Two Studies Show HIV-Positive Patients Taking HAART May Not Need Preventive Pneumonia Medication
Two new studies show that HIV-positive patients on highly active antiretroviral therapy whose CD4 cell counts are above 200 may safely go off of Pneumocystis carinii pneumonia prophylaxis, including those who have previously suffered a bout of pneumonia and are at high risk for a relapse, Reuters reports (Emery, Reuters, 1/17). In the early 1980s, AIDS-related P. carinii pneumonia, or PCP, was a "common and often fatal infection" in HIV-positive patients, and before the use of primary prophylaxis (preventive medication taken before an episode of pneumonia) became standard, the proportion of patients with PCP "as the initial event defining the presence of AIDS" was 62%, while about 80% of patients with CD4 cell counts below 200 per cubic millimeter experienced the infection. In addition, without secondary prophylaxis (preventive drugs taken after an episode of pneumonia), 50% of patients would relapse within 24 weeks after an episode of PCP (de Quiros et al., New England Journal of Medicine, 1/18).
No Prophylaxis Needed
The studies, both published in the Jan. 18 issue of the New England Journal of Medicine, show that both primary and secondary prophylaxis may be safely discontinued in patients who are taking HAART and whose CD4 counts are above 200. In the first study, 474 HIV-positive patients on HAART with no history of PCP were monitored for 20 months in 1998 and 1999. Among these patients, 240 were taken off primary prophylaxis against pneumonia, while 234 continued the regimen. According to lead author Dr. Juan Lopez Bernaldo de Quiros and colleagues at the Madrid, Spain-based Hospital Universitario Gregorio Maranon, the results showed that "[t]here were no episodes of P. carinii pneumonia in either group." The study also followed HIV-positive patients who had previously contracted pneumonia, and found that 60 of 113 patients who suffered previous episodes of pneumonia and discontinued preventive medication did not develop new cases of pneumonia. The second study, led by Dr. Bruno Ledergerber of University Hospital Zurich in Switzerland, focused only on patients who had previously contracted pneumonia, and were therefore at "high risk of relapse." The study found that among the 325 HIV-positive patients on HAART whose CD4 cell counts were above 200, "[n]o cases of recurrent P. carinii pneumonia were diagnosed" during the 13 months of discontinued secondary prophylaxis. Study authors concluded, "[I]t is safe to discontinue (treatment for those at risk of relapse) against P. carinii pneumonia in patients with HIV infection who have an immunologic response to HAART" (Reuters Health, 1/17) The two studies confirm a similar study performed two years ago by doctors at the Bern Hospital in Switzerland that showed that none of the 262 patients taken off pneumonia prophylaxis developed PCP "as long as their CD4 counts remained over 200" (Reuters, 1/17).
'Good News' for Treatment
An accompanying editorial in the NEJM by Dr. Pierre-Marie Girard of the Faculte de Medecine Saint-Antoine in Paris, France, states, "All these studies are good news for people living with HIV. ... These reports also support the value of long term ... studies that confirm, under real-life conditions, the results of controlled trials." Girard added, however, that drug companies are "unlikely" to fund "de-escalation studies such as these." (Reuters Health, 1/17). The editorial also notes that the studies "underscored the huge disadvantages faced by AIDS patients in poor countries, who cannot afford" antiretroviral drugs (Reuters, 1/17).
NPR's 'All Things Considered' Discusses Impact of Studies
"All Things Considered" reporter Richard Knox yesterday spoke with Dr. Yens Lungren, an author of the study that focused on secondary prophylaxis, and Dr. Steve Boswell, a "leading AIDS doctor" in Boston. Knox and the physicians discussed the potential impact of the studies on future treatment of AIDS patients, and how the two studies have shown that patients can "recover immunologically" with HAART to the point that they can ward off pneumonia without prophylaxis. Knox said, "This striking immune recovery is convincing many skeptics it's OK to delay aggressive antiviral treatment." Boswell replied, "There does appear to be a shift in treatment that's occurring, not only in the United States, but I think worldwide with regard to our approach to starting therapy." Boswell added that the recent trend of delaying antiretroviral therapy is a "very different approach than the one that was advocated just three to four years ago where the adage 'hit hard, hit early' was heard very frequently." Knox questioned whether the two studies would lead to the discontinuation of drugs to prevent infections other than PCP. Lungren replied, "My gut feeling is that when it's true for pneumocystis, it's probably also true for most other opportunistic infections." Boswell added, "I think we underestimate the ... emotional impact of taking these medications. And often ... with many patients, where we've been able to take people off, it's a sign of progress for people who, for many years, had relatively little hope of improvement. It's one more sign that they can, in fact, improve and that they have a future" (NPR, "All Things Considered," 1/17). To listen to the entire report, enter http://www.npr.org/ramfiles/atc/20010117.atc.13.rmm into your Web browser. Note: You will need RealPlayer to listen to this report.