Mega-HAART still effective after two years in 50%

Keith Alcorn
Estimated reading time 2 minutes
This article is more than 23 years old.

Just over half of highly treatment-experienced patients enrolled in a study of mega-HAART still had viral load below 50 copies/ml after more than two years on the regimen, according to a report from the Royal Free Hospital in London, published this week in the Journal of Acquired Immune Deficiency Syndromes.

Sixty patients with rising viral load were enrolled in the open label study, and had taken a median of two protease inhibitors before joining the study. However, 87% of participants were NNRTI-naïve. The median duration of treatment experience prior to joining the study was 2.9 years (with one quarter having received at least five years of antiretroviral treatment by the beginning of 1998). Sixty per cent of patients had a previous AIDS diagnosis.

Regimens were constructed around efavirenz (taken by all patients), ddI (taken by 73%), hydroxyurea (taken by 73%) and a protease inhibitor (mainly indinavir boosted with ritonavir). Drugs were not chosen on the basis of resistance testing because the study began in early 1998. The median number of drugs included in the regimen was five.

Glossary

multivariate analysis

An extension of multivariable analysis that is used to model two or more outcomes at the same time.

resistance testing

Laboratory testing to determine if an individual’s HIV strain is resistant to anti-HIV drugs. 

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

AIDS defining condition

Any HIV-related illness included in the list of diagnostic criteria for AIDS, which in the presence of HIV infection result in an AIDS diagnosis. They include opportunistic infections and cancers that are life-threatening in a person with HIV.

After two years, 31 patients (52%) had viral load below 50 copies, and ten patients stopped therapy altogether. Five individuals died during the study, and a further nine developed an AIDS-defining illness (three cases of lymphoma, two cases of Kaposi’s sarcoma, once case each of PML, PCP, wasting syndrome and oesophageal candida).

Of those on treatment, 72% had viral load below 50 copies after two years, and 72% had experienced CD4 cell increases (in two thirds of cases increases of more than 100 cells/mm3 were observed). The median number of drugs taken remained five after two years.

Multivariate analysis showed that the only factors associated with a reduced chance of viral load below 50 copies and a CD4 cell increase were a higher baseline viral load, and previous NNRTI use.

In this clinic population, patients were given intensive adherence support and preemptive anti-nausea treatment with ondansetron during the first weeks of therapy, together with other aggressive symptom control measures, to ensure that therapy was tolerated.

References

Youle M et al. Two year outcome of a multidrug regimen in patients who did not respond to a protease inhibitor regimen. Journal of Acquired Immune Deficiency Syndromes 29: 58-61, 2002.

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