and support was also offered using mobile phones.
A total of 197 people were recruited to the study between 2011 and 2012. CD4 count at baseline was high at a median of 564 cells/mm3 and median viral load was 22,400 copies/ml.
The overall retention rate was 98% at week 48. Rates of virological suppression at weeks 24 and 48 were 96% and 97%, respectively.
Adherence was excellent, with participants reporting taking all their doses in the preceding three days at 98% of study visits.
Treatment had good safety and tolerability. There were 22 grade 3 or 4 laboratory abnormalities, the most common being asymptomatic neutropenia. Creatinine elevations were observed in two people, but these resolved after tenofovir was discontinued.
Non-routine use of the services outside scheduled visits was rare. There were a total of 384 non-routine visits, most were unscheduled drop-in visits for minor skin conditions, respiratory complaints or gastrointestinal symptoms.
The average length of clinic visits was 25 to 54 minutes.
“We report excellent ART outcomes in Ugandan patients with CD4+ cell counts above 350 cells/mm3 using a nurse-driven care model,” conclude the authors. “Further research will be needed to demonstrate the long-term durability of streamlined care models for high CD4+ cell populations who are expected to preserve health and high CD4+ cell counts during long-term therapy.”
Jain V et al. Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts at least 350 cells/mm3 in rural Uganda. AIDS 28, online edition. DOI: 10.1097/QAD.0000000000000401 (2014).