CDC issues guidelines on treating OIs among adults
ART is cornerstone of treatment plan
The Centers for Disease Control and Prevention (CDC) has confirmed that in the age of antiretroviral therapy (ART), clinicians may choose to treat some opportunistic infections (OIs) less aggressively.
The CDC’s recent guidelines for treating OIs among HIV-infected adults and adolescents emphasize the importance of ART in reducing the incidence of OIs, particularly in individuals who have a CD4 t-cell count of less than 200 cells. But they also confirm that some OI treatment might pose more risks than benefits.1
"Now we have data to support what a lot of people have been doing in terms of stopping certain types of therapy," says Aaron Glatt, MD, professor and chairman of medicine for Our Lady of Mercy Medical Center in the Bronx, NY. Glatt is on the editorial advisory board of AIDS Alert.
Also, the guidelines provide a detailed analysis of various treatment options and show how strongly these options are supported by research evidence, using a rating scale of A through E and a quality of evidence scale from I to III, with recommendations followed by a letter and number rating; an A-I, for instance, suggests the strongest evidence-based best practice.
For example, the chart on Mycobacterium avium complex (MAC) disease states there is strong evidence from at least one well-designed trial that the preferred initial therapy consists of at least two drugs, including Clarithromycin 500 mg PO BID and ethambutol 15 mg/kg body weight PO QD.1
However, the guidelines say that the evidence for efficacy might not outweigh the potential for adverse effects if clinicians use NSAIDs in treating HIV patients who have developed MAC and also experience moderate to severe symptoms associated with ART-associated immune reconstitution syndrome. Likewise, the guidelines suggest the evidence is lukewarm for providing short-term treatment with systemic corticosteroid among MAC patients.1
Another example of restraint in the guidelines involves the use of antibiotic prophylaxis for the prevention of bacterial pneumonia. The guidelines again find that the benefits might not outweigh the risks when HIV patients are prescribed them in the event of frequent recurrences because of the possibility of the development of drug resistance and drug toxicities.1
"The bottom line is that we do not yet have all of the answers for some of these complicated and less common scenarios," Glatt says.
He suggests that in those problem cases, the physician weigh the benefits and advantages for that particular patient and treat accordingly. "And be careful to closely monitor for evidence that you made the wrong decision," Glatt says.
In the case of the OI Campylobacter jejuni, the guidelines suggest that for mild disease a clinician might withhold therapy unless the symptoms persist for several days, and the CDC panel says there is little evidence to support a clinician prescribing an additional aminoglycoside in bacteremic patients.1
"It’s important for people to understand there are some situations where the benefits of treatment are unclear, and the cardinal rule of medicine is, first, to do no harm," he explains.
"So it might be better if the HIV patient takes less OI medications, because it will improve adherence, reduce side effects, and save money," Glatt continues.
The guidelines also provide a great deal of information about the treatment of OIs in pregnant women, noting that there have been no large studies conducted on the epidemiology or manifestations of HIV-1-associated OIs in this population.1
The CDC panel suggests clinicians take into consideration the potential for physiologic changes during pregnancy to affect the presentation of acute OIs, such as the pregnant woman’s increased cardiac output by 30% to 50% and the placental transfer of drugs.1
The use of diagnostic testing also needs to be closely weighed against the risk to the fetus, and the CDC panel recommends pregnant women who have an OI but who are not on antiretroviral therapy should be started on ART with OI therapy immediately, depending on the fetus’ gestational age, maternal HIV-1 RNA levels, and clinical conditions, as well as the potential for toxicities and drug interactions.1
"As with all prescribing, but especially to pregnant women, open discussions between the physician, patient, and husband, when the patient’s married, are essential to obtain the best outcome medically and legally," Glatt notes.
Here are a few examples of the guidelines’ OI treatment recommendations:
- Cytomegalovirus (CMV) disease
The CDC guidelines suggest there is strong evidence for using Ganciclovir (GCV) intraocular implant and valganiciclovir 900 mg PO QD in treating CMV retinitis when there are immediate sight-threatening lesions. They also say treatment should be considered in patients with CMV pneumonitis who have histologic evidence of CMV pneumonitis and who do not respond to treatment of other pathogens, but there is no compelling evidence to provide maintenance therapy.1
Also, the CDC panel says there is no compelling evidence either for or against the recommendation of delaying ART among patients with CMV neurologic disease because of concerns about their disease worsening as a result of immune recovery inflammatory reaction.1
The guidelines recommend against preemptive treatment of patients with CMV viremia when there’s no evidence of organ involvement.1
Glatt recommends regular ophthalmologic examination for patients with HIV, especially when the CD4 cell count drops below 100, and urgent evaluation anytime new signs or symptoms occur.
"Many internists do not have the necessary expertise in funduscopy, and early consultation with an ophthalmologist is crucial," he points out.
- Herpes simplex virus (HSV) disease
Initial treatment or for recurrent genital HSV, the CDC guidelines recommend the use of Famciclovir 500 mg PO BID or valaciclovir 1 g PO BID or acyclovir 400 mg PO TID for seven to 10 days.
However, the CDC panel notes there is no compelling evidence either for or against the recommendation to use these three drugs in treating patients with frequent or severe recurrences as a chronic suppressive therapy.1
- Human papillomavirus (HPV) disease
The CDC panel recommends a patient-applied treatment of podofilox 0.5% solution or 0.5% gel to be applied to all lesions BID on three consecutive days and repeated weekly for up to four weeks. The guidelines specifically do not recommend the use of intralesional interferon-alfa because of the high cost, difficult administration, and potential for systemic side effects.1
In general, the guidelines are an excellent resource for physicians providing HIV care, Glatt notes.
"They are indicative of the steady, albeit sometimes frustratingly slow, progress we are making in the fight against HIV/AIDS," he says.
Reference
- Benson CA, Kaplan JE, Masur H, et al. Treating opportunistic infections among HIV-infected adults and adolescents: Recommendations from the CDC, the National Institutes of Health, and the HIV Medicine Association/ Infectious Diseases Society of America. MMWR 2004; 53(RR15):1-112. Web site: www.cdc.gov/mmwr/preview/ mmwrhtml/rr5315a1.htm.
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