Shandong Zhanhua Yonghao pharmaceutical & Tech Co.,Ltd

Patients infected with HIV have several benefits if they are treated with antiviral medication earlier than has been usual up to now: for a start, the severe AIDS-related complications occur less frequently, and additionally, the risk of developing other AIDS-unrelated diseases decreases. This important finding is from a large international study which enrolled 4685 HIV positive people from 35 countries. The results have recently been published in the New England Journal of Medicine.

Nowadays, treating human immunodeficiency virus (HIV) infections with a combination of different antiviral drugs is so effective that the onset of the immune deficiency syndrome AIDS can usually be prevented.

However, a complete cure is still not possible. In most cases, infected people are treated with a combination of antiretroviral drugs as soon as their immune system is noticeably weakened. An indicator of the course of the disease is the number of CD4 cells, the immune systems’ helper cells that get destroyed when the viruses replicate in the blood. As soon as their count is under 350 per microlitre, therapy is initiated.

In the above mentioned study START (Strategic Timing of AntiRetroviral Treatment), scientists discovered that an earlier start of therapy could be beneficial. “According to this study, therapy should be started when the number of helper cells is still over 500 per microlitre, that is, when the immune system is still stronger,” summarises Cologne infectologist Prof Gerd Fätkenheuer. The DZIF scientist from the University Hospital of Cologne has been investigating the treatment and prevention of AIDS for years, and led the START study in Germany.

“Strategically speaking, this is a pivotal study,” Fätkenheuer explains. This is because, for the first time, it has been shown that initiating treatment as early as possible is more beneficial than the potential damage from the side-effects. Analyses have shown that the affected people apparently benefit twofold. “Severe AIDS-related diseases—such as tuberculosis, pneumonia and lymphoma—were prevented, as also other diseases which are not typically related to HIV infection,” says Fätkenheuer. Starting therapy earlier showed a trend towards a lower risk of cancer, and an equal risk of cardiovascular diseases in both treatment groups. “This is an important result as well, because up to now, it has not been clear whether earlier treatment entails a risk of developing these diseases,” Fätkenheuer explains.  

The study enrolled 4685 HIV positive men and women who were 18 years of age or older and had not yet started antiretroviral therapy. Their immune systems were still relatively strong, meaning that the CD4 cell count was over 500 per microlitre of blood. This study was a randomised study: half the trial subjects were randomly assigned to receiving earlier drug therapy, which has been unusual up to now. The participants were monitored over a period of three years. “It is almost a miracle that such a broad-based and complex international study was successfully conducted through to the end,” emphasizes Fätkenheuer.

The Cologne scientist is convinced, “Every person who is tested HIV positive should now at least be given this option of starting therapy earlier.” Anthony S. Fauci, who as the Director of the National Institute of Allergy and Infectious Diseases (NIAID) co-initiated the study, also came to the same conclusion. However, in the discussion the scientists also point out that three years is a relatively short period of time for patients who then have to take the drugs for the rest of their lives. It will be important to assess risks and benefits over a longer period of time.

The START study was supported by the National Institutes of Health (NIH) and different institutions worldwide. In Germany, the BMBF significantly contributed to its financing.