Same-day initiation of ART feasible and safe without CD4 counts, Thai study shows

By | September 18, 2019

Three models of same-day antiretroviral therapy (ART), tested in different hospitals in Thailand, are feasible and safe, researchers report. The models have been implemented in Thailand since 2017, following a World Health Organization recommendation that all individuals diagnosed as HIV positive should receive ART on the same day of diagnosis, if they are ready.

Thai investigators previously reported that patients in the same-day antiretroviral therapy (SDART) programme of the Thai Red Cross anonymous clinic in Bangkok were 3.9 times more likely to start ART and 2.2 times more likely to achieve a suppressed viral load than other people. Based on these results, the team wanted to check if this SDART programme could be replicated in other settings in Thailand.

Therefore, they conducted an evaluation study, whose first results were presented by Dr Pich Seekaew, from the Thai Red Cross AIDS Research Centre, at the recent 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City. Data came from an observational cohort of 5733 HIV-positive people attending nine healthcare facilities in five HIV high-burden Thai provinces between 2017 and 2019.

Glossary

loss to follow up

In a research study, participants who drop out before the end of the study. In routine clinical care, patients who do not attend medical appointments and who cannot be contacted.

statistical significance

Statistical tests are used to judge whether the results of a study could be due to chance and would not be confirmed if the study was repeated. If result is probably not due to chance, the results are ‘statistically significant’. 

observational study

A study design in which patients receive routine clinical care and researchers record the outcome. Observational studies can provide useful information but are considered less reliable than experimental studies such as randomised controlled trials. Some examples of observational studies are cohort studies and case-control studies.

meningitis

Inflammation of the outer lining of the brain. Potential causes include bacterial or viral infections.

cryptococcosis

A type of fungal infection usually affecting the membrane around the brain, causing meningitis. It can also affect the lungs and chest.

All three models were aligned with the Thailand National Guidelines on HIV Treatment and Prevention, recommending a list of baseline tests at the time of HIV diagnosis, such as creatinine, a CD4 count, a kidney function test (eGFR), a syphilis test and chest X-ray. They also include an assessment of medical history, a physical examination and a determination of ART eligibility by a physician.

What differed between the models was whether people needed to wait until their baseline laboratory test results were available before initiating ART. Each healthcare facility adopted its own model, based on local hospital guidelines and physician preferences.

The facilities were categorised by requirements around laboratory test results, prior to ART initiation:

  • Model A: no laboratory results required.
  • Model B: CD4 count only.
  • Model C: other safety laboratory results required, to detect kidney disease, cryptococcal meningitis or other issues, but no CD4 count.

Seekaew described the overall performance of the models. Data from 4349 patients from the cohort (76%) were available for analysis. Among those, 3812 people (88%) agreed to immediate ART, and of these, 3385 (89%) were screened by physicians and considered as eligible for ART initiation.

A vast majority of the latter group of 3385 people had started ART in a short period of time  – 88% within 7 days:

  • 72.2% on the same day as HIV diagnosis.
  • 7.1% within 2-3 days.
  • 8.4% within 4-7 days.
  • 5.7% within 8-14 days.
  • 2.3% within 15-21 days.
  • 3.8% over 21 days.

After three months, 91.2% were retained in care, while 5.1% were lost to follow-up. After six months, 84.4% were retained and 7.1% lost to follow-up. A major concern, highlighted by Seekaew, was that only 65.6% of people on ART for at least six months had had a viral load test. Among these, only 84.7% had a suppressed viraemia.

Participants in Model A (no lab results needed) were mostly likely to start ART on the day of diagnosis (78.6%) or within one week (16.8%). On the other hand, participants in Model B (CD4 count required) tended to take longer.

Regarding adverse events, Model C showed the lowest rate (10.2%) but the difference with Model A (at 16.3%) was not statistically significant. Importantly, Model A showed the lowest death rate (0.1%), with a statistically significant difference in comparison with Models B (1.2%) and C (1.1%).

After adjustments for variables such as age, chest X-ray and education, the investigators found that same-day ART initiation was associated with:

  • Model A (adjusted odds ratio – aOR 5.48).
  • Being a transgender woman (aOR 2.15).
  • Earning less than 10.000 Thai bahts (326 US Dollars) a month (aOR 1.5).
  • Having a CD4 count between 101-200 (aOR 3.45); 201-350 (aOR 3.19); > 350 (aOR 3.58).

Pich Seekaew concluded that in the study, not using baseline laboratory results had facilitated faster ART initiation, with no increase in severe adverse events or deaths. Requiring a CD4 count before initiating ART had resulted in a longer time to start HIV treatment. However, some leading physicians still based their practice on anecdotal case report and experience, and had conservative requirements before prescribing ART to patients, he said.

He said Thailand’s next steps were to develop standardised clinical guidelines around same-day ART, viral load literacy programmes for people diagnosed with HIV and an ART initiation network in provinces with a high burden of HIV.   

References

Seekaew P et al. Same-day antiretroviral therapy initiation in Thailand: Different models and initial outcomes from scale-up in five provinces in Thailand. Tenth International AIDS Society Conference on HIV Science (IAS 2019), Mexico City, abstract WEAB0102, 2019.

View the abstract on the conference website.

HIV news from aidsmap.com