Abstract
HIV Infection
HPV Vaccine Safe and Effective in HIV-Infected Women
A trial of HIV-infected women ages 13–45 years in the US, Brazil, and South Africa was initiated to assess the immunogenicity and safety of the quadrivalent Gardasil vaccine against human papilloma virus (HPV). The female participants were stratified based on CD4 count: group A=>350 cells/mm3; group B=>200–350 cells/mm3; group C=
Source: Kojic EM, Kang M, Cespedes MS, et al. Immunogenicity and safety of a quadravalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis 2014;doi:10.1093/cid/ciu238.
Increased Risk for Subclinical Coronary Atherosclerosis
A comparison of HIV-infected versus uninfected men who have sex with men, ages 40–70 years, found a significantly increased prevalence of coronary plaque, and especially noncalcified plaque among HIV-infected men, even after taking into account risk factors for coronary artery disease. All of the study participants had noncontrast computed tomography (CT) and about three-quarters underwent coronary CT angiography to evaluate for the presence and extent of coronary artery calcium and of any plaque, and to identify stenosis. After adjustment for age, race, CT scanning center, and cohort, the HIV-infected men had a greater prevalence of coronary artery calcium (prevalence ratio 1.21) and of any plaque (prevalence ratio 1.14), including noncalcified (1.28) and mixed (1.35) plaque.
Source: Post WS, Budoff M, Kingsley L, et al. Associations between HIV infection and subclinical coronary atherosclerosis. Ann Intern Med 2014;160:458–467.
Pharmacy Use/Costs for New Health Exchange Enrollees
An analysis by Express Scripts provides insights into how patients enrolled in the Public Health Exchanges are using their pharmacy benefits. Among the key findings was that greater than 6 in every 1,000 prescriptions in the Exchange plans were for a medication to treat HIV. “This proportion is nearly four times higher in Exchange plans than in commercial health plans,” the report states. The New York Times quoted Carl E. Schmid, deputy executive director of the advocacy group AIDS Institute, as saying, “People with HIV were basically frozen out of the private insurance market up until now.” These findings show that the new law is working and HIV-infected individuals are able to get into care and on treatment. “But he expressed concern over the high out-of-pocket costs associated with many of the marketplace plans,” noted the NYT. “The Express Scripts study found that consumers with such plans paid a greater percentage of their drug costs in the first two months of this year compared with those in employer plans. The cost to health insurers for prescription drugs was 35 percent higher per member in employer plans than for those in the marketplace plans.” Some consumers saw substantial increases in their out-of-pocket medication costs when they switched to a new marketplace plan.
Source: Express Scripts. First Look: Health Exchange Medication Utilization. April 9, 2014. Available at
Thomas K. Study Looks at Earliest Health Law Enrollees. New York Times April 9, 2014.
Chronic Kidney Disease Risk with Tenofovir Use
A point-based score to predict an HIV-infected individual's risk of developing chronic kidney disease (CKD) over 5 years was developed and used to evaluate whether tenofovir use is associated with increased risk for CKD. More than 21,500 HIV-infected men from the Veterans Health Administration who began antiretroviral therapy between 1997 and 2010 were followed for a median of 6.3 years, and time to first occurrence of CKD was recorded. The main determinants of an increased CKD risk score were traditional kidney risk factors such as age, blood glucose level, hypertension, elevated triglyceride levels, and proteinuria. Whereas CD4 cell count was a factor, HIV RNA levels were not. Tenofovir users had a higher overall 5-year CKD rate (7.7%) than nonusers (3.8%), with an overall adjusted hazard ratio of 2.0. The progressive increase in 5-year CKD risk ranged from <1 to 16% among tenofovir nonusers and from 1.4 to 21.4% among tenofovir users.
Sources: Scherzer R, Gandhi M, Estrella MM, et al. A chronic kidney disease risk score to determine tenofovir safety in a prospective cohort of HIV-positive male veterans. AIDS2014;doi:10.1097/QAD.0000000000000258.
New Report on HIV Therapeutics Market
Due to upcoming patent expirations of several key antiretroviral therapies, the market value for HIV treatments will continue to grow but at a slow pace during the next few years, rising from $14.3 billion in 2012 to an estimated $16.3 billion by 2019. In a new report, GBI Research describes the current HIV pipeline as being strong with a high degree of novelty and diversity. The pipeline contains therapies “that address the unmet needs of drug resistance and toxicity,” such as the nucleoside reverse transcriptase inhibitors apricitabine, censavudine, and elvucitabine, and a pro-drug of enofovir called tenofovir alafenamide.
Source: Press Release. Patent protection losses will hinder HIV treatment market growth within seven years, says GBI Research. New York, NY: GBI Research, April 15, 2014.
Assessing Care of HIV-Infected Inmates
Of the 882 HIV-infected prisoners in the Connecticut Department of Correction system who were incarcerated for 90 days or more continuously between 2005 and 2012, while only about 30% of the HIV-infected prisoners receiving ART had achieved viral suppression on entry into a correctional facility, 70% had achieved viral suppression by release. ART regimens were modified in about 37% of cases, and the ability to optimize HIV treatment combined with the highly structured environment within the prison system likely contributed to the improved rate of viral suppression.
Source: Meyer JP, Cepeda J, Wu J, et al. Optimization of human immunodeficiency virus treatment during incarceration viral suppression at the prison gate. JAMA Intern Med 2013;doi:10.1001/jamainternmed.2014.601.
Hepatitis Virus Infection
Successful Retreatment with Interferon-Free Combination Therapy
A phase 3 trial demonstrated the efficacy of an interferon-free combination of ABT-450 with ritonavir (ABT-450/r), ombitasvir, dasabuvir, and ribaviron for the retreatment of hepatitis C virus (HCV) infection in patients without cirrhosis who received previous treatment with peginterferon-ribavirin and had either a relapse, a partial response, or a null response. Patients treated with this active regimen (versus placebo) had an overall 96.3% rate of sustained virologic response 12 weeks after the end of the treatment period. This was superior to the historical response rate (65%) among previously treated HCV-infected patients with no cirrhosis who received retreatment with telaprevir and peginterferon-ribavirin. Specific response rates varied from 95.2% among patients with a prior null response, to 95.3% for patients with a prior relapse, to 100% among patients with a prior partial response. The active regimen comprised coformulated ABT-450/r-ombitasvir (a once-daily dose of 150 mg ABT-450, 100 mg ritonavir, 25 mg ombitasvir), dasabuvir (250 mg twice daily), and ribavirin (1000 or 1200 mg once daily).
Source: Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1604–1614.
100% HCV Cure Reported in HIV–HCV Coinfection
Interim findings from the ERADICATE study presented at the EASL conference by researchers from the US National Institute of Allergy and Infectious Diseases showed that a 12-week regimen with a coformulation of the HCV polymerase inhibitor sofosbuvir (400 mg) and the NS5A inhibitor ledipasvir (90 mg), dosed once daily, led to a sustained HCV virologic response in all of the HIV/HCV-coinfected patients treated and followed for 12 weeks post-treatment. The study included two groups of patients, those not on antiretroviral (ARV) therapy (with a stable CD4 T-cell count and HIV RNA <500 copies/ml or a CD4 count >500 cells/mm3, and an ARV-treated cohort who had undetectable HIV RNA (<40 copies/ml) and a CD4 count greater than 100 cells/mm3 and were taking ARV agents that would not interact with sofosbuvir or ledipasvir. Treatment with the coformulated anti-HCV regimen lasted 12 weeks, and all of the treated patients had undetectable HCV RNA by week 4 of treatment, with continued sustained virologic response reported in all patients who were followed up to 12 weeks post-treatment.
Source: Osinusi A, et al. Use of sofosbuvir/ledipasvir fixed dose combination for treatment of HCV genotype-1 in patients coinfected with HIV. Presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), London, UK, 2014, Abstract 014.
Highleyman L. Sofosbuvir/Ledipasvir produces early cure for 100% of people with HIV and HCV coinfection. Available at
Viral Hepatitis Causes More Deaths Than HIV in Europe
Recently released findings from The Global Burden of Disease Study 2010, a large epidemiological study funded by the Bill and Melinda Gates Foundation and carried out by the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, indicate that in 2010, in the European Union, viral hepatitis was responsible for 10 times more deaths than were attributable to HIV infection. The estimated death toll from hepatitis C virus infection was 57,000 deaths, and from hepatitis B virus infection was 31,000, compared to 8,000 deaths in the EU from HIV/AIDS in 2010.
Source: News. Viral heptatitis more deadly than HIV in Europe. Science Codex April 11, 2014. Available at
Sexually Transmitted Infections
Importance of Extragenital Screening Among MSM
A review of patient data from 42 STD clinics assessed the proportion of men who have sex with men (MSM) who were tested and had a positive test result for extragenital gonorrhea or chlamydia during a 24-month period in 2010–2012. Among nearly 22,000 men, 83.9% were tested for urogenital gonorrhea or chlamydia infection, 65.9% for pharyngeal infection, 50.4% for rectal, 81.4% for urogenital, 31.7% for pharyngeal, and 45.9% for rectal. Of those tested, 11.1% were positive for a urogenital infection, 7.9% for pharyngeal, 10.2% for rectal, 8.4% for urogenital, 2.9% for pharyngeal, and 14.1% for rectal. The study results demonstrate the following: “More than 70% of extragenital GC infections and 85% of extragenital CT infections were associated with negative urethral tests at the same vitis and would not have been detected with urethral screening alone.”
Source: Patton ME, Kidd S, Llata E, et al. Extragenital gonorrhea and chalmydia testing and infection among men who have sex with men–STD Surveillance Network, United States, 2012-2012. Clin Infect Dis 2014;doi:10.1093/cid/ciu184.
Removing Barriers to Expedited Partner Therapy
Due to the high rates of chlamydia and gonorrhea infection in adolescents and young adults ages 14–24 years, screening for these disease is important in this group. Expedited Partner Therapy (EPT) is intended to prevent reinfection and involves the treatment of the sexual partner of a person diagnosed with chlamydia or gonorrhea without the need for an examination by a healthcare provider. A study of the potential barriers to implementing EPT focused on its use by providers in the “primary catchment area” of a children's hospital and included a survey of providers and patients (ages 12–24 years). The researchers concluded that, although pediatric providers are offering screening and diagnosis of STIs (nearly 82% reported doing so), adolescents are not being screened according to recommendations by the Centers for Disease Control and Prevention (CDC). Only 10.8% of teens reported that they had been screened for STIs. Additionally, only about 25% of the physicians reported using EPT in their practice, although most were willing to participate in an EPT training program. The main barriers to use of EPT were discomfort treating a patient they hadn't seen, treating an STI without screening for others, and liability concerns.
Source: Mears CJ, Kelly T, Kaviany S, et al. Expedited partner therapy and STI awareness. Presented at the annual meeting of the Society for Adolescent Health and Medicine, Austin, TX, March 23–26, 2014, Abstract 120.