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Table 2 Efficacy outcomes and adequate clinical and parasitilogical response rates by day 42 among the enrolled participants stratified by group of antiretroviral therapy

From: Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial

Variable

DPQ + efavirenz

N = 160

DPQ + nevirapine

N = 61

Early treatment failure-no. (%)

1 (0.6)

0

 Development of danger signs or severe malaria

0

0

 Parasitaemia on day 2 greater than day 0

0

0

 Parasitemia on day 3 ≥ 25% of count on day 0

1 (0.6)

0

 Parasitemia on day 3 with axillary temperature ≥ 37.5 °C

0

0

Late clinical failure-no. (%)

0

0

Late parasitological failure-no. (%)

7 (4.4)

0

 Recrudescence

0

0

 Reinfection

6 (3.8)

0

 Indeterminate or sample unavailable

1 (0.6)

0

Adequate clinical and parasitolocal response rates by different scenarios

 Intention-to-treat analysis

  PCR-corrected cure rate-% (95% CI)

   Scenario 1a

99.4 (95.6–99.9)

100

   Scenario 2b

93.1 (88.0–96.2)

100

  PCR-uncorrected cure rate-% (95% CI)

   Scenario 1a

95.6 (90.3–97.5)

100

   Scenario 2b

89.4 (83.5–93.3)

100

   Scenario 3c

89.9 (82.3–94.4)

100

   Scenario 4d

89.8 (77.4–95.8)

100

 Per-protocol analysis

  Number of patients

151

61

  PCR-corrected cure rate-% (95% CI)

   Scenario 5e

99.3 (95.4–99.9)

100

   Scenario 6f

98.8 (95.1–99.7)

100

  PCR-uncorrected cure rate-% (95% CI)

   Scenario 5e

95.3 (90.5–97.8)

100

   Scenario 6f

94.7 (89.7–97.3)

100

  1. aScenario 1: Indeterminate or unavailable PCR samples or loss to follow up by day 42 (n = 9, in efavirenz-ART group) in intention-to-treat population treated as treatment success
  2. bScenario 2: Indeterminate or unavailable PCR samples or loss to follow up by day 42 (n = 9, in efavirenz-ART group) in the intention-to-treat population treated as treatment failures
  3. cScenario 3: On cotrimoxazole prophylaxis in the intention-to treat analysis and combined with scenario 2 above
  4. dScenario 4: Not on cotrimoxazole prophylaxis in the intention-to treat and combined with scenario 2 above
  5. eScenario 5: Indeterminate or unavailable PCR samples in per-protocol population treated as treatment success
  6. fScenario 6: Indeterminate or unavailable PCR samples in per-protocol population treated as treatment failure