Biktarvy

Most common side effects observed in study participants include nausea (5%), headache (5%), and diarrhea (6%). Five individuals in Study 1490 and none in Study 1489 stopped Biktarvy due to side effects, none of which were due to kidney problems. Serum creatinine, estimated creatinine clearance, urine glucose, and urine protein should be obtained before initiating Biktarvy and should be monitored during therapy. There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients with pre-existing psychiatric conditions on an INSTI. Prior to initiation, people should be tested for hepatitis B (HBV) infection. Severe exacerbations of hepatitis B have been reported in people who are co-infected with hepatitis B and have discontinued the emtricitabine and/or tenofovir components. Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted.

• See Also Descovy, which is contained in this drug (bictegravir is not available separately).
• See package insert for more complete information on potential side effects and interactions.

Do not take with rifampin, the anti-arrhythmic dofetilide, or St. John’s wort. Not recommended to be taken with Epivir-HBV, Hepsera, or Vemlidy, all three for treatment of hepatitis B. Biktarvy should be taken two hours before taking laxatives or antacids, the ulcer medication sucralfate, oral iron or calcium supplements (but these two can be used with Biktarvy if taken together with food), or buffered medications. Start metformin at lowest dose and titrate based on glycemic control. Monitor for metformin adverse effects. When starting or stopping Biktarvy in people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control. Can be taken with the hepatitis C medications Epclusa, Harvoni, Sovaldi, and Vosevi. Not intended to be taken with other HIV medications, unless prescribed that way.

Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.

• See Also Descovy, which is contained in this drug (bictegravir is not available separately).
• See package insert for more complete information on potential side effects and interactions.

Received FDA approval in February 2018. Biktarvy is quickly becoming a top dog in HIV treatment. The data show that the bictegravir drug resistance barrier is comparable to that of dolutegravir and protease inhibitors (like Prezista). That is a huge advantage. Biktarvy is the first unboosted INSTI-containing STR with TAF, and the second unboosted INSTI STR overall (the other is Triumeq). (“Unboosted” means that the primary antiretroviral drug, in this case bictegravir, does not require another medication such as Norvir or cobicistat to increase its drug levels in the body.) This is a really big deal due to less drug interactions when there’s no boosting. Biktarvy is the second smallest INSTI-based STR tablet, which may help some individuals who have difficulty swallowing pills. Pediatric study is ongoing. New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir, which is chemically similar to bictegravir, at the time of conception. Consult your provider to discuss guidance on how to manage regimens containing an INSTI if there is any possibility of conception. At this time, the use of Biktarvy is not recommended during pregnancy due to lack of published data in pregnant women.

See package insert for more complete information on potential side effects and interactions.

Dr. David Hardy says:

Biktarvy became the eighth STR approved by the FDA, in February 2018. Many consider this three-drug, unboosted, integrase inhibitor-containing (bictegravir) and TAF-containing STR to be a crowning achievement of many years of HIV drug development. But is it any better than other ART regimens? Based on the clinical trial data, it is difficult to see distinct advantages of Biktarvy over Triumeq or Tivicay + Descovy or any clear advantage of switching from a suppressive and well-tolerated, boosted protease inhibitor or Triumeq—other than reducing the number of pills in an ART regimen or persistent nausea or other PLWH-reported side effects. One possible advantage of Biktarvy over Triumeq could be its use as a first-line ART regimen in same-day or rapid ART start programs due to the requirement for HLA-B*5701 testing for Triumeq. Data from two clinical trials (GS 380-1489 and 1490) comparing Biktarvy to Triumeq or to Tivicay plus Descovy showed very high and very close (92% vs. 93% and 89% vs. 93%, respectively) rates of undetectable viral loads among PLWH receiving their first ART regimen after one year of treatment. The conclusion from each study was that Biktarvy was as good as or similar to Triumeq or Tivicay plus Descovy. Although there was more mild to moderate nausea reported by PLWH receiving Triumeq versus those receiving Biktarvy, only 1 out of 315 PLWH stopped Triumeq due to nausea. The two-year follow-up of both of these studies continued to show high and similar rates of undetectable viral loads (87.9% vs. 89.8% and 84.1% vs. 86.5%, respectively) and no new differentiating characteristics between the regimens. Two clinical trials have studied the use of Biktarvy as a switch ART regimen for PLWH with undetectable viral loads receiving a boosted protease inhibitor regimen (Prezista + Norvir or Tybost, or Reyataz + Norvir or Tybost; GS 380-1878) or Triumeq (GS 380-1844). The one-year results of these studies showed that the PLWH who switched to Biktarvy and those who remained on their initial regimens both had excellent and similar results (1878: 92% vs. 89% and 1844: 94% vs. 95%) in terms of maintained undetectable viral loads and minimal side effects with both regimens. Of note, in the 1844 study, a decrease in nausea was reported in the PLWH who switched to Biktarvy. In all of these clinical trials studying Biktarvy, there were few PLWH who experienced virologic failure and when they did, their re-emerging HIV did not show any evidence of integrase inhibitor resistance—a finding very similar to Tivicay and Triumeq. To date, no emergent integrase resistance to Biktarvy has been reported in clinical practice.

Activist Moisés Agosto-Rosario says:

Bikarvy is a good option for those recently infected and treatment virgins and those treatment-experienced that are facing difficulties with their current treatment regimen. As with any drug, there are side effects and drug interactions to be aware of by both the patient and the doctor. For example, you should not take Biktarvy if you take dofetilide to treat irregular heartbeat; it could be serious and possibly fatal. Avoid rifampin, which is used to treat some bacterial infections like tuberculosis. In general Biktarvy is well tolerated and is very effective.