Viral Infections

Genvoya Labeling Updated with Interaction, Long-Term Study Data

By August 16, 2017

Under drug interactions, new clinical comments regarding concomitant systemic/inhaled/nasal/ophthalmic corticosteroids have been added.

Study Reveals Diverse Neurologic Complications with Zika Virus

August 15, 2017

Forty patients were enrolled, including 29 with Guillain-Barré syndrome (GBS), 7 with encephalitis, 3 with transverse myelitis, and 1 with newly diagnosed chronic inflammatory demyelinating polyneuropathy. Diverse Spectrum of Neurologic Syndromes Seen With Zika

Fixed-Dose, Single-Tablet HIV Regimen Granted Priority Review

By August 14, 2017

The investigational fixed-dose treatment combines bictegravir (BIC) 50mg, a novel integrase strand transfer inhibitor (INSTI), with emtricitabine (FTC) 200mg and tenofovir alafenamide (TAF) 25mg, a dual-NRTI backbone.

Regeneron to Discontinue Development of RSV Treatment

By August 14, 2017

The primary endpoint of RSV prevention - assessed through day 150 of treatment - was not significantly reached.

HIV Viral Load Rebound Observed After Suppression in Pregnancy

August 14, 2017

The researchers found that 318 of the 470 women in the database met inclusion criteria. Nineteen women (6%) had viral load rebound with a mean log10 viral load near delivery of 2.71 copies/mL (=513 copies/mL), while 6 women (32%) had a viral load above 1,000 copies/mL.

Contraindication Added to OCs, Other Ethinyl Estradiol-Containing Drugs

By August 10, 2017

The concomitant use of HCV drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to the potential for liver enzyme elevations.

Data Support ACIP Decision Not to Use Live Attenuated Flu Vaccine

August 10, 2017

The researchers found that 19% of the 6,879 eligible participants tested positive for influenza virus, predominantly for A(H1N1)pdm09 and influenza B (11 and 7%, respectively).

FDA Approves Concomitant Administration of Zostavax and Flu Vaccines

By August 09, 2017

Zostavax is a vaccine indicated for the prevention of herpes zoster (shingles) in adults aged ≥50 years.

APA: Aging HIV Patient Population Presents Care Challenge

August 07, 2017

In this population, the stigma due to age, sexual orientation, and other factors can lead to negative outcomes.

Neonate Antibody Response Examined After Maternal Flu Vaccination

August 04, 2017

The researchers found that, compared to the 50 women with no vaccination in the previous year, the 91 women vaccinated the prior year exhibited higher baseline antibody titers and/or seroprotection rates against all four influenza strains, after controlling for covariates.

FDA Approves Mavyret, a Pan-Genotypic Treatment for HCV

By August 03, 2017

Mavyret is a once-daily, ribavirin-free treatment that combines glecaprevir, an HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor.

Epclusa Indication Expanded to Include HCV/HIV Co-Infected Patients

By August 02, 2017

The supplemental New Drug Application (sNDA) approval was based on data from the Phase 3 open-label, ASTRAL-5 study.

Study Examines Potential of Saliva in Transmitting Zika

August 02, 2017

Researchers conducted experiments with monkeys and concluded that casual saliva contact such as kissing or sharing eating utensils is not enough for Zika to move from one host to another.

Clinically Meaningful Reductions in HIV-Related Diarrhea with Long-Term Crofelemer

By July 27, 2017

Data from the analysis showed a 73% mean reduction in diarrhea episodes from baseline after treatment with Mytesi for 24 weeks.

Teens Find Vaginal Ring for HIV Prevention Acceptable

By July 26, 2017

Previous Phase 3 studies enrolling >4,500 women (ASPIRE and The Ring Study) have already demonstrated the vaginal ring to be safe and effective in protecting women aged 18-45 years against HIV.

Doravirine Comparable to Efavirenz in Combination with Other ART for HIV

By July 26, 2017

Doravirine is being investigated in other Phase 3 trials including DRIVE-AHEAD, DRIVE-FORWARD, and DRIVE-SHIFT.

Vaccine Regimens Generate Anti-HIV Immune Responses in Early-Stage Trial

By July 26, 2017

The early-stage clinical trial studied "mosaic" vaccines created to induce immune responses against various HIV subtypes responsible for infections across the world.

Child with HIV Maintains Remission without ART for Over 8 Years

By July 25, 2017

A reservoir of virus incorporated in a small proportion of immune cells was observed but no signs of HIV infection were noted in a 9-year-old child who started anti-HIV therapy at 1 month.

Vaccine Hesitancy Linked to Substantial Public Health Consequences

July 25, 2017

The researchers determined that just a 5% drop in measles, mumps, and rubella vaccine coverage would triple the number of measles cases in children aged 2 to 11 years nationally every year.

Promising Results for Two-Drug, Long-Acting Injectable HIV Regimen

By July 24, 2017

This Phase 2b trial assessed HIV-1 viral suppression with rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) given together every 4 or 8 weeks.

Fixed-Dose HIV Combo Containing Bictegravir Found to Be Safe, Effective

By July 24, 2017

In addition to these studies, bictegravir in combination with FTC/TAF is also being evaluated in two ongoing studies involving virologically suppressed adult patients.

Long-Term Data for Isentress HD Reinforce Safety, Efficacy

By July 24, 2017

Data from Week 48 previously showed that once-daily Isentress HD achieved the primary efficacy endpoint of non-inferiority vs. twice-daily Isentress.

Seqirus Begins Shipping Flu Vaccines for 2017/18 Season

By July 21, 2017

Specific vaccines in the Seqirus portfolio for the upcoming flu season include Afluria Quadrivalent (ages ≥18 years), the egg-based quadrivalent influenza vaccine, and Afluria (ages ≥5 years) and Fluvirin (ages ≥4 years), the egg-based trivalent influenza vaccines.

Enhanced Prophylaxis Plus ART May Improve Survival in HIV

July 20, 2017

The researchers found that the rate of death was lower with enhanced versus standard prophylaxis in the Kaplan-Meier analysis at 24 weeks (8.9 versus 12.2%; hazard ratio, 0.73); overall, 11.0 and 14.4% of patients, respectively, had died by 48 weeks (hazard ratio, 0.76).

Single-Tablet Hepatitis C Virus Regimen Approved as Salvage Therapy

By July 18, 2017

Vosevi combines sofosbuvir, a HCV NS5B polymerase inhibitor, velpatasvir, a HCV NS5A inhibitor, with voxilaprevir, a pangenotypic NS3/4A protease inhibitor.

Widespread Shipment of Fluzone Product Line Will Begin in Early August

By July 18, 2017

The Fluzone vaccines should not be given to any individual with a severe allergic reaction to any vaccine component, including eggs, egg products, thimerosol, or to a previous dose of any flu vaccine.

CDC: Outbreak of Measles Identified in Minnesota

July 18, 2017

Genotyping identified genotype B3 virus in three children, who attended the same child care center

Eye Exams Should Be Requirement for Infants Potentially Exposed to Zika

July 18, 2017

One in 5 of the infants had sight-threatening eye abnormalities, with optic nerve and retinal abnormalities the most common.

Many Parents Unsure About Teen Vaccine Schedules

By July 17, 2017

Surveyed parents reported that an appointment scheduled by the provider (44%), mentioning vaccination during an office visit by a clinician (40%), or a reminder sent by the clinician's office (11%) were the primary methods by which they were informed of the need for additional vaccines.

ART Regimen Alters Kidney Transplant Outcomes

July 17, 2017

The researchers found that, compared with those on non-PI regimens, recipients on PI-based regimens were significantly more likely to have an estimated post-transplant score >20% (70.9 versus 56.3%).