HIV & AIDS Update: New Treatments, Easier Options
Medically reviewed by L. Anderson, PharmD. Last updated on Nov 29, 2018.
HIV Options Are Numerous and Far Easier
The diagnosis of HIV can be a shock to anyone.
However, current treatments coupled with early diagnosis have significantly improved the outcomes of patients living with HIV. In fact, many people who are treated appropriately and monitored closely can live close to a normal life-span today.
That doesn't mean HIV's impact isn't still significant.
In 2016, 39,782 people were diagnosed with HIV in the U.S. Even more concerning: more than 1.1 million people in the U.S. are living with HIV today, but 1 in 7 of them don’t know it. While there is still no cure for HIV AIDs, research has greatly expanded since the 1980's.
Combinations of treatments -- many recently approved -- have become more effective, easier to take, and with fewer side effects.
HIV Advances: One Convienent Pill
HIV treatments involve several antiretroviral therapy (ART) medications, often combined into one convenient pill. Combination treatments:
- make it easier to stay on course
- fight drug resistance
- help prevent treatment failures.
No more taking handfuls of pills every few hours.
Experts recommend starting HIV treatment as soon as diagnosed, regardless of the T-cell count (which is an indicator of how healthy the immune system is).
Plus, many of the latest, easiest combinations are recommended to be used in "treatment-naive" patients -- that is, patients who have never received any HIV medication. HIV drug-resistance testing is recommended in all patients.
TAF: The Latest Tenofovir
Tenofovir disoproxil fumarate (TDF) is a Nucleotide Reverse Transcriptase Inhibitor (NRTI) used in combination with other HIV medicines. A new form of tenofovir is now approved called tenofovir alafenamide (TAF). TAF was first approved in November 2015 and is found in Gilead's HIV pills:
- Genvoya (elvitegravir + cobicistat + emtricitabine + tenofovir alafenamide)
- Odefsey (emtricitabine + rilpivirine + tenofovir alafenamide)
- Descovy (emtricitabine + tenofovir alafenamide)
- Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide).
TAF is similar to TDF, the single ingredient found in Viread and also found in other HIV combination treatments:
- Stribild (cobicistat + elvitegravir +emtricitabine + tenofovir)
- Atripla (efavirenz + emtricitabine + tenofovir disoproxil)
- Complera (emtricitabine + rilpivirine + tenofovir disoproxil)
- Truvada (emtricitabine + tenofovir disoproxil)
- Symfi-Lo (efavirenz + lamivudine + tenofovir disoproxil)
- Cimduo (lamivudine + tenofovir disoproxil)
But what are the advantages for TAF compared to TDF?
How Does Tenofovir Alafenamide (TAF) Work?
TAF is known as a "prodrug" of tenofovir and is inactive when it is first taken. After it enters the body, it is changed to its active form in the cell (not in the blood like tenofovir disoproxil fumarate [TDF]). TAF enters the HIV-infected cell much more efficiently than TDF, which results in much lower levels of drug in the blood, but higher levels within the cells where HIV-1 replicates. Therefore, TAF can be given at roughly 1/10th the dose of TDF (Viread).
Due to smaller doses and lower levels of drug in the blood, researchers state kidney toxicity and decreased bone mineral density may be less of a concern as with TAF (based on observed laboratory measures).
However, TDF is associated with lower lipid levels (such as cholesterol). When deciding which tenofovir agent to select, the clinician and patient should consider safety, cost, and ease of access between these drugs.
Descovy (emtricitabine + tenofovir alafenamide)
In April, 2016 FDA approved another TAF agent Gilead's Descovy (emtricitabine + tenofovir alafenamide [TAF]), an HIV nucleoside/tide reverse transcriptase inhibitor (NRTI) for the treatment of HIV-1 infection.
Descovy is used with other antiretroviral agents to treat HIV-1 in adults and children 12 years and older who weight at least 35 kg (77 lb).
In studies, Descovy is as effective as regimens with tenofovir disoproxil fumarate (TDF) in reducing the HIV virus, but with less kidney toxicity and bone loss based on lab values, a problematic side effect for TDF.
Descovy: Similar to Truvada, But Not for PrEP
Descovy is intended to be a safer replacement for Truvada (emtricitabine + tenofovir disoproxil fumarate [TDF]), another common HIV-1 infection treatment.
But unlike Truvada, Descovy is NOT approved for pre-exposure prophylaxis (PrEP). PrEP is the use of anti-HIV medication to help lower the chances that an at-risk HIV negative person might become infected.
Truvada is still the only FDA-approved PrEP regimen. PrEP medicines like Truvada work by blocking important pathways used by HIV to set up an infection.
Descovy: Facts to Know
The recommended dosage for Descovy is one tablet taken once daily with or without food. To adequately treat HIV, Descovy must be taken together with other HIV-1 medicines.
The most common side effect, occurring in greater than 10% of patients (10 of every 100 patients) is an upset stomach (nausea).
Other side effects include:
- fat redistribution
- bone softening
- immune system changes
- kidney problems.
Be sure to talk with your doctor about all possible side effects with Descovy.
Genvoya (cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide)
Genvoya is an updated TAF version of Stribild, and can be used as a complete HIV regimen for patients 12 years and older and weighing at least 35 kilograms (77 lbs) who are treatment-naïve (no antiretroviral treatment history) or virally suppressed (along with other criteria).
Genvoya is a fixed-dose combination tablet that contains 3 ART classes:
Genvoya: Recommended in Guidelines
This regimen is recommended as one of the first-line, one tablet regimens in treatment-naive patients by US HIV treatment guidelines from The Dept. of Heath and Human Services (DHHS).
The recommended dose of Genvoya is one tablet taken orally once daily with a meal; nausea may be a common side effect. Genvoya is used in patients with a body weight at least 25 kg and creatinine clearance (a measure of kidney function) greater than or equal to 30 mL per minute. A one tablet per day regimen is especially advantageous for patients who desire a once-a-day regimen or who may have issues with compliance.
Like other TAF agents, lower bone and kidney toxicity may be seen due to the lower blood concentrations of tenofovir achieved with TAF.
Genvoya carries a Boxed Warning of a build-up of lactic acid in the blood and the possibility for severe liver problems, as do the other new TAF agents Descovy and Odefsey that contain nuceloside analogs.
Genvoya: Facts to Know
Besides being a once-a-day pill, a major advantage of Genvoya is that it can be used in patients with moderately reduced kidney function (creatinine clearance [CrCl] of 30 or higher). In contrast, Stribild, which contains TDF, should generally only be used in patients with CrCl of 70 or higher.
Drug interactions with most HIV treatments, including Genvoya, are common and should be screened for on a regular basis by a healthcare provider.
Out of several regimens, both Stribild and Genvoya are both recommended as a complete regimen for treatment-naive adults and adolescents by the US Department of Health and Human Services (DHHS). These regimens are recommended regardless of viral load, have optimal effectiveness, good tolerability, and are easy to use. Selection should be based on safety, cost, and accessibility.
Odefsey (rilpivirine + emtricitabine + tenofovir alafenamide)
Odefsey is approved in:
- Patients 12 years and older who have not received anti-HIV-1 medicines in the past (treatment-naive) and who have no more than 100,000 copies/mL of HIV-1 RNA in their blood (HIV viral load).
- To replace current HIV-1 medicines in people who have been on the same drug regimen for at least 6 months, and who have an amount of HIV-1 in their blood that is less than 50 copies/mL, and have never failed past HIV-1 treatment.
Biktarvy: The 4th TAF HIV Agent
In February 2018, the FDA approved Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide, or BIC/FTC/TAF) from Gilead.
Biktarvy is an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination for the treatment of HIV-1 infection in adults. It is a complete, once-daily, single tablet regimen for the treatment of 2 HIV groups: either those who have no antiretroviral treatment history or those who are virologically suppressed on another stable HIV regimen for at least three months.
In four Phase 3 studies of 2,415 participants, Biktarvy met its primary endpoint of non-inferiority (meaning Biktarvy was not worse than the active controls) at 48 weeks across all four groups. In addition, Biktarvy does not require testing for HLA-B5701, can be taken with or without food, and has no baseline viral load or CD4 count restrictions.
The most common adverse reactions in clinical studies were diarrhea (6%), nausea (5%), and headache (5%).
Odefsey: A New Version of Complera
Odefsey (rilpivirine, emtricitabine, tenofovir alafenamide) is the more recently (2016) approved version of Complera that contains tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF).
The recommended dose of Odefsey is one tablet taken orally once daily with a meal. Common side effects may include:
- skin rash
- difficulty sleeping
Stop taking Odefsey and get emergency help if a skin rash appears that appears blistered, or is accompanied by a fever, swelling of the face or throat, or trouble breathing.
Odefsey: Drug Interactions
There are important drug interactions to be aware with Odefsey. Always have your pharmacist run a drug interaction screen if you start any new prescription or over-the-counter medications (OTC), including herbal products.
In fact, some common OTC and herbal products not to be used with Odefsey include:
Prezcobix (darunavir + cobicistat)
Prezcobix was FDA-approved in January 2015 for the treatment of HIV-1 infection in adults in combination with other antiretroviral therapy. Prezcobix contains Janssen's protease inhibitor darunavir (Prezista) and Gilead's pharmacokinetic enhancer cobicistat (Tybost). A booster is used to help raise the drug levels of protease inhibitors like darunavir or atazanavir (Reyataz).
Prezcobix can be used in treatment-naive and treatment-experienced adult patients with no darunavir resistance, and testing for this is recommended prior to starting treatment.
The dose of Prezcobix is one tablet daily with food. Use darunavir with caution in patients with a sulfonamide allergy.
Vitekta (elvitegravir) and Tybost (cobicistat)
In October 2014, FDA approved two single entity drugs from Gilead used in HIV-1 treatment - elvitegravir and cobicistat - both already found in the once-daily, four drug combination tablet Stribild.
Vitekta (elvitegravir) is an integrase inhibitor for the combination treatment of HIV-1 infection in treatment-experienced adults.
Tybost (cobicistat), as mentioned before, is a potent cytochrome P450 3A enzyme inhibitor (not an antiretroviral) that acts as a "boosting" agent for HIV antiviral drugs. Tybost is used in combination with protease inhibitors atazanavir or darunavir and increases the amount of those medicines in the blood.
Triumeq (abacavir, dolutegravir and lamivudine) from ViiV Healthcare was first approved for HIV-1 in August of 2014. It is a fixed-dose combination tablet containing dolutegravir, an integrase strand transfer inhibitor, and the nucleoside reverse transcriptase inhibitors abacavir and lamivudine. Triumeq is a recommended DHHS regimen for treatment-naïve patients.
The recommended dose of Triumeq in adults is one tablet once daily orally with or without food. The most common side effects include trouble sleeping, headache, and tiredness. Use with caution in patients with heart disease.
Due to the abacavir component, Triumeq should not be used in patients who test positive for HLA-B * 5701 serotype, as abacavir is associated with potentially serious allergic skin reactions. Patients should be tested for this prior to starting any abacavir regimen, and if the results are positive, it should be listed as an abacavir allergy in the patient's chart.
Atripla (efavirenz + emtricitabine + TDF)
Another convenient option is Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate), a combination NRTI/NNRTI from BMS/Gilead.
Atripla is recommended as an alternative NNRTI-based regimen for treatment-naive patients in the HIV guidelines from the DHHS. Atripla is used to treat patients 12 years and older (at least 40 kg [88 lbs]). The dose is easy for Atripla, too; one pill taken once a day at bedtime on an empty stomach.
Atripla should not be used in kidney disease (creatinine clearance below 50 mL/min). Certain nervous system side effects are common at the beginning of therapy (drowsiness, dizziness, sleep disturbances) but typically improve in a few weeks, and that's why it's best to take it at bedtime. Due to fetal harm, the manufacturer recommends that pregnancy should be avoided in women receiving Atripla.
Juluca: The First Complete Two Drug Regimen
In November 2017, the FDA approved ViiV Healthcare's Juluca (dolutegravir and rilpivirine), the first single-tablet, complete treatment regimen containing only two drugs, instead of three or more, for HIV maintenance. Juluca is used in eligible adults with suppressed HIV-1 virus on a stable medication regimen for at least six months, with no history of treatment failure and no resistance to the individual components of Juluca.
Juluca is a combination integrase inhibitor (dolutegravir) and NNRTI (rilpivirine).
Juluca was evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Groups were randomly assigned to stay on their current regimen or switch to Juluca. The studies demonstrated that Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.
Common side effects in patients taking Juluca were diarrhea and headache. Serious side effects include skin rash, allergies, liver problems, depression or other mood changes. Juluca also has multiple drug interactions with common medicines and should not be given with other anti-HIV drugs.
Trogarzo: First-In-Class for Drug-Resistant HIV
Trogarzo (ibalizumab-uiyk) from TaiMed Biologics is the first monoclonal antibody approved for the treatment of MDR HIV-1 infection. Trogarzo is given by a healthcare provider as a 15 to 30 minute infusion into the vein every two weeks.
In clinical trials, 40 MDR HIV-1 patients with high HIV virus levels were studied who had already received multiple other HIV treatments (some patients with 10 or more other treatments). After 24 weeks of Trogarzo plus other antiretroviral drugs, 43% of the trial’s participants achieved HIV RNA suppression.
Diarrhea, dizziness, nausea and rash were commonly reported side effects with Trogarzo.
Symtuza Approved: A 4-Drug Single Tablet Regimen
Symtuza is the first darunavir-based, single-tablet regimen given once daily for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. Darunavir provides a high barrier to drug resistance.
Individually, the drugs in Symtuza are classified as follows:
- darunavir is a protease inhibitor (Prezista)
- cobicistat is a pharmacokinetic antiviral enhancer that allows lower doses of antiviral medicines to be used, therefore increasing safety (Tybost)
- emtricitabine is a nucleoside reverse transcriptase inhibitor (Emtriva)
- tenofovir alafenamide is a nucleoside reverse transcriptase inhibitor (Vemlidy)
In two Phase 3 studies, Symtuza was compared to control regimens in those with no prior antiretroviral therapy history (AMBER study) and in virologically suppressed adults (EMERALD study). Symtuza was found effective and well-tolerated, with up to 95% of patients achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL) in both studies.
Side effects (2% or more of subjects) included:
- stomach pain
- intestinal gas.
Recommended Regimens for Treatment-Naive HIV-1 Infected Patients
The Panel on Antiretroviral Guidelines for Adults/Adolescents (DHHS) classifies the following regimens as recommended first-line therapy for antiretroviral-naive patients; regimens may be updated as new approvals become available:
Integrase Strand Transfer Inhibitor-Based Regimens:
- Dolutegravir/abacavir/lamivudine (Triumeq) -- only for patients who are HLA-B*5701 negative
- Dolutegravir (Tivicay) plus tenofovir disoproxil fumarate/emtricitabine (Truvada) OR tenofovir alafenamide/emtricitabine ([Descovy](https://www.drugs.com/pro/descovy.html))
- Elvitegravir/cobicistat/tenofovir alafenamide/emtricitabine (Genvoya) -- only for patients with pre-antiretroviral therapy CrCl ≥30 mL/min
- Elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine (Stribild) -- only for patients with pre-antiretroviral therapy CrCl >70 mL/min
- Raltegravir (Isentress) plus tenofovir disoproxil fumarate/emtricitabine (Truvada) OR tenofovir alafenamide/emtricitabine ([Descovy](https://www.drugs.com/pro/descovy.html))
Protease Inhibitor-Based Regimen:
- Darunavir [Prezista] boosted with ritonavir [Novir] or darunavir boosted with cobicistat [Prezcobix]) plus tenofovir disoproxil fumarate/emtricitabine (Truvada) OR tenofovir alafenamide/emtricitabine ([Descovy](https://www.drugs.com/pro/descovy.html))
NOTE: Lamivudine (3TC) may substitute for emtricitabine (FTC) or vice versa. Alternative regimens may be preferable, but have less or limited supporting data compared with the recommended regimens.
Additional alternative options include other boosted PI + 2 NRTIs, NNRTI-based regimens, or integrase strand transfer inhibitor plus nucleoside reverse transcriptase inhibitors (NRTI) regimens. See guidelines for complete listing.
Goals and Principles of Antiretroviral Therapy (ART)
To review, the overarching goal of ART is to reduce further disease and early death from HIV/AIDS, as well as to prevent transmission of HIV to others.
- ART should be offered to all HIV-1 infected patients, regardless of immune status.
- Highly effective ART regimens, such as those found in the DHHS HIV guidelines, should be considered for initial treatment.
- Drug therapy should always be patient-specific and determined based on kidney and liver function, HBV status, cardiovascular risk, drug resistance testing, genotype/phenotype, and HLA-B*5701 status (if abacavir use).
- Therapy should be directed by clinicians with significant experience in HIV treatment.
- Patient education and importance of therapy adherence should be emphasized at the point of care.
- Caregiver education should be considered, if needed.
An Added Tool: Vaccinations
Vaccination is an important preventive tool for patients with HIV. Avoiding viral and bacterial illnesses is paramount, when possible, and vaccination offers an important option to help remain healthy. Here are the types of vaccines a patient with HIV will want to discuss with their healthcare provider. You may not need all of these and you may have already had some:
- Influenza vaccine each year to protect against seasonal flu.
- Tdap vaccine to protect against whooping cough and tetanus (Boostrix, Adacel)
- Pneumococcal vaccine (eg, Pneumovax 23) to protect against pneumonia and other pneumococcal diseases.
- Meningococcal conjugate vaccine series (Menactra, Menveo) which protects against meningococcal disease.
- Hepatitis B vaccine series to protect against hepatitis B.
- HPV vaccine series to protect against human papillomavirus if you are a man or woman up to age 26 years
- MMR vaccine to protect against measles, mumps, and rubella if you were born in 1957 or after and have not gotten this vaccine or have immunity to these diseases.
- Varicella vaccine to protect against chickenpox if you were born in 1980 or after and have not gotten two doses of this vaccine or have immunity to this disease.
Join Forces to Fight HIV
Treatment of HIV is complex and requires an experienced and dedicated health care team AND a motivated and compliant patient. However, thanks to many years of research, there are multiple options today for patients living with HIV.
ART for treatment-naive patients may consist of two NRTIs in combination with a third active antiretroviral drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor (PI) with a pharmacokinetic enhancer (cobicistat or ritonavir).
There is a 2 drug option today, as well, for certain patients -- Juluca (dolutegravir and rilpivirine) -- approved in November 2017. Juluca is an integrase strand transfer inhibitor (INSTI) and an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) combination for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed.
Keeping up with the news on the latest HIV treatments may seem like a full-time task. Consider joining the Drugs.com HIV Infection Support Group to help you stay on top of the latest news and research, voice your opinion, and ask questions of those who share your same concerns -- whether patients or caregivers.
Finished: HIV & AIDS Update: New Treatments, Easier Options
- FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV. Drugs.com. March 6, 2018. Accessed March 18, 2018 at https://www.drugs.com/newdrugs/fda-approves-trogarzo-ibalizumab-uiyk-experienced-patients-multidrug-resistant-hiv-4706.html
- Biktarvy Package Insert and Patient Information. Gilead Sciences. Feb 2018. Accessed Feb. 8, 2018 at http://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf
- Juluca Package Insert and Patient Information. ViiV Healthcare. Dec. 2017. Accessed March 18, 2018 at https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Juluca/pdf/JULUCA-PI-PIL.PDF
- CDC. HIV Infection and Adult Vaccination. Page last updated: January 30, 2017. Accessed March 18, 2018 at https://www.cdc.gov/vaccines/adults/rec-vac/health-conditions/hiv.html
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. Available at https://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed November 27, 2016
- Genyova Package Insert and Patient Information. Gilead Sciences. Revised 11/2017. Accessed March 18, 2018 at http://www.gilead.com/~/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi.pdf
- Bartlett JG, Sax P, et al. UpToDate. Selecting antiretroviral regimens for the treatment-naive patient. Accessed March 18, 2018 at https://www.uptodate.com/contents/selecting-antiretroviral-regimens-for-the-treatment-naive-hiv-infected-patient
- FDA. Antiretroviral drugs used in the treatment of HIV infection. Accessed November 27, 2016 at http://www.fda.gov/ForPatients/Illness/HIVAIDS/Treatment/ucm118915.htm