BACKGROUND:To assess the implications of HIV pre-exposure prophylaxis (PrEP) shortages, we conducted a survey among PrEP users and individuals interested in PrEP. The survey explored coping strategies, HIV prevention and sexual behavior and stress levels due to the drug shortages. Furthermore, barriers to PrEP access among people with unmet PrEP demand were investigated. METHODS:An anonymous online survey was conducted from 28.01.-27.02.2024. Recruitment occurred via social media, professional societies, network channels, and flyers at HIV specialists. Factors associated with high stress levels and unmet PrEP demand were investigated using multivariable logistic regression. RESULTS:Among 926 PrEP users, most were male (98%), aged 31-45 (54%), identified as men (97%), lived in large cities (54%), and used PrEP daily (78%). Due to the shortage, 63% paused or switched to on-demand use. Most intended to resume PrEP once available (65%), followed by relying on condoms (41%) or reducing sexual partners (39%). High stress level was reported by 78%. Predictors of higher stress levels included feeling less protected against HIV and having more than 11 sexual partners; using on-demand PrEP with fewer than 20 monthly pills was significantly less likely. Unmet PrEP demand was more common among female and gender-diverse individuals and less common among those living in large cities. CONCLUSIONS:Involuntary changes in PrEP use may have hindered users' ability to adapt sexual behavior, increasing HIV risks. PrEP users most at risk and most reliant on PrEP experienced greater psychological burden. Expanding PrEP education and outreach alongside with prescriber capacity is essential to ensure PrEP continuity and meet unmet PrEP demand. Individualized counseling could help to determine actual PrEP need and benefits. CLINICAL TRIAL NUMBER:Not applicable.

Zusammenfassung Hintergrund Untersucht wurden die Auswirkungen der HIV-Präexpositionsprophylaxe (PrEP) als neue Leistung der gesetzlichen Krankenversicherung (GKV) auf das Infektionsgeschehen von HIV und anderen sexuell übertragbaren Infektionen (STI) in Deutschland. Zusätzlich wurden PrEP-Bedarfe sowie Zugangsbarrieren analysiert. Methoden Im Rahmen des Evaluationsprojektes wurden folgende Daten ausgewertet: HIV- und Syphilis-Meldedaten und erweiterte Surveillance des Robert Koch-Instituts (RKI), Apothekenabrechnungsdaten, GKV-Daten, PrEP-Gebrauch in HIV-Schwerpunktzentren, Checkpoint‑, BRAHMS- und PrApp-Studie sowie ein Community-Beirat. Ergebnisse Die PrEP-Nutzenden waren zum größten Teil männlich (98–99 %), zum Großteil im Alter zwischen 25–45 Jahren und überwiegend deutscher Staatsangehörigkeit oder Herkunft (67–82 %). Der Großteil zählte zur Gruppe der Männer, die Sex mit Männern haben (99 %). In Bezug auf HIV-Infektionen zeigte sich die PrEP als hocheffektiv. Es fanden nur vereinzelt HIV-Infektionen statt (HIV-Inzidenzrate 0,08/100 Personenjahre), in den meisten Fällen war der vermutete Grund eine geringe Adhärenz. Die Inzidenzen von Chlamydien, Gonorrhö und Syphilis nahmen nicht zu, sondern blieben nahezu gleich oder gingen sogar zurück. Es zeigte sich Informationsbedarf zur PrEP für Personen in trans*/nichtbinären Communitys, Sexarbeitende, Migrant*innen und Drogengebrauchende. Notwendig wären bedarfsgerechte Angebote für Zielgruppen mit erhöhtem HIV-Risiko. Diskussion Die PrEP erwies sich als eine sehr wirkungsvolle HIV-Präventionsmethode. Die teils befürchteten indirekten negativen Einflüsse auf STI-Raten wurden in dieser Untersuchung nicht bestätigt. Aufgrund der zeitlichen Überschneidung mit den Eindämmungsmaßnahmen während der COVID-19-Pandemie wäre für eine abschließende Beurteilung ein längerer Beobachtungszeitraum wünschenswert.

BACKGROUND:We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS:The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS:The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION:PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

In den westlichen finanzstarken Ländern sinken seit einigen Jahren die HIV-Infektionen.Dahingegen steigen die Inzidenz und Prävalenz bei den anderen STI wie Syphilis und

Abstract IntroductionObjectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence of infections with HIV, chlamydia, gonorrhea, syphilis, hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with chlamydia/gonorrhea and syphilis infections were assessed.MethodsAnonymous data of PrEP users were collected at 47 HIV-specialty centers from 09/2019-12/2020. Incidence rates were calculated per 100 person years (py). Using longitudinal mixed models, we analyzed risk factors associated with sexually transmitted infections (STIs).Results4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32-45), 98.6% men who have sex with men (MSM). The median duration of observation was 451 days (IQR 357-488), totaling 5132 py.Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029-0.208). For two suboptimal adherence was reported and in the third case suboptimal adherence and resistance to emtricitabine was observed. One infection was likely acquired before PrEP start.Incidence rates were 21.6/100py for chlamydia, 23.7/100py for gonorrhea, 10.1/100py for syphilis and 55.4/100py for any STI and decreased significantly during the observation period. 65.5% of syphilis, 55.6% of chlamydia and 50.1% of gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for chlamydia/gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for chlamydia/gonorrhea and syphilis. A significantly lower risk for chlamydia/gonorrhea and syphilis was found for observations during the covid-19 pandemic period.ConclusionsWe found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV-infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value.

Introduction Objectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence of infections with HIV, chlamydia, gonorrhea, syphilis, hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with chlamydia/gonorrhea and syphilis infections were assessed. Methods Anonymous data of PrEP users were collected at 47 HIV-specialty centers from 09/2019–12/2020. Incidence rates were calculated per 100 person years (py). Using longitudinal mixed models, we analyzed risk factors associated with sexually transmitted infections (STIs). Results 4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32–45), 98.6% men who have sex with men (MSM). The median duration of PrEP exposure was 451 days (IQR 357–488), totaling 5132 py. Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029–0.208). For two, suboptimal adherence was reported and in the third case, suboptimal adherence and resistance to emtricitabine were observed. One infection was likely acquired before PrEP start. Incidence rates were 21.6/100py for chlamydia, 23.7/100py for gonorrhea, 10.1/100py for syphilis and 55.4/100py for any STI and decreased significantly during the observation period. 65.5% of syphilis, 55.6% of chlamydia and 50.1% of gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for chlamydia/gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for chlamydia/gonorrhea and syphilis. A significantly lower risk for chlamydia/gonorrhea and syphilis was found for observations during the COVID-19 pandemic period. Conclusions We found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value.

IntroductionObjectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence and prevalence of infections with HIV, Chlamydia, Gonorrhea, Syphilis, Hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with Chlamydia/Gonorrhea and Syphilis infections were assessed.MethodsAnonymous data of PrEP users were collected at HIV-specialty centers from 09/2019-12/2020. Incidence rates were calculated per 100 person years (py). Logistic regression was used to analyze risk factors associated with sexually transmitted infections (STIs).Results4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32-45), PrEP indication 98.6% men who have sex with men (MSM). Duration of PrEP use were 5132 py; median duration 451 days (IQR 357-488).Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029-0.208). For two suboptimal adherence was reported and in the third case suboptimal adherence and resistance to emtricitabine was observed. One infection was likely acquired before PrEP start.Incidence rates were 21.6/100py for Chlamydia, 23.7/100py for Gonorrhea, 10.1/100py for Syphilis and 55.4/100py for any STI and decreased significantly. 65.5% of Syphilis, 55.6% of Chlamydia and 50.1% of Gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for Chlamydia/Gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for Chlamydia/Gonorrhea and Syphilis.ConclusionsWe found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV-infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were likely influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value.

Background Guillain–Barré syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. Pre-licensure clinical trials did not observe an association between human papillomavirus (HPV) vaccination and GBS, a post-marketing study from 2017 reported an increased relative risk. Aim We assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis. Methods We searched Embase, MEDLINE and Cochrane for studies reporting on the risk of GBS after HPV vaccination in individuals aged ≥ 9 years, published between 1 January 2000 and 4 April 2020, excluding studies without a comparator group. Seven studies reporting relative effect sizes were pooled using random-effects meta-analysis. We assessed quality of evidence using the GRADE approach. Study protocol was registered (PROSPERO No. #CRD42019123533). Results Of 602 identified records, we included 25 studies. Based on over 10 million reports, cases of GBS were rare. In 22 studies no increased risk was observed, while in three studies a signal of increased risk of GBS after HPV vaccination was identified. Meta-analysis yielded a pooled random-effects ratio of 1.21 (95% CI: 0.60–2.43); I 2 = 72% (95% CI: 36–88). This translates to a number needed to harm of one million to be vaccinated to generate one GBS case. Quality of evidence was very low. Conclusions The absolute and relative risk of GBS after HPV vaccination is very low and lacks statistical significance. This is reassuring for the already implemented vaccination programmes and should be used in respective communication activities.

Background Instruments controlling statutory healthcare medical supply have long been a topic of debate in health policy reform discussions. Over the years, a variety of tools have been developed, most of which are aimed at controlling drug expenditure. The instruments controlling regional prescriptions primarily focus on controlling behavioural patterns of the prescribing physicians. Important to note is the increased use of indication-directed quotas, primarily of drug leads and/or generics/biosimilars. These are now also available in the area of the human immunodeficiency virus (HIV), such as the generic quotas for HIV medications introduced in Bavaria and Berlin in 2020. Objective The aim of this article is to analyse the benefits and limitations of generic quota solutions in HIV care using statutory health insurance drug prescription data and to outline recommendations for action. Results It was observed that the quota potential for generics in the area of patent-free drugs in HIV care has already been largely exhausted. This can be explained by HIV prescribers supporting product exchange on the prescription. Discussion The best-case scenario in terms of regulation has almost been reached. This is due to a suitable set of instruments, including the framework agreement for medical supply as well as prescribing according to guidelines - in conjunction with the Pharmaceuticals Market Reorganisation Act (AMNOG) and reference prices for drugs. Conforming with guidelines and (existing) single-tablet regimens play an integral role in maintaining good quality of care.

Background The aim of this study was to develop a standardized method to reconstruct persons’ individual viral load (VL) courses to determine viral suppression and duration of viremia for the HIV care continuum in Germany using longitudinal cohort data. Methods We analyzed data from two large, multi-center German cohort studies under the direction of the Robert Koch Institute. We included data from 1999 to 2018 of all diagnosed people and of people who initiated antiretroviral treatment (ART). We developed a model generating virtual VL values and an individual VL course corresponding to real VL measurements with a maximum distance of 180 days, considering ART status and VL dynamics. If the distance between VL measurements was > 180 days, the time between was defined as gap time. Additionally, we considered blips, which we defined as a single detectable VL < 1000 copies/ml within 180 days. Results A total of 22,120 people (164,691 person-years, PY) after ART initiation were included in the analyses. The proportion of people with viral suppression (VL < 50 copies/ml) increased from 34% in 1999 to 93% in 2018. The proportion of people with VL < 200 copies/ml increased from 47% in 1999 to 96% in 2018. The proportion of people with viremia > 1000 copies/ml decreased from 37% in 1999 to 3% in 2018. The proportion of people with gap time fluctuated and ranged between 18 and 28%. An analysis of the first VL after gap time showed that 90% showed viral suppression, 5% VL between 50- < 1000 copies/ml and 5% VL > 1000 copies/ml. Conclusion We provide a method for estimating viral suppression and duration of viremia using longitudinal VL data. We observed a continuous and remarkable increase of viral suppression. Furthermore, a notable proportion of those with viremia showed low-level viremia and were therefore unlikely to transmit HIV. Individual health risks and HIV drug resistance among those with low-level viremia are problematic, and viral suppression remains the goal. In 2018, 93 and 96% of people after ART initiation showed VL < 50 copies/ml and VL < 200 copies/ml, respectively. Therefore, using the threshold of VL < 200 copies/ml, Germany reached the UNAIDS 95 target of viral suppression since 2017.

Zusammenfassung Hintergrund Die Steuerungsinstrumente der Arzneimittelversorgung in der gesetzlichen Krankenversicherung (GKV) sind schon länger Bestandteil der gesundheitspolitischen Reformdebatte. Über die Jahre hat sich eine Gemengelage sehr verschiedener Werkzeuge herausgebildet, die zumeist auf eine Kontrolle der Arzneimittelausgaben zielen. Die Instrumente der regionalen Verordnungssteuerung fokussieren vor allem auf eine Verhaltenssteuerung des verordnenden Arztes. Zu erwähnen ist nicht zuletzt der verstärkte Einsatz von indikationsbezogenen Quoten, vorrangig Leitsubstanzen und/oder Generika/Biosimilars. Diese gibt es mittlerweile auch im Bereich des Humanen Immundefizienz-Virus (HIV), etwa die seit 2020 in Bayern und Berlin eingeführten Generikaquoten für HIV-Therapeutika. Zielstellung Ziel des vorliegenden Beitrages ist es, auf Grundlage von GKV-Apothekenabrechnungsdaten das Potenzial sowie Grenzen von Generikaquotenlösungen in der HIV-Versorgung zu analysieren und Handlungsempfehlungen zu skizzieren. Ergebnisse Es zeigte sich, dass das Quotenpotenzial für Generika im patentfreien Bereich in der HIV-Versorgung bereits weitgehend ausgeschöpft wird. Dieser Umstand ist vor allem darauf zurückzuführen, dass die HIV-Verordner den Austausch durch Verzicht auf Aut-idem-Kreuze auf dem Kassenrezept unterstützen. Diskussion Das steuerungspolitische Optimum ist fast erreicht. Dies ist auf das geeignete Instrumentarium zurückzuführen, das aus dem Rahmenvertrag zur Arzneimittelversorgung und einer leitliniengerechten Wirkstoffverordnung durch den Arzt besteht – in Verbindung mit dem AMNOG(Arzneimittelmarktneuordnungsgesetz)-Verfahren und Festbeträgen. Leitlinienkonformität und (existierende) Eintablettenregime müssen beibehalten werden, damit die gute Versorgungsqualität gewährleistet bleibt.

Background A persistently low CD4/CD8 ratio has been reported to inversely correlate with the risk of non-AIDS defining cancer in people living with human immunodeficiency virus (HIV; PLWH) efficiently treated by combination antiretroviral therapy (cART). We evaluated the impact of the CD4/CD8 ratio on the risk of Kaposi sarcoma (KS) or non-Hodgkin lymphoma (NHL), still among the most frequent cancers in treated PLWH. Methods PLWH from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) were included if they achieved virological control (viral load ≤ 500 copies/mL) within 9 months following cART and without previous KS/LNH diagnosis. Cox models were used to identify factors associated with KS or NHL risk, in all participants and those with CD4 ≥ 500/mm3 at virological control. We analyzed the CD4/CD8 ratio, CD4 count and CD8 count as time-dependent variables, using spline transformations. Results We included 56 708 PLWH, enrolled between 2000 and 2014. At virological control, the median (interquartile range [IQR]) CD4 count, CD8 count, and CD4/CD8 ratio were 414 (296–552)/mm3, 936 (670–1304)/mm3, and 0.43 (0.28–0.65), respectively. Overall, 221 KS and 187 NHL were diagnosed 9 (2–37) and 18 (7–42) months after virological control. Low CD4/CD8 ratios were associated with KS risk (hazard ratio [HR] = 2.02 [95% confidence interval {CI } = 1.23–3.31]) when comparing CD4/CD8 = 0.3 to CD4/CD8 = 1) but not with NHL risk. High CD8 counts were associated with higher NHL risk (HR = 3.14 [95% CI = 1.58–6.22]) when comparing CD8 = 3000/mm3 to CD8 = 1000/mm3). Similar results with increased associations were found in PLWH with CD4 ≥ 500/mm3 at virological control (HR = 3.27 [95% CI = 1.60–6.56] for KS; HR = 5.28 [95% CI = 2.17–12.83] for NHL). Conclusions Low CD4/CD8 ratios and high CD8 counts despite effective cART were associated with increased KS/NHL risks respectively, especially when CD4 ≥ 500/mm3.

Monitoring recency of infection helps to identify current transmission in vulnerable populations for effective disease control. We have established an in-house avidity based hepatitis C virus (HCV) recency assay based on the Monolisa Anti-HCV PLUS Version 3 ELISA kit for use of dried serum/plasma spots (DS/PS) in order to distinguish recent and long-term infections. A first panel of DS/PS (n = 218; genotype 1 n = 170 and non-genotype 1 n = 48) consisting of primary and at least one follow up sample was used to analyze the temporal changes of the Avidity Index (AI) over time. Sub-panels of longitudinal DS/PS (n = 66) and acute cases (<26 weeks; n = 34) were taken to calculate the Mean Duration of Recent Infection (MDRI) and the False Long-term Rate (FLTR), respectively. A second panel of DS/PS >104 weeks (n = 132) and a third panel of DS/PS prepared from resolved infections (≥180 days since last positive; n = 32) were used to calculate the False Recent Rate (FRR). For all genotypes, the optimal AI cut-off was determined to be 40% resulting in an MDRI of 364 days (95% CI: 223–485). FLTR was 5.9% (95% CI: 0.7–19.7), 8.3% (95% CI: 1–27), and 0% (−) and FRR was 13.6% (95% CI: 8.3–20.7), 11.7% (95% CI: 6.6–19), and 30.6% (95% CI: 9.1–61.4) for all genotypes, genotype 1, and non-genotype 1 infections, respectively. For resolved infections, the FRR was 53.1% (95% CI: 35.8–70.4). Thus, this assay performs particularly well for genotype 1 reaching a high rate of correct discriminations between infections acquired less than a year before diagnosis and those acquired earlier by applying an AI cut-off of 40%. Due to a rapid decline in avidity post resolution of an HCV infection this assay is not recommended to be used in HCV RNA negative patients.

Pre-Exposure Prophylaxis (PrEP) has been widely accepted as an effective method to prevent HIV infections, but high costs precluded a widespread use in Germany. A novel distribution pathway of tenofovir-disoproxil fumarate and emtricitabine PrEP was implemented, which reduced monthly PrEP costs by 16-fold in Germany. Over a period of 6 months, we recorded prescription data, demographics, and sexual behavior of PrEP users, including self-reported sexually transmitted infections (STIs), alcohol and drug use. Within a month, prescriptions almost doubled from 585 to 1,009 and reached a cumulative number of 6,059 at the end of the 6-month observation period. Extrapolation of the data suggests an estimated maximal number of PrEP users of the order of 10,000. PrEP users demonstrated to be a population of well-educated men (407/686) who have sex with men (629/686), median age 38 (range:18-71), and of German descent (571/686). The majority used PrEP to compensate for risk of HIV infection when having condomless anal intercourse (372/686). At start of PrEP implementation, the majority perceived their own risk to acquire HIV as none to medium (78.6%; n = 539), while only a subset (18.8%; n = 129) considered themselves to be at high or very high risk for HIV infection. In contrast, within the last 6 months, 28.4% of the PrEP users had an STI diagnosis and over 70% had condomless anal intercourse with more than 6 partners. Taken together, our data from PrEP implementation in Germany demonstrate a large uptake once it became affordable in individuals who wish to compensate for HIV risk when having condomless anal intercourse.

BackgroundLate presentation (LP), defined as a CD4 count <350/mm(3) or an AIDS-event at HIV-diagnosis, remains a significant problem across Europe. Linking cohort and surveillance data, we assessed the country-specific burden of LP during 2010-2016 and the occurrence of new AIDS events or deaths within 12months of HIV-diagnosis believed to be attributable to LP.MethodsCountry-specific percentages of LP and AIDS-events/death rates (assessed with Poisson regression) observed in The Collaboration of Observational HIV Epidemiological Research Europe (COHERE) and EuroSIDA cohorts, were applied to new HIV-diagnoses reported to the European Centre for Disease Prevention and Control. The estimated number of LP in the whole population was then calculated, as was the number of excess AIDS-events/deaths in the first 12months following HIV-diagnosis assumed to be attributable to LP (difference in estimated events between LP and non-LP).ResultsThirty-nine thousand two hundred four persons were included from the COHERE and EuroSIDA cohorts, of whom 18,967 (48.4%; 95% Confidence Interval [CI] 47.9-48.9) were classified as LP, ranging from 36.9% in Estonia (95%CI 25.2-48.7) and Ukraine (95%CI 30.0-43.8) to 64.2% in Poland (95%CI 57.2-71.3). We estimated a total of >320,000 LP and 12,050 new AIDS-events/deaths attributable to LP during 2010-2016, with the highest estimated numbers of LP and excess AIDS-events/deaths in Eastern Europe. Country-level estimates of excess events ranged from 17 AIDS-events/deaths (95%CI 0-533) in Denmark to 10,357 (95%CI 7768-147,448) in Russia.ConclusionsAcross countries in Europe, the burden of LP was high, with the highest estimated number of LP and excess AIDS-events/deaths being in Eastern Europe. Effective strategies are needed to reduce LP and the attributable morbidity and mortality that could be potentially avoided.

Die Anzahl der in Deutschland auf HIV getesteten Personen ist schwer zu ermitteln. Unter bestimmten Voraussetzungen sind HIV-Tests Leistung der gesetzlichen Krankenversicherung (GKV). Ziel dieser Analyse war die Untersuchung des Testumfangs in der vertragsärztlichen Versorgung. Vertragsärztliche Abrechnungsdaten des Zentralinstituts für die kassenärztliche Versorgung (Zi) wurden hinsichtlich HIV-Such- und -Bestätigungstests der Jahre 2010–2015 analysiert. Die Auswertung erfolgte deskriptiv; zeitliche Trends wurden mit linearen Regressionen überprüft. Die Anzahl der Bestätigungstests wurde mit den an das Robert Koch-Institut (RKI) gemeldeten HIV-Neudiagnosen verglichen. Im Jahresdurchschnitt wurden 1,7 % der GKV-Versicherten auf HIV getestet. Der Suchtestumfang stieg im Zeitverlauf an. Durchschnittlich 82,5 % der Untersuchten waren Frauen, von denen 81,2 % während der Schwangerschaft getestet wurden. Bestätigungstests wurden im Gesamtzeitraum bei 16.034 Versicherten durchgeführt (durchschnittlich 0,3 % der Versicherten mit Suchtest), darunter im Durchschnitt 51,2 % Männer. Im selben Zeitraum wurden 18.446 HIV-Neudiagnosen (davon 82,8 % Männer) ans RKI gemeldet. Erstmalig wurde die Personenzahl mit HIV-Test im Bereich der GKV bestimmt. Die hohe Suchtestzahl bei Frauen ist auf Tests in der Schwangerschaft zurückzuführen. Aus der im Vergleich zu den gemeldeten HIV-Neudiagnosen geringeren Zahl von abgerechneten Bestätigungstests kann geschlossen werden, dass in unbekanntem Umfang in anderen Testeinrichtungen und nicht über die GKV auf HIV getestet und diagnostiziert wurde.

Hepatitis C virus (HCV) antigen/antibody (Ag/Ab) assays offer the benefit of reducing the window period compared to assays that detect only HCV-Ab. In this study the performance of the Murex Ag/Ab (Murex, Abbott) and Monolisa Ag/Ab Ultra (Monolisa, Bio-Rad) ELISAs was compared for the use of filter dried serum/plasma spots (DS/PS) with a focus on the sensitivity and the percentage of correct positive test results. Correct positive ELISA results were assumed for samples that subsequently tested positive for HCV RNA by RT-qPCR, or RNA negative samples that tested positive in a Western blot (confirmed ELISA results). Sensitivity was evaluated from DS/PS eluates using HCV seroconversion panels [plasma samples of subtypes-(St) 1a, 2b)] and longitudinal HCV antibody positive serum panels (St 1b, 2b, 3a, and 4d). The proportion of correct positive test results was evaluated using 1102 newly diagnosed HIV positive clinical dried serum spots (DSS) eluates for screening of potential HCV co-infection. For the plasma HCV seroconversion samples, which were used as a reference for DSS eluates, the Murex became reactive earlier for antigen positive bleeds. However, for the HCV antibody positive eluates and dilutions thereof, the Monolisa demonstrated a superior sensitivity. Of the clinical DSS 22.8 % (28/123) of samples reactive in the Murex were negative in a subsequent RT-qPCR and Western blot, while only 1.9 % (2/105) of the samples reactive in the Monolisa were negative in these confirmatory assays. Our results indicate that the Monolisa provides fewer false positive results for HCV detection in DSS, whereas for undiluted plasma or serum samples, the Murex can serve as an additional diagnostic tool to narrow the window period.