Delaying HAART during Opportunistic Infection Treatment Leads to Disease Progres

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This is so interesting to me. I always thought it was very weird when doctors used to stop HIV treatments when my friends would end up in the hospital with an OI.

Delaying HAART during Opportunistic Infection Treatment Leads to Disease Progression and Death By Liz Highleyman

Pneumonia caused by the fungal infection Pneumocystis carinii is the most prevalent opportunistic infection in patients with AIDS.Some experts have recommended that people with HIV/AIDS who require treatment for opportunistic infections (OIs) should defer antiretroviral therapy until OI treatment is completed, due to the risk of drug interactions and intensified additive side effects. But this appears to be a risky strategy, according to a presentation at the 15th Conference on Retroviruses and Opportunistic Infections this month in Boston. Zolopa and colleagues with the ACTG A5164 Study Group conducted a Phase IV (post-marketing) strategy trial in which 282 patients were randomly assigned to receive either immediate antiretroviral therapy upon study entry or deferred antiretroviral therapy after acute OI treatment was completed (at least 4 weeks after study entry). Most study participants (85%) were men, the median age was 38 years, 37% were black, 36% were Hispanic, and 23% were white. Overall, they had advanced HIV disease, with a median baseline CD4 cell count of 29 cells/mm3; most (90%) had not previously taken any antiretroviral drugs. Participants were stratified by CD4 cell count (< or > 50 cells/mm3). The study provided lopinavir/ritonavir (Kaletra), d4T (stavudine, Zerit), and tenofovir/emtricitabine (Truvada), but clinicians were free to prescribe any standard antiretroviral regimen they deemed appropriate.

Patients were also stratified by OIs. The most frequent infections were Pneumocystis pneumonia (63%), cryptococcal meningitis (16%), and bacterial infections such as pneumonia or sepsis (12%); these bacterial infections are not "classical" OIs, but occur more often in people with AIDS and were regarded as OIs for the purposes of this study. About one-third of patients had more than one infection. Individuals with tuberculosis were excluded, since there was insufficient information about antiretroviral and anti-TB drug interactions when the trial began, as were patients with OIs with no proven treatment. At 48 weeks, the investigators assessed rates of AIDS progression or death; no AIDS progression but continued HIV viral load of 50 copies/mL or greater; or no AIDS progression with HIV suppression below 50 copies/mL.Results

• The immediate and deferred arms started antiretroviral therapy a median of 12 and 45 days, respectively, after initiating OI treatment. • There were no significant differences in initial antiretroviral regimens in the 2 arms. • There was no statistically significant difference in the immediate and deferred arms with regard to:

• Rate of AIDS progression or death: 14% vs 24%, respectively;• No progression with detectable viral load: 38% vs 31%;• No progression with HIV suppression: 48% vs 45%.

• Both arms achieved similar viral load reductions and CD4 cell gains by week 24. • However, the immediate antiretroviral therapy arm had:

• Fewer cases of AIDS progression or death;• Longer time to AIDS progression or death (hazard ratio 0.51);• More rapid achievement of a CD4 count above 50 cells/mm3 (median 8 vs 4 weeks) and above 100 cells/mm3 (median 12 vs 4 weeks).

• There was a trend toward changing antiretroviral therapy earlier in the immediate arm, but this did not reach statistical significance (P = 0.15).• There were no significant differences in rates of severe (grade 3 or 4) adverse events, treatment adherence, or frequency or length of hospitalization.• The rate of immune reconstitution inflammatory syndrome was also statistically similar, with 8 cases in the immediate arm and 12 in the deferred arm.

Conclusion"Although there was no significant difference between immediate and deferred antiretroviral therapy in the primary endpoint that includes both clinical and virological response, immediate antiretroviral therapy reduced death/AIDS progression over 48 weeks," the researchers concluded. The reduced frequency of AIDS progression and death in the immediate antiretroviral therapy arm was especially pronounced during the first 6 months, and the more rapid increase in CD4 cell count reduced the "window of vulnerability" to disease progression and death, the researchers suggested.They added that, "This randomized strategy trial suggests that, absent contraindications, consideration should be given to early use of antiretroviral therapy in HIV-infected patients presenting with an acute opportunistic infections."Stanford Univ, Palo Alto, CA; Statistical and Data Analysis Ctr, Harvard School of Public Health, Boston, MA; Univ of Southern California, Los Angeles, CA; Frontier Sci & Tech Research Fndtn, Buffalo, NY; Univ of the Witswatersrand, Johannesburg, South Africa; Social & Sci Systems, Silver Spring, MD; Univ College Dublin, Ireland.2/26/08

ReferenceA Zolopa, J Andersen, L Komarow, and others. Immediate vs Deferred ART in the Setting of Acute AIDS-related Opportunistic Infection: Final Results of a Randomized Strategy Trial, ACTG A5164. 15th Conference on Retroviruses and Opportunistic Infections (CROI 2008). Boston, MA. February 3-6, 2008. Abstract 142.

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