We assessed whether mutations in the Plasmodium falciparum multidrug-resistance gene 1 (pfmdr1) (C1034S, D1042N, and Y1246D) would predict treatment outcome during a 28-day in vivo treatment trial in the Peruvian Amazon. Mefloquine (MQ) was compared with mefloquine-artesunate (MQ-AS) in a randomized, multi-clinic protocol for the first time in the Americas. Of 115 patients enrolled in the in vivo arm, 97 patients were eligible for molecular analysis. All 97 patients remained parasite-free during 28 days of follow-up (MQ, n = 46; MQ-AS, n = 51), indicating 100% clinical efficacy of the MQ and MQ-AS treatment regimens. The reported MQ-sensitive alleles (C1034, D1042, and Y1246) were present in 48.5% (n = 47) of the cases, whereas 49 isolates (50.5%) contained the D1246 mutation reported to confer MQ resistance in vitro. However, neither this mutation nor a double mutation (S1034, D1246; n = 16) was predictive of MQ treatment outcome.
The diagnostic potential of recombinant leishmanial antigens for Latin American tegumentary leishmaniasis (LATL) was examined. Two Leishmania (Viannia) peruviana recombinant proteins, T26-U2 and T26-U4, were assessed by their reactivity to detect specific anti-leishmanial antibodies. Seventy-eight individual sera from persons with LATL, 39 from those with other diseases, and 10 negative control sera were tested by Western blotting and enzyme-linked immunosorbent assay. The sensitivity of the test using T26-U2 plus T26-U4 was similar to that obtained with whole parasite extract (92%). However, the specificity obtained using both recombinant antigens (87%) was higher than that of the whole parasite extract (65%). All tests using recombinant proteins (T26-U2, T26-U2 plus T26-U4 or T26-U4) had a higher positive predictive value (89%, 92% and 98%, respectively) than the value obtained using total parasites (81%). Eleven Colombian sera were also tested, and the results indicated that T26-U2 plus T26-U4 could be used successfully in Peru and in other Latin American countries.
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