Posts filed under ‘Antirretrovirales’

Human Immunodeficiency Virus Drug Resistance: 2018 Recommendations of the International Antiviral Society–USA Panel

Clinical Infectious Diseases January 15, 2019 V.68 N.2 P.177–187

Huldrych F Günthard; Vincent Calvez; Roger Paredes; Deenan Pillay; Robert W Shafer …


Contemporary antiretroviral therapies (ART) and management strategies have diminished both human immunodeficiency virus (HIV) treatment failure and the acquired resistance to drugs in resource-rich regions, but transmission of drug-resistant viruses has not similarly decreased. In low- and middle-income regions, ART roll-out has improved outcomes, but has resulted in increasing acquired and transmitted resistances. Our objective was to review resistance to ART drugs and methods to detect it, and to provide updated recommendations for testing and monitoring for drug resistance in HIV-infected individuals.


A volunteer panel of experts appointed by the International Antiviral (formerly AIDS) Society–USA reviewed relevant peer-reviewed data that were published or presented at scientific conferences. Recommendations were rated according to the strength of the recommendation and quality of the evidence, and reached by full panel consensus.


Resistance testing remains a cornerstone of ART. It is recommended in newly-diagnosed individuals and in patients in whom ART has failed. Testing for transmitted integrase strand-transfer inhibitor resistance is currently not recommended, but this may change as more resistance emerges with widespread use. Sanger-based and next-generation sequencing approaches are each suited for genotypic testing. Testing for minority variants harboring drug resistance may only be considered if treatments depend on a first-generation nonnucleoside analogue reverse transcriptase inhibitor. Different HIV-1 subtypes do not need special considerations regarding resistance testing.


Testing for HIV drug resistance in drug-naive individuals and in patients in whom antiretroviral drugs are failing, and the appreciation of the role of testing, are crucial to the prevention and management of failure of ART.




January 20, 2019 at 11:08 am

Trends in utilization of statin therapy and contraindicated statin use in HIV-infected adults treated with antiretroviral therapy from 2007 through 2015

Journal of the American Heart Association December 18, V.7 N.24 P.:e010345

Rosenson RS et al.


HIV is associated with an increased risk for atherosclerotic cardiovascular disease, which may result in many people living with HIV taking a statin. Some statins are contraindicated with certain antiretroviral therapies ( ART ) and other medications commonly used by HIV -infected patients.

Methods and Results

We analyzed trends in the use of statins, including contraindicated statins, between 2007 and 2015 among HIV -infected patients aged ≥19 years taking ART who had employer-sponsored or Medicare supplemental health insurance in the Marketscan database (n=186 420). Statin use was identified using pharmacy claims. Contraindicated statin use was defined by a pharmacy claim for HIV protease inhibitors, cobicistat, hepatitis C protease inhibitors, anti-infectives, calcium channel blockers, amiodarone, gemfibrozil, or nefazodone followed by a fill for a contraindicated statin type and dosage within 90 days. The percentage of beneficiaries with HIV taking a statin remained unchanged between 2007 (24.6%) and 2015 (24.7%). Among those taking a statin, the percentage taking a contraindicated statin declined from 16.3% in 2007 to 9.0% in 2014 and then increased to 9.8% in 2015. The proportion of contraindicated statin fills attributable to HIV protease inhibitors declined from 63.9% in 2007 to 51.0% in 2015, while those attributable to cobicistat increased from 0% before 2012 to 20.6% in 2015.


Changes in ART regimens resulted in a decline in contraindicated statin use from 2007 to 2014, but this favorable trend was attenuated in 2015 because of increased use of cobicistat-containing ART regimens.



January 17, 2019 at 4:04 pm

Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.   January 4, 2019. 366 pag

Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.   January 4, 2019.  366 pag

Developed by the HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission – A Working Group of the Office of AIDS Research Advisory Council (OARAC)

What’s New in the Guidelines

Text, references, and appendices were updated to include new data and publications where relevant.

The sections that address infant feeding now include links to a new section that was added on March 27, 2018, titled Guidance for Counseling and Managing Women Living with HIV in the United States Who Desire to Breastfeed.

Major content changes are summarized below; all changes are highlighted throughout the guidelines.


January 8, 2019 at 8:08 am

Undetectable = Untransmittable and Your Health: The Personal Benefits of Early and Continuous Therapy for HIV Infection

Journal of Infectious Diseases, 7 January 2019 V.219 N.2 P.173–176


Mark J Siedner; Virginia Triant

In 2016, the Prevention Action Campaign launched the “U = U” (Undetectable = Untransmittable) campaign to publicize the preventative benefits of human immunodeficiency virus (HIV) antiretroviral therapy (ART) [1]. Based on accruing evidence from randomized clinical trials [2] and observational cohorts [3], the campaign intends to widely disseminate the message that an undetectable viral load means the virus is untransmittable to sexual partners and offspring. Indeed, the preventative benefits of effective HIV therapy have been responsible for averting vertical transmission to an estimated 1.6 million children, and to countless others through reductions in sexual transmission…



January 5, 2019 at 11:58 am

The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis

Journal of Infectious Diseases, 7 January 2019, V.219 N.2  P.254–263


Álvaro H Borges; Jacqueline Neuhaus; Shweta Sharma; James D Neaton; Keith Henry …


Pooled data from the SMART and START trials were used to compare deferred/intermittent versus immediate/continuous antiretroviral therapy (ART) on disease risk.


Endpoints assessed were AIDS, serious non-AIDS (SNA), cardiovascular disease (CVD), cancer, and death. Pooled (stratified by study) hazard ratios (HRs) from Cox models were obtained for deferred/intermittent ART versus immediate/continuous ART; analyses were conducted to assess consistency of HRs across baseline-defined subgroups.


Among 10156 participants, there were 124 AIDS, 247 SNA, 117 cancers, 103 CVD, and 120 deaths. Interventions in each trial led to similar differences in CD4 count and viral suppression. Pooled HRs (95% confidence interval) of deferred/intermittent ART versus immediate/continuous ART were for AIDS 3.63 (2.37–5.56); SNA 1.62 (1.25–2.09); CVD 1.59 (1.07–2.37); cancer 1.93 (1.32–2.83); and death 1.80 (1.24–2.61). Underlying risk was greater in SMART than START. Given the similar HRs for each trial, absolute risk differences between treatment groups were greater in SMART than START. Pooled HRs were similar across subgroups.


Treatment group differences in CD4 count and viral suppression were similar in SMART and START. Likely as a consequence, relative differences in risk of AIDS and SNA between immediate/continuous ART and deferred/intermittent ART were similar.

Clinical Trials Registration – NCT00027352 and NCT00867048.




January 5, 2019 at 11:57 am

Being PrEPared  – Preexposure Prophylaxis and HIV Disparities.

N Engl J of Med October 4, 2018 V.379 P.1293-1295


Robert H. Goldstein, M.D., Ph.D., Carl G. Streed, Jr., M.D., and Sean R. Cahill, Ph.D.

If current trends persist, one in six U.S. men who have sex with men will be infected with human immunodeficiency virus (HIV) in their lifetime, according to the Centers for Disease Control and Prevention (CDC).1 This prediction highlights the long road ahead if we are to end the spread of HIV in the United States, but it does not tell the full story, which is complicated and nuanced….



November 6, 2018 at 8:21 am

Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Pre-exposure Prophylaxis among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study.

Clinical Infectious Diseases September 15, 2018.             

Liu AY1,2, Vittinghoff E3, von Felten P1, Amico KR4, Anderson PL5, Lester R6, Andrew E1, Estes I7,8, Serrano P7,8, Brothers J7,8, Buchbinder S1,2,3, Hosek S7,8, Fuchs JD2,9.

Author information

1 Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, USA.

2 Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

3 Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.

4 Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.

5 Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO USA.

6 Division of Infectious Diseases, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.

7 Ruth M. Rothstein CORE Center, Chicago, IL, USA.

8 Stroger Hospital of Cook County, Department of Psychiatry, Chicago, IL.

9 Center for Learning & Innovation, San Francisco Department of Public Health, San Francisco, CA, USA.



Young men who have sex with men (MSM) are among the most vulnerable to HIV infection in the United States. While pre-exposure prophylaxis (PrEP) has demonstrated effectiveness, adherence and retention in care have been low among youth.


We conducted a randomized controlled trial to evaluate the impact of a youth-tailored, bi-directional text-messaging PrEP support intervention (PrEPmate) on study retention and PrEP adherence. Young individuals at risk for HIV acquisition initiating PrEP within Chicago’s safety-net hospital system were randomized 2:1 to receive PrEPmate or standard of care (SoC) for 36 weeks. The primary retention outcome was study-visit completion, and the primary adherence outcome was tenofovir diphosphate (TFV-DP) concentrations ≥700 fmol/punch (consistent with ≥4 doses/week) assessed at 4, 12, 24, and 36 weeks. The impact of PrEPmate on retention and adherence was evaluated using generalized estimating equation logistic models with robust standard errors.


From April 2015 to March 2016, 121 participants enrolled (mean age 24; 27% Black, 36% Latino). Across all visits, participants who received PrEPmate were more likely to attend study visits (86% PrEPmate vs. 71% SoC, OR=2.62, 95%CI 1.24-5.54) and have TFV-DP levels consistent with ≥4 doses/week (72% PrEPmate vs. 57% SoC, OR=2.05, 95%CI 1.06-3.94). PrEPmate efficacy did not differ significantly by age, race/ethnicity, education, or insurance. Overall, 88% reported PrEPmate to be very/somewhat helpful, and 92% would recommend PrEPmate to others.


An interactive text-messaging intervention had high acceptability and significantly increased study-visit retention and PrEP adherence among young individuals at risk for HIV acquisition.



October 9, 2018 at 7:52 am

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