Acute HIV-1 Infection in Patients with Hemophilia B Treated with β-Propiolactone-UV-lnactivated Clotting Factor

Kleim, Jörg‐Peter; Bailly, E.; Schneweis, K. E.; Brackmann, H.‐H.; Hammerstein, U.; Hanfland, P.; Loo, B. van; Oldenburg, J.

doi:10.1055/s-0038-1647314

Cited by 60 publications

(18 citation statements)

References 5 publications

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“…Previously, postauthorization safety surveillance (PASS) in haemophilia A has been focused on the transmission of human blood-borne pathogens, owing to infection with hepatitis C and the previously unknown human immunodeficiency virus, both of which were transmitted by human plasma-derived FVIII (pdFVIII) products [11][12][13][14][15][16]. Human pdFVIII products now typically undergo multiple distinct virus removal or inactivation steps [17][18][19][20]; however, risk of transmission cannot be completely eliminated.…”

Section: Introductionmentioning

confidence: 99%

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practice

Oldenburg¹,

Goudemand

Valentino

et al. 2010

Haemophilia

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Postauthorization safety surveillance of factor VIII (FVIII) concentrates is essential for assessing rare adverse event incidence. We determined safety and efficacy of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method, (rAHF-PFM)] during routine clinical practice. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Among 408 evaluable subjects, 386 (95%) received excellent/good efficacy ratings for all on-demand assessments; the corresponding number for subjects with previous FVIII inhibitors was 36/41 (88%). Among 276 evaluable subjects receiving prophylaxis continuously in the study, 255 (92%) had excellent/good ratings for all prophylactic assessments; the corresponding number for subjects with previous FVIII inhibitors was 41/46 (89%). Efficacy of surgical prophylaxis was excellent/good in 16/16 evaluable procedures. Among previously treated patients (PTPs) with >50 exposure days (EDs) and FVIII≤2%, three (0.75%) developed low-titre inhibitors. Two of these subjects had a positive inhibitor history; thus, the incidence of de novo inhibitor formation in PTPs with FVIII≤2% and no inhibitor history was 1/348 (0.29%; 95% CI, 0.01-1.59%). A PTP with moderate haemophilia developed a low-titre inhibitor. High-titre inhibitors were reported in a PTP with mild disease (following surgery), a previously untreated patient (PUP) with moderate disease (following surgery) and a PUP with severe disease. The favourable benefit/risk profile of rAHF-PFM previously documented in prospective clinical trials has been extended to include a broader range of haemophilia patients, many of whom would have been ineligible for registration studies.

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Section: Introductionmentioning

confidence: 99%

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practice

Oldenburg¹,

Goudemand

Valentino

et al. 2010

Haemophilia

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“…Such examples of HIV infection have been well documented among hemophiliacs in the nineties (Kleim et al, 1990), which was followed by several other outbreaks of blood borne pathogens worldwide, such as HCV (Bresee et al, 1996; Echevarria et al, 1996; Lawlor et al, 1999; Lefrere et al, 1996), Parvovirus 19, and Hepatitis A virus (Blumel et al, 2002; Jee et al, 2006; Johnson et al, 1995; Kupfer et al, 1995; Mannucci et al, 1994; Soucie, Siwak, Hooper, Evatt, & Hollinger, 2004). Since HIV incidence is rising along the U.S./Mexico border (Strathdee & Magis-Rodriguez, 2008), it is worthy to consider that HIV antibody screening could theoretically miss a small number of HIV-infected IDUs in the window period.…”

Section: Discussionmentioning

confidence: 99%

Cross-border paid plasma donation among injection drug users in two Mexico–U.S. border cities

Volkow¹,

Brouwer²,

Loza³

et al. 2009

International Journal of Drug Policy

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Objective-Paid plasma donation has contributed to HIV epidemics in many countries. Eleven million liters of plasma are fractionated annually in the U.S., mainly from paid donors. Deferral of high risk donors such as injection drug users (IDUs) is required for paid donations. We studied circumstances surrounding paid plasma donation among IDUs in two Mexican-U.S. border cities.Methods-In 2005, IDUs ≥18 years old in Tijuana (N=222) and Cd. Juarez (N=206) who injected in the last month were recruited through respondent-driven sampling. Subjects underwent antibody testing for HIV and HCV and an interviewer-administered survey including questions on donating and selling whole blood and plasma.Results-Of 428 IDUs, HIV and HCV prevalence were 3% and 96%, respectively; 75 (17.5%) reported ever having donated/sold their blood or plasma, of whom 28 (37%) had sold their plasma for an average of $16 USD. The majority of IDUs selling plasma were residents of Ciudad Juarez (82%); 93% had sold their plasma only in the U.S. The last time they sold their plasma, 65% of IDUs had been asked if they injected drugs. Although the median time since last selling plasma was 13 years ago, 3 had done so within the prior two years, one within the prior 6 months; of these 3 IDUs, 2 were from Cd. Juarez, one from Tijuana; all 3 had only sold their plasma in the U.S.Conclusions-Although selling plasma appears uncommon among IDUs in these two Mexican border cities, the majority sold plasma in the U.S and only one-third were deferred as high-risk donors. Paying donors for plasma should be a matter of public inquiry to encourage strict compliance with regulations. Plasma clinics should defer donors not only on behavioral risks, but should specifically inspect for injection stigmata.

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“…Virus transmission is a potential risk associated with plasma products 3 that has been known for more than five decades. Even after the general introduction of effective VI/R methods in 1985, incidents have been reported in which one or several batches of plasma products have transmitted HAV, 24,26,29,30,55–57 HBV, 20 HCV, 74 and HIV 32,47 . With modern molecular methods, such as NAT, genotyping, and genome sequencing, it is now possible to confirm or disprove suspected virus transmission.…”

Section: Discussionmentioning

confidence: 99%

“…If demonstration of virus transmission by NAT is impossible, virus‐inactivation and/or ‐reduction (VI/R) methods employed in the manufacturing process must be reevaluated. Several incidents of virus transmission due to insufficient effectiveness of VI/R methods have occurred in the past: HIV infection transmitted by β‐propiolactone/UV‐inactivated prothrombin complex concentrate, 20,32,47,48 several HCV transmissions by IVIG manufactured by Cohn fractionation 16,22,27,28,49–53 or the Hoppe method, 33,54 and a series of HAV transmissions by FVIII products inactivated by the S/D method 24,26,29,30,55–57 . The lesson to be learned from these incidents is that small changes in plasma screening and/or the manufacturing process may have considerable impact on viral safety 58 and may require revalidation according to relevant guidelines 59…”

Section: Methodsmentioning

confidence: 99%

Causality assessment of suspected virustransmission by human plasma products

et al. 2001

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Acute HIV-1 Infection in Patients with Hemophilia B Treated with β-Propiolactone-UV-lnactivated Clotting Factor

Cited by 60 publications

References 5 publications

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practice

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practice

Cross-border paid plasma donation among injection drug users in two Mexico–U.S. border cities

Causality assessment of suspected virustransmission by human plasma products

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