Table 4.
Failure rates of the studies in support of the current post-travel regimen.
| Author | Study size | Efficacy | Failures |
|---|---|---|---|
| Sulyok et al., 2017 [31] | 6 AP subjects | All subjects were protected | 0 |
| Soto et al., 2006 [24] | 120 AP subjects in ITT analysis 110 AP subjects in PP1 analysis 97 AP subjects in PP2 analysis 8/9 AP failures included in ITT analysis withdrew consent and were not administered any drug |
Protective efficacy of AP in PP1 for all malaria and P. vivax 97% (LL 95% CI = 74%) and 97% (LL 95% CI = 69%), respectively. Protective efficacy in PP2 of AP for all malaria and P. vivax was 100% (LL 95% CI = 63) and 100% (LL 95% CI = 58), respectively. No cases of falciparum malaria reported. |
0 falciparum malaria and 1 vivax malaria case in PP1 0 falciparum malaria and 0 vivax malaria in PP2 |
| Camus et al., 2004 [32] | 110 AP subjects | No subjects were diagnosed with malaria at any time during the study. | 0 |
| Schlagenhauf et al., 2003 [17] | 154 AP subjects | No cases of malaria reported for any study arm. | 0 |
| Faucher et al., 2002 [26] | 150 AP subjects included in efficacy analysis | Prophylactic efficacy of AP was 97% (95% CI = 79–100). | 1 case of falciparum malaria |
| Ling et al., 2002 [25] | 150 AP subjects included in efficacy analysis | Protective efficacy of AP was 84% (95% CI = 44–95) for vivax malaria, 96% (95% CI = 72–99) for falciparum malaria and 93% (95% CI = 77–98) for all malaria. | 1 case of falciparum malaria (co-infecton with a vivax malaria case) and 2 vivax malaria cases |
| Berman et al., 2001 [10] | 12 AP subjects | No AP recipient acquired malaria (P < .00l). Protective efficacy of 100%. | 0 |
| Overbosch et al., 2001 [30] | 486 AP subjects included in efficacy analysis | Minimal and maximum efficacy was 100% (95% CI = 48–100) and 100% (95% CI = 99–100), respectively. No confirmed cases of malaria. | 0 |
| Hogh et al., 2000 [18] | 501 AP subjects included in efficacy analysis | Estimated minimum efficacy for prevention of falciparum malaria was 100% (95% CI = 59–100) in the AP group. | 0 |
| Sukwa et al., 1999 [27] | 102 AP subjects included in efficacy analysis | Success rate of 98% for P. falciparum (P = .001). Efficacy rate for P. falciparum was 95% (95% CI = 79–100). | 2 cases of falciparum malaria |
| Shanks et al., 1998 [28] | 54 low dose AP subjects included in efficacy analysis | Prophylactic efficacy and success rate in both the high and low dose treatment groups were 100% (95% CI = 77–100). | 0 |
| Lell et al., 1998 [29] | 115 AP subjects included in efficacy analysis | Prophylactic efficacy of AP was 100% (95% CI = 83–100). No cases of malaria in the AP group (P = .001). | 0 |
| Bloechliger et al., 2014 [2] | 108,344 AP prescriptions of which 99.9% prescribed as chemoprophylaxis | Estimated malaria incidence rate of 13 per 100,000 person-years. | – |
| Gimnig et al., 2013 [35] | 152 AP subjects | All collectors provided with AP were protected during HLC | 0 |
| Kato et al., 2013 [39] | 278 AP subjects | 1 subject diagnosed with malaria | 1 |
| Mavrogordato et al., 2012 [40] | 11 AP subjects | None diagnosed with malaria | 0 |
| Zuckerman et al., 2009 [33] | 1.26 million prescriptions of AP by estimation | 2.9 (1.3 by removing confounding factors) cases of falciparum malaria per 100,000 prescriptions | – |
| Andersson et al., 2008 [34] | 161 AP subjects | No reported cases of falciparum malaria resulted in 100% effectiveness for long-term prophylaxis. | 0 |
| van Genderen et al., 2007 [36] | 169 AP subjects | Prophylactic efficacy of 97% against P. falciparum. | 5 |
| Kofoed et al., 2003 [38] | 45 AP subjects | Estimated efficacy of AP in fully compliant users was 1:1943 (falciparum malaria cases per prescription). | 3 cases of falciparum malaria |
| van der Berg et al., 1999 [37] | 113 AP subjects included in efficacy analysis | Prophylaxis success 97% (95% CI = 92–99). | 0 cases of malaria as a results of withdrawal of 3 subjects due to AEs |
| Total subjects: 2866 (including the PP2 cohort and excluding the studies with data on AP prescriptions) | Total failures: 13 cases excluding vivax malaria cases |
AP, atovaquone-proguanil; AE(s), adverse event(s); HLC, human landing catches; ITT, intention to treat; PP1 is defined as being compliant and visiting for weekly blood smear; PP2 is defined as having adequate drug concentrations; CI, confidence interval; LL, lower limit.