Hans Veeken

Ethiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome

We evaluated generic sodium stibogluconate (SSG) (International Dispensary Association, Amsterdam) versus Pentostam (sodium stibogluconate, GlaxoWellcome, London) under field conditions in Ethiopian patients with visceral leishmaniasis (VL; kala-azar). The 199 patients were randomly assigned to Pentostam (n = 104) or SSG (n = 95) in 1998/99; both drugs were given at 20 mg/kg intra-muscularly for 30 days. A clinical cure after 30-days treatment was achieved in 70.2% (Pentostam) and 81.1% (SSG). There were no significant differences between the 2 drugs for the following parameters: frequency of intercurrent events (vomiting, diarrhoea, bleeding or pneumonia) or main outcome (death during treatment and death after 6-month follow-up; relapse or post kala-azar dermal leishmaniasis at 6-months follow-up). Twenty-seven patients had confirmed co-infection with HIV. On admission, HIV co-infected VL patients were clinically indistinguishable from HIV-negative VL patients. The HIV co-infected VL patients had a higher mortality during treatment (33.3% vs 3.6%). At 6-month follow-up, HIV-positive patients had a higher relapse rate (16.7% vs 1.2%), a higher death rate during the follow-up period (14.3% vs 2.4%), and more frequent moderate or severe post kala-azar dermal leishmaniasis (27.3% vs 13.3%). Only 43.5% of the HIV-positive patients were considered cured at 6-months follow-up vs 92.1% of the HIV-negative patients. HIV-positive patients relapsing with VL could become a reservoir of antimonial-resistant Leishmania donovani.

Visceral leishmaniasis and HIV in Tigray, Ethiopia

Objectives To identify characteristics that increased the risk of mortality in Ethiopian visceral leishmaniasis patients in a treatment programme managed by Médecins sans Frontières, in Tigray, Northern Ethiopia.

A randomized comparison of branded sodium stibogluconate and generic sodium stibogluconate for the treatment of visceral leishmaniasis under field conditions in Sudan.

Summary objective  To compare the outcome of treatment of Sudanese kala‐azar patients treated under field conditions with either branded sodium stibogluconate (SSG) (Pentostam GlaxoWellcome) or generic SSG (Albert David Ltd, Calcutta, supplied by International Dispensary Association, Amsterdam).

Comparison of an rK39 dipstick rapid test with direct agglutination test and splenic aspiration for the diagnosis of kala-azar in Sudan

We compared an rK39 dipstick rapid test (Amrad ICT, Australia) with a direct agglutination test (DAT) and splenic aspirate for the diagnosis of kala‐azar in 77 patients. The study was carried out under field conditions in an endemic area of north‐east Sudan. The sensitivity of the rK39 test compared with splenic aspiration was 92% (46/50), the specificity 59% (16/27), and the positive predictive value 81% (46/57). Compared with the diagnostic protocol used by Médecins sans Frontières, the sensitivity of the rK39 test was 93% (50/54), the specificity 70% (16/23), and the positive predictive value 88% (50/57). Compared with splenic aspirates, the sensitivity of a DAT with a titre ≥1:400 was 100% (50/50), but its specificity only 55% (15/27) and the positive predictive value was 80% (50/62). Using a DAT titre ≥1:6400, the sensitivity was 84% (42/50), the specificity 85% (23/27) and the positive predictive value 91% (42/46). All four patients with DAT titre ≥1:6400 but negative splenic aspirate were also rK39 positive; we consider these are probably ‘true’ cases of kala‐azar, i.e. false negative aspirates, rather than false DAT and rK39 seropositives. There were no false negative DATs (DAT titre ≤1:400 and aspirate positive), but there were four false negative rK39 tests (rK39 negative and aspirate positive). The rK39 dipstick is a good screening test for kala‐azar; but further development is required before it can replace the DAT as a diagnostic test in endemic areas of the Sudan.

Comparison of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis in Kenya

OBJECTIVE To compare the use of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis (kala-azar). METHODS A total of 102 patients with confirmed kala-azar were treated in a mission hospital in West Pokot region, Kenya, with sodium stibogluconate (20 mg/kg/day for 30 days)--either as Pentostam (PSM) or generic sodium stibogluconate (SSG); 51 patients were allocated alternately to each treatment group. FINDINGS There were no significant differences in baseline demographic characteristics or disease severity, or in events during treatment. There were 3 deaths in the PSM group and 1 in the SSG group; 2 patients defaulted in each group. Only 1 out of 80 test-of-cure splenic aspirates was positive for Leishmania spp.; this patient was in the SSG group. Follow-up after > or = 6 months showed that 6 out of 58 patients had relapsed, 5 in the SSG group and 1 in the PSM group. No outcome variable was significantly different between the two groups. CONCLUSION The availability of cheaper generic sodium stibogluconate, subject to rigid quality controls, now makes it possible for the health authorities in kala-azar endemic areas to provide treatment to many more patients in Africa.

Letter from Peru: Peru revisited

“Twelve years I have been away from my village, twelve years; that is a long time, you know.” The old man looks at me as if he expects that I cannot grasp the suffering he went through. Maybe I cannot, but the picture speaks for itself. His village, Umaro, had sparkled in the valley when we approached it from the mountain. The descent by car was spectacular, as was the bridge we had to cross by foot. The bridge was made of two cables suspended from one side of the river to the other. Across the wires were planks, but many were missing and, worse, some were so rotten that we dared not tread on them; we had to jump, with the turbulent stream 20 metres below. The village had once been a prosperous place, but now only remnants of this past, overgrown by weeds, remained. The old man shows us around. “The church has no roof, only the walls stand, but the bell shines in the sun,” he says proudly. “It has been stolen twice, but we retrieved it.” Umaro, a small village in the middle of the Andes, is an example of the situation faced by returnees. Twelve years ago the residents were forced to leave their village, owing to the attacks of the “terrucos” (terrorists of Sendero Luminoso). “Over 60 of my people have died,” he tells me as we walk on. “After four attacks there was no other way than to leave our village. I moved with my family to Ayacucho, others to Lima or Ica, but we stayed in contact. We always wanted to return; it is not easy to leave your place when you are 70,” he says. “How long have you been back?” I ask him. “We returned one year ago,” he answers, …