START study shows that people starting HIV treatment earlier have better quality of life

Findings provide reassurance about side-effects

Rather than treatment side-effects having a negative impact on people’s quality of life when they start HIV treatment, data from the large randomised START study show a modest but statistically significant improvement in quality of life, the recent Conference on Retroviruses and Opportunistic Infections (CROI 2016) in Boston heard.

While the ability of antiretroviral therapy (ART) to protect the immune system and prevent serious illnesses in the long term is generally accepted by people considering starting treatment, some individuals continue to be concerned that side-effects may harm their quality of life. Negative beliefs about antiretrovirals being ‘strong’ or ‘toxic’ medicines can contribute to some people preferring to delay HIV treatment until they feel it is ‘really necessary’.

For example, in one recent qualitative study a newly diagnosed Australian gay man talked about starting treatment:

Glossary

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’. 

placebo

A pill or liquid which looks and tastes exactly like a real drug, but contains no active substance.

opportunistic infection (OI)

An infection that occurs more frequently or is more severe in people with weakened immune systems, such as people with low CD4 counts, than in people with healthy immune systems. Opportunistic infections common in people with advanced HIV disease include Pneumocystis jiroveci pneumonia; Kaposi sarcoma; cryptosporidiosis; histoplasmosis; other parasitic, viral, and fungal infections; and some types of cancer. 

immune system

The body's mechanisms for fighting infections and eradicating dysfunctional cells.

qualitative

Qualitative research is used to explore and understand people’s beliefs, experiences, attitudes or behaviours. It asks questions about how and why. Qualitative research might ask questions about why people find it hard to use HIV prevention methods. It wouldn’t ask how many people use them or collect data in the form of numbers. Qualitative research methods include interviews, focus groups and participant observation.

“Yeah, it’s a little bit scary. I don’t mind going on treatment. I’m just worried about it being toxic in my body over a long period of time and how I might cope with that. But if I need to go on – and I probably will – when I need to, then I’ll start treatment.”

The Strategic Timing of AntiRetroviral Treatment (START) study has already provided definitive evidence of the benefit of starting treatment promptly. The trial enrolled 4685 men and women with HIV who had never taken ART, were in generally good health and had a CD4 cell count over 500 cells/mm3. Based on random allocation, half the participants started ART immediately, while the other half deferred treatment until their CD4 cell count declined to 350 cells/mm3. Those who deferred treatment knew that they had done so (they were not given a placebo).

Before the trial began, the researchers identified serious AIDS-related illnesses, serious non-AIDS illnesses and death as the outcomes by which the benefit of immediate treatment would be judged. In the group starting treatment immediately, 1.8% of participants experienced one of these events, compared with 4.1% in the deferred treatment group – a 57% reduction. The most common events in both arms of the study were tuberculosis and cancers.

However, these serious events are quite rare. In deciding whether to start treatment, some people may also be concerned about less serious health issues and drug side-effects which could affect larger numbers of people.  

The researchers therefore also collected data on health-related quality of life, asking study participants to rate their own quality of life on a regular basis. Four measures were used. Participants made a self-assessment of their health, using both a ‘visual analogue scale’ (marking a score somewhere between 0 to 100 for their current health) and rating their general health as either poor, fair, good, very good or excellent. They were asked about whether pain had recently interfered with their normal work. They were asked how often they had felt calm and peaceful in the past month.

Each time data were collected, the researchers compared the ratings with those given at baseline, at the beginning of the study.

After beginning treatment, people gave higher ratings for their current and general health, while those in the deferred arm gave similar or slightly lower ratings than they did before. Throughout follow-up, all four measures of quality of life were better rated by the immediate treatment group (p<0.001 for each measure). These differences were modest, but statistically significant.

For those beginning treatment earlier, there was a particular improvement in the frequency with which people said they had felt calm and peaceful.

The researchers note that the START study recruited people who were generally in good health and had not yet taken HIV treatment. Maintaining a good quality of life after starting HIV treatment is an important goal for this group, they say. “These findings provide further support to the superiority of early ART as reported for major clinical outcomes in the START study,” they conclude.

References

Lifson AR et al. Increased Quality of Life With Immediate ART Initiation: Results From the START Trial. Conference on Retroviruses and Opportunistic Infections (CROI 2016), Boston. Abstract 475, 2016.

View the abstract and e-poster on the conference website.