Six weeks of DOT can yield CD4 increases and fall in HIV viral load lasting six months

Michael Carter
Estimated reading time 2 minutes
This article is more than 21 years old.

Six weeks of adherence support involving directly observed therapy can lead to a significant improvement in CD4 cell count and HIV viral load for up to six months, according to a small pilot study conducted amongst outpatients in Los Angeles and published in the August15th edition of the Journal of Acquired Immune Deficiency Syndromes.

Directly observed therapy (DOT) has been shown to improve adherence amongst HIV patients requiring close medical supervision, such as individuals in institutions, or on methadone programmes. However, the feasibility of DOT in HAART-treated HIV outpatients has been little studied. Indeed, it has been questioned if DOT is a feasible strategy in this patient group given that HAART is a life-long commitment.

Investigators at the AIDS Healthcare Foundation in Los Angeles wished to see if a short period of DOT lead to sustained improvements in CD4 cell count and viral load.

Glossary

directly observed therapy (DOT)

When a health care professional watches as a person takes each dose of a medication, to verify that all doses are taken as prescribed.

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.

 

referral

A healthcare professional’s recommendation that a person sees another medical specialist or service.

on treatment analysis

Participants in a clinical trial are only included in the final analysis if they complete the full course of treatment they were originally assigned to. 

intent to treat analysis

All participants in a clinical trial are included in the final analysis, in the groups they were originally assigned to, whether or not they actually completed their course of treatment. This method provides a better estimate of the real-world effect of a treatment than an ‘on treatment’ analysis.

Patients who were recognised by their doctor as being non-adherent and failing on their therapy were referred to the study, which involved a six week programme of DOT. Patients were visited in their homes during the working week and at weekends adherence was monitored using electronic chips in the caps of medication.

A total of 14 patients were referred to the study, with an average CD4 cell count of 107 cells/mm3 and HIV viral load of 297,000 copies/mL. However, six patients failed to complete the study, and the investigators conducted both intention-to-treat and on-treatment analyses. Viral load and CD4 cell count were measured at weeks four, eight, twelve, 16, 20 and 24.

In the intent-to-treat analysis, CD4 cell count had increased by an average of 77 cells/mm3 by week twelve and 37 cells/mm3 by week 24. HIV viral load had fallen to an average of 100,000 copies/mL at week twelve, and to 200,000 copies at week 24. In the on-treatment analysis CD4 cell count had increased by 71 cells/mm3 at week twelve and 65 cells/mm3 at week 24, with a fall in viral load to 6,300 copies at week twelve and 63,000 copies at week 24 (all p

The investigators conclude, “the results of our pilot program reveal that 6 weeks of DOT resulted in improvements in CD4 cell counts and viral loads at 6 months, especially in those who completed 6 weeks of DOT intervention.”

They suggest that longer DOT programmes “will yield more impressive and sustained outcomes.”

Further information on this website

Adherence - factsheet

Adherence tips - factsheet

Late/missed doses - factsheet

Adherence - booklet in the information for HIV-positive people

References

Khanlou H et al. Pilot study of directly observed therapy in highly nonadherent HIV-infected patients in an urban community-based institutionJAIDS 33: 651 – 653, 2003.

Print