Evaluation of Multi-Drug Therapy for Leprosy in the United States Using Daily Rifampin

Dacso, Mara M.; Jacobson, Raymond L.; Scollard, David M.; Stryjewska, Barbara M.; Prestigiacomo, John F.

doi:10.1097/smj.0b013e31822d6014

Cited by 14 publications

(10 citation statements)

References 15 publications

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“…Their evaluation about relapses shows smaller risk than those published with intermittent rifampicin regimens [41].…”

Section: Who Multidrug Therapy: Rationale Evidence and Criticismsmentioning

confidence: 95%

Considerations in the design of clinical trials for multibacillary leprosy treatment

Penna¹

2014

Clinical Investigation

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In 1991, the World Health Assembly adopted a resolution to attain the goal of global elimination of leprosy as a public health problem by the year 2000, based on universal access to multidrug therapy established by the WHO. The WHO multidrug therapy recommendation was not based on clinical trial results, but was based on all scientific knowledge available at the time and incorporated some financial constraints, such as the impossibility of daily rifampin use. Further decisions regarding treatment duration were needed to allow the World Health Assembly resolution target to be reached, which was set without a deep epidemiological evaluation. At present there are many uncertainties about leprosy treatment, including for instance, its ideal duration including decisions concerning daily or intermittent use of drugs, the use of immune modulators with antibacterial drugs as prophylaxis, and treatment of reactions during and after chemotherapy. To advance our knowledge of leprosy treatment, knowledge revision of the available research would be the first step to develop comprehensive Bayesian clinical trials designed to shed light on these uncertainties.

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“…Their evaluation about relapses shows smaller risk than those published with intermittent rifampicin regimens [41].…”

Section: Who Multidrug Therapy: Rationale Evidence and Criticismsmentioning

confidence: 95%

Considerations in the design of clinical trials for multibacillary leprosy treatment

Penna¹

2014

Clinical Investigation

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“…10,15,17 Daily administration of rifampin, as currently recommended in the United States for the multidrug therapy of leprosy, appears to be safer from an immunologic standpoint. 8,18 Received September 23, 2011. Accepted for publication November 8, 2011.…”

Section: Discussionmentioning

confidence: 99%

Recurrent Disseminated Intravascular Coagulation Caused by Intermittent Dosing of Rifampin

Havey

Cserti‐Gazdewich²,

Sholzberg³

et al. 2012

The American Society of Tropical Medicine and Hygiene

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Abstract. Daily rifampin therapy is associated with minimal adverse effects, but administration on an intermittent or interrupted basis has been associated with severe immunoallergic reactions such as hemolytic anemia, acute renal failure, and disseminated intravascular coagulation. We describe a patient with Mycobacterium leprae infection who experienced recurrent episodes of disseminated intravascular coagulation after intermittent exposures to rifampin, and review eight previously reported cases of rifampin-associated disseminated intravascular coagulation. In six (75%) cases, previous exposure to rifampin was reported and seven (87.5%) patients were receiving the medication on an intermittent or interrupted basis. Clinical features of rifampin-associated disseminated intravascular coagulation included fever, hypotension, abdominal pain, and vomiting within hours of ingestion. Average time to reaction was 3-6 doses if rifampin was being administered on a monthly schedule. Three (37.5%) of eight reported cases were fatal. A complete history of previous exposure to rifampin is recommended before intermittent therapy with this medication. CASE REPORTA 66-year-old woman was hospitalized in July 2009 after acute onset of fever, nausea, and vomiting. Her medical history was significant for lepromatous leprosy diagnosed at age 19, for which she had received multiple courses of therapy that included dapsone, rifampin, clofazimine, and thalidomide. Her leprosy remained quiescent on monotherapy with dapsone from 1986 until November 2008. At that time, she was started on the World Health Organization multidrug treatment regimen for leprosy that included ofloxacin, 300 mg orally/day; dapsone, 100 mg orally/day; and rifampin, 600 mg orally/month to alleviate the need for lifetime monotherapy with dapsone. Minocycline, 50 mg orally/day was substituted for ofloxacin after development of diarrhea. Other medical history included pulmonary tuberculosis diagnosed at age 37 that was treated with multidrug therapy including rifampin, cirrhosis secondary to hepatitis B virus infection for which she was receiving lamivudine, papillary thyroid cancer, bipolar affective disorder, and type II diabetes mellitus.On July 21, 2009, she ingested her ninth monthly dose of rifampin as part of her intermittent dosing regimen. Within three hours, she experienced sudden onset of fever, nausea, and hematemesis and came to the Emergency Department. On examination, her blood pressure was 81/38 mm of Hg, her heart rate was 130/minute, and her temperature was 39.0˚C. She was icteric. There was bleeding from the nares, oral cavity, urinary tract, and venipuncture sites. There was mild tenderness to palpation of the abdomen.Laboratory investigations obtained within 12 hours of admission were compatible with disseminated intravascular coagulation (DIC): international normalized ratio = 3.33 (reference = 0.8-1.2); prothrombin time = 80 seconds (reference = 26-28 seconds); fibrinogen < 1.5 g/L (reference = 1.5-3.50 g/L), and D-dimers > 4,000 mg/L (refere...

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“…The US National Hansen's Disease Program recommends the use of daily rather than monthly RFM and for a longer period of time than WHO-MDT: 24 months for MB and 12 months for PB patients [71]. Several researchers also favor this scheme [22].…”

Section: Clinical Trials With Standard Who-mdtmentioning

confidence: 99%

Considerations on clinical trials of leprosy treatment: need of novel drug combinations

Illarramendi¹,

Oliveira²,

Sales³

et al. 2013

Clinical Investigation

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Considering that after 30 years of using multidrug therapy (MDT), leprosy eradication has still not been achieved, leprosy treatment must remain on the drug discovery agenda. Due to the complexities inherent in leprosy disease and the many methodological issues involved in clinical trials, the task of translating the bench findings into clinical practice has been arduous. While the effectiveness of reducing the currently recommended MDT remains controversial, a number of highly bactericidal antibiotics and immune-modulatory drugs have emerged as prospective candidates to improve patient adherence and quality of life, reduce adverse effects and prevent resistance. To replace the standard WHO-MDT, the new combination must be the shortest, simplest and, consequently, most affordable treatment possible.

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Evaluation of Multi-Drug Therapy for Leprosy in the United States Using Daily Rifampin

Abstract: These data are remarkable for the absence of relapse with daily rifampin, as contrasted with the published experience using the WHO protocol with monthly rifampin.

Cited by 14 publications

References 15 publications

Considerations in the design of clinical trials for multibacillary leprosy treatment

Considerations in the design of clinical trials for multibacillary leprosy treatment

Recurrent Disseminated Intravascular Coagulation Caused by Intermittent Dosing of Rifampin

Considerations on clinical trials of leprosy treatment: need of novel drug combinations

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