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Quick Guide to The Lung Infection PCP
Prophylaxis Results in
Children
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Pathogen:
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Sites of Infection:
Usually the lungs. Rarely, in extrapulmonary sites, including the lymph nodes, bone marrow, spleen, and liver.
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Symptoms:
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Diagnosis:
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Treatment Results:
Hughes et al. compared atovaquone (750 mg tid) and TMP/SMX (320 mg/l,600 mg tid) for the treatment of mild to moderately severe PCP. Therapy was successful in 99/160 (62%) patients randomized to atovaquone and 103/162 (64%) patients randomized to TMP/SMX. More patients in the atovaquone group failed due to lack of response, with more patients in the TMP/SMX group failed due to drug toxicity (20% of atovaquone recipients and 7% of TMP/SMX recipients discontinued due to inadequate response, while 7% of atovaquone recipients and 20% of TMP/SMX recipients discontinued due to drug toxicity). Toxicities included rash, liver function abnormalities, vomiting and fever. Mortality within four weeks of the completion of treatment was higher in the atovaquone group (11 patients) than in the TMP/SMX group (1 patient) (P = 0.003).
Dohn et al. compared atovaquone (750 mg tid PO) to pentamidine (3- 4 mg/kg/day IV) as primary therapy in patients with mild or moderate PCP. Success was achieved in 32/56 (57%) and 21/53 (40%) of patients randomized to atovaquone and pentatnidine, respectively (P= 0.085). Lack of response was observed in 15/56 (29%) and 10/53 (19%) of atovaquone and pentamidine recipients, respectively (P=0.176). Adverse events requiring discontinuation of therapy occurred in 5/56 (7%) and 29/53 (55%) of atovaquone and pentamidine recipients, respectively (P < 0.001). Seven patients in the atovaquone group and 13 in the pentamidine group died within the first four weeks (P=0.529).
Sattler et al. reported results from a multicenter study (ACTG 029/031) comparing trimetrexate (TMTX) with concurrent leucovorin to TMP/SMX as first line treatment for acute moderately severe PCP in 215 patients. The cumulative incidence of serious and treatment-terminating adverse events including hematologic toxicities was less with trimetrexate (P< 0.001). Although the response rates were similar for both drugs, survival was greater in the TMP/SMX arm (mortality was 12% in the TMP/SMX group and 20% in the TMTX group (P= .088)). The investigators concluded that TMP/SMX is a superior first-line therapy for moderately severe PCP.
ACTG 039 investigated trimetrexate in patients who did not respond to or were intolerant of TMP/SMX and IV pentamidine. 84/159 (53%) patients intolerant to both standard therapies and 48/160 (30%) patients either unresponsive to both or unresponsive to one and intolerant of the other tolerated at least 14 days of treatment with trimetrexate and survived at least one month. Investigators concluded that trimetrexate is a useful and well-tolerated salvage therapy. Feinberg et al. evaluated the results of an expanded-access program which provided trimetrexate to 752 patients unable to take TMP/SMX and pentamidine. 34% of patients were classified as responders.
Leoung et al. treated 15 patients for a first episode of mild to moderate PCP with trimethoprim (20 mg/kg PO qd x 2l d) and dapsone (100 mg PO qd x 2l d). All improved within 3-10 days. Side effects (nausea, vomiting, rash) occurred in 14/15, with treatment discontinued in 2/15 (severe rash).
Medina et al. randomized 60 patients with AIDS and mild to moderately-severe PCP to receive either TMP/dapsone (20 mg/day and 100 mg/day PO respectively) or TMP/SMX (20 mg/kg/day and 100 mg/kg/day PO respectively). No patients received concomitant AZT. 2/30 patients in the TMP/dapsone group failed, and 3/30 in the TMP/SMX group failed. TMP/SMX was associated with significantly greater toxicity: 9/30 patients who received TMP/dapsone and 17/30 who received TMP/SMX had a major adverse reaction requiring a switch to IV pentamidine. The most frequent toxicity in the TMP/dapsone group was rash; in the TMP/SMX group elevated LFTs, neutropenia, and rash were most frequently observed.
Montgomery et al. enrolled 379 patients with PCP and a pO2 less than 55 mmHg in a randomized, double-blind trial comparing TMP/SMX to aerosol pentamidine (AP) for treatment of acute PCP. AP was associated with a slower clinical response and more relapses than TMP/SMX, while TMP/SMX was associated with more adverse reactions (rash, elevated liver-enzyme levels, fever, neutropenia, and nausea). Investigators also noted that the risk of pneumothorax and extrapulmonary PCP is greater with AP than with TMP/SMX.
Waskin et al. found that the incidence of transient diabetes among PCP patients was 22% with IV pentamidine and 6% among long-term users of aerosolized pentamidine for PCP prophylaxis.
Adjunctive corticosteroid administration (used in conjunction with TMP/SMX or pentamidine IV), when initiated at the beginning of treatment of an acute episode of moderate to severe PCP improves clinical outcome by decreasing the potentially life-threatening inflammatory response and respiratory distress. A consensus conference convened by the NIAID to review the results of five separate studies concluded that early adjunctive steroid therapy reduces the likelihood of death, respiratory failure and deterioration in moderate to severe PCP when initiated as early as possible; no benefit has been demonstrated in milder cases of PCP. Adjunctive corticosteroids are now standard therapy for moderate to severe PCP, defined by a room air p02 less than 70 mmHg, although long-term benefit of adjunctive use of corticosteroids has not been established. Adjunctive corticosteroid treatment has not bee n shown to reactivate tuberculosis or fungal diseases with a detectable increase in frequency.
A non-randomized retrospective chart review found that corticosteroid use was associated with a reduced incidence of adverse skin reactions to TMP/SMX in AIDS patients receiving treatment for acute PCP (Caumes et al.). 38 patients in the review received TMP/SMX alone, and 23 received TMP/SMX plus corticosteroids for hypoxemia. Rashes occurred in 18/38 (47%) patients receiving TMP/SMX alone and 3/23 (13%) receiving TMP/SMX and corticosteroids. A higher rate of mucocutaneous herbes simplex infections was observed in the patients receiving corticosteroids (P= 0.012).
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Prophylaxis Results in Adults:
Schneider et el. (1995) studied 260 HIV-positive patients with a CD4+ count < 200 cells/mm3. Patients were randomized to receive 480 mg (n=131) or 960 mg (n=129) TMP/SMX. Of the 260 participants, 104 completed the study. 63/156 dropped out of the study because the could not tolerate TMP/SMX; 50/156 died during the study; and 43/156 were noncompliant. The median follow-up time was 409 days. No episodes of PCP occurred in either TMP/SMX group. After 1 year, there was no difference in the cumulative incidence of death between the low and high-dose groups (15% and 12%, respectively).
Several studies suggest that TMP/SMX as one DS tablet daily delivered three times a week (as opposed to daily) is effective as primary prophylaxis for PCP with reduced incidence of adverse reactions. Ruskin et al. conducted a retrospective analysis of TMP/SMX three times weekly as PCP prophylaxis in 116 patients (71 had a prior history of active PCP, mean follow-up 18.5 months; 45 never had PCP, but CD4 below 200/mm3; mean follow-up 24.2 months). None of 116 patients developed PCP; 28% had side effects (rash, pruritus, nausea); 15/116 discontinued treatment, with 11/15 clearly drug intolerant.
A number of studies have also suggested that TMP/SMX desensitization is possible in patients with a history of intolerance to the standard prophylaxis dose. Carl et al. recently reported the results of a TMP/SMX desensitization study in 39 intolerant HIV-positive patients. An eight- day regimen of serial dilutions of TMP/SMX oral suspension was administered. No antihistamines or corticosteroids were administered. 15/39 (37%) were successfully desensitized and continued on TMP/SMX; 13/39 (32%) were successfully desensitized but did not continue on TMP/SMX due to non-allergic toxicities; and 11/39 (27%) failed desensitization.
The AmFAR Community-Based Clinical Trials Network (CBCTN) is conducting a randomized, double-blind trial comparing the success of two approaches to the reintroduction and maintenance of TMP/SMX for prophylaxis of Pneumocystis carinii pneumonia (CBCT 06). A second TMP/SMX desensitization protocol is currently being conducted by the AIDS Clinical Trials Group (ACTG 268).
Aerosolized pentamidine, administered by the Respirgard® II nebulizer, is approved for the primary prophylaxis of PCP in HIV-infected patients with less than 200 CD4+ cells/mm3 and as secondary prophylaxis. The U.S. Public Health Service Task Force on PCP prophylaxis recommends aerosol pentamidine as primary or secondary prophylaxis in patients who cannot tolerate TMP/SMX or dapsone. The Task Force recommends either the Respirgard II nebulizer (300 mg/month) or the Fisons® nebulizer (five 60 mg loading doses over a two-week period, followed by 60 mg every 2 weeks). Common side effects include cough and bronchospasm; less common side effects include pneumothorax and transient diabetes. AP is not effective in preventing extrapulmonary PCP.
Schneider et al. randomized 213 HIV-positive patients with CD4 counts <200/mm3 and no history of PCP to receive one of two regimens of TMP/SMX (one single strength or double-strength tablet daily) or aerosolized pentamidine (300 mg monthly via Respirgard II nebulizer). After a mean follow-up of 264 days, 6/71 pentamidine recipients had a confirmed episode of PCP, while no patient in either TMP/SMX group had PCP (P= 0.002). Adverse reactions requiring treatment discontinuation were higher in both TMP/SMX groups (17/71 on 480 mg/day and 18/71 on 960 mg/day) compared to the aerosolized pentamidine group (2/71). Adverse effects occurred earlier in the higher-dose TMP/SMX group than in the lower-dose TMP/SMX group.
Hardy et al. randomized 310 AIDS patients who had recovered from one episode of PCP to receive either one double-strength TMP/SMX tablet a day or aerosolized pentamidine 300 mg delivered by a Respirgard II nebulizer every 4 weeks (ACTG 021). All patients received zidovudine. After a mean follow-up of 17.4 months, PCP had recurred in 14/154 (9%) patients randomized to TMP/SMX and 36/156 (23%) patients randomized to aerosolized pentamidine. Adverse reactions requiring a change in treatment occurred in 42/154 (27%) of TMP/SMX recipients and 6/156 (4%) of aerosolized pentamidine recipients. Rash and fever accounted for most of the toxicities. There were no differences in the rates of hematologic or hepatic abnormalities between the two groups. Survival was equivalent in the two groups.
Borleffs et al. randomized 230 patients with CD4 <200/mm3 and no previous PCP to receive aerosolized pentamidine (300 mg once monthly) or one of two doses of TMP/SMX (one single-strength or double-strength tablet daily). After 9 months' follow-up, an interim analysis showed that 11% of aerosolized pentamidine recipients and no TMP/SMX recipients had developed PCP. Adverse reactions requiring a switch in treatment occurred in 2% of the aerosolized pentamidine group, 17% of the low-dose TMP/SMX group and 18% of the high- dose TMP/SMX group.
Bozzette et al. have reported results from a trial (ACTG 081) comparing three regimens for the primary prophylaxis of PCP. 842 patients with CD4 counts <200/mm3 and no prior history of PCP were randomized to receive TMP/SMX (one double-strength tablet daily), aerosolized pentamidine (300 mg monthly), or dapsone (50 mg twice daily). The median follow-up was 39 months. Upon intent-to-treat analysis, PCP occurred with equal frequency in the three groups. Forty- two, 54 and 41 cases of PCP occurred in the TMP/SMX, aerosol pentamidine, and dapsone groups, respectively (P= 0.22). Among patients entering the trial with fewer than 100 CD4+ cells/mm3, the estimated 36 month cumulative risks or reported PCP were 19%, 22%, and 33%, respectively. Survival was equivalent in the three groups (134, 131, and 138 deaths). Fewer side effects requiring a switch in treatment assignment occurred in the aerosol pentamidine group (P < 0.001 ). The mean time to discontinuation of assigned treatment was 14.6, 17.1, and 13.7 months in the TMP/SMX, aerosolized pentamidine, and dapsone groups respectively.
Blum et al. prospectively compared dapsone (100 mg/day) and TMP/SMX (one double-strength tablet/day) as primary prophylaxis for PCP in HIV-positive patients with CD4+ counts below 200/mm3. After 1,638 patient months of follow up, 1/47 (2%) patients randomized to dapsone and 1/39 (3%) patients randomized to TMP/SMX developed PCP. 33/47 (70%) dapsone recipients and 25/39 (64%) TMP/SMX recipients discontinued their study therapy, most frequently for rash. Ten patients switched from dapsone to TMP/SMX, 4 successfully; and 11 patients crossed over from TMP/SMX to dapsone, 6 successfully.
Salmon-Ceron et al. have reported results from a randomized, unblinded study that compared aerosolized pentamidine, 300 mg every month, and dapsone, 50 mg/day, for secondary prophylaxis in 196 HIV- positive patients. The study was prematurely discontinued due to excess mortality in the dapsone group. After a mean follow-up of 13 months, 22/103 (21 %) of patients in the pentamidine group were dead compared with 39/93 (42%) receiving dapsone; the estimated mortality rates at 18 months were 24.6% and 53.1 %, respectively (P < 0.003).
Slavin et al. conducted a randomized comparison of dapsone (100 mg PO twice weekly) and aerosolized pentamidine (400 mg nebulized monthly) for PCP prophylaxis in patients with CD4 counts below 200/mm3 or a previous episode of PCP. 37/50 (74%) dapsone recipients and 32/46 (70%) AP recipients had a previous episode of PCP. Mean CD4 counts at entry were 128/mm3 and 124/mm3 in the dapsone and AP groups, respectively. All patients received AZT. After a median follow up of 18 months, 9/50 (18%) dapsone recipients and 8/46 (17%) AP recipients had developed PCP (no difference). The rates of adverse reactions were equal in the two groups (4 rash and 2 nausea on dapsone, and 5 cough and 1 dizziness on AP).
Opravil et al. randomized 528 patients to receive either dapsone/pyrimethamine (200 mg daily /75 mg once weekly) or aerosolized pentamidine (300 mg once monthly via Respirgard II nebulizer). All patients had CD4 counts below 200/mm3 at baseline and 20% had previous PCP. After 335 days' mean follow up, intent-to-treat analysis showed that 12/291 (4%) dapsone/pyrimethamine recipients and 13/242 (5%) AP recipients had developed PCP (no significant difference). Intolerance requiring a switch in treatment occurred in 30% of dapsone/pyrimethamine recipients and 4% of AP recipients. Most frequent side effects were nausea, fever, and hematologic toxicity.
Girard et al. randomized 349 symptomatic patients with CD4 counts below 200/mm3 to receive dapsone/pyrimethamine (50 mg daily/50 mg weekly) or aerosolized pentamidine (300 mg monthly) on an open- label basis. After a median follow-up of 539 days, 10/173 (6%) dapsone/pyrimethamine recipients and 10/176 (3%) aerosolized pentamidine recipients had developed PCP. 42 dapsone/pyrimethamine recipients and 3 aerosolized pentamidine recipients discontinued therapy due to toxicity. No difference in survival was observed.
Two randomized studies indicate that low-dose dapsone (100 mg/week) with pyrimethamine is less effective than other strategies for PCP prophylaxis. Antinori et al. randomized 197 patients with CD4 counts below 200/mm3 and no prior PCP to receive dapsone/pyrimethamine (100 mg weekly/25 mg twice weekly), aerosolized pentamidine (300 mg monthly via Respirgard II nebulizer), or TMP/SMX (one double-strength tablet every other day). After a median follow-up of 7.7 months, PCP had developed in 9/63 (14%), 4/68 (6%) and 1/66 (2%) of dapsone/pyrimethamine, aerosolized pentamidine and TMP/SMX recipients respectively. Upon intent-to-treat analysis, the difference between the TMP/SMX and D/P groups was significant (P = 0.0008). Other comparisons did not show significant differences. Podzamczer et al. randomized166 patients with CD4 counts below 200/mm3 to receive dapsone/pyrimethamine (100 mg weekly/25 mg weekly) or TMP/SMX (2 double-strength tablets three times weekly). After a mean follow-up of 380 days, intent-to-treat analysis showed that PCP had developed in 13/85 (15.2%) of dapsone/pyrimethamine recipients and 3/81 (3.7%) of TMP/SMX recipients (P = 0.01).
By contrast, the results of another randomized study (Mollolas et al.) suggest that weekly dapsone/pyrimethamine may be comparable to standard therapies. 331 HIV-infected patients with CD4 counts <206-/mm3 or a previous diagnosis of AIDS were randomized to receive dapsone/pyrimethamine (100/25 mg weekly), aerosolized pentamidine (300 mg monthly) or TMP/SMX (160/800 mg thrice weekly). The mean follow-up was 313 days. Upon intention- to-treat analysis, the PCP rates per year of observation were 8.3%, 5.6%, and 3.0% in the D/P, AP and TMP/SMX groups, respectively. These differences were not statistically significant.
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Prophylaxis Results in Children:
The recommended regimen is TMP 150 mg/m2/d PO with SMX 750 mg/m2/day PO in divided doses three times weekly on consecutive days (e.g. M-Tue-W). Alternative schedules include the same dosages given as a single daily dose three times weekly on consecutive days; the same dosages given in two divided doses every day; and the same dosages given as two divided doses three times weekly on alternating days (e.g. M-W-F). In the case of intolerance to TMP/SMX, alternative regimens are aerosolized pentamidine 300 mg/month via the Respirgard II nebulizer; dapsone (for children > 1 month of age) 1 mg/kg/day PO; or IV pentamidine 4 mg/kg every two or four weeks.
The safety of aerosolized pentamidine in infants was evaluated by
Hand et al. Seven
infants (mean age 6.7 months) with HIV infection were given
monthly treatments
with aerosolized pentamidine, with the dose calculated to be
equivalent to an adult
dosage of 300 to 600 mg/month. The side effects observed were
similar to those
seen in adults, with mild coughing and wheezing being most
frequent. The
investigators concluded that aerosolized pentamidine is safe in this
population.
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Pneumonia Menu
Antinori A et al. Failure of low-dose dapsone-pyrimethamine in
primary
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OTHER REPORTS:
Bozzette SA et al. A controlled trial of early adjunctive treatment
with
corticosteroids for Pneumocystis carinii pneumonia in
the acquired
immunodeficiency syndrome.
NEJM 323: 1451-7,1990.
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